TEXTS ADOPTED
P5_TA(2003)0573
Members' Statute
European Parliament resolution on the Statute for Members of the European Parliament
The European Parliament,
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having regard to the Council and Commission statements made in Parliament on 17 December 2003, |
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having regard to Article 190(5) of the Treaty establishing the European Community and Article 108(4) of the Treaty establishing the European Atomic Energy Community, |
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having regard to its decision of 3 June 2003 (1) and its resolution of 4 June 2003 (2) on the adoption of a Statute for Members of the European Parliament, |
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having regard to the Bureau decision of 28 May 2003 concerning the new rules governing the reimbursement of Members' expenses, |
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having regard to Rule 37(2), (3), (4) and (5) of the Rules of Procedure, |
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whereas, in its letter of 25 June 2003, the Council pointed out that there were still significant differences between the respective positions of the Council and of Parliament, which were preventing it from giving its approval, |
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whereas, in its letter of 21 November 2003, the Council emphasised that, almost twenty-five years after the first elections by direct universal suffrage and six years after the establishment of the necessary legal basis by the Treaty of Amsterdam, it was important that the Statute for Members of the European Parliament now be adopted, and that it wished to step up dialogue in order to achieve compromise solutions that would be acceptable to both institutions, |
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Calls on the Council to inform Parliament as soon as possible (preferably before the end of the Italian Presidency and, in any event, by 15 January 2004) whether it is in a position to accept the proposed compromise and to approve the Statute for Members of the European Parliament should the decision which Parliament adopted on 3 and 4 June 2003 be amended accordingly; |
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Believes that an overall compromise on the Statute for Members of the European Parliament could comprise the following points:
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Instructs its President to forward this resolution to the Council and the Commission. |
(1) P5_TA(2003)0236.
(2) P5_TA(2003)0241.
P5_TA(2003)0574
Tax on commercial diesel fuel *
European Parliament legislative resolution on the proposal for a Council directive amending Directive 92/81/EEC and Directive 92/82/EEC to introduce special tax arrangements for diesel fuel used for commercial purposes and to align the excise duties on petrol and diesel fuels (COM(2002) 410 — C5-0409/2002 — 2002/0191(CNS))
(Consultation procedure)
The European Parliament,
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having regard to the Commission proposal to the Council (COM(2002) 410) (1), |
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having regard to Article 93 of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0409/2002), |
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having regard to Rule 67 of its Rules of Procedure, |
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having regard to the report of the Committee on Economic and Monetary Affairs and the opinion of the Committee on the Environment, Public Health and Consumer Policy, the Committee on Industry, External Trade, Research and Energy and Committee on Regional Policy, Transport and Tourism (A5-0383/2003), |
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Rejects the Commission proposal; |
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Calls on the Commission to withdraw its proposal and submit a new one; |
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Instructs its President to forward its position to the Council and the Commission. |
P5_TA(2003)0575
Environmental liability ***II
European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive on environmental liability with regard to the prevention and remedying of environmental damage (10933/5/2003 — C5-0445/2003 — 2002/0021(COD))
(Codecision procedure: second reading)
The European Parliament,
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having regard to the Council common position (10933/5/2003 — C5-0445/2003) (1), |
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having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2002) 17) (3), |
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having regard to Article 251(2) of the EC Treaty, |
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having regard to Rule 80 of its Rules of Procedure, |
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having regard to the recommendation for second reading of the Committee on Legal Affairs and the Internal Market (A5-0461/2003), |
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Amends the common position as follows; |
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Instructs its President to forward its position to the Council and Commission. |
(1) OJ C 277 E, 18.11.2003, p. 10.
(2) Texts Adopted, 14.5.2003, P5_TA(2003)0211.
P5_TC2-COD(2002)0021
Position of the European Parliament adopted at second reading on 17 December 2003 with a view to the adoption of Directive 2003/.../EC of the European Parliament and of the Council on environmental liability with regard to the prevention and remedying of environmental damage
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the Opinion of the European Economic and Social Committee (2),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
Whereas:
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(1) |
There are currently many contaminated sites in the Community, posing significant health risks, and the loss of biodiversity has dramatically accelerated over the last decades. Failure to act could result in increased site contamination and greater loss of biodiversity in the future. Preventing and remedying, insofar as is possible, environmental damage contributes to implementing the objectives and principles of the Community's environment policy as set out in the Treaty. Local conditions should be taken into account when deciding how to remedy damage. |
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(2) |
The prevention and remedying of environmental damage should be implemented through the furtherance of the ‘polluter pays’ principle, as indicated in the Treaty and in line with the principle of sustainable development. The fundamental principle of this Directive should therefore be that an operator whose activity has caused the environmental damage or the imminent threat of such damage is to be held financially liable, in order to induce operators to adopt measures and develop practices to minimise the risks of environmental damage so that their exposure to financial liabilities is reduced. |
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(3) |
Since the objective of this Directive, namely to establish a common framework for the prevention and remedying of environmental damage at a reasonable cost to society, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level by reason of the scale of this Directive and its implications in respect of other Community legislation, namely Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (4), Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (5), and Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (6), the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. |
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Environmental damage also includes damage caused by airborne elements insofar as they cause damage to water, land or protected species or natural habitats. |
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Concepts instrumental for the correct interpretation and application of the scheme provided for by this Directive should be defined, especially as regards the definition of environmental damage. When the concept in question derives from other relevant Community legislation, the same definition should be used so that common criteria can be used and uniform application promoted. |
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Protected species and natural habitats might also be defined by reference to species and habitats protected in pursuance of national legislation on nature conservation. Account should nevertheless be taken of specific situations where Community, or equivalent national, legislation makes provision for certain derogations from the level of protection afforded to the environment. |
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For the purposes of assessing damage to land as defined in this Directive, the use of risk assessment procedures to determine to what extent human health is likely to be adversely affected is desirable. |
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This Directive should apply, as far as environmental damage is concerned, to occupational activities which present a risk for human health or the environment. Those activities should be identified, in principle, by reference to the relevant Community legislation which provides for regulatory requirements in relation to certain activities or practices considered as posing an actual or potential risk for human health or the environment. |
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This Directive should also apply, as regards damage to protected species and natural habitats, to any occupational activities other than those already directly or indirectly identified by reference to Community legislation as posing an actual or potential risk for human health or the environment. In such cases the operator should only be liable under this Directive whenever he is at fault or negligent. |
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Express account should be taken of the Euratom Treaty and relevant international conventions and of Community legislation regulating more comprehensively and more stringently the operation of any of the activities falling under the scope of this Directive. This Directive, which does not provide for additional rules governing the conflict of laws when it specifies the powers of the competent authorities, is without prejudice to the rules on international jurisdiction of courts as provided, inter alia, in Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (7). This Directive should not apply to activities the main purpose of which is to serve national defence or international security. |
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(11) |
This Directive aims at preventing and remedying environmental damage, and does not affect rights of compensation for traditional damage granted under any relevant international agreement regulating civil liability. |
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Many Member States are party to international agreements dealing with civil liability in relation to specific fields. These Member States should be able to remain so after the entry into force of this Directive, whereas other Member States should not lose their freedom to become parties to these agreements. |
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Not all forms of environmental damage can be remedied by means of the liability mechanism. For the latter to be effective, there need to be one or more identifiable polluters, the damage should be concrete and quantifiable, and a causal link should be established between the damage and the identified polluter(s). Liability is therefore not a suitable instrument for dealing with pollution of a widespread, diffuse character, where it is impossible to link the negative environmental effects with acts or failure to act of certain individual actors. |
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This Directive does not apply to cases of personal injury, to damage to private property or to any economic loss and does not affect any right regarding these types of damage. |
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Since the prevention and remedying of environmental damage is a task directly contributing to the pursuit of the Community's environment policy, public authorities should ensure the proper implementation and enforcement of the scheme provided for by this Directive. |
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Restoration of the environment should take place in an effective manner ensuring that the relevant restoration objectives are achieved. A common framework should be defined to that end, the proper application of which should be supervised by the competent authority. |
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Appropriate provision should be made for those situations where several instances of environmental damage have occurred in such a manner that the competent authority cannot ensure that all the necessary remedial measures are taken at the same time. In such a case, the competent authority should be entitled to decide which instance of environmental damage is to be remedied first. |
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According to the ‘polluter pays’ principle, an operator causing environmental damage or creating an imminent threat of such damage should, in principle, bear the cost of the necessary preventive or remedial measures. In cases where a competent authority acts, itself or through a third party, in the place of an operator, that authority should ensure that the cost incurred by it is recovered from the operator. It is also appropriate that the operators should ultimately bear the cost of assessing environmental damage or, as the case may be, assessing an imminent threat of such damage occurring. |
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Member States may provide for flat-rate calculation of administrative, legal, enforcement and other general costs to be recovered. |
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An operator should not be required to bear the costs of preventive or remedial action taken pursuant to this Directive in situations where the damage in question or imminent threat thereof is the result of certain events beyond the operator's control. Member States may allow that operators who are not at fault or negligent shall not bear the cost of remedial measures, in situations where the damage in question is the result of emissions or events explicitly authorised or where the potential for damage could not have been known when the event or emission took place. |
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Operators should bear the costs relating to preventive measures when those measures should have been taken as a matter of course in order to comply with the legislative, regulatory and administrative provisions regulating their activities or the terms of any permit or authorisation. |
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Member States may establish national rules covering cost allocation in cases of multiple party causation. Member States may take into account, in particular, the specific situation of users of products who might not be held responsible for environmental damage in the same conditions as those producing such products. In this case, apportionment of liability should be determined in accordance with national law. |
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Competent authorities should be entitled to recover the cost of preventive or remedial measures from an operator within a reasonable period of time from the date on which those measures were completed. |
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It is necessary to ensure that effective means of implementation and enforcement are available, while ensuring that the legitimate interests of the relevant operators and other interested parties are adequately safeguarded. Competent authorities should be in charge of specific tasks entailing appropriate administrative discretion, namely the duty to assess the significance of the damage and to determine which remedial measures should be taken. |
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Persons adversely affected or likely to be adversely affected by environmental damage should be entitled to ask the competent authority to take action. Environmental protection is, however, a diffuse interest on behalf of which individuals will not always act or will not be in a position to act. Non-governmental organisations promoting environmental protection should therefore also be given the opportunity to properly contribute to the effective implementation of this Directive. |
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The relevant natural or legal persons concerned should have access to procedures for the review of the competent authority's decisions, acts or failure to act. |
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(27) |
Member States should take measures to encourage the use by operators of any appropriate insurance or other forms of financial security and the development of financial security instruments and markets in order to provide effective cover for financial obligations under this Directive. |
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Where environmental damage affects or is likely to affect several Member States, those Member States should cooperate with a view to ensuring proper and effective preventive or remedial action in respect of any environmental damage. Member States may seek to recover the costs for preventive or remedial action. |
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This Directive should not prevent Member States from maintaining or enacting more stringent provisions in relation to the prevention and remedying of environmental damage; nor should it prevent the adoption by Member States of appropriate measures in relation to situations where double recovery of costs could occur as a result of concurrent action by a competent authority under this Directive and by a person whose property is affected by the environmental damage. |
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Damage caused before the expiry of the deadline for implementation of this Directive should not be covered by its provisions. |
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Member States should report to the Commission on the experience gained in the application of this Directive so as to enable the Commission to consider, taking into account the impact on sustainable development and future risks to the environment, whether any review of this Directive is appropriate, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Subject matter
The purpose of this Directive is to establish a framework of environmental liability based on the ‘polluter pays’ principle, to prevent and remedy environmental damage.
Article 2
Definitions
For the purpose of this Directive the following definitions shall apply:
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‘environmental damage’ means:
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‘damage’ means a measurable adverse change in a natural resource or measurable impairment of a natural resource service which may occur directly or indirectly; |
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‘protected species and natural habitats’ means:
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‘conservation status’ means:
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‘waters’ mean all waters covered by Directive 2000/60/EC; |
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‘operator’ means any natural or legal, private or public person who operates or controls the occupational activity or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of such an activity has been delegated, including the holder of a permit or authorisation for such an activity or the person registering or notifying such an activity; |
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‘occupational activity’ means any activity carried out in the course of an economic activity, a business or an undertaking, irrespectively of its private or public, profit or non-profit character; |
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‘emission’ means the release in the environment, as a result of human activities, of substances, preparations, organisms or micro-organisms; |
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‘imminent threat of damage’ means a sufficient likelihood that environmental damage will occur in the near future; |
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‘preventive measures’ means any measures taken in response to an event, act or failure to act that has created an imminent threat of environmental damage, with a view to preventing or minimising that damage; |
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‘remedial measures’ means any action or combination of actions, including mitigating or interim measures, to restore, rehabilitate or replace damaged natural resources and/or impaired services, or to provide an equivalent alternative to those resources or services, as foreseen in Annex II; |
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‘natural resource’ means protected species and natural habitats, water and land; |
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‘services’ and ‘natural resources services’ mean the functions performed by a natural resource for the benefit of another natural resource or the public; |
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‘baseline condition’ means the condition at the time of the damage of the natural resources and services that would have existed had the environmental damage not occurred, estimated on the basis of the best information available; |
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‘recovery’, including ‘natural recovery’, means, in the case of water, protected species and natural habitats, the return of damaged natural resources and/or impaired services to baseline condition and, in the case of land damage, the elimination of any significant risk of adversely affecting human health; |
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‘costs’ means costs which are justified by the need to ensure the proper and effective implementation of this Directive including the costs of assessing environmental damage, an imminent threat of such damage, alternatives for action as well as the administrative, legal, and enforcement costs, the costs of data collection and other general costs, monitoring and supervision costs. |
Article 3
Scope
1. This Directive shall apply to:
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environmental damage caused by any of the occupational activities listed in Annex III, and to any imminent threat of such damage occurring by reason of any of those activities; |
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damage to protected species and natural habitats caused by any occupational activities other than those listed in Annex III, and to any imminent threat of such damage occurring by reason of any of those activities, whenever the operator has been at fault or negligent. |
2. This Directive shall apply without prejudice to more stringent Community legislation regulating the operation of any of the activities falling within the scope of this Directive and without prejudice to Community legislation containing rules governing conflicts of jurisdiction.
3. Without prejudice to relevant national legislation, this Directive shall not give private parties a right of compensation as a consequence of environmental damage or of an imminent threat of such damage.
Article 4
Exceptions
1. This Directive shall not cover environmental damage or an imminent threat of such damage caused by:
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an act of armed conflict, hostilities, civil war or insurrection; |
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a natural phenomenon of exceptional, inevitable and irresistible character. |
2. This Directive shall not apply to environmental damage or to any imminent threat of such damage arising from an incident in respect of which liability or compensation falls within the scope of any of the International Conventions listed in Annex IV, including any future amendments thereof, which is in force in the Member State concerned.
3. This Directive shall not apply to such nuclear risks or environmental damage or imminent threat of such damage as may be caused by the activities covered by the Treaty establishing the European Atomic Energy Community or caused by an incident or activity in respect of which liability or compensation falls within the scope of any of the international instruments listed in Annex V, including any future amendments thereof.
4. This Directive shall only apply to environmental damage or to an imminent threat of such damage caused by pollution of a diffuse character, where it is possible to establish a causal link between the damage and the activities of individual operators.
5. This Directive shall not apply to activities the main purpose of which is to serve national defence or international security nor to activities the sole purpose of which is to protect from natural disasters.
Article 5
Preventive action
1. Where environmental damage has not yet occurred but there is an imminent threat of such damage occurring, the operator shall, without delay, take the necessary preventive measures.
2. Member States shall provide that, where appropriate, and in any case whenever an imminent threat of environmental damage is not dispelled despite the preventive measures taken by the operator, operators are to inform the competent authority of all relevant aspects of the situation, as soon as possible.
3. The competent authority may, at any time:
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require the operator to provide information on any imminent threat of environmental damage or in suspected cases of such an imminent threat; |
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require the operator to take the necessary preventive measures; |
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give instructions to the operator to be followed on the necessary preventive measures to be taken; or |
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itself take the necessary preventive measures. |
4. The competent authority shall require that the preventive measures are taken by the operator. If the operator fails to comply with any obligation incumbent upon it pursuant to paragraph 1 or 3(b) or (c), cannot be identified or is not required to bear the costs under this Directive, the competent authority may take these measures itself.
Article 6
Remedial action
1. Where environmental damage has occurred the operator shall, without delay, inform the competent authority of all relevant aspects of the situation and take:
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all practicable steps to immediately control, contain, remove or otherwise manage the relevant contaminants and/or any other damage factors in order to limit or to prevent further environmental damage and adverse effects on human health or further impairment of services, and |
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the necessary remedial measures, in accordance with Article 7. |
2. The competent authority may, at any time:
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require the operator to provide supplementary information on any damage that has occurred; |
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take, require the operator to take or give instructions to the operator concerning, all practicable steps to immediately control, contain, remove or otherwise manage the relevant contaminants and/or any other damage factors in order to limit or to prevent further environmental damage and adverse effects on human health, or further impairment of services; |
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require the operator to take the necessary remedial measures; |
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give instructions to the operator to be followed on the necessary remedial measures to be taken; or |
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itself take the necessary remedial measures , as a last resort . |
3. The competent authority shall require that the remedial measures are taken by the operator. If the operator fails to comply with any obligation incumbent upon it pursuant to paragraph 1 or 2(b), (c) or (d), cannot be identified or is not required to bear the costs under this Directive, the competent authority may take these measures itself.
Article 7
Determination of remedial measures
1. Operators shall identify, in accordance with Annex II, potential remedial measures and submit them to the competent authority for its approval, unless the competent authority has taken action under Article 6(2)(e) and (3).
2. The competent authority shall decide which remedial measures shall be implemented in accordance with Annex II, and with the cooperation of the relevant operator, as required.
3. Where several instances of environmental damage have occurred in such a manner that the competent authority cannot ensure that the necessary remedial measures are taken at the same time, the competent authority shall be entitled to decide which instance of environmental damage must be remedied first.
In making that decision, the competent authority shall have regard, inter alia, to the nature, extent and gravity of the various instances of environmental damage concerned, and to the possibility of natural recovery. Risks to human health shall also be taken into account.
4. The competent authority shall invite the persons referred to in Article 12(1) and in any case the persons on whose land remedial measures would be carried out to submit their observations and shall take them into account.
Article 8
Prevention and remediation costs
1. The operator shall bear the costs for the preventive or remedial action taken pursuant to this Directive.
2. Subject to paragraphs 3 and 4, the competent authority shall recover, inter alia, via security over property or other appropriate guarantees from the operator who has caused the damage or the imminent threat of damage, the costs it has incurred in relation to the preventive or remedial action taken under this Directive.
However, the competent authority may decide not to recover the full costs where the expenditure required to do so would be greater than the recoverable sum or where the operator cannot be identified.
3. An operator shall not be required to bear the cost of preventive or remedial action taken pursuant to this Directive when he can prove that the environmental damage or imminent threat of such damage:
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was caused by a third party and occurred despite the fact that appropriate safety measures were in place; or |
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resulted from compliance with a compulsory order or instruction emanating from a public authority other than an order or instruction consequent upon an emission or incident caused by the operator's own activities. |
In such cases Member States shall take the appropriate measures to enable the operator to recover the costs incurred.
4. The Member States may allow the operator not to bear the cost of remedial action taken pursuant to this Directive where he demonstrates that he was not at fault or negligent and that the environmental damage was caused by:
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an emission or event expressly authorised by, and fully in accordance with the conditions of, an authorisation conferred by or given under applicable national laws and regulations which implement those legislative measures adopted by the Community specified in Annex III, as applied at the date of the emission or event; |
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an emission or activity or any manner of using a product in the course of an activity which the operator demonstrates was not considered likely to cause environmental damage according to the state of scientific and technical knowledge at the time when the emission was released or the activity took place. |
5. Measures taken by the competent authority in pursuance of Article 5(3) and (4) and Article 6(2) and (3) shall be without prejudice to the liability of the relevant operator under this Directive and without prejudice to Articles 87 and 88 of the Treaty.
Article 9
Cost allocation in cases of multiple party causation
This Directive is without prejudice to any provisions of national law concerning cost allocation in cases of multiple party causation, in particular regarding the apportionment of liability between the producer and the user of a product.
Article 10
Limitation period for recovery of costs
The competent authority shall be entitled to initiate cost recovery proceedings against the operator, or if appropriate, a third party who has caused the damage or the imminent threat of damage in relation to any measures taken in pursuance of this Directive within five years from the date on which those measures have been completed or the liable operator, or third party, has been identified, whichever is the later.
Article 11
Competent authority
1. Member States shall designate the competent authority(ies) responsible for fulfilling the duties provided for in this Directive.
2. The duty to establish which operator has caused the damage or the imminent threat of damage, to assess the significance of the damage and to determine which remedial measures should be taken with reference to Annex II shall rest with the competent authority. To that effect, the competent authority shall be entitled to require the relevant operator to carry out his own assessment and to supply any information and data necessary.
3. Member States shall ensure that the competent authority may empower or require third parties to carry out the necessary preventive or remedial measures.
4. Any decision taken pursuant to this Directive which imposes preventive or remedial measures shall state the exact grounds on which it is based. Such decision shall be notified forthwith to the operator concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time-limits to which such remedies are subject.
Article 12
Request for action
1. Natural or legal persons:
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affected or likely to be affected by environmental damage or |
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having a sufficient interest in environmental decision-making relating to the damage or, alternatively, |
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alleging the impairment of a right, where administrative procedural law of a Member State requires this as a precondition, |
shall be entitled to submit to the competent authority any observations relating to instances of environmental damage or an imminent threat of such damage of which they are aware and shall be entitled to request the competent authority to take action under this Directive.
What constitutes a ‘sufficient interest’ and ‘impairment of a right’ shall be determined by the Member States.
To this end, the interest of any non-governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed sufficient for the purpose of subparagraph (b). Such organisations shall also be deemed to have rights capable of being impaired for the purpose of subparagraph (c).
2. The request for action shall be accompanied by the relevant information and data supporting the observations submitted in relation to the environmental damage in question.
3. Where the request for action and the accompanying observations show in a plausible manner that environmental damage exists, the competent authority shall consider any such observations and requests for action. In such circumstances the competent authority shall give the relevant operator an opportunity to make his views known with respect to the request for action and the accompanying observations.
4. The competent authority shall, as soon as possible and in any case in accordance with the relevant provisions of national law, inform the persons referred to in paragraph 1, which submitted observations to the authority, of its decision to accede to or refuse the request for action and shall provide the reasons for it.
5. Member States may decide not to apply paragraphs 1 and 4 to cases of imminent threat of damage.
Article 13
Review procedures
1. The persons referred to in Article 12(1) shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of the decisions, acts or failure to act of the competent authority under this Directive.
2. This Directive shall be without prejudice to any provisions of national law which regulate access to justice and those which require that administrative review procedures be exhausted prior to recourse to judicial proceedings.
Article 14
Financial security
1. Member States shall take measures to encourage the development of financial security instruments and markets by the appropriate economic and financial operators, including financial mechanisms in case of insolvency, with the aim of enabling operators to use financial guarantees to cover their liabilities under this Directive.
2. Five years after the entry into force of this Directive, the Commission shall report to the European Parliament and the Council on the measures adopted by the Member States pursuant to paragraph 1.
If no appropriate instruments or markets for insurance or other forms of financial security have been established, the Commission shall, in the light of that report, submit proposals for a harmonised compulsory financial guarantee for water and land damage based on a gradual approach. After a twoyear assessment period, these provisions shall also apply to the remediation of damage caused to protected species and natural habitats.
3. A ceiling may be established for the financial guarantee by case and by location, to be determined in accordance with a sliding scale drawn up by the Member States, taking into account in particular the risks of the activities carried out and the annual turnover.
4. Member States may decide not to apply these provisions to low risk activities and may consider establishing thresholds in relation to any insurance requirements under these provisions.
Article 15
Cooperation between Member States
1. Where environmental damage affects or is likely to affect several Member States, those Member States shall cooperate, including through the appropriate exchange of information, with a view to ensuring that preventive action and, where necessary, remedial action is taken in respect of any such environmental damage.
2. Where environmental damage has occurred, the Member State in whose territory the damage originates shall provide sufficient information to the potentially affected Member States.
3. Where a Member State identifies damage within its borders which has not been caused within them it may report the issue to the Commission and any other Member State concerned; it may make recommendations for the adoption of preventive or remedial measures and it may seek, in accordance with this Directive, to recover the costs it has incurred in relation to the adoption of such measures.
Article 16
Relationship with national law
1. This Directive shall not prevent Member States from maintaining or adopting more stringent provisions in relation to the prevention and remedying of environmental damage, including the identification of additional activities to be subject to the prevention and remediation requirements of this Directive and the identification of additional responsible parties.
2. This Directive shall not prevent Member States from adopting appropriate measures, such as the prohibition of double recovery of costs, in relation to situations where double recovery could occur as a result of concurrent action by a competent authority under this Directive and by a person whose property is affected by environmental damage.
Article 17
Temporal application
This Directive shall not apply to:
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damage caused by an emission, event or incident that took place before the date referred to in Article 19(1), |
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damage caused by an emission, event or incident which takes place subsequent to the date referred to in Article 19(1) when it derives from a specific activity that took place and finished before the said date, |
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damage, if more than 30 years have passed since the occurrence of the emission, event or incident resulting in the damage. |
Article 18
Reports and review
1. Member States shall report to the Commission on the experience gained in the application of this Directive by ... (8) at the latest. The reports shall include the information and data set out in Annex VI.
2. On that basis, the Commission shall submit a report to the European Parliament and to the Council before ... (9), which shall include any appropriate proposals for amendment.
3. The report referred to in paragraph 2 shall include a review of:
|
a) |
the application of Article 4(2) and (3) in relation to the exclusion of pollution covered by the international instruments listed in Annexes IV and V from the scope of this Directive, particularly in the light of experience gained within relevant international Conventions and fora, such as the IMO and Euratom, and the extent to which these instruments have entered into force and/or have been implemented by Member States and/or have been modified, taking account of all relevant instances of environmental damage resulting from such activities and the remedial action taken, and considering the relationship between shipowners' liability and oil receivers' contributions ; |
|
b) |
the application of this Directive to environmental damage caused by genetically modified organisms (GMOs), particularly in the light of experience gained within relevant international fora and Conventions, such as the Convention on Biological Diversity and the Cartagena Protocol on Biosafety, as well as the results of any incidents of environmental damage caused by GMOs; |
|
c) |
the application of this Directive in relation to protected species and natural habitats; |
|
d) |
the instruments that may be eligible for incorporation into Annexes III, IV and V. |
Article 19
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... (10) at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication.The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive together with a table showing how the provisions of this Directive correspond to the national provisions adopted.
Article 20
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 21
Addressees
This Directive is addressed to the Member States.
Done at ...,
For the European Parliament
The President
For the Council
The President
(1) OJ C 151 E, 25.6.2002, p. 132.
(2) OJ C 241, 7.10.2002, p. 162.
(3) Position of the European Parliament of 14 May 2003 (not yet published in the Official Journal). Council Common Position of 18 September 2003 (OJ C 277 E, 18.11.2003, p. 10) and Position of the European Parliament of 17 December 2003.
(4) OJ L 103, 25.4.1979, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
(5) OJ L 206, 22.7.1992, p. 7. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
(6) OJ L 327, 22.12.2000, p. 1. Directive as last amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(7) OJ L 12, 16.1.2001, p. 1. Regulation as amended by Commission Regulation (EC) No 1496/2002 (OJ L 225, 22.8.2002, p. 13).
(8) Nine years after the entry into force of this Directive.
(9) Ten years after the entry into force of this Directive.
(10) Three years after the entry into force of this Directive.
ANNEX I
CRITERIA REFERRED TO IN ARTICLE 2(1)(a)
The significance of any damage that has adverse effects on reaching or maintaining the favourable conservation status of habitats or species has to be assessed by reference to the conservation status at the time of the damage, the services provided by the amenities they produce and their capacity for natural regeneration. Significant adverse changes to the baseline condition should be determined by means of measurable data such as:
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— |
the number of individuals, their density or the area covered, |
|
— |
the role of the particular individuals or of the damaged area in relation to the species or to the habitat conservation, the rarity of the species or habitat (assessed at local, regional and higher level including at Community level), |
|
— |
the species' capacity for propagation (according to the dynamics specific to that species or to that population), its viability or the habitat's capacity for natural regeneration (according to the dynamics specific to its characteristic species or to their populations), |
|
— |
the species' or habitat's capacity, after damage has occurred, to recover within a short time, without any intervention other than increased protection measures, to a condition which leads, solely by virtue of the dynamics of the species or habitat, to a condition deemed equivalent or superior to the baseline condition. |
Damage with a proven effect on human health must be classified as significant damage.
The following does not have to be classified as significant damage:
|
— |
negative variations that are smaller than natural fluctuations regarded as normal for the species or habitat in question, |
|
— |
negative variations due to natural causes or resulting from intervention relating to the normal management of sites, as defined in habitat records or target documents or as carried on previously by owners or operators, |
|
— |
damage to species or habitats for which it is established that they will recover, within a short time and without intervention, either to the baseline condition or to a condition which leads, solely by virtue of the dynamics of the species or habitat, to a condition deemed equivalent or superior to the baseline condition. |
ANNEX II
REMEDYING OF ENVIRONMENTAL DAMAGE
This Annex sets out a common framework to be followed in order to choose the most appropriate measures to ensure the remedying of environmental damage.
1. REMEDIATION OF DAMAGE TO WATER OR PROTECTED SPECIES AND NATURAL HABITATS
Remedying of environmental damage, in relation to water or protected species and natural habitats, is achieved through the restoration of the environment to its baseline condition by way of primary, complementary and compensatory remediation, where:
|
(a) |
‘Primary’ remediation is any remedial measure which returns the damaged natural resources and/or impaired services to, or towards, baseline condition; |
|
(b) |
‘Complementary’ remediation is any remedial measure taken in relation to natural resources and/or services to compensate for the fact that primary remediation does not result in fully restoring the damaged natural resources and/or services; |
|
(c) |
‘Compensatory’ remediation is any action taken to compensate for interim losses of natural resources and/or services that occur from the date of damage occurring until primary remediation has achieved its full effect; |
|
(d) |
‘interim losses’ means losses which result from the fact that the damaged natural resources and/or services are not able to perform their ecological functions or provide services to other natural resources or to the public until the primary or complementary measures have taken effect. It does not consist of financial compensation to members of the public. |
Where primary remediation does not result in the restoration of the environment to its baseline condition, then complementary remediation will be undertaken. In addition, compensatory remediation will be undertaken to compensate for the interim losses.
Remedying of environmental damage, in terms of damage to water or protected species and natural habitats, also implies that any significant risk of human health being adversely affected be removed.
1.1. Remediation objectives
Purpose of primary remediation
|
1.1.1. |
The purpose of primary remediation is to restore the damaged natural resources and/or services to, or towards, baseline condition. |
Purpose of complementary remediation
|
1.1.2. |
Where the damaged natural resources and/or services do not return to their baseline condition, then complementary remediation will be undertaken. The purpose of complementary remediation is to provide a similar level of natural resources and/or services, including, as appropriate, at an alternative site, as would have been provided if the damaged site had been returned to its baseline condition. Where possible and appropriate the alternative site should be geographically linked to the damaged site, taking into account the interests of the affected population. |
Purpose of compensatory remediation
|
1.1.3. |
Compensatory remediation shall be undertaken to compensate for the interim loss of natural resources and services pending recovery. This compensation consists of additional improvements to protected natural habitats and species or water at either the damaged site or at an alternative site. It does not consist of financial compensation to members of the public. |
1.2. Identification of remedial measures
Identification of primary remedial measures
|
1.2.1. |
Options comprised of actions to directly restore the natural resources and services towards baseline condition on an accelerated time frame, or through natural recovery, shall be considered. |
Identification of complementary and compensatory remedial measures
|
1.2.2. |
When determining the scale of complementary and compensatory remedial measures, the use of resource-to-resource or service-to-service equivalence approaches shall be considered first. Under these approaches, actions that provide natural resources and/or services of the same type, quality and quantity as those damaged shall be considered first. Where this is not possible, then alternative natural resources and/or services shall be provided. For example, a reduction in quality could be offset by an increase in the quantity of remedial measures. |
|
1.2.3. |
If it is not possible to use the first choice resource-to-resource or service-to-service equivalence approaches, then alternative valuation techniques shall be used. The competent authority may prescribe the method, for example monetary valuation, to determine the extent of the necessary complementary and compensatory remedial measures. If valuation of the lost resources and/or services is practicable, but valuation of the replacement natural resources and/or services cannot be performed within a reasonable time-frame or at a reasonable cost, then the competent authority may choose remedial measures whose cost is equivalent to the estimated monetary value of the lost natural resources and/or services. The complementary and compensatory remedial measures should be so designed that they provide for additional natural resources and/or services to reflect time preferences and the time profile of the remedial measures. For example, the longer the period of time before the baseline condition is reached, the greater the amount of compensatory remedial measures that will be undertaken (other things being equal). |
1.3. Choice of the remedial options
|
1.3.1. |
The reasonable remedial options should be evaluated, using best available technologies, based on the following criteria:
|
|
1.3.2. |
When evaluating the different identified remedial options, primary remedial measures that do not fully restore the damaged water or protected species or natural habitat to baseline condition or that restore it more slowly can be chosen. This decision can be taken only if the natural resources and/or services foregone at the primary site as a result of the decision are compensated for by increasing complementary or compensatory actions to provide a similar level of natural resources and/or services as were foregone. This will be the case, for example, when the equivalent natural resources and/or services could be provided elsewhere at a lower cost. These additional remedial measures shall be determined in accordance with the rules set out in section 1.2.2. |
|
1.3.3. |
Notwithstanding the rules set out in section 1.3.2. and in accordance with Article 7(3), the competent authority is entitled to decide that no further remedial measures should be taken if:
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2. REMEDIATION OF LAND DAMAGE
The necessary measures shall be taken to ensure, as a minimum, that the relevant contaminants are removed, controlled, contained or diminished so that the contaminated land, taking account of its current use or approved future use at the time of the damage, no longer poses any significant risk of adversely affecting human health. The presence of such risks shall be assessed through risk-assessment procedures taking into account the characteristics and function of the soil, the type and concentration of the harmful substances, preparations, organisms or micro-organisms, their risk and the possibility of their dispersion. Use shall be ascertained on the basis of the land use regulations, or other relevant regulations, in force, if any, when the damage occurred.
If the use of the land is changed, all necessary measures shall be taken to prevent any adverse effects on human health.
If land use regulations, or other relevant regulations, are lacking, the nature of the relevant area where the damage occurred, taking into account its expected development, shall determine the use of the specific area.
A natural recovery option, that is to say an option in which no direct human intervention in the recovery process would be undertaken, shall be considered.
ANNEX III
ACTIVITIES REFERRED TO IN ARTICLE 3(1)
|
1. |
The operation of installations subject to permit in pursuance of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (1). That means all activities listed in Annex I of Directive 96/61/EC with the exception of installations or parts of installations used for research, development and testing of new products and processes. |
|
2. |
Waste management operations, including the collection, transport, recovery and disposal of waste and hazardous waste, including the supervision of such operations and after-care of disposal sites, subject to permit or registration in pursuance of Council Directive 75/442/EEC of 15 July 1975 on waste (2) and Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (3). Those operations include, inter alia, the operation of landfill sites under Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (4) and the operation of incineration plants under Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste (5). For the purpose of this Directive, Member States may decide that those operations shall not include the spreading of sewage sludge from urban waste water treatment plants, treated to an approved standard, for agricultural purposes. |
|
3. |
All discharges into the inland surface water, which require prior authorisation in pursuance of Council Directive 76/464/EEC of 4 May 1976 on pollution caused by certain dangerous substances, discharged into the aquatic environment of the Community (6). |
|
4. |
All discharges of substances into groundwater which require prior authorisation in pursuance of Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances (7). |
|
5. |
The discharge or injection of pollutants into surface water or groundwater which require a permit, authorisation or registration in pursuance of Directive 2000/60/EC. |
|
6. |
Water abstraction and impoundment of water subject to prior authorisation in pursuance of Directive 2000/60/EC. |
|
7. |
Manufacture, use, storage, processing, filling, release into the environment and onsite transport of
|
|
8. |
Transport by road, rail, inland waterway, sea or air of dangerous goods or polluting goods as defined either in Annex A to Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (12) or in the Annex to Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (13) or as defined in Council Directive 93/75/EEC of 13 September 1993 concerning minimum requirements for vessels bound for or leaving Community ports and carrying dangerous or polluting goods (14). |
|
9. |
The operation of installations subject to authorisation in pursuance of Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants (15) in relation to the release into the air of any of the polluting substances covered by the aforementioned Directive. |
|
10. |
Any contained use, including transport, involving genetically modified micro-organisms as defined by Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms (16). |
|
11. |
Any deliberate release into the environment, transport and placing on the market of genetically modified organisms as defined by Directive 2001/18/EC of the European Parliament and of the Council (17). |
|
12. |
Transboundary shipment of waste within, into or out of the European Union, requiring an authorisation or prohibited in pursuance of Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community (18). |
(1) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 1882/2003.
(2) OJ L 194, 25.7.1975, p. 39. Directive as last amended by Regulation (EC) No 1882/2003.
(3) OJ L 377, 31.12.1991, p. 20. Directive as amended by Directive 94/31/EC (OJ L 168, 2.7.1994, p. 28).
(4) OJ L 182, 16.7.1999, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
(5) OJ L 332, 28.12.2000, p. 91.
(6) OJ L 129, 18.5.1976, p. 23. Directive as last amended by Directive 2000/60/EC.
(7) OJ L 20, 26.1.1980, p. 43. Directive as amended by Directive 91/692/EEC (OJ L 377, 31.12.1991, p. 48).
(8) OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003.
(9) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.
(10) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
(11) OJ L 123, 24.4.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
(12) OJ L 319, 12.12.1994, p. 7. Directive as last amended by Commission Directive 2003/28/EC (OJ L 90, 8.4.2003, p. 45).
(13) OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2003/29/EC (OJ L 90, 8.4.2003, p. 47).
(14) OJ L 247, 5.10.1993, p. 19. Directive as last amended by Directive 2002/84/EC of the European Parliament and of the Council (OJ L 324, 29.11.2002, p. 53).
(15) OJ L 188, 16.7.1984, p. 20. Directive as amended by Directive 91/692/EEC (OJ L 377, 31.12.1991, p. 48).
(16) OJ L 117, 8.5.1990, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.
(17) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).
(18) OJ L 30, 6.2.1993, p. 1. Regulation as last amended by Commission Regulation (EC) No 2557/2001 (OJ L 349, 31.12.2001, p. 1).
ANNEX IV
INTERNATIONAL CONVENTIONS REFERRED TO IN ARTICLE 4(2)
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a) |
the International Convention of 27 November 1992 on Civil Liability for Oil Pollution Damage; |
|
b) |
the International Convention of 27 November 1992 on the Establishment of an International Fund for Compensation for Oil Pollution Damage; |
|
c) |
the International Convention of 23 March 2001 on Civil Liability for Bunker Oil Pollution Damage; |
|
d) |
the International Convention of 3 May 1996 on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea; |
|
e) |
the Convention of 10 October 1989 on Civil Liability for Damage Caused during Carriage of Dangerous Goods by Road, Rail and Inland Navigation Vessels. |
ANNEX V
INTERNATIONAL INSTRUMENTS REFERRED TO IN ARTICLE 4(3)
|
a) |
the Paris Convention of 29 July 1960 on Third Party Liability in the Field of Nuclear Energy and the Brussels Supplementary Convention of 31 January 1963; |
|
b) |
the Vienna Convention of 21 May 1963 on Civil Liability for Nuclear Damage; |
|
c) |
the Convention of 12 September 1997 on Supplementary Compensation for Nuclear Damage; |
|
d) |
the Joint Protocol of 21 September 1988 relating to the Application of the Vienna Convention and the Paris Convention; |
|
e) |
the Brussels Convention of 17 December 1971 relating to Civil Liability in the Field of Maritime Carriage of Nuclear Material. |
ANNEX VI
INFORMATION AND DATA REFERRED TO IN ARTICLE 18(1)
The reports referred to in Article 18(1) shall include a list of instances of environmental damage and instances of liability under this Directive, with the following information and data for each instance:
|
1) |
Type of environmental damage, date of occurrence and/or discovery of the damage and date on which proceedings were initiated under this Directive. |
|
2) |
Activity classification code of the liable legal person(s) (1). |
|
3) |
Whether there has been resort to judicial review proceedings either by liable parties or qualified entities. (The type of claimants and the outcome of proceedings shall be specified.) |
|
4) |
Outcome of the remediation process. |
|
5) |
Date of closure of proceedings. |
Member States may include in their reports any other information and data they deem useful to allow a proper assessment of the functioning of this Directive, for example:
|
1) |
Costs incurred with remedial and preventive measures, as defined in this Directive:
|
|
2) |
Results of the actions to promote, and the implementation of, the financial security instruments used in accordance with this Directive. |
|
3) |
An assessment of the additional administrative costs incurred annually by the public administration in setting up and operating the administrative structures needed to implement and enforce this Directive. |
(1) The NACE code can be used (Council Regulation (EEC) No 3037/90 of 9 October 1990 on the statistical classification of economic activities in the European Community (OJ L 293, 24.10.1990, p. 1)).
P5_TA(2003)0576
European Medicines Agency ***II
European Parliament legislative resolution on the common position adopted by the Council with a view to adopting a European Parliament and Council regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (10949/2/2003 — C5-0463/2003 — 2001/0252(COD))
(Codecision procedure: second reading)
The European Parliament,
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— |
having regard to the Council common position (10949/2/2003 — C5-0463/2003) (1), |
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— |
having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2001) 404) (3), |
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— |
having regard to the amended proposal (COM(2002) 735) (4), |
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— |
having regard to Article 251(2) of the EC Treaty, |
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— |
having regard to Rule 80 of its Rules of Procedure, |
|
— |
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0425/2003), |
|
1. |
Amends the common position as follows; |
|
2. |
Instructs its President to forward its position to the Council and Commission. |
(1) OJ C 297 E, 9.12.2003, p. 1.
(2) Texts Adopted, 23.10.2002, P5_TA(2002)0504.
(3) OJ C 75 E, 26.3.2002, p. 189.
(4) Not yet published in OJ.
P5_TC2-COD(2001)0252
Position of the European Parliament adopted at second reading on 17 December 2003 with a view to the adoption of Regulation (EC) No .../2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 and Article 152(4)(b) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the Opinion of the European Economic and Social Committee (2),
After consulting the Committee of the Regions,
In accordance with the procedure laid down in Article 251 of the Treaty (3),
Whereas:
|
(1) |
Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (4) provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation. |
|
(2) |
In the light of the Commission's report on the experience gained, it has proved necessary to improve the operation of the authorisation procedures for the placing of medicinal products on the market in the Community and to amend certain administrative aspects of the European Agency for the Evaluation of Medicinal Products. In addition, the name of that Agency should be simplified and changed to the European Medicines Agency, (hereinafter referred to as the ‘Agency’). |
|
(3) |
It emerges from the conclusions of that report that the amendments to be made to the centralised procedure set up by Regulation (EEC) No 2309/93 consist of corrections to some of the operating procedures and adaptations to take account of the probable development of science and technology and the future enlargement of the European Union. It also emerges from the report that the general principles previously established which govern the centralised procedure should be maintained. |
|
(4) |
Moreover, since the European Parliament and the Council have adopted Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (5) and Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products (6), all the references to the codified Directives in Regulation (EEC) No 2309/93 should be updated. |
|
(5) |
For the sake of clarity, it is necessary to replace the said Regulation with a new Regulation. |
|
(6) |
It is appropriate to preserve the Community mechanism set up by the repealed Community legislation for concertation prior to any national decision relating to a high-technology medicinal product. |
|
(7) |
Experience gained since the adoption of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (7) has shown that it is necessary to create a centralised authorisation procedure that is compulsory for high-technology medicinal products, particularly those resulting from biotechnical processes, in order to maintain the high level of scientific evaluation of these medicinal products in the European Union and thus to preserve the confidence of patients and the medical professions in the evaluation. This is particularly important in the context of the emergence of new therapies, such as gene therapy and associated cell therapies, and xenogenic somatic therapy. This approach should be maintained, particularly with a view to ensuring the effective operation of the internal market in the pharmaceutical sector. |
|
(8) |
With a view to harmonising the internal market for new medicinal products, this procedure should also be made compulsory for orphan medicinal products and any medicinal product for human use containing an entirely new active substance, i.e. one that has not yet been authorised in the Community, and for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes. Four years after the date of entry into force of this Regulation, the procedure should also become compulsory for medicinal products for human use containing a new active substance, and for which the therapeutic indication is for the treatment of auto-immune diseases and other immune dysfunctions and viral diseases. It should be possible to review the provisions in point 3 of the Annex via a simplified decision-making procedure not earlier than four years after the entry into force of this Regulation. |
|
(9) |
As regards medicinal products for human use, optional access to the centralised procedure should also be provided for in cases where use of a single procedure produces added value for the patient. This procedure should remain optional for medicinal products which, although not belonging to the abovementioned categories, are nevertheless therapeutically innovative. It is also appropriate to allow access to this procedure for medicinal products which, although not innovative, may be of benefit to society or to patients if they are authorised from the outset at Community level, such as certain medicinal products which can be supplied without a medical prescription. This option may be extended to generic medicinal products authorised by the Community, provided that this in no way undermines either the harmonisation achieved when the reference medicinal product was evaluated or the results of that evaluation. |
|
(10) |
In the field of veterinary medicinal products, administrative measures should be laid down in order to take account of the specific features of this field, particularly those due to the regional distribution of certain diseases. It should be possible to use the centralised procedure for the authorisation of veterinary medicinal products used within the framework of Community provisions regarding prophylactic measures for epizootic diseases. Optional access to the centralised procedure should be maintained for veterinary medicinal products containing a new active substance. |
|
(11) |
For medicinal products for human use, the period for protection of data relating to pre-clinical tests and clinical trials should be the same as that provided for in Directive 2001/83/EC. For medicinal products for veterinary use, the period for protection of data relating to pre-clinical tests and clinical trials as well as safety and residue tests should be the same as that provided for in Directive 2001/82/EC. |
|
(12) |
In order to reduce the cost for small and medium—sized enterprises of marketing medicinal products authorised via the centralised procedure, provisions should be adopted to allow for a reduction of fees, deferring the payment of fees, taking over responsibility for translations and offering administrative assistance in respect of these enterprises. |
|
(13) |
In the interest of public health, authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic and other considerations. However, Member States should be able exceptionally to prohibit the use in their territory of medicinal products for human use which infringe objectively defined concepts of public policy and public morality. Moreover, a veterinary medicinal product is not to be authorised by the Community if its use would contravene the rules laid down within the framework of the Common Agricultural Policy or if presented for a use prohibited under other Community provisions, inter alia Directive 96/22/EC (8). |
|
(14) |
Provision should be made for the quality, safety and efficacy criteria in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Community and it should be possible to assess the risk-benefit balance of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate. |
|
(15) |
The Community is required, pursuant to Article 178 of the Treaty, to take account of the development policy aspects of any measure and to promote the creation of conditions fit for human beings worldwide. Pharmaceutical law should continue to ensure that only efficacious, safe and top-quality medicinal products are exported, and the Commission should consider creating further incentives to carry out research into medicinal products against widespread tropical diseases. |
|
(16) |
There is also a need to provide for the ethical requirements of Directive 2001/20/EC of 4 April 2001 of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (9) to apply to medicinal products authorised by the Community. In particular, with respect to clinical trials conducted outside the Community on medicinal products destined to be authorised within the Community, at the time of the evaluation of the application for authorisation, it should be verified that these trials were conducted in accordance with the principles of good clinical practice and the ethical requirements equivalent to the provisions of the said Directive. |
|
(17) |
The Community should have the means to carry out a scientific assessment of the medicinal products presented in accordance with the decentralised Community authorisation procedures. Moreover, with a view to ensuring the effective harmonisation of administrative decisions taken by Member States with regard to medicinal products presented in accordance with decentralised authorisation procedures, it is necessary to endow the Community with the means to resolve disagreements between Member States concerning the quality, safety and efficacy of medicinal products. |
|
(18) |
The structure and operation of the various bodies making up the Agency should be designed in such a way as to take into account the need constantly to renew scientific expertise, the need for cooperation between Community and national bodies, the need for adequate involvement of civil society, and the future enlargement of the European Union. The various bodies of the Agency should establish and develop appropriate contacts with the parties concerned, in particular representatives of patients and health-care professionals. |
|
(19) |
The chief task of the Agency should be to provide Community institutions and Member States with the best possible scientific opinions so as to enable them to exercise the powers regarding the authorisation and supervision of medicinal products conferred on them by Community legislation in the field of medicinal products. Only after a single scientific evaluation procedure addressing the quality, safety and efficacy of high-technology medicinal products has been conducted by the Agency, applying the highest possible standards, should marketing authorisation be granted by the Community, and this should be done by means of a rapid procedure ensuring close cooperation between the Commission and Member States. |
|
(20) |
In order to ensure close cooperation between the Agency and scientists operating in Member States, the composition of the Management Board should be such as to guarantee that the competent authorities of the Member States are closely involved in the overall management of the Community system for authorising medicinal products. |
|
(21) |
The Agency's budget should be composed of fees paid by the private sector and contributions paid out of the Community budget to implement Community policies. |
|
(22) |
Paragraph 25 of the Interinstitutional Agreement of 6 May 1999 between the European Parliament, the Council and the Commission on budgetary discipline and improvement of budgetary procedure (10) provides for the Financial Perspective to be adjusted in order to cover the new needs resulting from enlargement. |
|
(23) |
Exclusive responsibility for preparing the Agency's opinions on all questions concerning medicinal products for human use should be vested in a Committee for Medicinal Products for Human Use. As far as veterinary medicinal products are concerned, such responsibility should be vested in a Committee for Medicinal Products for Veterinary Use. As regards orphan medicinal products, the task should fall to the Committee on Orphan Medicinal Products set up under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (11). Lastly, as regards herbal medicinal products, this responsibility should be vested in the Committee on Herbal Medicinal Products set up under Directive 2001/83/EC. |
|
(24) |
The creation of the Agency will make it possible to reinforce the scientific role and independence of the committees, particularly through the setting-up of a permanent technical and administrative secretariat. |
|
(25) |
The field of activity of the Scientific Committees should be enlarged and their operating methods and composition modernised. Scientific advice for future applicants seeking marketing authorisation should be provided more generally and in greater depth. Similarly, structures allowing the development of advice for companies, in particular small and medium-sized enterprises, should be put in place. The committees should be able to delegate some of their evaluation duties to standing working parties open to experts from the scientific world appointed for this purpose, whilst retaining total responsibility for the scientific opinions issued. The re-examination procedures should be amended to provide a better guarantee for applicants' rights. |
|
(26) |
The number of members of the Scientific Committees participating in the centralised procedure should be established with a view to ensuring that the committees remain of an efficient size after the enlargement of the European Union. |
|
(27) |
It is also necessary to reinforce the role of the Scientific Committees in such a way as to enable the Agency to participate actively in international scientific dialogue and to develop certain activities that will be necessary, in particular regarding international scientific harmonisation and technical cooperation with the World Health Organisation. |
|
(28) |
Furthermore, in order to create greater legal certainty it is necessary to define the responsibilities regarding the transparency rules for the Agency's work, to set certain conditions for the marketing of medicinal products authorised by the Community, to confer on the Agency powers to monitor the distribution of medicinal products authorised by the Community and to specify the sanctions and the procedures for implementing them in the event of failure to observe the provisions of this Regulation and the conditions contained in the authorisations granted under the procedures it establishes. |
|
(29) |
It is also necessary to take measures for the supervision of medicinal products authorised by the Community, and in particular for the intensive supervision of undesirable effects of these medicinal products within the framework of Community pharmacovigilance activities, so as to ensure the rapid withdrawal from the market of any medicinal product presenting a negative risk-benefit balance under normal conditions of use. |
|
(30) |
In order to enhance the efficiency of market surveillance, the Agency should be responsible for coordinating Member States' pharmacovigilance activities. A number of provisions need to be introduced to put in place stringent and efficient pharmacovigilance procedures, to allow the competent authority to take provisional emergency measures, including the introduction of amendments to the marketing authorisation and, finally, to permit a reassessment to be made at any time of the risk-benefit balance of a medicinal product. |
|
(31) |
It is also appropriate to entrust the Commission, in close cooperation with the Agency and after consultations with the Member States, with the task of coordinating the execution of the various supervisory responsibilities vested in the Member States, and in particular with the tasks of providing information on medicinal products and of checking the observance of good manufacturing, laboratory and clinical practices. |
|
(32) |
It is necessary to provide for the coordinated implementation of Community procedures for the authorisation of medicinal products, and of the national procedures of Member States which have already been harmonised to a considerable degree by Directives 2001/83/EC and 2001/82/EC. It is appropriate that the operation of the procedures laid down by this Regulation be re-examined by the Commission every ten years on the basis of experience gained. |
|
(33) |
In order to meet, in particular, the legitimate expectations of patients and to take account of the increasingly rapid progress of science and therapies, accelerated assessment procedures should be set up, reserved for medicinal products of major therapeutic interest, and procedures for obtaining temporary authorisations subject to certain annually reviewable conditions. In the field of medicinal products for human use, a common approach should also be followed, whenever possible, regarding the criteria and conditions for the compassionate use of new medicinal products under Member States' legislation. |
|
(34) |
Member States have developed an evaluation of the comparative efficacy of medicinal products aimed at positioning a new medicinal product with respect to those that already exist in the same therapeutic class. Similarly, the Council, in its Conclusions on medicinal products and public health (12), adopted on 29 June 2000, emphasised the importance of identifying medicinal products that presented an added therapeutic value. However this evaluation should not be conducted in the context of the marketing authorisation, for which it is agreed that the fundamental criteria should be retained. It is useful in this respect to allow for the possibility of gathering information on the methods used by the Member States to determine the therapeutic benefit obtained by each new medicinal product. |
|
(35) |
In line with the current provisions of Directives 2001/83/EC and 2001/82/EC, the term of validity of a Community marketing authorisation should be limited initially to a period of five years, upon the expiry of which it should be renewed. Thereafter the marketing authorisation should normally be of unlimited validity. Furthermore, any authorisation not used for three consecutive years, that is to say, one which has not led to the placing on the market of a medicinal product in the Community during that period, should be considered invalid, in order, in particular, to avoid the administrative burden of maintaining such authorisations. However, this rule should be subject to exemptions when these are justified on public health grounds. |
|
(36) |
Environmental risks may arise from medicinal products containing or consisting of genetically modified organisms. It is thus necessary to subject such products to an environmental riskassessment procedure similar to the procedure under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (13), to be conducted in parallel with the evaluation, under a single Community procedure, of the quality, safety and efficacy of the product concerned. |
|
(37) |
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (14). |
|
(38) |
The provisions of Regulation (EC) No 1647/2003 (15) amending Regulation (EEC) No 2309/93 as regards the budgetary and financial rules applicable to the Agency and access to the Agency's documents should be fully incorporated into this Regulation, |
HAVE ADOPTED THIS REGULATION:
TITLE I
DEFINITIONS AND SCOPE
Article 1
The purpose of this Regulation is to lay down Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use, and to establish a European Medicines Agency (hereinafter referred to as ‘the Agency’).
The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies.
Article 2
The definitions laid down in Article 1 of Directive 2001/83/EC and those laid down in Article 1 of Directive 2001/82/EC shall apply for the purposes of this Regulation.
The holder of a marketing authorisation for medicinal products covered by this Regulation must be established in the Community. The holder shall be responsible for the placing on the market of those medicinal products, whether he does it himself or via one or more persons designated to that effect.
Article 3
1. No medicinal product appearing in the Annex may be placed on the market within the Community unless a marketing authorisation has been granted by the Community in accordance with the provisions of this Regulation.
2. Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Community in accordance with the provisions of this Regulation, if:
|
a) |
the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community; or |
|
b) |
the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients or animal health at Community level. |
Immunological veterinary medicinal products for the treatment of animal diseases that are subject to Community prophylactic measures may also be granted such authorisation.
3. A generic medicinal product of a reference medicinal product authorised by the Community may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC and Directive 2001/82/EC under the following conditions:
|
a) |
the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC or Article 13 of Directive 2001/82/EC; |
|
b) |
the summary of the product characteristics is in all relevant respects consistent with that of the medicinal product authorised by the Community except for those parts of the summary of product characteristics referring to indications or dosage forms which were still covered by patent law at the time when the generic medicine was marketed; and |
|
c) |
the generic medicinal product is authorised under the same name in all the Member States where the application has been made. For the purposes of this provision, all the linguistic versions of the INN (international non-proprietary name) shall be considered to be the same name. |
4. After the competent committee of the Agency has been consulted, the Annex may be re-examined in the light of technical and scientific progress, with a view to making any necessary amendments without extending the scope of the centralised procedure. Such amendments shall be adopted in accordance with the procedure referred to in Article 87(2).
Article 4
1. Applications for the marketing authorisations referred to in Article 3 shall be submitted to the Agency.
2. The Community shall grant and supervise marketing authorisations for medicinal products for human use in accordance with Title II.
3. The Community shall grant and supervise marketing authorisations for veterinary medicinal products in accordance with Title III.
TITLE II
AUTHORISATION AND SUPERVISION OF MEDICINAL PRODUCTS FOR HUMAN USE
Chapter 1
Submission and examination of applications — Authorisations
Article 5
1. A Committee for Medicinal Products for Human Use is hereby established. The Committee shall be part of the Agency.
2. Without prejudice to Article 56 or to other tasks which Community law may confer on it, the Committee for Medicinal Products for Human Use shall be responsible for drawing up the opinion of the Agency on any matter concerning the admissibility of the files submitted in accordance with the centralised procedure, the granting, variation, suspension or revocation of an authorisation to place a medicinal product for human use on the market in accordance with the provisions of this Title, and pharmacovigilance.
3. At the request of the Executive Director of the Agency or the Commission representative, the Committee for Medicinal Products for Human Use shall also draw up an opinion on any scientific matter concerning the evaluation of medicinal products for human use. The Committee shall take due account of any requests by Member States for an opinion. The Committee shall also formulate an opinion whenever there is disagreement in the evaluation of medicinal products through the mutual recognition procedure. The opinion of the Committee shall be made publicly accessible.
Article 6
1. Each application for the authorisation of a medicinal product for human use shall specifically and completely include the particulars and documents as referred to in Articles 8(3), 10, 10a, 10b or 11 of, and Annex I to, Directive 2001/83/EC. The documents must include a statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC. These particulars and documents shall take account of the unique, Community nature of the authorisation requested and, otherwise than in exceptional cases relating to the application of the law on trade marks, shall include the use of a single name for the medicinal product.
The application shall be accompanied by the fee payable to the Agency for the examination of the application.
2. In the case of a medicinal product for human use containing or consisting of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC, the application shall be accompanied by:
|
a) |
a copy of the competent authorities' written consent to the deliberate release into the environment of the genetically modified organisms for research and development purposes where provided for in Part B of Directive 2001/18/EC or in Part B of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (16); |
|
b) |
the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC; |
|
c) |
the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and |
|
d) |
the results of any investigations performed for the purposes of research or development. |
Articles 13 to 24 of Directive 2001/18/EC shall not apply to medicinal products for human use containing or consisting of genetically modified organisms.
3. The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 210 days after receipt of a valid application.
The duration of the analysis of the scientific data in the file concerning the application for marketing authorisation must be at least 80 days, except in cases where the rapporteur and co-rapporteur declare that they have completed their assessment before that time.
On the basis of a duly reasoned request, the said Committee may call for the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation to be extended.
In the case of a medicinal product for human use containing or consisting of genetically modified organisms, the opinion of the said Committee shall respect the environmental safety requirements laid down by Directive 2001/18/EC. During the process of evaluating applications for marketing authorisations for medicinal products for human use containing or consisting of genetically modified organisms, the rapporteur shall carry out necessary consultations of bodies that the Community or Member States have set up in accordance with Directive 2001/18/EC.
4. The Commission shall, in consultation with the Agency, Member States and interested parties, draw up a detailed guide regarding the form in which applications for authorisation are to be presented.
Article 7
In order to prepare its opinion, the Committee for Medicinal Products for Human Use:
|
a) |
shall verify that the particulars and documents submitted in accordance with Article 6 comply with the requirements of Directive 2001/83/EC, and shall examine whether the conditions specified in this Regulation for granting a marketing authorisation are satisfied; |
|
b) |
may request that an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose test the medicinal product for human use, its starting materials and, if need be, its intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory; |
|
c) |
may request that the applicant supplement the particulars accompanying the application within a specific time period. Where the said Committee avails itself of this option, the time-limit laid down in Article 6(3), first subparagraph, shall be suspended until such time as the supplementary information requested has been provided. Likewise, this time-limit shall be suspended for the time allowed for the applicant to prepare oral or written explanations. |
Article 8
1. Upon receipt of a written request from the Committee for Medicinal Products for Human Use, a Member State shall forward the information showing that the manufacturer of a medicinal product or the importer from a third country is able to manufacture the medicinal product concerned and/or carry out the necessary control tests in accordance with the particulars and documents supplied pursuant to Article 6.
2. Where it considers it necessary in order to complete its examination of an application, the said Committee may require the applicant to undergo a specific inspection of the manufacturing site of the medicinal product concerned. Such inspections may be made unannounced.
The inspection shall be carried out within the time-limit laid down in the first subparagraph of Article 6(3) by inspectors from the Member State holding the appropriate qualifications; they may be accompanied by a rapporteur or an expert appointed by the Committee.
Article 9
1. The Agency shall forthwith inform the applicant if the opinion of the Committee for Medicinal Products for Human Use is that:
|
a) |
the application does not satisfy the criteria for authorisation set out in this Regulation; |
|
b) |
the summary of the product characteristics proposed by the applicant needs to be amended; |
|
c) |
the labelling or package leaflet of the product is not in compliance with Title V of Directive 2001/83/EC; |
|
d) |
the authorisation needs to be granted subject to the conditions provided for in Article 14(7) and (8). |
2. Within 15 days after receipt of the opinion referred to in paragraph 1, the applicant may give written notice to the Agency that he wishes to request a re-examination of the opinion. In that case, the applicant shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion.
Within 60 days following receipt of the grounds for the request, the said Committee shall re-examine its opinion in accordance with the conditions laid down in the fourth subparagraph of Article 62(1). The reasons for the conclusion reached shall be annexed to the final opinion.
3. Within 15 days after its adoption, the Agency shall send the final opinion of the said Committee to the Commission, to the Member States and to the applicant, together with a report describing the assessment of the medicinal product by the Committee and stating the reasons for its conclusions.
4. If an opinion is favourable to the granting of the relevant authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion:
|
a) |
a draft summary of the product characteristics, as referred to in Article 11 of Directive 2001/83/EC; |
|
b) |
details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, in accordance with the criteria laid down in Title VI of Directive 2001/83/EC; |
|
c) |
details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product; |
|
d) |
the draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Title V of Directive 2001/83/EC; |
|
e) |
the assessment report. |
Article 10
1. Within 15 days after receipt of the opinion referred to in Article 5(2), the Commission shall prepare a draft of the decision to be taken in respect of the application.
Where a draft decision envisages the granting of a marketing authorisation, it shall include or make reference to the documents mentioned in Article 9(4)(a), (b), (c) and (d).
Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.
The draft decision shall be forwarded to Member States and the applicant.
2. The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 87(3).
3. The Standing Committee on Medicinal Products for Human Use referred to in Article 87(1) shall adjust its rules of procedure so as to take account of the tasks incumbent upon it under this Regulation.
The adjustments shall provide that:
|
(a) |
the opinion of the said Standing Committee is to be given in writing; |
|
(b) |
Member States shall have 22 days to forward their written observations on the draft decision to the Commission. However, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days; |
|
(c) |
Member States may request in writing that the draft decision referred to in paragraph 1 be discussed by a plenary meeting of the said Standing Committee, stating their reasons in detail. |
4. Where, in the opinion of the Commission, a Member State's written observations raise important new questions of a scientific or technical nature which the opinion delivered by the Agency has not addressed, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.
5. The Commission shall adopt the provisions necessary for the implementation of paragraph 4 in accordance with the procedure referred to in Article 87(2).
6. The Agency shall disseminate the documents referred to in Article 9(4)(a), (b), (c) and (d).
Article 11
If an applicant withdraws an application for a marketing authorisation submitted to the Agency before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the Agency. The Agency shall make this information publicly accessible and shall publish the assessment report, if available, after deletion of all information of a commercially confidential nature.
Article 12
1. The marketing authorisation shall be refused if, after verification of the particulars and documents submitted in accordance with Article 6, it appears that the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product.
Authorisation shall likewise be refused if particulars or documents provided by the applicant in accordance with Article 6 are incorrect or if the labelling and package leaflet proposed by the applicant are not in accordance with Title V of Directive 2001/83/EC.
2. The refusal of a Community marketing authorisation shall constitute a prohibition on the placing on the market of the medicinal product concerned throughout the Community.
3. Information about all refusals and the reasons for them shall be made publicly accessible.
Article 13
1. Without prejudice to Article 4(4) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community. It shall confer the same rights and obligations in each of the Member States as a marketing authorisation granted by that Member State in accordance with Article 6 of Directive 2001/83/EC.
Authorised medicinal products for human use shall be entered in the Community Register of Medicinal Products and shall be given a number, which shall appear on the packaging.
2. Notification of marketing authorisation shall be published in the Official Journal of the European Union, quoting in particular the date of authorisation and the registration number in the Community Register, any International Non-proprietary Name (INN) of the active substance of the medicinal product, its pharmaceutical form, and any Anatomical Therapeutic Chemical Code (ATC).
3. The Agency shall immediately publish the assessment report on the medicinal product for human use drawn up by the Committee for Medicinal Products for Human Use and the reasons for its opinion in favour of granting authorisation, after deletion of any information of a commercially confidential nature.
The European Public Assessment Report (EPAR) shall include a summary written in a manner that is understandable to the public. The summary shall contain in particular a section relating to the conditions of use of the medicinal product.
4. After a marketing authorisation has been granted, the holder of the authorisation shall inform the Agency of the dates of actual marketing of the medicinal product for human use in the Member States, taking into account the various presentations authorised.
The holder shall also notify the Agency if the product ceases to be placed on the market, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product.
Upon request by the Agency, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the Agency with all data relating to the volume of sales of the medicinal product at Community level, broken down by Member State, and any data in the holder's possession relating to the volume of prescriptions.
Article 14
1. Without prejudice to paragraphs 4, 5 and 7 a marketing authorisation shall be valid for five years.
2. The marketing authorisation may be renewed after five years on the basis of a re-evaluation by the Agency of the risk-benefit balance.
To this end, the marketing authorisation holder shall provide the Agency with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1.
3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the Commission decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2.
4. Any authorisation which is not followed by the actual placing of the medicinal product for human use on the Community market within three years after authorisation shall cease to be valid.
5. When an authorised medicinal product previously placed on the market is no longer actually present on the market for three consecutive years, the authorisation shall cease to be valid.
6. In exceptional circumstances and on public health grounds the Commission may grant exemptions from paragraphs 4 and 5. Such exemptions must be duly justified.
7. Following consultation with the applicant, an authorisation may be granted subject to certain specific obligations, to be reviewed annually by the Agency. The list of these obligations shall be made publicly accessible.
By way of derogation from paragraph 1, such authorisation shall be valid for one year, on a renewable basis.
The provisions for granting such authorisation shall be laid down in a Commission Regulation adopted in accordance with the procedure referred to in Article 87(2).
8. In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. This authorisation may be granted only for objective, verifiable reasons and must be based on one of the grounds set out in Annex I to Directive 2001/83/EC. Continuation of the authorisation shall be linked to the annual reassessment of these conditions.
9. When an application is submitted for a marketing authorisation in respect of medicinal products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. The request shall be duly substantiated.
If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(3), first subparagraph, shall be reduced to 150 days.
10. When adopting its opinion, the Committee for Medicinal Products for Human Use shall include a proposal concerning the criteria for the prescription or use of the medicinal products in accordance with Article 70(1) of Directive 2001/83/EC.
11. Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.
Article 15
The granting of authorisation shall not affect the civil or criminal liability of the manufacturer or of the holder of the marketing authorisation pursuant to the applicable national law in Member States.
Chapter 2
Supervision and penalties
Article 16
1. After an authorisation has been granted in accordance with this Regulation, the holder of the marketing authorisation for a medicinal product for human use shall, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h) of Directive 2001/83/EC, take account of technical and scientific progress and make any variations that may be required to enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods. He shall apply for approval of such variations in accordance with this Regulation.
2. The holder of the marketing authorisation shall forthwith supply to the Agency, to the Commission and to the Member States any new information which might entail the variation of the particulars or documents referred to in Articles 8(3), 10, 10a, 10b and 11 of Directive 2001/83/EC, in Annex I thereto, or in Article 9(4) of this Regulation.
In particular, he shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product for human use concerned.
In order that the risk-benefit balance may be continuously assessed, the Agency may at any time ask the holder of the marketing authorisation to forward data demonstrating that the risk-benefit balance remains favourable.
3. If the holder of the authorisation for a medicinal product for human use proposes to make any variation of the particulars and documents referred to in paragraph 2, he shall submit the relevant application to the Agency.
4. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation in accordance with the procedure referred to in Article 87(2).
Article 17
The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and of the data submitted.
Article 18
1. In the case of medicinal products for human use manufactured within the Community, the supervisory authorities shall be the competent authorities of the Member State or Member States which granted the manufacturing authorisation provided for in Article 40(1) of Directive 2001/83/EC in respect of the medicinal product concerned.
2. In the case of medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member State or Member States that granted the authorisation provided for in Article 40(3) of Directive 2001/83/EC to the importer, unless appropriate agreements have been made between the Community and the exporting country to ensure that those controls are carried out in the exporting country and that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community.
A Member State may request assistance from another Member State or from the Agency.
Article 19
1. The supervisory authorities shall be responsible for verifying on behalf of the Community that the holder of the marketing authorisation for the medicinal product for human use or the manufacturer or importer established within the Community satisfies the requirements laid down in Titles IV, IX and XI of Directive 2001/83/EC.
2. Where, in accordance with Article 122 of Directive 2001/83/EC, the Commission is informed of serious differences of opinion between Member States as to whether the holder of the marketing authorisation for the medicinal product for human use or a manufacturer or importer established within the Community satisfies the requirements referred to in paragraph 1, the Commission may, after consultation with the Member States concerned, request an inspector from the supervisory authority to undertake a new inspection of the marketing authorisation holder, the manufacturer or the importer; the inspector in question shall be accompanied by two inspectors from Member States which are not party to the dispute or by two experts nominated by the Committee for Medicinal Products for Human Use.
3. Subject to any agreements which may have been concluded between the Community and third countries in accordance with Article 18(2), the Commission may, following a reasoned request from a Member State or from the said Committee, or on its own initiative, require a manufacturer established in a third country to submit to an inspection.
The inspection shall be undertaken by inspectors from the Member States who possess the appropriate qualifications; they may be accompanied by a rapporteur or expert appointed by the said Committee. The report of the inspectors shall be made available to the Commission, the Member States and the said Committee.
Article 20
1. Where the supervisory authorities or the competent authorities of any other Member State are of the opinion that the manufacturer or importer established within the Community territory is no longer fulfilling the obligations laid down in Title IV of Directive 2001/83/EC, they shall forthwith inform the Committee for Medicinal Products for Human Use and the Commission, stating their reasons in detail and indicating the course of action proposed.
The same shall apply where a Member State or the Commission considers that one of the measures envisaged in Titles IX and XI of Directive 2001/83/EC should be applied in respect of the medicinal product concerned or where the said Committee has delivered an opinion to that effect in accordance with Article 5 of this Regulation.
2. The Commission shall request the opinion of the Agency within a time-limit which it shall determine in the light of the urgency of the matter, in order to examine the reasons advanced. Whenever practicable, the holder of the authorisation for placing the medicinal product for human use on the market shall be invited to provide oral or written explanations.
3. Following an opinion by the Agency, the Commission shall adopt the necessary provisional measures, which shall be applied immediately.
A final decision shall be adopted within six months, in accordance with the procedure referred to in Article 87(3).
4. Where urgent action is essential to protect human health or the environment, a Member State may, on its own initiative or at the Commission's request, suspend the use in its territory of a medicinal product for human use which has been authorised in accordance with this Regulation.
When it does so on its own initiative, it shall inform the Commission and the Agency of the reasons for its action at the latest on the next working day following the suspension. The Agency shall inform the other Member States without delay. The Commission shall immediately initiate the procedure provided for in paragraphs 2 and 3.
5. In this case, the Member State shall ensure that health-care professionals are rapidly informed of its action and the reasons for the action. Networks set up by professional associations may be used to this effect. The Member States shall inform the Commission and the Agency of actions taken for this purpose.
6. The suspensive measures referred to in paragraph 4 may be maintained in force until such time as a definitive decision has been reached in accordance with the procedure referred to in Article 87(3).
7. The Agency shall, upon request, inform any person concerned of the final decision and make the decision publicly accessible immediately after it has been taken.
Chapter 3
Pharmacovigilance
Article 21
For the purposes of this Chapter, Article 106(2) of Directive 2001/83/EC shall apply.
Article 22
The Agency, acting in close cooperation with the national pharmacovigilance systems established in accordance with Article 102 of Directive 2001/83/EC, shall receive all relevant information concerning suspected adverse reactions to medicinal products for human use which have been authorised by the Community in accordance with this Regulation. Where appropriate, the Committee for Medicinal Products for Human Use shall, in accordance with Article 5 of this Regulation, draw up opinions on the measures necessary. These opinions shall be made publicly accessible.
The measures referred to in the first paragraph may include amendments to the marketing authorisation granted in accordance with Article 10. They shall be adopted in accordance with the procedure referred to in Article 87(3).
The holder of the marketing authorisation and the competent authorities of Member States shall ensure that all relevant information concerning suspected adverse reactions to the medicinal products authorised under this Regulation are brought to the attention of the Agency in accordance with the provisions of this Regulation. Patients shall be encouraged to communicate any adverse reaction to health-care professionals.
Article 23
The holder of an authorisation for a medicinal product for human use granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
That qualified person shall reside in the Community and shall be responsible for the following:
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a) |
establishing and managing a system which ensures that information concerning all suspected adverse reactions which are reported to the personnel of the company and to medical representatives is collected, evaluated and collated so that it may be accessed at a single point within the Community; |
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b) |
preparing the reports referred to in Article 24(3) for the competent authorities of the Member States and the Agency in accordance with the requirements of this Regulation; |
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c) |
ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the risks and benefits of a medicinal product is answered fully and promptly, including the provision of information regarding the volume of sales or prescriptions for the medicinal product concerned; |
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d) |
providing the competent authorities with any other information relevant to the evaluation of the risks and benefits of a medicinal product, particularly information concerning post-authorisation safety studies. |
Article 24
1. The holder of the marketing authorisation for a medicinal product for human use shall ensure that all suspected serious adverse reactions to a medicinal product authorised in accordance with this Regulation occurring within the Community which a health-care professional brings to his attention are recorded and reported promptly to Member States within the territory of which the incident occurred, and no later than 15 days following the receipt of the information.
The holder of the marketing authorisation shall record any other suspected serious adverse reactions occurring within the Community, in accordance with the guide referred to in Article 26, of which he may reasonably be expected to be aware, and promptly notify the competent authority of Member States in the territory of which the incident occurred and the Agency, and no later than 15 days following receipt of the information.
2. The holder of the marketing authorisation for a medicinal product for human use shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to Member States and the Agency, and no later than 15 days following receipt of the information. The provisions for the reporting of suspected unexpected adverse reactions which are not serious, whether occurring in the Community or in a third country, shall be adopted in accordance with the procedure referred to in Article 87(2).
Save in exceptional circumstances, these reactions shall be transmitted electronically in the form of a report and in accordance with the guide referred to in Article 26.
3. The holder of the marketing authorisation for a medicinal product for human use shall maintain detailed records of all suspected adverse reactions within or outside the Community which are reported to him by a health-care professional.
Unless other requirements have been laid down as a condition for the granting of the marketing authorisation by the Community, these records shall be submitted, in the form of a periodic safety update report, to the Agency and Member States immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the Community market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request.
These reports shall be accompanied by a scientific evaluation, particularly of the risk-benefit balance of the medicinal product.
4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. The Commission shall adopt any such provisions in accordance with the procedure referred to in Article 87(2).
5. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the Agency.
In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading.
Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties.
Article 25
Each Member State shall ensure that all suspected serious adverse reactions occurring within their territory to a medicinal product for human use authorised in accordance with this Regulation which are brought to their attention are recorded and reported promptly to the Agency and the marketing authorisation holder, and no later than 15 days following receipt of the information.
The Agency shall forward the information to the national pharmacovigilance systems set up in accordance with Article 102 of Directive 2001/83/EC.
Article 26
The Commission, in consultation with the Agency, Member States and interested parties, shall draw up a guide on the collection, verification and presentation of adverse-reaction reports. This guide shall contain, in particular, for the benefit of health-care professionals, recommendations concerning the communication of information on adverse reactions.
In accordance with this guide, holders of marketing authorisations shall use the medical terminology accepted at international level for the transmission of adverse-reaction reports.
The Agency, in consultation with Member States and the Commission, shall set up a data-processing network for the rapid transmission of information to the competent Community authorities in the event of an alert relating to faulty manufacture, serious adverse reactions and other pharmacovigilance data regarding medicinal products authorised in accordance with Article 6 of Directive 2001/83/EC. Such data shall be made publicly accessible, if relevant, after evaluation.
For a period of five years following the initial placing on the market in the Community, the Agency may request that the marketing authorisation holder arrange for specific pharmacovigilance data to be collected from targeted groups of patients. The Agency shall state the reasons for the request. The marketing authorisation holder shall collate and assess the data collected and submit it to the Agency for evaluation.
Article 27
The Agency shall collaborate with the World Health Organisation in matters of international pharmacovigilance and shall take the necessary steps to submit to it, promptly, appropriate and adequate information regarding the measures taken in the Community which may have a bearing on public health protection in third countries; it shall send a copy thereof to the Commission and the Member States.
Article 28
The Agency and Member States' competent authorities shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of routes of authorisation, including the use of collaborative approaches, to maximise use of resources available within the Community.
Article 29
Any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 87(2).
TITLE III
AUTHORISATION AND SUPERVISION OF VETERINARY MEDICINAL PRODUCTS
Chapter 1
Submission and examination of applications — Authorisations
Article 30
1. A Committee for Medicinal Products for Veterinary Use is hereby established. The Committee shall be part of the Agency.
2. Without prejudice to Article 56 and other tasks which Community law may confer on it, in particular under Regulation (EEC) No 2377/90 (17), the Committee for Medicinal Products for Veterinary Use shall be responsible for drawing up the opinion of the Agency on any question concerning the admissibility of files submitted in accordance with the centralised procedure, the granting, variation, suspension or revocation of an authorisation to place a veterinary medicinal product on the market arising in accordance with the provisions of this Title, and pharmacovigilance.
3. At the request of the Executive Director of the Agency or the Commission representative, the Committee for Medicinal Products for Veterinary Use shall also draw up opinions on any scientific matters concerning the evaluation of veterinary medicinal products. The Committee shall take due account of any requests from Member States for an opinion. The Committee shall also formulate an opinion whenever there is disagreement in the assessment of a veterinary medicinal product through the mutual recognition procedure. The opinion of the Committee shall be made publicly accessible.
Article 31
1. Each application for the authorisation of a medicinal product for veterinary use shall specifically and exhaustively include the particulars and documents as referred to in Articles 12(3), 13, 13a, 13b and 14 of, and Annex I to, Directive 2001/82/EC. These particulars and documents shall take account of the unique, Community nature of the authorisation requested and, otherwise than in exceptional cases relating to the application of the law on trade marks, shall include the use of a single name for the medicinal product.
The application shall be accompanied by the fee payable to the Agency for the examination of the application.
2. In the case of a veterinary medicinal product containing or consisting of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC, the application shall also be accompanied by:
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a copy of the written consent of the competent authorities to the deliberate release into the environment of the genetically modified organisms for research and development purposes, as provided for in Part B of Directive 2001/18/EC or in Part B of Directive 90/220/EEC; |
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the complete technical file supplying the information required under Annexes III and IV to Directive 2001/18/EC; |
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the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and |
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the results of any investigations performed for the purposes of research or development. |
Articles 13 to 24 of Directive 2001/18/EC shall not apply to veterinary medicinal products containing or consisting of genetically modified organisms.
3. The Agency shall ensure that the opinion of the Committee for Medicinal Products for Veterinary Use is given within 210 days after the receipt of a valid application.
In the case of a veterinary medicinal product containing or consisting of genetically modified organisms, the opinion of the said Committee must respect the environmental safety requirements laid down by Directive 2001/18/EC. During the process of evaluating applications for marketing authorisations for veterinary medicinal products containing or consisting of genetically modified organisms, necessary consultations shall be held by the rapporteur with the bodies set up by the Community or the Member States in accordance with Directive 2001/18/EC.
4. The Commission shall, in consultation with the Agency, Member States and interested parties, draw up a detailed guide regarding the form in which applications for authorisation are to be presented.
Article 32
1. In order to prepare its opinion, the Committee for Medicinal Products for Veterinary Use:
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shall verify that the particulars and documents submitted in accordance with Article 31 comply with the requirements of Directive 2001/82/EC and examine whether the conditions specified in this Regulation for granting a marketing authorisation are satisfied; |
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may request that an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose test the veterinary medicinal product, its starting materials and, where appropriate, its intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application are satisfactory; |
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may request a Community reference laboratory, Official Medicines Control Laboratory or laboratory that a Member State has designated for that purpose to verify, using samples provided by the applicant, that the analytical detection method proposed by the applicant for the purposes of Article 12(3)(j), second indent, of Directive 2001/82/EC is satisfactory and is suitable for use to reveal the presence of residue levels, particularly those above the maximum residue level accepted by the Community in accordance with the provisions of Regulation (EEC) No 2377/90; |
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may request the applicant to supplement the particulars accompanying the application within a specific time-limit. Where the said Committee avails itself of this option, the time-limit laid down in Article 31(3), first subparagraph shall be suspended until such time as the supplementary information requested has been provided. Likewise, the time-limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations. |
2. In those cases where the analytical method has not been subject to verification by one of the abovementioned laboratories under the procedures established by Regulation (EEC) No 2377/90, the verification shall be carried out within the framework of this Article.
Article 33
1. Upon receipt of a written request from the Committee for Medicinal Products for Veterinary Use, a Member State shall forward the information establishing that the manufacturer of a veterinary medicinal product or the importer from a third country is able to manufacture the veterinary medicinal product concerned and/or carry out the necessary control tests in accordance with the particulars and documents supplied pursuant to Article 31.
2. Where it considers it necessary in order to complete its examination of the application, the said Committee may require the applicant to undergo a specific inspection of the manufacturing site of the veterinary medicinal product concerned. Such inspections may be made unannounced.
The inspection, which shall be completed within the time-limit referred to in Article 31(3), first subparagraph, shall be undertaken by inspectors from the Member State who possess the appropriate qualifications; they may be accompanied by a rapporteur or expert appointed by the said Committee.
Article 34
1. The Agency shall forthwith inform the applicant if the opinion of the Committee for Medicinal Products for Veterinary Use is that:
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the application does not satisfy the criteria for authorisation set out in this Regulation; |
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the summary of the product characteristics should be amended; |
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the labelling or package leaflet of the product is not in compliance with Title V of Directive 2001/82/EC; |
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the authorisation should be granted subject to the conditions provided for in Article 39(7). |
2. Within 15 days after receipt of the opinion referred to in paragraph 1, the applicant may provide written notice to the Agency that he wishes to request a re-examination of the opinion. In that case the applicant shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion.
Within 60 days after receipt of the grounds for the request, the said Committee shall re-examine its opinion in accordance with the conditions laid down in Article 62(1), fourth subparagraph. The reasons for the conclusion reached shall be annexed to the final opinion.
3. Within 15 days after its adoption, the Agency shall forward the final opinion of the said Committee to the Commission, to Member States and to the applicant, together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions.
4. If an opinion is favourable to the granting of the relevant authorisation to place the relevant veterinary medicinal product on the market, the following documents shall be annexed to the opinion:
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a draft summary of the product characteristics, as referred to in Article 14 of Directive 2001/82/EC; where appropriate, this draft shall reflect differences in the veterinary conditions in the Member States; |
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in the case of a veterinary medicinal product intended for administration to food-producing animals, a statement of the maximum residue level which may be accepted by the Community in accordance with Regulation (EEC) No 2377/90; |
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c) |
details of any conditions or restrictions which should be imposed on the supply or use of the veterinary medicinal product concerned, including the conditions under which the veterinary medicinal product may be made available to users, in conformity with the criteria laid down in Directive 2001/82/EC; |
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details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product; |
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the draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Title V of Directive 2001/82/EC; |
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the assessment report. |
Article 35
1. Within 15 days after receipt of the opinion referred to in Article 30(2), the Commission shall prepare a draft of the decision to be taken in respect of the application.
Where a draft decision envisages the granting of marketing authorisation, it shall include or make reference to the documents mentioned in Article 34(4)(a) to (e).
Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.
The draft decision shall be forwarded to Member States and the applicant.
2. The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 87(3).
3. The Standing Committee for Veterinary Medicinal Products referred to in Article 87(1) shall adjust its rules of procedure so as to take account of the tasks assigned to it by this Regulation.
The adjustments shall provide that:
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the opinion of the said Standing Committee is to be given in writing; |
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Member States shall have 22 days to forward their written observations on the draft decision to the Commission; however, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days; |
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Member States may request in writing that the draft decision referred to in paragraph 1 be discussed at a plenary meeting of the said Standing Committee, stating their reasons in detail. |
4. Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion delivered by the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.
5. The provisions necessary for the implementation of paragraph 4 shall be adopted by the Commission in accordance with the procedure referred to in Article 87(2).
6. The Agency shall disseminate the documents referred to in Article 34(4) (a) to (e).
Article 36
If an applicant withdraws an application for a marketing authorisation submitted to the Agency before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the Agency. The Agency shall make this information publicly accessible and shall publish the assessment report, if available, after deletion of all information of a commercially confidential nature.
Article 37
1. The marketing authorisation shall be refused if, after verification of the particulars and documents submitted in accordance with Article 31, it appears that:
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the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the veterinary medicinal product; |
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in the case of zootechnical veterinary medicinal products and performance enhancers, when the safety and welfare of the animals and/or consumer safety have not been sufficiently taken into account; |
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the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard for the consumer or is insufficiently substantiated; |
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the veterinary medicinal product is presented for a use prohibited under other Community provisions. |
Authorisation shall likewise be refused if particulars or documents provided by the applicant in accordance with Article 31 are incorrect or if the labelling and package leaflets proposed by the applicant are not in accordance with Title V of Directive 2001/82/EC.
2. The refusal of a Community marketing authorisation shall constitute a prohibition on the placing on the market of the veterinary medicinal product concerned throughout the Community.
3. Information about all refusals and the reasons for them shall be made publicly accessible.
Article 38
1. Without prejudice to Article 71 of Directive 2001/82/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community. It shall confer the same rights and obligations in each of the Member States as a marketing authorisation granted by that Member State in accordance with Article 5 of Directive 2001/82/EC.
Authorised veterinary medicinal products shall be entered in the Community Register of Medicinal Products and shall be given a number which shall appear on the packaging.
2. Notification of marketing authorisation shall be published in the Official Journal of the European Union, quoting in particular the date of authorisation and the number in the Community Register, any International Non-proprietary Name (INN) of the active substance of the medicinal product, its pharmaceutical form, and any Anatomical Therapeutic Chemical Veterinary Code (ATC Vet Code).
3. The Agency shall immediately publish the assessment report on the veterinary medicinal product drawn up by the Committee for Medicinal Products for Veterinary Use and the reasons for its opinion in favour of granting authorisation, after deletion of any information of a commercially confidential nature.
The European Public Assessment Report (EPAR) shall include a summary written in a manner that is understandable to the public. The summary shall contain in particular a section relating to the conditions of use of the medicinal product.
4. After a marketing authorisation has been granted, the holder of the authorisation shall inform the Agency of the dates of actual placing on the market of the veterinary medicinal product in Member States, taking into account the various presentations authorised.
The holder shall also notify the Agency if the product ceases to be placed on the market, either temporarily or permanently. Such notification shall, other than in exceptional circumstances, be made no less than 2 months before the interruption in the placing of the product on the market.
Upon request by the Agency, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the Agency with all data relating to the volume of sales of the medicinal product at Community level, broken down by Member State, and any data in the holder's possession relating to the volume of prescriptions.
Article 39
1. Without prejudice to paragraphs 4 and 5, a marketing authorisation shall be valid for five years.
2. The marketing authorisation may be renewed after five years on the basis of a re-evaluation by the Agency of the risk-benefit balance.
To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. The Agency may require the applicant to submit the listed documents at any time.
3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the Commission decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2.
4. Any authorisation which is not followed by the actual placing of the medicinal product for veterinary use on the Community market within three years after authorisation shall cease to be valid.
5. When an authorised medicinal product previously placed on the market is no longer actually present on the market for three consecutive years, the authorisation shall cease to be valid.
6. In exceptional circumstances and on public and/or animal health grounds the Commission may grant exemptions from the provisions of paragraphs 4 and 5. Such exemptions must be duly justified.
7. In exceptional circumstances and following consultation with the applicant, authorisation may be granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning product safety, notification to the relevant authorities of any incident relating to its use, and action to be taken. This authorisation may be granted only for objective, verifiable reasons. Continuation of the authorisation shall be linked to the annual reassessment of these conditions.
8. When an application is submitted for a marketing authorisation in respect of veterinary medicinal products of major interest, particularly from the point of view of animal health and from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. The request shall be duly substantiated.
If the Committee for Medicinal Products for Veterinary Use accepts the request, the time-limit laid down in Article 31(3), first subparagraph, shall be reduced to 150 days.
9. When adopting its opinion, the said Committee shall include a proposal concerning the conditions for the prescription or use of the veterinary medicinal products.
10. Veterinary medicinal products which have been authorised in accordance with the provisions of this Regulation shall benefit from the provisions on protection in Articles 13 and 13a of Directive 2001/82/EC.
Article 40
The granting of authorisation shall not affect the civil or criminal liability of the manufacturer or the holder of the marketing authorisation pursuant to the applicable national law in Member States.
Chapter 2
Supervision and sanctions
Article 41
1. After an authorisation has been granted in accordance with this Regulation, the holder of the marketing authorisation shall, in respect of the methods of manufacture and control provided for in Article 12(3)(d) and (i) of Directive 2001/82/EC, take account of technical and scientific progress and make any variations that may be required to enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods. He shall apply for approval of these variations in accordance with this Regulation.
2. The competent authority of a Member State or the Agency may require the holder of the marketing authorisation to provide substances in sufficient quantities for the performance of tests to detect the presence of residues of the veterinary medicinal products concerned in foodstuffs of animal origin.
3. At the request of the competent authority of a Member State or the Agency, the holder of the marketing authorisation shall provide technical expertise to facilitate the implementation of the analytical method for detecting residues of veterinary medicinal products by the Community reference laboratory or, where appropriate, national reference laboratories designated in accordance with Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (18).
4. The holder of the marketing authorisation shall forthwith supply to the Agency, the Commission and the Member States any new information which might entail the variation of the particulars or documents referred to in Articles 12(3), 13, 13a, 13b and 14 of Directive 2001/82/EC, in Annex I thereto, or in Article 34(4) of this Regulation.
He shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the veterinary medicinal product concerned.
In order that the risk-benefit balance may be continuously assessed, the Agency may at any time ask the holder of the marketing authorisation to forward data justifying that the risk-benefit balance remains favourable.
5. If the holder of the marketing authorisation for the veterinary medicinal product proposes to make any variation of the particulars and documents referred to in paragraph 4, he shall submit the relevant application to the Agency.
6. The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation in accordance with the procedure referred to in Article 87(2).
Article 42
The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and of the data submitted.
Article 43
1. In the case of veterinary medicinal products manufactured within the Community, the supervisory authorities shall be the competent authorities of the Member State or Member States which granted the manufacturing authorisation provided for in Article 44(1) of Directive 2001/82/EC in respect of the manufacture of the medicinal product concerned.
2. In the case of veterinary medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member State or Member States that granted the authorisation provided for in Article 44(3) of Directive 2001/82/EC to the importer, unless appropriate agreements have been made between the Community and the exporting country to ensure that those controls are carried out in the exporting country and that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community.
A Member State may request assistance from another Member State or the Agency.
Article 44
1. The supervisory authorities shall be responsible for verifying on behalf of the Community that the holder of the marketing authorisation for the veterinary medicinal product or the manufacturer or importer established within the Community satisfies the requirements laid down in Titles IV, VII and VIII of Directive 2001/82/EC.
2. Where, in accordance with Article 90 of Directive 2001/82/EC, the Commission is informed of serious differences of opinion between Member States as to whether the holder of the marketing authorisation for the veterinary medicinal product or a manufacturer or importer established within the Community satisfies the requirements referred to in paragraph 1, the Commission may, after consultation with the Member States concerned, request an inspector from the supervisory authority to undertake a new inspection of the holder of the marketing authorisation, the manufacturer or the importer; the inspector in question shall be accompanied by two inspectors from Member States which are not party to the dispute and/or by two experts nominated by the Committee for Medicinal Products for Veterinary Use.
3. Subject to any agreements which may have been concluded between the Community and third countries in accordance with Article 43(2), the Commission may, upon receipt of a reasoned request from a Member State or from the said Committee, or on its own initiative, require a manufacturer established in a third country to submit to an inspection.
The inspection shall be undertaken by inspectors from the Member State who possess the appropriate qualifications; they may be accompanied by a rapporteur or expert appointed by the said Committee. The report of the inspectors shall be made available to the Commission, the Member States and the said Committee.
Article 45
1. Where the supervisory authorities or the competent authorities of any other Member State are of the opinion that the manufacturer or importer established within the Community is no longer fulfilling the obligations laid down in Title VII of Directive 2001/82/EC, they shall forthwith inform the Committee for Medicinal Products for Veterinary Use and the Commission, stating their reasons in detail and indicating the course of action proposed.
The same shall apply where a Member State or the Commission considers that one of the measures envisaged in Title VIII of Directive 2001/82/EC should be applied in respect of the veterinary medicinal product concerned or where the said Committee has delivered an opinion to that effect in accordance with Article 30 of this Regulation.
2. The Commission shall request the opinion of the Agency within a time-limit which it shall determine in the light of the urgency of the matter, in order to examine the reasons advanced. Whenever practicable, the holder of the marketing authorisation for the medicinal product shall be invited to provide oral or written explanations.
3. Following an opinion by the Agency, the Commission shall adopt the necessary provisional measures, which shall be applied immediately.
A final decision shall be adopted within six months, in accordance with the procedure referred to in Article 87(3).
4. Where urgent action is essential to protect human or animal health or the environment, a Member State may, on its own initiative or at the Commission's request, suspend the use on its territory of a veterinary medicinal product which has been authorised in accordance with this Regulation.
When it does so on its own initiative, the Member State shall inform the Commission and the Agency of the reasons for its action at the latest on the next working day following the suspension. The Agency shall inform the other Member States without delay. The Commission shall immediately initiate the procedure provided for in paragraphs 2 and 3.
5. In this case, the Member State shall ensure that health-care professionals are rapidly informed of its action and the reasons for the action. Networks set up by professional associations may be used to this effect. Member States shall inform the Commission and the Agency of actions taken for this purpose.
6. The suspensive measures referred to in paragraph 4 may be maintained until such time as a definitive decision has been reached in accordance with the procedure referred to in Article 87(3).
7. The Agency shall, upon request, inform any person concerned of the final decision and make the decision publicly accessible, immediately after it has been taken.
Chapter 3
Pharmacovigilance
Article 46
For the purpose of this Chapter, Article 77(2) of Directive 2001/82/EC shall apply.
Article 47
The Agency, acting in close cooperation with the national pharmacovigilance systems established in accordance with Article 73 of Directive 2001/82/EC, shall receive all relevant information about suspected adverse reactions to veterinary medicinal products which have been authorised by the Community in accordance with this Regulation. Where appropriate the Committee for Medicinal Products for Veterinary Use shall, in accordance with Article 30 of this Regulation, draw up opinions on the measures necessary. These opinions shall be made publicly accessible.
These measures may include amendments to the marketing authorisation granted in accordance with Article 35. They shall be adopted in accordance with the procedure referred to in Article 87(3).
The holder of the marketing authorisation and the competent authorities of the Member States shall ensure all relevant information about suspected adverse reactions to the veterinary medicinal products authorised under this Regulation is brought to the attention of the Agency in accordance with the provisions of this Regulation. Animal owners and breeders shall be encouraged to communicate any adverse reaction to health-care professionals or to the competent national authorities responsible for pharmacovigilance.
Article 48
The holder of the marketing authorisation for a veterinary medicinal product granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
That qualified person shall reside in the Community and shall be responsible for the following:
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a) |
establishing and managing a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company and to medical representatives is collected, evaluated and collated so that it may be accessed at a single point within the Community; |
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b) |
preparing the reports referred to in Article 49(3) for the competent authorities of the Member States and the Agency in accordance with the requirements of this Regulation; |
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c) |
ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the risks and benefits of a veterinary medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions for the veterinary medicinal product concerned; |
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d) |
providing the competent authorities with any other information relevant to the evaluation of the risks and benefits of a veterinary medicinal product, particularly information concerning post-authorisation safety studies, including information regarding the validity of the withdrawal period or lack of expected efficacy or potential environmental problems. |
Article 49
1. The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious adverse reactions, and adverse human reactions to a veterinary medicinal product authorised in accordance with the provisions of this Regulation occurring within the Community which a health-care professional brings to his attention are recorded and reported promptly to the Member States in the territory of which the incident occurred no later than 15 days following receipt of the information.
The holder of the marketing authorisation shall record any other suspected serious adverse reactions and human adverse reactions occurring within the Community, in accordance with the guidelines referred to in Article 51, of which he may reasonably be expected to be aware, and promptly notify Member States in the territory of which the incident occurred and the Agency, and no later than 15 days following receipt of the information.
2. The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious unexpected adverse reactions, and adverse human reactions, and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to the Member States and the Agency, and no later than 15 days following receipt of the information. The provisions for the reporting of suspected unexpected adverse reactions which are not serious, whether occurring in the Community or in a third country, shall be adopted in accordance with the procedure referred to in Article 87(2).
Save in exceptional circumstances, these reactions shall be transmitted electronically in the form of a report and in accordance with the guide referred to in Article 51.
3. The holder of the marketing authorisation for a veterinary medicinal product shall maintain detailed records of all suspected adverse reactions occurring within or outside the Community which are reported to him.
Unless other requirements have been laid down as a condition for the granting of the marketing authorisation by the Community, these records shall be submitted, in the form of a periodic safety update report, to the Agency and Member States immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the Community market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request.
These reports shall be accompanied by a scientific evaluation, particularly of the risk-benefit balance of the medicinal product.
4. The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation. The Commission shall adopt any such provisions in accordance with the procedure referred to in Article 87(2).
5. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the Agency.
In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading.
Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties.
Article 50
Each Member State shall ensure that all suspected serious adverse reactions, and adverse human reactions, occurring within its territory to a veterinary medicinal product authorised in accordance with the provisions of this Regulation which are brought to its attention are recorded and reported promptly to the Agency and the holder of the marketing authorisation for the veterinary medicinal product, and no later than 15 days following receipt of the information.
The Agency shall forward the information to the national pharmacovigilance systems set up in accordance with Article 73 of Directive 2001/82/EC.
Article 51
The Commission, in consultation with the Agency, Member States and interested parties, shall draw up a guide on the collection, verification and presentation of adverse-reaction reports. This guide shall contain, in particular, for the benefit of health-care professionals, recommendations concerning the communication of information on adverse reactions.
In accordance with this guide, holders of marketing authorisations shall use the medical terminology accepted at international level for the transmission of adverse-reaction reports.
The Agency, in consultation with the Member States and the Commission, shall set up a data-processing network for the rapid transmission of data between the competent Community authorities in the event of an alert relating to faulty manufacture, serious adverse reactions and other pharmacovigilance data regarding veterinary medicinal products authorised in accordance with Article 5 of Directive 2001/82/EC.
For a period of five years following the initial placing on the market in the Community, the Agency may request that the marketing authorisation holder arrange for specific pharmacovigilance data to be collected from targeted groups of animals. The Agency shall state the reasons for the request. The marketing authorisation holder shall collate and assess the data collected and submit it to the Agency for evaluation.
Article 52
The Agency shall cooperate with international organisations concerned with veterinary pharmacovigilance.
Article 53
The Agency and the Member States' competent authorities shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of routes of authorisation, including the use of collaborative approaches, to maximise use of resources available within the Community.
Article 54
Any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 87(2).
TITLE IV
THE EUROPEAN MEDICINES AGENCY RESPONSIBILITIES AND ADMINISTRATIVE STRUCTURE
Chapter 1
Tasks of the Agency
Article 55
A European Medicines Agency is hereby established.
The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
Article 56
1. The Agency shall comprise:
|
a) |
the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use; |
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b) |
the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use; |
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c) |
the Committee on Orphan Medicinal Products; |
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d) |
the Committee on Herbal Medicinal Products; |
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e) |
a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them; |
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f) |
an Executive Director, who shall exercise the responsibilities set out in Article 64; |
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g) |
a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67. |
2. The committees referred to in paragraph 1(a) to (d) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30.
When establishing working parties and scientific advisory groups, the committees shall in their rules of procedures referred to in Article 61(8) provide for:
|
a) |
the appointment of members of these working parties and scientific advisory groups on the basis of the lists of experts referred to in the second subparagraph of Article 62(2); and |
|
b) |
consultation of these working parties and scientific advisory groups. |
3. The Executive Director, in close consultation with the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use, shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in Article 57(1)(n), particularly regarding the development of new therapies.
Each committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings.
4. The Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.
Article 57
1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.
To this end, the Agency, acting particularly through its committees, shall undertake the following tasks:
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a) |
coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorisation procedures; |
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b) |
transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; |
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c) |
coordination of the supervision, under practical conditions of use, of medicinal products which have been authorised within the Community and the provision of advice on the measures necessary to ensure the safe and effective use of these products, in particular by evaluation, coordination of the implementation of pharmacovigilance obligations and the monitoring of such implementation; |
|
d) |
ensuring the dissemination of information on adverse reactions to medicinal products authorised in the Community, by means of a database permanently accessible to all Member States; health-care professionals, marketing authorisation holders and the public shall have appropriate levels of access to these databases, with personal data protection being guaranteed; |
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e) |
assisting Member States with the rapid communication of information concerning pharmacovigilance to health-care professionals; |
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f) |
distributing appropriate pharmacovigilance information to the general public; |
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g) |
advising on the maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin in accordance with Regulation (EEC) No 2377/90; |
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h) |
providing scientific advice on the use of antibiotics in food-producing animals in order to minimise the occurrence of bacterial resistance in the Community; this advice shall be updated when needed; |
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i) |
coordinating the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and the verification of compliance with pharmacovigilance obligations; |
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j) |
upon request, providing technical and scientific support in order to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of medicinal products, in particular in the context of discussions organised in the framework of international conferences on harmonisation; |
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k) |
recording the status of marketing authorisations for medicinal products granted in accordance with Community procedures; |
|
l) |
creating a database on medicinal products, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner; |
|
m) |
assisting the Community and Member States in the provision of information to health-care professionals and the general public about medicinal products evaluated by the Agency; |
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n) |
advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products; |
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o) |
checking that the conditions laid down in Community legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation; |
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p) |
drawing up, at the Commission's request, any other scientific opinion concerning the evaluation of medicinal products or the starting materials used in the manufacture of medicinal products; |
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q) |
with a view to the protection of public health, compilation of scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products available to prevent, or to treat, the effects of such agents; |
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r) |
coordination of the supervision of the quality of medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose; |
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s) |
forwarding annually to the budgetary authority any information relevant to the outcome of the evaluation procedures. |
2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the Community.
Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public.
Article 58
1. The Agency may give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply.
2. The said Committee shall establish specific procedural rules for the implementation of paragraph 1, as well as for the provision of scientific advice.
Article 59
1. The Agency shall take care to ensure early identification of potential sources of conflict between its scientific opinions and those of other bodies established under Community law carrying out a similar task in relation to issues of common concern.
2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific information is shared and to identify the scientific points which potentially conflict.
3. Where there is a fundamental conflict over scientific points and the body concerned is a Community agency or a scientific committee, the Agency and the body concerned shall work together either to resolve the conflict or to submit a joint document to the Commission clarifying the scientific points of conflict. This document shall be published immediately after its adoption.
4. Save as otherwise provided in this Regulation, in Directive 2001/83/EC or in Directive 2001/82/EC, where there is a fundamental conflict over scientific points and the body concerned is a body in a Member State, the Agency and the national body concerned shall work together either to resolve the conflict or to prepare a joint document clarifying the scientific points of conflict. This document shall be published immediately after its adoption.
Article 60
At the request of the Commission, the Agency shall, in respect of authorised medicinal products, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product provides.
Article 61
1. Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use and one member and one alternate to the Committee for Medicinal Products for Veterinary Use.
The alternates shall represent and vote for the members in their absence and may act as rapporteurs in accordance with Article 62.
Members and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human and veterinary use as appropriate and shall represent the competent national authorities.
2. The committees may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
With a view to the co-opting of such members, the committees shall identify the specific complementary scientific competence of the additional member(s). Co-opted members shall be chosen among experts nominated by Member States or the Agency.
3. The members of each Committee may be accompanied by experts in specific scientific or technical fields.
4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the committees, working parties and scientific advisory groups and all other meetings convened by the Agency or its committees.
5. In addition to their task of providing objective scientific opinions to the Community and Member States on the questions which are referred to them, the members of each committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorisation.
6. Members of the committees and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies. Each competent national authority shall monitor the scientific level and independence of the evaluation carried out and facilitate the activities of nominated committee members and experts. Member States shall refrain from giving committee members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency.
7. When preparing the opinion, each committee shall use its best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based.
8. Each committee shall establish its own rules of procedure.
These rules shall, in particular, lay down:
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a) |
procedures for appointing and replacing the Chairman; |
|
b) |
procedures relating to working parties and scientific advisory groups; and |
|
c) |
a procedure for the urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance. |
They shall enter into force after receiving a favourable opinion from the Commission and the Management Board.
Article 62
1. Where, in accordance with the provisions of this Regulation, the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products or the Committee for Medicinal Products for Veterinary Use is required to evaluate a medicinal product, it shall appoint one of its members to act as rapporteur for the coordination of the evaluation. The Committee concerned may appoint a second member to act as co-rapporteur.
When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) and Article 31(3) are met.
The substance of the opinion shall be included in the assessment report published pursuant to Article 13(3) and Article 38(3).
If there is a request for re-examination of one of its opinions, the Committee concerned shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the initial opinion. The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the initial opinion. The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination.
2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products or the Committee for Medicinal Products for Veterinary Use, together with an indication of their qualifications and specific areas of expertise.
The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and other experts appointed directly by the Agency. The list shall be updated.
3. The provision of services by rapporteurs or experts shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and his employer.
The person concerned, or his employer, shall be remunerated in accordance with a scale of fees to be included in the financial arrangements established by the Management Board.
4. The performance of scientific services for which there are several potential providers may result in a call for an expression of interest, if the scientific and technical context allows, and if it is compatible with the tasks of the Agency, in particular to ensure a high level of public health protection.
The Management Board shall adopt the appropriate procedures on a proposal from the Executive Director.
5. The Agency or any of the committees referred to in Article 56(1) may use the services of experts for the discharge of other specific tasks for which they are responsible.
Article 63
1. The membership of the committees referred to in Article 56(1) shall be made public. When each appointment is published, the professional qualifications of each member shall be specified.
2. Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices.
The Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts.
Members of the Management Board, members of the committees, rapporteurs and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence with respect to the items on the agenda. These declarations shall be made available to the public.
Article 64
1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post.
2. The Executive Director shall be the legal representative of the Agency. He shall be responsible:
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a) |
for the day-to-day administration of the Agency; |
|
b) |
for managing all the Agency resources necessary for conducting the activities of the committees referred to in Article 56(1), including making available appropriate scientific and technical support; |
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c) |
for ensuring that the time-limits laid down in Community legislation for the adoption of opinions by the Agency are complied with; |
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d) |
for ensuring appropriate coordination between the committees referred to in Article 56(1); |
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e) |
for the preparation of the draft statement of estimates of the Agency's revenue and expenditure, and execution of its budget; |
|
f) |
for all staff matters; |
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g) |
for providing the secretariat for the Management Board. |
3. Each year the Executive Director shall submit a draft report covering the activities of the Agency in the previous year and a draft work programme for the coming year to the Management Board for approval, making a distinction between the Agency's activities concerning medicinal products for human use, those concerning herbal medicinal products and those concerning veterinary medicinal products.
The draft report covering the activities of the Agency in the previous year shall include information about the number of applications evaluated within the Agency, the time taken for completion of the evaluation and the medicinal products authorised, rejected or withdrawn.
Article 65
1. The Management Board shall consist of one representative of each Member State, two representatives of the Commission and two representatives of the European Parliament.
In addition, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint the Management Board.
The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographic spread within the European Union.
2. The members of the Management Board shall be appointed on the basis of their relevant expertise in management and, if appropriate, experience in the field of medicinal products for human or veterinary use.
3. Each Member State and the Commission shall appoint their members of the Management Board as well as an alternate who will replace the member in his absence and vote on his behalf
4. The term of office of the representatives shall be three years. The term of office may be renewed.
5. The Management Board shall elect its Chairman from among its members.
The term of office of the Chairman shall be three years and shall expire when he ceases to be a member of the Management Board. The term of office may be renewed once.
6. Decisions of the Management Board shall be adopted by a majority of two-thirds of its members.
7. The Management Board shall adopt its rules of procedure.
8. The Management Board may invite the chairmen of the scientific committees to attend its meetings, but they shall not have the right to vote.
9. The Management Board shall approve the annual work programme of the Agency programme and forward it to the European Parliament, the Council, the Commission and the Member States.
10. The Management Board shall adopt the annual report on the Agency's activities and forward it by 15 June at the latest to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States.
Article 66
The Management Board shall:
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a) |
adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use (Article 61); |
|
b) |
adopt procedures for the performance of scientific services (Article 62); |
|
c) |
appoint the Executive Director (Article 64); |
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d) |
adopt the annual work programme and forward it to the European Parliament, the Council, the Commission and the Member States (Article 65); |
|
e) |
approve the annual report on the Agency's activities and forward it by 15 June at the latest to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States (Article 65); |
|
f) |
adopt the budget of the Agency (Article 67); |
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g) |
adopt the internal financial provisions (Article 67); |
|
h) |
adopt provisions implementing the Staff Regulations (Article 75); |
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i) |
develop contacts with stakeholders and stipulate the conditions applicable (Article 78); |
|
j) |
adopt provisions for providing assistance to pharmaceutical companies (Article 79); |
|
k) |
adopt rules to ensure the availability to the public of information concerning the authorisation or supervision of medicinal products (Article 80). |
Chapter 2
Financial Provisions
Article 67
1. Estimates of all the revenue and expenditure of the Agency shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the budget of the Agency.
2. The revenue and expenditure shown in the budget shall be in balance.
3. The Agency's revenue shall consist of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency.
The European Parliament and the Council (hereinafter referred to as ‘the budgetary authority’) shall reexamine, when necessary, the level of the Community contribution on the basis of an evaluation of needs and taking account of the level of fees.
4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall receive adequate public funding commensurate with the tasks conferred.
5. The expenditure of the Agency shall include staff remuneration, administrative and infrastructure costs, and operating expenses as well as expenses resulting from contracts entered into with third parties.
6. Each year the Management Board, on the basis of a draft drawn up by the Executive Director, shall produce an estimate of revenue and expenditure for the Agency for the following financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest.
7. The estimate shall be forwarded by the Commission to the budgetary authority together with the preliminary draft general budget of the European Union.
8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.
9. The budgetary authority shall authorise the appropriations for the subsidy to the Agency.
The budgetary authority shall adopt the establishment plan for the Agency.
10. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly.
11. Any modification of the establishment plan and of the budget shall be the subject of an amending budget, which is forwarded for the purposes of information to the budgetary authority.
12. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof.
Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 68
1. The Executive Director shall implement the budget of the Agency.
2. By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation applicable to the general budget of the European Communities (19) (hereinafter referred to as the ‘general Financial Regulation’).
3. By 31 March at the latest following each financial year, the Commission's accounting officer shall submit the Agency's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and the Council.
4. On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of the general Financial Regulation, the Executive Director shall draw up the Agency's final accounts under his own responsibility and submit them to the Management Board for an opinion.
5. The Management Board of the Agency shall deliver an opinion on the Agency's final accounts.
6. The Executive Director shall, by 1 July at the latest following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion.
7. The final accounts shall be published.
8. The Agency's Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board.
9. The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation.
10. The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.
11. The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (20), unless specifically required for the Agency's operation and with the Commission's prior consent.
Article 69
1. In order to combat fraud, corruption and other unlawful activities the provisions of Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (21) shall apply without restriction.
2. The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by the European Anti-Fraud Office (OLAF) and shall issue, without delay, the appropriate provisions applicable to all the employees of the Agency.
Article 70
1. The structure and the level of the fees referred to in Article 67(3) shall be established by the Council acting under the conditions provided for by the Treaty on a proposal from the Commission, once the Commission has consulted organisations representing the interests of the pharmaceutical industry at Community level.
2. However, provisions shall be adopted in accordance with the procedure referred to in Article 87(2), establishing the circumstances in which small and medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance.
Chapter 3
General Provisions governing the Agency
Article 71
The Agency shall have legal personality. In all Member States it shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may in particular acquire or dispose of movable and immovable property and may be a party to legal proceedings.
Article 72
1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice of the European Communities shall have jurisdiction pursuant to any arbitration clause contained in a contract concluded by the Agency.
2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its servants in the performance of their duties.
The Court of Justice shall have jurisdiction in any dispute relating to compensation for any such damage.
3. The personal liability of its servants towards the Agency shall be governed by the relevant rules applying to the staff of the Agency.
Article 73
Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (22) shall apply to documents held by the Agency.
The Agency shall set up a register pursuant to Article 2(4) of Regulation (EC) No 1049/2001 to make available all documents that are publicly accessible pursuant to this Regulation.
The Management Board shall adopt the arrangements for implementing Regulation (EC) No 1049/2001 within six months of entry into force of this Regulation.
Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to the lodging of a complaint with the Ombudsman or form the subject of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.
Article 74
The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency.
Article 75
The staff of the Agency shall be subject to the rules and regulations applicable to officials and other staff of the European Communities. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority.
The Management Board, in agreement with the Commission, shall adopt the necessary implementing provisions.
Article 76
Members of the Management Board, members of the committees referred to in Article 56(1), and experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the obligation of professional secrecy.
Article 77
The Commission may, in agreement with the Management Board and the relevant committee, invite representatives of international organisations with an interest in the harmonisation of regulations applicable to medicinal products to participate as observers in the work of the Agency. The conditions for participation shall be determined beforehand by the Commission.
Article 78
1. The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the health professions. These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.
2. The committees referred to in Article 56(1) and any working parties and scientific advisory groups established in accordance with that Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products, in particular patient organisations and healthcare professionals' associations. Rapporteurs appointed by these committees may, on an advisory basis, establish contacts with representatives of patient organisations and health-care professionals' associations relevant to the indication of the medicinal product concerned.
Article 79
The Management Board shall, in the case of veterinary medicinal products which have limited markets, or in the case of veterinary medicinal products intended for diseases with a regional distribution, adopt the necessary measures to provide assistance to companies at the time of submission of their applications.
Article 80
To ensure an appropriate level of transparency, the Management Board, on the basis of a proposal by the Executive Director and in agreement with the Commission, shall adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature.
The internal rules and procedures of the Agency, its committees and its working groups shall be made available to the public at the Agency and on the Internet.
TITLE V
GENERAL AND FINAL PROVISIONS
Article 81
1. All decisions to grant, refuse, vary, suspend, withdraw or revoke a marketing authorisation which are taken in accordance with this Regulation shall state in detail the reasons on which they are based. Such decisions shall be notified to the party concerned.
2. An authorisation to place a medicinal product governed by this Regulation on the market shall not be granted, refused, varied, suspended, withdrawn or revoked except through the procedures and on the grounds set out in this Regulation.
Article 82
1. Only one authorisation may be granted to an applicant for a specific medicinal product.
However, the Commission shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for comarketing reasons.
2. As regards medicinal products for human use, Article 98(3) of Directive 2001/83/EC shall apply to medicinal products authorised under this Regulation.
3. Without prejudice to the unique, Community nature of the content of the documents referred to in Article 9(4)(a), (b), (c) and (d) and in Article 34(4)(a) to (e), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product covered by a single authorisation.
Article 83
1. By way of exemption from Article 6 of Directive 2001/83/EC Member States may make a medicinal product for human use belonging to the categories referred to in Article 3(1) and (2) of this Regulation available for compassionate use.
2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3(1) and (2) available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who can not be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 of this Regulation or must be undergoing clinical trials.
3. When a Member State makes use of the possibility provided for in paragraph 1 it shall notify the Agency.
4. When compassionate use is envisaged, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated on a regular basis.
5. Member States shall take account of any available opinions.
6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4, which shall be published on its website. Article 24(1) and Article 25 shall apply mutatis mutandis.
7. The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation.
8. Where a compassionate use programme has been set up, the applicant shall ensure that patients taking part also have access to the new medicinal product during the period between authorisation and placing on the market.
9. This Article shall be without prejudice to Directive 2001/20/EC and to Article 5 of Directive 2001/83/EC.
Article 84
1. Without prejudice to the Protocol on the Privileges and Immunities of the European Communities, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the regulations adopted pursuant to it and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive.
Member States shall inform the Commission of these provisions no later than 31 December 2004. They shall notify any subsequent alterations as soon as possible.
2. Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.
3. At the Agency's request, the Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection with the authorisations. The maximum amounts as well as the conditions and methods for collection of these penalties shall be laid down in accordance with the procedure referred to in Article 87(2).
The Commission shall publish the names of the marketing authorisation holders involved and the amounts of and reasons for the financial penalties imposed.
Article 85
This Regulation shall not affect the competences vested in the European Food Safety Authority created by Regulation (EC) No 178/2002 (23).
Article 86
At least every ten years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter 4 of Title III of Directive 2001/83/EC and in Chapter 4 of Title III of Directive 2001/82/EC.
Article 87
1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121 of Directive 2001/83/EC and by the Standing Committee on Veterinary Medicinal Products set up by Article 89 of Directive 2001/82/EC.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
4. The committees shall adopt their Rules of Procedure.
Article 88
Regulation (EEC) No 2309/93/EC is hereby repealed.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 89
The periods of protection provided for in Articles 14(11) and 39(10) shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date referred to in Article 90, second paragraph.
Article 90
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
By way of derogation from the first paragraph, Titles I, II, III and V shall apply from ... (24) and point 3, fifth and sixth indent of the Annex shall apply from ... (25).
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at ...,
For the European Parliament
The President
For the Council
The President
(1) OJ C 75 E, 26.3.2002, p. 189 and OJ: (not yet published in the Official Journal).
(3) Position of the European Parliament of 23 October 2002 (OJ C 300 E, 11.12.2003, p. 308), Council Common Position of 29 September 2003 (OJ C 297 E, 9.12.2003, p. 1), Position of the European Parliament of 17 December 2003.
(4) OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regulation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).
(5) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Council Directive 2004/.../EC (see p. ... of this Official Journal).
(6) OJ L 311, 28.11.2001, p. 1. Directive as amended by Council Directive 2004/.../EC (see p. ... of this Official Journal).
(7) OJ L 15, 17.1.1987, p. 38. Directive repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40).
(8) Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of â-agonists (OJ L 125, 23.5.1996, p. 3).
(9) OJ L 121, 1.5.2001, p. 34.
(10) OJ C 172, 18.6.1999, p. 1.
(11) OJ L 18, 22.1.2000, p. 1.
(12) OJ C 218, 31.7.2000, p. 10.
(13) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 24).
(14) OJ L 184, 17.7.1999, p. 23.
(15) OJ L 245, 29.9.2003, p. 19.
(16) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive 2001/18/EC, but continues to have certain legal effects.
(17) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 1029/2003 (OJ L 149, 17.6.2003, p. 15).
(18) OJ L 125, 23.5.1996, p. 10. Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
(19) Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (OJ L 248, 16.9.2002, p. 1).
(20) OJ L 357, 31.12.2002, p. 72.
(21) OJ L 136, 31.5.1999, p. 1.
(22) OJ L 145, 31.5.2001, p. 43.
(23) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(24) 18 months after the date of entry into force of this Regulation.
(25) Four years after the date of entry into force of this Regulation.
ANNEX
MEDICINAL PRODUCTS TO BE AUTHORISED BY THE COMMUNITY
|
1. |
Medicinal products developed by means of one of the following biotechnological processes:
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|
2. |
Medicinal products for veterinary use intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals. |
|
3. |
Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community, for which the therapeutic indication is the treatment of any of the following diseases:
|
After ... (1), the Commission, having consulted the Agency, may present any appropriate proposal modifying this point and the Council shall take a decision on that proposal by qualified majority.
|
4. |
Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000. |
(1) Four years after the date of entry into force of this Regulation.
P5_TA(2003)0577
Community code on medicinal products for human use ***II
European Parliament legislative resolution on the common position adopted by the Council with a view to adopting a European Parliament and Council directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (10950/03/2003 — C5-0464/2003 — 2001/0253(COD))
(Codecision procedure: second reading)
The European Parliament,
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— |
having regard to the Council common position (10950/3/2003 — C5-0464/2003) (1), |
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— |
having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2001) 404) (3), |
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— |
having regard to the amended Commission proposal (COM(2003) 163) (4), |
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— |
having regard to Article 251(2) of the EC Treaty, |
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— |
having regard to Rule 80 of its Rules of Procedure, |
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— |
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0446/2003), |
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1. |
Amends the common position as follows; |
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2. |
Instructs its President to forward its position to the Council and Commission. |
(1) OJ C 297 E, 9.12.2003, p. 41.
(2) Texts Adopted, 23.10.2002, P5_TA(2002) 0505.
(3) OJ C 75 E, 26.3.2002, p. 216.
(4) Not yet published in OJ.
P5_TC2-COD(2001)0253
Position of the European Parliament adopted at second reading on 17 December 2003 with a view to the adoption of Directive 2004/.../EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal by the Commission (1),
Having regard to the Opinion of the European Economic and Social Committee (2),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
Whereas:
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(1) |
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4), codified and consolidated in a single text the texts of Community legislation on medicinal products for human use, in the interests of clarity and rationalisation. |
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(2) |
The Community legislation so far adopted has made a major contribution to the achievement of the objective of the free and safe movement of medicinal products for human use and the elimination of obstacles to trade in such products. However, in the light of the experience acquired, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement. |
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(3) |
It is therefore necessary to align the national laws, regulations and administrative provisions which contain differences with regard to the basic principles in order to promote the operation of the internal market while realising a high level of human health protection. |
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(4) |
The main purpose of any regulation on the manufacture and distribution of medicinal products for human use should be to safeguard public health. However, this objective should be achieved by means which do not hinder the development of the pharmaceutical industry or trade in medicinal products in the Community. |
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(5) |
Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions. |
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(6) |
In the light of the Commission's report on the experience acquired, it has proved necessary to improve the operation of the marketing authorisation procedures for medicinal products in the Community. |
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(7) |
Particularly as a result of scientific and technical progress, the definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products for human use. In order to take account both of the emergence of new therapies and of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, the definition of ‘medicinal product’ should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. This definition should specify the type of action that the medicinal product may exert on physiological functions. This enumeration of actions will also make it possible to cover medicinal products such as gene therapy, radiopharmaceutical products as well as certain medicinal products for topical use. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a medicinal product but could also fall within the definition of other regulated products, it is necessary, in case of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, this Directive should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation. |
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(8) |
Wherever it is proposed to change the scope of the centralised procedure, it should no longer be possible to opt for the mutual-recognition procedure or the decentralised procedure in respect of orphan medicinal products and medicinal products which contain new active substances and for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes. Four years after the date of entry into force of Regulation (EC) No .../2004 (6), it should no longer be possible to opt for the mutual-recognition procedure or the decentralised procedure in respect of medicinal products which contain new active substances and for which the therapeutic indication is the treatment of auto-immune diseases and other immune dysfunctions and viral diseases. |
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(9) |
On the other hand, in the case of generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual-recognition or decentralised procedure should be available as an option for medicinal products which represent a therapeutic innovation or which are of benefit to society or to patients. |
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(10) |
In order to increase availability of medicinal products, in particular on smaller markets, it should, in cases where an applicant does not apply for an authorisation for a medicinal product in the context of the mutual-recognition procedure in a given Member State, be possible for that Member State, for justified public health reasons, to authorise the placing on the market of the medicinal product. |
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(11) |
Evaluation of the operation of marketing authorisation procedures has revealed the need to revise, in particular, the mutual-recognition procedure in order to improve the opportunities for cooperation between Member States. This cooperation process should be formalised by setting up a coordination group for this procedure and by defining its operation so as to settle disagreements within the framework of a revised decentralised procedure. |
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(12) |
With regard to referrals, the experience acquired reveals the need for an appropriate procedure, particularly in the case of referrals relating to an entire therapeutic class or to all medicinal products containing the same active substance. |
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(13) |
There is a need to provide for the ethical requirements of Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (7) to apply to all medicinal products authorised within the Community. In particular, with respect to clinical trials conducted outside the Community on medicinal products destined to be authorised within the Community, it should be verified, at the time of the evaluation of the application for authorisation, that these trials were conducted in accordance with the principles of good clinical practice and the ethical requirements equivalent to the provisions of that Directive. |
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(14) |
Since generic medicines account for a major part of the market in medicinal products, their access to the Community market should be facilitated in the light of the experience acquired. Furthermore, the period for protection of data relating to pre-clinical tests and clinical trials should be harmonised. |
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(15) |
Biological medicinal products similar to a reference medicinal product do not usually meet all the conditions to be considered as a generic medicinal product mainly due to manufacturing process characteristics, raw materials used, molecular characteristics and therapeutic modes of action. When a biological medicinal product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both. |
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(16) |
The criteria of quality, safety and efficacy should enable the risk-benefit balance of all medicinal products to be assessed both when they are placed on the market and at any other time the competent authority deems this appropriate. In this connection, it is necessary to harmonise and adapt the criteria for refusal, suspension and revocation of marketing authorisations. |
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(17) |
A marketing authorisation should be renewed once five years after the granting of the marketing authorisation. Thereafter, the marketing authorisation should normally be of unlimited validity. Furthermore, any authorisation not used for three consecutive years, that is to say one which has not led to the placing on the market of a medicinal product in the Member States concerned during that period, should be considered invalid, in order, in particular, to avoid the administrative burden of maintaining such authorisations. However, exemptions from this rule should be granted when these are justified on public health grounds. |
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(18) |
The environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit it should be envisaged. In any event this impact should not constitute a criterion for refusal of a marketing authorisation. |
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(19) |
The quality of medicinal products for human use manufactured or available in the Community should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice in relation to those medicinal products. It has proved necessary to reinforce the Community provisions on inspections and to compile a Community register of the results of those inspections. |
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(20) |
Pharmacovigilance and, more generally, market surveillance and sanctions in the event of failure to comply with the provisions should be stepped up. In the field of pharmacovigilance, account should be taken of the facilities offered by new information technologies to improve exchanges between Member States. |
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(21) |
As part of the proper use of medicinal products, the rules on packaging should be adapted to take account of the experience acquired. |
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(22) |
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8). |
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(23) |
Directive 2001/83/EC should be amended accordingly, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Directive 2001/83/EC is hereby amended as follows:
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1) |
Article 1 shall be amended as follows:
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2) |
Article 2 shall be replaced by the following: ‘Article 2 1. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process. 2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply. 3. Notwithstanding paragraph 1 and Article 3(4), Title IV of this Directive shall apply to medicinal products intended only for export and to intermediate products.’ |
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3) |
Article 3 shall be amended as follows:
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4) |
Article 5 shall be replaced by the following: ‘Article 5 1. A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility. 2. Member States may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. 3. Without prejudice to paragraph 1, Member States shall lay down provisions in order to ensure that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised indications or from the use of an unauthorised medicinal product, when such use is recommended or required by a competent authority in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not national or Community authorisation has been granted. 4. Liability for defective products, as provided for by Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States, concerning liability for defective products (11), shall not be affected by paragraph 3. (11) OJ L 210, 7.8.1985, p. 29. Directive as last amended by Directive 1999/34/EC of the European Parliament and of the Council (OJ L 141, 4.6.1999, p. 20).’" |
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5) |
Article 6 shall be amended as follows:
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6) |
in Article 7, ‘radionuclide kits’ shall be replaced by ‘kits’; |
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7) |
Article 8(3) shall be amended as follows:
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8) |
Article 10 shall be replaced by the following: ‘Article 10 1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation. The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies. 2. For the purposes of this Article:
3. In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided. 4. Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate preclinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided. 5. In addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication. 6. Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.’ |
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9) |
the following Articles shall be inserted: ‘Article 10a By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the test and trial results shall be replaced by appropriate scientific literature. Article 10b In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance. Article 10c Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.’ |
|
10) |
Article 11 shall be replaced by the following: ‘Article 11 The summary of the product characteristics shall contain, in the order indicated below, the following information:
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11) |
Article 12 shall be replaced by the following: ‘Article 12 1. The applicant shall ensure that, before the detailed summaries referred to in the last subparagraph of Article 8(3) are submitted to the competent authorities, they have been drawn up and signed by experts with the necessary technical or professional qualifications, which shall be set out in a brief curriculum vitae. 2. Persons having the technical and professional qualifications referred to in paragraph 1 shall justify any use made of scientific literature under Article 10a in accordance with the conditions set out in Annex I. 3. The detailed summaries shall form part of the file which the applicant submits to the competent authorities.’ |
|
12) |
Article 13 shall be replaced by the following: ‘Article 13 1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In the case of registrations, Article 28 and Article 29(1) to (3) shall apply. 2. Member States shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in Article 14.’ |
|
13) |
Article 14 shall be amended as follows:
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|
14) |
Article 15 shall be amended as follows:
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|
15) |
Article 16 shall be amended as follows:
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16) |
Articles 17 and 18 shall be replaced by the following: ‘Article 17 1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days after the submission of a valid application. Applications for marketing authorisations in two or more Member States in respect of the same medicinal product shall be submitted in accordance with Articles 27 to 39. 2. Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 27 to 39 apply. Article 18 Where a Member State is informed in accordance with Article 8(3)(1) that another Member State has authorised a medicinal product which is the subject of a marketing authorisation application in the Member State concerned, it shall reject the application unless it was submitted in compliance with Articles 27 to 39.’ |
|
17) |
Article 19 shall be amended as follows:
|
|
18) |
in point (b) of Article 20, ‘in exceptional and justifiable cases’ shall be replaced by ‘in justifiable cases’; |
|
19) |
in Article 21, paragraphs 3 and 4 shall be replaced by the following: ‘3. The competent authorities shall make publicly available without delay the marketing authorisation together with the summary of the product characteristics for each medicinal product which they have authorised. 4. The competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned. The competent authorities shall make publicly accessible without delay the assessment report, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each indication applied for.’ |
|
20) |
Article 22 shall be replaced by the following: ‘Article 22 In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to meet certain conditions, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. This authorisation may be granted only for objective, verifiable reasons and must be based on one of the grounds set out in Annex I. Continuation of the authorisation shall be linked to the annual reassessment of these conditions. The list of these conditions shall be made publicly accessible without delay, together with deadlines and dates of fulfilment.’ |
|
21) |
in Article 23, the following paragraphs shall be added: ‘The authorisation holder shall forthwith supply to the competent authority any new information which might entail the amendment of the particulars or documents referred to in Articles 8(3), 10, 10a, 10b and 11, or 32(5), or Annex I. In particular, he shall forthwith inform the competent authority of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product for human use concerned. In order that the risk-benefit balance may be continuously assessed, the competent authority may at any time ask the holder of the marketing authorisation to forward data demonstrating that the riskbenefit balance remains favourable.’ |
|
22) |
the following Article shall be inserted: ‘Article 23a After a marketing authorisation has been granted, the holder of the authorisation shall inform the competent authority of the authorising Member State of the date of actual marketing of the medicinal product for human use in that Member State, taking into account the various presentations authorised. The holder shall also notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product. Upon request by the competent authority, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, and any data in his possession relating to the volume of prescriptions.’ |
|
23) |
Article 24 shall be replaced by the following: ‘Article 24 1. Without prejudice to paragraphs 4 and 5, a marketing authorisation shall be valid for five years. 2. The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the competent authority of the authorising Member State. To this end, the marketing authorisation holder shall provide the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. 3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2. 4. Any authorisation which within three years of its granting is not followed by the actual placing on the market of the authorised product in the authorising Member State shall cease to be valid. 5. When an authorised product previously placed on the market in the authorising Member State is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid. 6. The competent authority may, in exceptional circumstances and on public health grounds grant exemptions from paragraphs 4 and 5. Such exemptions must be duly justified.’ |
|
24) |
Article 26 shall be replaced by the following: ‘Article 26 1. The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8, 10, 10a, 10b and 10c, it is clear that:
2. Authorisation shall likewise be refused if any particulars or documents submitted in support of the application do not comply with Articles 8, 10, 10a, 10b and 10c. 3. The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and the data submitted.’ |
|
25) |
the heading of Chapter 4 of Title III shall be replaced by the following: ‘Chapter 4 Mutual recognition procedure and decentralised procedure’ |
|
26) |
Articles 27 to 32 shall be replaced by the following: ‘Article 27 1. A coordination group shall be set up for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in this Chapter. The Agency shall provide the secretariat of this coordination group. 2. The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts. 3. The coordination group shall draw up its own Rules of Procedure, which shall enter into force after a favourable opinion has been given by the Commission. These Rules of Procedure shall be made public. Article 28 1. With a view to the granting of a marketing authorisation for a medicinal product in more than one Member State, an applicant shall submit an application based on an identical dossier in these Member States. The dossier shall contain the information and documents referred to in Articles 8, 10, 10a, 10b, 10c and 11. The documents submitted shall include a list of Member States concerned by the application. The applicant shall request one Member State to act as “reference Member State” and to prepare an assessment report on the medicinal product in accordance with paragraphs 2 or 3. 2. Where the medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be sent to the concerned Member States and to the applicant. 3. In cases where the medicinal product has not received a marketing authorisation at the time of application, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. The reference Member State shall prepare these draft documents within 120 days after receipt of a valid application and shall send them to the concerned Member States and to the applicant. 4. Within 90 days of receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly. 5. Each Member State in which an application has been submitted in accordance with paragraph 1 shall adopt a decision in conformity with the approved assessment report, the summary of product characteristics and the labelling and package leaflet as approved, within 30 days after acknowledgement of the agreement. Article 29 1. If, within the period laid down in Article 28(4), a Member State cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health, it shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be forthwith referred to the coordination group. 2. Guidelines to be adopted by the Commission shall define a potential serious risk to public health. 3. Within the coordination group, all Member States referred to in paragraph 1 shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make his point of view known orally or in writing. If, within 60 days of the communication of the points of disagreement, the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Article 28(5) shall apply. 4. If the Member States fail to reach an agreement within the 60-day period laid down in paragraph 3, the Agency shall be immediately informed, with a view to the application of the procedure under Articles 32, 33 and 34. The Agency shall be provided with a detailed statement of the matters on which the Member States have been unable to reach agreement and the reasons for their disagreement. A copy shall be forwarded to the applicant. 5. As soon as the applicant is informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of Article 28(1). 6. In the circumstances referred to in paragraph 4, Member States that have approved the assessment report, the draft summary of product characteristics and the labelling and package leaflet of the reference Member State may, at the request of the applicant, authorise the medicinal product without waiting for the outcome of the procedure laid down in Article 32. In that event, the authorisation granted shall be without prejudice to the outcome of that procedure. Article 30 1. If two or more applications submitted in accordance with Articles 8, 10, 10a, 10b, 10c and 11 have been made for marketing authorisation for a particular medicinal product, and if Member States have adopted divergent decisions concerning the authorisation of the medicinal product or its suspension or revocation, a Member State, the Commission or the applicant or the marketing authorisation holder may refer the matter to the Committee for Medicinal Products for Human Use, hereinafter referred to as ‘the Committee’, for the application of the procedure laid down in Articles 32, 33 and 34. 2. In order to promote harmonisation of authorisations for medicinal products authorised in the Community, Member States shall, each year, forward to the coordination group a list of medicinal products for which a harmonised summary of product characteristics should be drawn up. The coordination group shall lay down a list taking into account the proposals from all Member States and shall forward this list to the Commission. The Commission or a Member State, in agreement with the Agency and taking into account the views of interested parties, may refer these products to the Committee in accordance with paragraph 1. Article 31 1. The Member States or the Commission or the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for application of the procedure laid down in Articles 32, 33 and 34 before any decision is reached on a request for a marketing authorisation or on the suspension or revocation of an authorisation, or on any other variation to the terms of a marketing authorisation which appears necessary, in particular to take account of the information collected in accordance with Title IX. The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder. The Member States and the applicant or the marketing authorisation holder shall supply the Committee with all available information relating to the matter in question. 2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to certain specific parts of the authorisation. In that event, Article 35 shall apply to those medicinal products only if they were covered by the authorisation procedures referred to in this Chapter. Article 32 1. When reference is made to the procedure laid down in this Article, the Committee shall consider the matter concerned and shall issue a reasoned opinion within 60 days of the date on which the matter was referred to it. However, in cases submitted to the Committee in accordance with Articles 30 and 31, this period may be extended by the Committee for a further period of up to 90 days, taking into account the views of the applicants or the marketing authorisation holders concerned. In an emergency, and on a proposal from its Chairman, the Committee may agree to a shorter deadline. 2. In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks. 3. Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit which it shall specify. The opinion of the Committee shall be accompanied by a draft summary of product characteristics for the product and a draft text of the labelling and package leaflet. If necessary, the Committee may call upon any other person to provide information relating to the matter before it. The Committee may suspend the time-limits referred to in paragraph 1 in order to allow the applicant or the marketing authorisation holder to prepare explanations. 4. The Agency shall forthwith inform the applicant or the marketing authorisation holder where the opinion of the Committee is that:
Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No .../2004 (13). The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5 of this Article. 5. Within 15 days after its adoption, the Agency shall forward the final opinion of the Committee to the Member States, to the Commission and to the applicant or the marketing authorisation holder, together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions. In the event of an opinion in favour of granting or maintaining an authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion:
(13) Note to OJ: Regulation No as in footnote 1 to recital 5.’" |
|
27) |
Article 33 shall be amended as follows:
|
|
28) |
Article 34 shall be replaced by the following: ‘Article 34 1. The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 121(3). 2. The rules of procedure of the Standing Committee established by Article 121(1) shall be adjusted to take account of the tasks incumbent upon it under this Chapter. Those adjustments shall entail the following provisions:
Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion delivered by the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration. The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 121(2). 3. The decision as referred to in paragraph 1 shall be addressed to all Member States and reported for information to the marketing authorisation holder or applicant. The concerned Member States and the reference Member State shall either grant or revoke the marketing authorisation, or vary its terms as necessary to comply with the decision within 30 days following its notification, and they shall refer to it. They shall inform the Commission and the Agency accordingly.’ |
|
29) |
the third subparagraph of Article 35(1) shall be deleted; |
|
30) |
in Article 38, paragraph 2 shall be replaced by the following: ‘2. At least every ten years the Commission shall publish a report on the experience acquired on the basis of the procedures described in this Chapter and shall propose any amendments which may be necessary to improve those procedures. The Commission shall submit this report to the European Parliament and to the Council.’ |
|
31) |
Article 39 shall be replaced by the following: ‘Article 39 Article 29(4), (5) and (6) and Articles 30 to 34 shall not apply to the homeopathic medicinal products referred to in Article 14. Articles 28 to 34 shall not apply to the homeopathic medicinal products referred to in Article 16(2).’ |
|
32) |
the following paragraph shall be added to Article 40: ‘4. The Member States shall forward to the Agency a copy of the authorisation referred to in paragraph 1. The Agency shall enter that information on the Community database referred to in Article 111(6).’ |
|
33) |
in Article 46, point (f) shall be replaced by the following:
|
|
34) |
the following Article shall be inserted: ‘Article 46a 1. For the purposes of this Directive, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials. 2. Any amendments necessary to adapt paragraph 1 to new scientific and technical developments shall be laid down in accordance with the procedure referred to in Article 121(2).’ |
|
35) |
in Article 47, the following paragraphs shall be added: ‘The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 shall be adopted in the form of detailed guidelines. The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 40(1), on the reports referred to in Article 111(3) and on the form and content of the certificate of good manufacturing practice referred to in Article 111(5).’ |
|
36) |
in Article 49(1), ‘minimum’ shall be deleted; |
|
37) |
in Article 49(2), fourth subparagraph, first indent ‘Applied physics’ shall be replaced by ‘Experimental physics’; |
|
38) |
in Article 50(1), ‘in the State concerned’ shall be replaced by ‘within the Community’; |
|
39) |
in Article 51(1), point (b) shall be replaced by the following:
|
|
40) |
Article 54 shall be amended as follows:
|
|
41) |
Article 55 shall be amended as follows:
|
|
42) |
the following Article shall be inserted: ‘Article 56a The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted.’ |
|
43) |
in Article 57, the following paragraph shall be added: ‘For medicinal products authorised under Regulation (EC) No .../2004 (14), Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive. (14) Note to OJ. Regulation No as in footnote to recital 5.’" |
|
44) |
Article 59 shall be replaced by the following: ‘Article 59 1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:
2. The list set out in point (c) of paragraph 1 shall:
3. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.’ |
|
45) |
Article 61(1) shall be replaced by the following: ‘1. One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorising marketing when the marketing authorisation is requested. The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority.’ |
|
46) |
in Article 61(4), ‘or as appropriate’ shall be replaced by ‘and’; |
|
47) |
in Article 62, ‘for health education’ shall be replaced by ‘for the patient’; |
|
48) |
Article 63 shall be amended as follows:
|
|
49) |
Article 65 shall be replaced by the following: ‘Article 65 In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular:
|
|
50) |
Article 66(3), fourth indent shall be replaced by:
|
|
51) |
Article 69(1) shall be amended as follows:
|
|
52) |
Article 70(2) shall be amended as follows:
|
|
53) |
Article 74 shall be replaced by the following: ‘Article 74 When new facts are brought to their attention, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product by applying the criteria listed in Article 71.’ |
|
54) |
the following Article shall be inserted: ‘Article 74a Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised.’ |
|
55) |
Article 76 shall be amended as follows:
|
|
56) |
the second indent of point (e) of Article 80 shall be replaced by the following:
|
|
57) |
Article 81 shall be replaced by the following: ‘Article 81 With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities. The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.’ |
|
58) |
in Article 82, the second indent of the first paragraph shall be replaced by the following:
|
|
59) |
Article 84 shall be replaced by the following: ‘Article 84 The Commission shall publish guidelines on good distribution practice. To this end, it shall consult the Committee for Medicinal Products for Human Use and the Pharmaceutical Committee established by Council Decision 75/320/EEC (16). |
|
60) |
Article 85 shall be replaced by the following: ‘Article 85 This Title shall apply to homeopathic medicinal products.’ |
|
61) |
the fourth indent of Article 86(2) shall be replaced by the following:
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62) |
Article 88 shall be replaced by the following: ‘Article 88 1. Member States shall prohibit the advertising to the general public of medicinal products which:
2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary. 3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed. 4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States. 5. The prohibition referred to in paragraph 1 shall apply without prejudice to Article 14 of Directive 89/552/EEC. 6. Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes.’ |
|
63) |
the following text is inserted after Article 88: ‘TITLE VIIIa: INFORMATION AND ADVERTISING Article 88a Within three years of the entry into force of Directive 2004/.../EC (17), the Commission shall, following consultations with patients' and consumers' organisations, doctors' and pharmacists' organisations, Member States and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision — particularly on the Internet — and its risks and benefits for patients. Following analysis of the above data, the Commission shall, if appropriate, put forward proposals setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products and other treatments and shall address the question of the information source's liability. (17) Note for OJ: Insert number of present Directive.’" |
|
64) |
Article 89 shall be amended as follows:
|
|
65) |
in Article 90, point (l) shall be deleted; |
|
66) |
in Article 91, paragraph 2 shall be replaced by the following: ‘2. Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark, if it is intended solely as a reminder.’ |
|
67) |
Article 94(2) shall be replaced by the following: ‘2. Hospitality at sales promotion events shall always be strictly limited to their main purpose and must not be extended to persons other than health-care professionals.’ |
|
68) |
Article 95 shall be replaced by the following: ‘Article 95 The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than health-care professionals.’ |
|
69) |
point (d) of Article 96(1) shall be replaced by the following:
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|
70) |
in Article 98, the following paragraph shall be added: ‘3. The Member States shall not prohibit the co-promotion of a medicinal product by the holder of the marketing authorisation and one or more companies nominated by him.’ |
|
71) |
Article 100 shall be replaced by the following: ‘Article 100 Advertising of the homeopathic medicinal products referred to in Article 14(1) shall be subject to the provisions of this Title with the exception of Article 87(1). However, only the information specified in Article 69(1) may be used in the advertising of such medicinal products.’ |
|
72) |
in Article 101, the second paragraph shall be replaced by the following: ‘The Member States may impose specific requirements on doctors and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions.’ |
|
73) |
Article 102 shall be replaced by the following: ‘Article 102 In order to ensure the adoption of appropriate and harmonised regulatory decisions concerning the medicinal products authorised within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall operate a pharmacovigilance system. This system shall be used to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, and to evaluate such information scientifically. Member States shall ensure that suitable information collected within this system is communicated to the other Member States and the Agency. The information shall be recorded in the database referred to in point (l) of the second subparagraph of Article 57(1) of Regulation (EC) No .../2004 (18) and shall be permanently accessible to all Member States and without delay to the public. This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks. (18) Note to OJ: Regulation No as in footnote to recital 5.’" |
|
74) |
the following Article shall be inserted: ‘Article 102a The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee their independence.’ |
|
75) |
in Article 103, the introductory phrase of the second paragraph shall be replaced by the following: ‘That qualified person shall reside in the Community and shall be responsible for the following:’ |
|
76) |
Articles 104 to 107 shall be replaced by the following: ‘Article 104 1. The marketing authorisation holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country. Save in exceptional circumstances, these reactions shall be communicated electronically in the form of a report in accordance with the guidelines referred to in Article 106(1). 2. The marketing authorisation holder shall be required to record all suspected serious adverse reactions which are brought to his attention by a health-care professional and to report them promptly to the competent authority of the Member State on whose territory the incident occurred, and no later than 15 days following the receipt of the information. 3. The marketing authorisation holder shall be required to record and report all other suspected serious adverse reactions which meet the notification criteria in accordance with the guidelines referred to in Article 106(1), of which he can reasonably be expected to have knowledge, promptly to the competent authority of the Member State in whose territory the incident occurred, and no later than 15 days following the receipt of the information. 4. The marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly in accordance with the guidelines referred to in Article 106(1), so that the Agency and the competent authorities of the Member States in which the medicinal product is authorised are informed of them, and no later than 15 days following the receipt of the information. 5. By way of derogation from paragraphs 2, 3 and 4, in the case of medicinal products which are covered by Directive 87/22/EEC or which have qualified for the procedures laid down in Articles 28 and 29 of this Directive or which have been the subject of the procedures under Articles 32, 33 and 34 of this Directive, the marketing authorisation holder shall also ensure that all suspected serious adverse reactions occurring in the Community are reported in such a way as to be accessible to the reference Member State or to any competent authority acting as reference Member State. The reference Member State shall assume the responsibility of analysing and monitoring such adverse reactions. 6. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation, or subsequently as indicated in the guidelines referred to in Article 106(1), reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, immediately upon request or at least every six months after authorisation and until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request. The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the medicinal product. 7. The Commission may lay down provisions to amend paragraph 6 in view of experience gained through its operation. The Commission shall adopt the provisions in accordance with the procedure referred to in Article 121(2). 8. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in paragraph 6 in accordance with the procedure laid down by Commission Regulation (EC) No 1084/2003 (19). 9. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the competent authority. In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading. Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties. Article 105 1. The Agency, in collaboration with the Member States and the Commission, shall set up a dataprocessing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the Community in order to allow all competent authorities to share the information at the same time. 2. Making use of the network referred to in paragraph 1, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are promptly made available to the Agency and the other Member States, and in any case within 15 days after their notification at the latest. 3. The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are promptly made available to the marketing authorisation holder, and in any case within 15 days after their notification at the latest. Article 106 1. In order to facilitate the exchange of information on pharmacovigilance within the Community, the Commission, after consulting the Agency, the Member States and interested parties, shall draw up guidelines on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats, and shall publish a reference to an internationally agreed medical terminology. Acting in accordance with the guidelines, marketing authorisation holders shall use internationally agreed medical terminology for the reporting of adverse reactions. These guidelines shall be published in Volume 9 of The Rules governing Medicinal Products in the European Community and shall take account of international harmonisation work carried out in the field of pharmacovigilance. 2. For the interpretation of the definitions referred to in points (11) to (16) of Article 1 and of the principles outlined in this Title, the marketing authorisation holder and the competent authorities shall follow the guidelines referred to in paragraph 1. Article 107 1. Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, revoked or varied in accordance with the guidelines referred to in Article 106(1), it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder. 2. Where urgent action to protect public health is necessary, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided that the Agency, the Commission and the other Member States are informed no later than the following working day. When the Agency is informed in accordance with paragraph 1 in relation to suspensions and revocation, or the first subparagraph of this paragraph, the Committee shall prepare an opinion within a time-frame to be determined depending on the urgency of the matter. In relation to variations, the Committee may upon request from a Member State prepare an opinion. Acting on the basis of this opinion, the Commission may request all Member States in which the product is being marketed to take temporary measures immediately. The final measures shall be adopted in accordance with the procedure referred to in Article 121(3). |
|
77) |
Article 111 shall be amended as follows:
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|
78) |
in Article 114(1) and (2), the terms ‘by a State laboratory or a laboratory designated for that purpose’ shall be replaced by the terms ‘by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose’; |
|
79) |
Article 116 shall be replaced by the following: ‘Article 116 The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is taken that the product is harmful under normal conditions of use, or that it lacks therapeutic efficacy, or that the risk-benefit balance is not positive under the normal conditions of use, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is concluded that therapeutic results cannot be obtained from the medicinal product. An authorisation shall also be suspended, revoked, withdrawn or varied where the particulars supporting the application as provided for in Article 8 or Articles 10, 10a, 10b, 10c and 11 are incorrect or have not been amended in accordance with Article 23, or where the controls referred to in Article 112 have not been carried out.’ |
|
80) |
Article 117(1) shall be replaced by the following: ‘1. Without prejudice to the measures provided for in Article 116, Member States shall take all appropriate steps to ensure that the supply of the medicinal product is prohibited and the medicinal product withdrawn from the market, if the view is taken that:
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|
81) |
Article 119 shall be replaced by the following: ‘Article 119 The provisions of this Title shall apply to homeopathic medicinal products.’ |
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82) |
Articles 121 and 122 shall be replaced by the following: ‘Article 121 1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, hereinafter called “the Standing Committee”, in the task of adapting to technical progress the directives on the removal of technical barriers to trade in the medicinal products sector. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month. 4. The Standing Committee shall adopt its own rules of procedure which shall be made public. Article 122 1. Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements placed on the authorisations referred to in Articles 40 and 77, on the certificates referred to in Article 111(5) or on the marketing authorisations are fulfilled. 2. Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 111(3) to the competent authorities of another Member State. 3. The conclusions reached in accordance with Article 111(1) shall be valid throughout the Community. However, in exceptional cases, if a Member State is unable, for reasons relating to public health, to accept the conclusions reached following an inspection under Article 111(1), that Member State shall forthwith inform the Commission and the Agency. The Agency shall inform the Member States concerned. When the Commission is informed of these divergences of opinion, it may, after consulting the Member States concerned, ask the inspector who performed the original inspection to perform a new inspection; the inspector may be accompanied by two other inspectors from Member States which are not parties to the disagreement.’ |
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83) |
in Article 125, the third subparagraph shall be replaced by the following: ‘Decisions to grant or revoke a marketing authorisation shall be made publicly available.’ |
|
84) |
the following Article shall be inserted: ‘Article 126a 1. In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member State in accordance with this Directive, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product. 2. When a Member State avails itself of this possibility, it shall adopt the necessary measures in order to ensure that the requirements of this Directive are complied with, in particular those referred to in Titles V, VI, VIII, IX and XI. 3. Before granting such an authorisation a Member State shall:
4. The Commission shall set up a publicly accessible register of medicinal products authorised under paragraph 1. Member States shall notify the Commission if any medicinal product is authorised, or ceases to be authorised, under paragraph 1, including the name or corporate name and permanent address of the authorisation holder. The Commission shall amend the register of medicinal products accordingly and make this register available on their website. 5. No later than ... (21), the Commission shall present a report to the European Parliament and the Council concerning the application of this provision with a view to proposing any necessary amendments. (21) Four years after the date of entry into force of this Directive.’" |
|
85) |
the following Article 126b is inserted: ‘Article 126b In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry which could affect their impartiality. These persons shall make an annual declaration of their financial interests. In addition, the Member States shall ensure that the competent authority makes publicly accessible its rules of procedure and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.’ |
|
86) |
the following Article shall be inserted: ‘Article 127a When a medicinal product is to be authorised in accordance with Regulation (EC) .../2004 (22) and the Scientific Committee in its opinion refers to recommended conditions or restrictions with regard to the safe and effective use of the medicinal product as provided for in Article 9(4) (c) of that Regulation, a decision addressed to the Member States shall be adopted in accordance with the procedure provided for in Articles 33 and 34 of this Directive, for the implementation of those conditions or restrictions. (22) Note to OJ. Regulation No as in footnote to recital 5.’" |
|
87) |
the following Article shall be inserted: ‘Article 127b Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.’ |
Article 2
The periods of protection provided for in Article 1, point 8, which amends Article 10(1) of Directive 2001/83/EC, shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date of transposition referred to in Article 3 first paragraph.
Article 3
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than ... (23). They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 5
This Directive is addressed to the Member States.
Done at ...,
For the European Parliament
The President
For the Council
The President
(1) OJ C 75 E, 26.3.2002, p. 216 and OJ C (not yet published in the Official Journal).
(3) Position of the European Parliament of 23 October 2002 (OJ C 300 E, 11.12.2003, p. 353), Council Common Position of 29 September 2003 (OJ C 297 E, 9.12.2003, p. 41), Position of the European Parliament of 17 December 2003.
(4) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).
(5) OJ L 214, 21.8.1993, p. 1. Regulation repealed by Regulation (EC) No .../2004 (see p. ... of this Official Journal). (Note to OJ: Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.)
(6) OJ L ... (note for OJ: Regulation No as in footnote to recital 5).
(7) OJ L 121, 1.5.2001, p. 34.
(8) OJ L 184, 17.7.1999, p. 23.
(19) OJ L 159, 27.6.2003, p. 1.’
(23) 18 months after the entry into force of this Directive.
P5_TA(2003)0578
Community code on veterinary medicinal products ***II
European Parliament legislative resolution on the common position adopted by the Council with a view to adopting a European Parliament and Council directive amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (10951/3/2003 — C5-0465/2003 — 2001/0254(COD))
(Codecision procedure: second reading)
The European Parliament,
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— |
having regard to the Council common position (10951/3/2003 — C5-0465/2003) (1), |
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— |
having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2001) 404) (3), |
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— |
having regard to the amended proposal (COM(2003) 163) (4), |
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— |
having regard to Article 251(2) of the EC Treaty, |
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— |
having regard to Rule 80 of its Rules of Procedure, |
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— |
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0444/2003), |
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1. |
Amends the common position as follows; |
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2. |
Instructs its President to forward its position to the Council and Commission. |
(1) OJ C 297 E, 9.12.2003, p. 72.
(2) Texts Adopted,23.10.2002, P5_TA(2003)0506.
(3) OJ C 75 E, 26.3.2002, p. 234.
(4) Not yet published in OJ.
P5_TC2-COD(2001)0254
Position of the European Parliament adopted at second reading on 17 December 2003 with a view to the adoption of Directive 2004/.../EC of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 and Article 152(4)(b) thereof,
Having regard to the proposal of the Commission (1),
Having regard to the Opinion of the European Economic and Social Committee (2),
After consulting the Committee of the Regions,
Acting in accordance with the procedure referred to in Article 251 of the Treaty (3),
Whereas:
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(1) |
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (4) codified and consolidated previous Community legislation on veterinary medicinal products in a single text in the interests of clarity and rationalisation. |
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(2) |
The Community legislation so far adopted has made a major contribution to the achievement of the objective of free and safe movement of veterinary medicinal products and the elimination of obstacles to trade in such products. However, in the light of the experience gained, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement. |
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(3) |
It is therefore necessary to align national laws, regulations and administrative provisions that contain differences with regard to the basic principles in order to promote the operation of the internal market without adversely affecting public health. |
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(4) |
The main purpose of any regulation on the manufacture and distribution of veterinary medicinal products should be to safeguard animal health and welfare as well as public health. The legislation on marketing authorisations for veterinary medicinal products, and the criteria governing the granting of authorisations, are such as to strengthen the protection of public health. That aim should, however, be achieved by means that do not hinder the development of the pharmaceutical industry or trade in veterinary medicinal products within the Community. |
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(5) |
Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions. |
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(6) |
In the light of the Commission's report on the experience acquired, it has proved necessary to improve the operation of the marketing authorisation procedures for veterinary medicinal products in the Community. |
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(7) |
Particularly as a result of scientific and technical progress in the field of animal health, the definitions and scope of Directive 2001/82/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of veterinary medicinal products. In order to take account both of the emergence of new therapies and of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, the definition of ‘medicinal product’ should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a veterinary medicinal product, but could also fall within the definition of other regulated products, it is necessary, in cases of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, feed, feed additives or biocides, this Directive should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation. |
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(8) |
The veterinary medicinal products sector has a number of very specific features. Veterinary medicinal products for food-producing animals may be authorised only on conditions that guarantee that the foodstuffs produced will be harmless to consumers as regards any residues of such medicinal products. |
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(9) |
The costs of research and development to meet increased requirements as regards the quality, safety and efficacy of veterinary medicinal products are leading to a gradual reduction in the range of products authorised for the species and indications representing smaller market sectors. |
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(10) |
The provisions of Directive 2001/82/EC also need, therefore, to be adapted to the specific features of the sector, particularly to meet the health and welfare needs of food-producing animals on terms that guarantee a high level of consumer protection, and in a context that provides adequate economic interest for the veterinary medicinal products industry. |
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(11) |
In certain circumstances, particularly where certain types of pets are concerned, the need to obtain a marketing authorisation for a veterinary medicinal product in accordance with Community provisions is clearly disproportionate. Moreover, the absence of authorisation to market an immunological product in the Community should not be an obstacle to international movements of certain live animals for the purpose of which binding health measures have to be taken. The provisions on the authorisation or use of such medicinal products to take account of measures to combat certain infectious animal diseases at Community level also need to be adapted. |
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(12) |
Evaluation of the operation of market authorisation procedures has revealed the need to revise, in particular, the mutual-recognition procedure in order to improve the opportunities for cooperation between Member States. This cooperation process should be formalised by setting up a coordination group for this procedure and by defining its operation so as to settle disagreements within the framework of a revised decentralised procedure. |
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(13) |
With regard to referrals, the experience acquired reveals the need for an appropriate procedure, particularly in the case of referrals relating to an entire therapeutic class or to all veterinary medicinal products containing the same active substance. |
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(14) |
Marketing authorisation for veterinary medicinal products should be limited initially to five years. After this first renewal, the marketing authorisation should normally be valid for an unlimited period. Furthermore, any authorisation not used for three consecutive years, that is to say, one which has not led to the placing on the market of a veterinary medicinal product in the Member States concerned during that period, should be considered invalid, in order, in particular, to avoid the administrative burden of maintaining such authorisations. However, exemptions from this rule should be granted when these are justified on public or animal health grounds. |
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(15) |
Biological medicinal products similar to a reference medicinal product do not usually meet all the conditions to be considered as a generic medicinal product mainly due to manufacturing process characteristics, raw materials used, molecular characteristics and therapeutic modes of action. When a biological product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both. |
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(16) |
The criteria of quality, safety and efficacy should enable the risk-benefit balance of all veterinary medicinal products to be assessed both when they are placed on the market and at any other time the competent authority deems this appropriate. In this connection, it is necessary to harmonise and adapt the criteria for refusal, suspension and revocation of marketing authorisations. |
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(17) |
In the veterinary sector, if no medicinal product has been authorised for a given species or a given disorder, the possibility of using other existing products should be made a straightforward matter, but without prejudicing consumer health in the case of medicinal products intended for administration to food-producing animals. In particular, medicinal products should be used only under conditions that guarantee that the foodstuffs produced will be harmless to consumers as regards any residues of medicinal products. |
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(18) |
There is also a need to stimulate the interest of the veterinary pharmaceuticals industry in certain market segments in order to encourage the development of new veterinary medicinal products. The period of administrative data-protection vis-à-vis generics should be harmonised. |
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(19) |
There is also a need to clarify the obligations of, and division of responsibilities between, the applicant for a marketing authorisation, the holder of a marketing authorisation and the competent authorities in charge of monitoring the quality of foodstuffs, particularly through compliance with the provisions on the use of veterinary medicinal products. In addition, in order to facilitate the testing of new medicinal products while guaranteeing a high level of protection for consumers, sufficiently long withdrawal periods should be laid down for foodstuffs that animals involved in tests might produce. |
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(20) |
Without prejudice to the provisions aimed at guaranteeing consumer protection, the specific characteristics of homeopathic veterinary medicinal products, and particularly their use in organic farming, should be taken into account by establishing a simplified procedure for registration on terms defined in advance. |
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(21) |
In order to increase the information available to users and to improve consumer protection in the case of food-producing animals, the provisions on the labelling of veterinary medicinal products and the accompanying package leaflet should be strengthened. The requirement that a veterinary medicinal product may only be dispensed after a veterinary prescription has been made out should, as a general principle, be extended to all medicinal products for food-producing animals. However, it should be possible to grant exemptions, where appropriate. The administrative procedures for supplying medicinal products for pets, on the other hand, should be simplified. |
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(22) |
The quality of veterinary medicinal products manufactured or available in the Community should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice. It has proved necessary to reinforce the Community provisions on inspections and to compile a Community register of the results of those inspections. The provisions for the official release of batches of immunological medicinal products should be reviewed in order to take account of the improvement of the general system for monitoring the quality of medicinal products and to reflect technical and scientific progress, and also in order to make mutual recognition fully effective. |
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(23) |
The environmental impact should be studied and consideration should be given on a case-by-case basis to specific provisions seeking to limit it. |
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(24) |
Pharmacovigilance and, more generally, market surveillance and sanctions in the event of failure to comply with the provisions should be stepped up. In the field of pharmacovigilance, account should be taken of the facilities offered by new information technologies to improve exchanges between Member States. |
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(25) |
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). |
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(26) |
Directive 2001/82/EC should be amended accordingly, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Directive 2001/82/EC shall be amended as follows:
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1) |
Article 1 shall be amended as follows:
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2) |
Articles 2 and 3 shall be replaced by the following: ‘Article 2 1. This Directive shall apply to veterinary medicinal products, including pre-mixes for medicated feedingstuffs, intended to be placed on the market in Member States and prepared industrially or by a method involving an industrial process. 2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “veterinary medicinal product” and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply. 3. Notwithstanding paragraph 1, this Directive shall also apply to active substances used as starting materials to the extent set out in Articles 50, 50a, 51 and 80 and additionally to certain substances that may be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties to the extent set out in Article 68. Article 3 1. This Directive shall not apply to:
However, medicated feedingstuffs referred to in subparagraph (a) may be prepared only from premixes that have been authorised under this Directive. 2. Except for the provisions on the possession, prescription, dispensing and administration of veterinary medicinal products, this Directive shall not apply to:
(8) OJ L 92, 7.4.1990, p. 42." (9) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).’" |
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3) |
Article 4(2) shall be replaced by the following: ‘2. In the case of veterinary medicinal products intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept exclusively as pets, Member States may permit exemptions, in their territory, from the provisions in Articles 5 to 8, provided that such products do not contain substances the use of which requires veterinary control and that all possible measures are taken to prevent unauthorised use of the products for other animals.’ |
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4) |
Articles 5 and 6 shall be replaced by the following: ‘Article 5 1. No veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation has been granted by the competent authorities of that Member State in accordance with this Directive or a marketing authorisation has been granted in accordance with Regulation (EC) No .../2004 (10). When a veterinary medicinal product has been granted an initial authorisation in accordance with the first subparagraph, any additional species, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions, shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 13(1). 2. The marketing authorisation holder shall be responsible for the marketing of the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility. Article 6 1. A veterinary medicinal product may not be the subject of a marketing authorisation for the purpose of administering it to one or more food-producing species unless the pharmacologically active substances which it contains appear in Annexes I, II or III to Regulation (EEC) No 2377/90. 2. If an amendment to the Annexes to Regulation (EEC) No 2377/90 so warrants, the marketing authorisation holder or, where appropriate, the competent authorities shall take all necessary measures to amend or revoke the marketing authorisation within 60 days of the date on which the amendment to the Annexes to that Regulation was published in the Official Journal of the European Union. 3. By way of derogation from paragraph 1, a veterinary medicinal product containing pharmacologically active substances not included in Annexes I, II or III to Regulation (EEC) No 2377/90 may be authorised for particular animals of the equidae family that have been declared, in accordance with Commission Decision 93/623/EEC of 20 October 1993 establishing the identification document (passport) accompanying registered equidae (11) and Commission Decision 2000/68/EC of 22 December 1999 amending Decision 93/623/EEC and establishing the identification of equidae for breeding and production (12), as not being intended for slaughter for human consumption. Such veterinary medicinal products shall neither include active substances that appear in Annex IV to Regulation (EEC) No 2377/90 nor be intended for use in the treatment of conditions, as detailed in the authorised Summary of Product Characteristics, for which a veterinary medicinal product is authorised for animals of the equidae family. (10) Note to OJ. Regulation No as in footnote to Recital 5." (11) OJ L 298, 3.12.1993, p. 45. Decision as amended by Commission Decision 2000/68/EC (OJ L 23, 28.1.2000, p. 72)." |
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5) |
Article 8 shall be replaced by the following: ‘Article 8 In the event of serious epizootic diseases, Member States may provisionally allow the use of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use. The Commission may avail itself of the option set out in the first paragraph when explicit provision is made for that option under Community rules concerning certain serious epizootic diseases. If an animal is being imported from, or exported to, a third country and is thereby subject to specific binding health rules, a Member State may permit the use, for the animal in question, of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the Member State in question but is authorised under the legislation of the third country. Member States shall take all appropriate measures concerning the supervision of the importation and the use of such immunological products.’ |
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6) |
Articles 10 to 13 shall be replaced by the following: ‘Article 10 1. Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a non food-producing species, by way of exception, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animal concerned with:
The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility. 2. By way of derogation from Article 11, the provisions of paragraph 1 of this Article shall also apply to the treatment by a veterinarian of an animal belonging to the equidae family provided that it has been declared, in accordance with Commission Decisions 93/623/EEC and 2000/68/EC, as not being intended for slaughter for human consumption. 3. By way of derogation from Article 11, and in accordance with the procedure referred to in Article 89(2), the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Commission Decisions 93/623/EEC and 2000/68/EC. Article 11 1. Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing species, by way of exception, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned on a particular holding with:
The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility. 2. Paragraph 1 shall apply provided that pharmacologically active substances included in the medicinal product are listed in Annex I, II or III to Regulation (EEC) No 2377/90, and that the veterinarian specifies an appropriate withdrawal period. Unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than:
However, these specific withdrawal periods may be modified in accordance with the procedure referred to in Article 89(2). 3. With regard to homeopathic veterinary medicinal products in which active principles figure in Annex II to Regulation (EEC) No 2377/90, the withdrawal period referred to in the second subparagraph of paragraph 2 shall be reduced to zero. 4. When a veterinarian has recourse to the provisions of paragraphs 1 and 2 of this Article, he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the doses administered, the duration of treatment and the withdrawal periods recommended, and shall make these records available for inspection by the competent authorities for a period of at least five years. 5. Without prejudice to the other provisions of this Directive, Member States shall take all necessary measures concerning the import, distribution, dispensing of and information on the medicinal products which they permit for administration to food-producing animals in accordance with paragraph 1(b)(ii). Article 12 1. For the purposes of obtaining a marketing authorisation in respect of a veterinary medicinal product, otherwise than under the procedure established by Regulation (EC) No .../2004 (13), an application shall be lodged with the competent authority of the Member State concerned. In the case of veterinary medicinal products which are intended for one or more food-producing species but whose pharmacologically active substances have not yet been included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a marketing authorisation may not be applied for until after a valid application has been made for the establishment of maximum residue limits in accordance with that Regulation. At least six months shall elapse between a valid application for the establishment of maximum residue limits and an application for a marketing authorisation. However, in the case of veterinary medicinal products referred to in Article 6(3), a marketing authorisation may be applied for without a valid application in accordance with Regulation (EEC) No 2377/90. All the scientific documentation necessary for the demonstration of the quality, safety and efficacy of the veterinary medicinal product, as provided for in paragraph 3, shall be submitted. 2. A marketing authorisation may only be granted to an applicant established in the Community. 3. The application for marketing authorisation shall include all the administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in question. The file shall be submitted in accordance with Annex I and shall contain, in particular, the following information:
The documents and particulars relating to the results of the tests referred to in point (j) of the first subparagraph shall be accompanied by detailed and critical summaries, drawn up as specified in Article 15. Article 13 1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the pre-clinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 5 for not less than eight years in a Member State or the Community. A generic veterinary medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subparagraph shall also apply when the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit, within a period of one month, confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation. However, the ten-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated in accordance with the procedure referred to in Article 89(2). 2. For the purposes of this Article:
3. In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided. 4. Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided. 5. In the case of veterinary medicinal products intended for one or more food-producing species and containing a new active substance that has not been authorised in the Community by ... (14) the ten-year period provided for in the second subparagraph of paragraph 1 shall be extended by one year for each extension of the marketing authorisation to another food-producing species, if it is authorised within the five years following the granting of the initial marketing authorisation. This period shall not, however, exceed a total of 13 years, for a marketing authorisation for four or more food-producing species. The extension of the ten-year period to 11, 12, or 13 years for a veterinary medicinal product intended for food-producing species shall be granted only if the marketing authorisation holder also originally applied for determination of the maximum residue limits established for the species covered by the authorisation. 6. Conducting the necessary studies, tests and trials with a view to the application of paragraphs 1 to 5 and the consequential practical requirements shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for medicinal products. |
|
7) |
the following Articles shall be inserted: ‘Article 13a 1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety and residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the applicant shall provide appropriate scientific literature. 2. The assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits in accordance with Regulation (EEC) No 2377/90 may be used in an appropriate manner as literature, particularly for the safety tests. 3. If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in accordance with Regulation (EEC) No 2377/90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to Article 13, for a period of three years from the grant of the authorisation for which they were carried out. Article 13b In the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with point (j) of the first subparagraph of Article 12(3), but it shall not be necessary to provide scientific references relating to each individual active substance. Article 13c After the marketing authorisation has been granted, the marketing authorisation holder may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical documentation contained in the file for the veterinary medicinal product with a view to examining a subsequent application for a veterinary medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form. Article 13d By way of derogation from point (j) of the first subparagraph of Article 12(3), and in exceptional circumstances with respect to immunological veterinary medicinal products, the applicant shall not be required to provide the results of certain field trials on the target species if these trials cannot be carried out for duly substantiated reasons, in particular on account of other Community provisions.’ |
|
8) |
Articles 14 to 16 shall be replaced by the following: ‘Article 14 The summary of the product characteristics shall contain, in the order indicated below, the following information:
For authorisation under Article 13, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included. Article 15 1. Applicants shall ensure that the detailed and critical summaries referred to in the second subparagraph of Article 12(3) are drafted and signed by persons with the requisite technical or professional qualifications, set out in a brief curriculum vitae, before being submitted to the competent authorities. 2. Persons with the technical or professional qualifications referred to in paragraph 1 shall justify any use made of the scientific literature referred to in Article 13a(1) in accordance with the conditions set out in Annex I. 3. A brief curriculum vitae of the persons referred to in paragraph 1 shall be appended to the detailed critical summaries. Article 16 1. Member States shall ensure that homeopathic veterinary medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 17, 18 and 19, except where such veterinary medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In the case of homeopathic medicinal products registered in accordance with Article 17, Article 32 and Article 33(1) to (3) shall apply. 2. Member States shall establish a simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 17. 3. By way of derogation from Article 10, homeopathic veterinary medicinal products may be administered to non-food producing animals under the responsibility of a veterinarian. 4. By way of derogation from Article 11(1) and (2), Member States shall permit the administration of homeopathic veterinary medicinal products intended for food-producing species the active constituents of which appear in Annex II to Regulation (EEC) No 2377/90 under the responsibility of a veterinarian. Member States shall take appropriate measures to control the use of veterinary homeopathic medicinal products registered or authorised in another Member State in accordance with this Directive for use in the same species.’ |
|
9) |
Article 17 shall be amended as follows:
|
|
10) |
Article 18 shall be amended as follows:
|
|
11) |
Article 19 shall be replaced by the following: ‘Article 19 1. Homeopathic veterinary medicinal products other than those referred to in Article 17(1) shall be authorised in accordance with Articles 12, 13a, 13b, 13c, 13d and 14. 2. A Member State may introduce or retain on its territory specific rules for the safety tests and preclinical and clinical trials of homeopathic veterinary medicinal products intended for pet species and non-food-producing exotic species other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force.’ |
|
12) |
Articles 21, 22 and 23 shall be replaced by the following: ‘Article 21 1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for a veterinary medicinal product is completed within a maximum of 210 days after the submission of a valid application. Applications for marketing authorisations for the same veterinary medicinal product in two or more Member States, shall be submitted in accordance with Articles 31 to 43. 2. Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 31 to 43 apply. Article 22 Where a Member State is informed, in accordance with point (n) of Article 12(3), that another Member State has authorised a veterinary medicinal product which is the subject of an application for authorisation in the Member State concerned, that Member State shall reject the application unless it was submitted in compliance with Articles 31 to 43. Article 23 In order to examine the application submitted pursuant to Articles 12 to 13d, Member States' competent authorities:
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|
13) |
Article 25 shall be replaced by the following: ‘Article 25 1. When granting a marketing authorisation, the competent authority shall inform the holder of the summary of product characteristics that it has approved. 2. The competent authority shall take all necessary measures to ensure that information concerning the veterinary medicinal product, and in particular the labelling and package leaflet, is in conformity with the summary of product characteristics approved when the marketing authorisation was granted or subsequently. 3. The competent authority shall make the marketing authorisation publicly available without delay, together with the summary of product characteristics for each veterinary medicinal product that it has authorised. 4. The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned. The competent authority shall make the assessment report and its reasons for the opinion publicly available without delay, after deleting any information of a commercially confidential nature.’ |
|
14) |
Article 26 shall be amended as follows:
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|
15) |
Article 27 shall be amended as follows:
|
|
16) |
the following Article shall be inserted: ‘Article 27a After a marketing authorisation has been granted, the holder of the authorisation shall inform the competent authority of the authorising Member State of the date of the actual placing on the market of the veterinary medicinal product in that Member State, taking into account the various presentations authorised. The holder shall also notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. Upon request by the competent authority, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the veterinary medicinal product, and any data in his possession relating to the volume of prescriptions.’ |
|
17) |
Article 28 shall be replaced by the following: ‘Article 28 1. Without prejudice to paragraphs 4 and 5, a marketing authorisation shall be valid for five years. 2. The authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance. To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. The competent authority may require the applicant to submit the listed documents at any time. 3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2. 4. Any authorisation that is not followed within three years of its granting by the actual placing on the market of the authorised veterinary medicinal product in the authorising Member State shall cease to be valid. 5. When an authorised veterinary medicinal product previously placed on the market in the authorising Member State is no longer actually present on the market in that Member State for a period of three consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid. 6. The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant exemptions from paragraphs 4 and 5. Such exemptions shall be duly justified.’ |
|
18) |
Article 30 shall be replaced by the following: ‘Article 30 The marketing authorisation shall be refused if the file submitted to the competent authorities does not comply with Articles 12 to 13d and Article 15. The authorisation shall also be refused if, after examination of the documents and particulars listed in Articles 12 and 13(1), it is clear that:
However, when a Community legislative framework is in the course of being adopted, the competent authority may refuse authorisation for a veterinary medicinal product where such action is necessary for the protection of public health, consumer or animal health. The applicant or marketing authorisation holder shall be responsible for the accuracy of documents and data submitted.’ |
|
19) |
the title of Chapter 4 shall be replaced by the following: ‘Chapter 4 Mutual recognition procedure and decentralised procedure’ |
|
20) |
Articles 31 to 37 shall be replaced by the following: ‘Article 31 1. A coordination group shall be set up for the examination of any question relating to marketing authorisation of a veterinary medicinal product in two or more Member States in accordance with the procedures laid down in this Chapter. The Agency shall provide the secretariat of this coordination group. 2. The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Members of the group may arrange to be accompanied by experts. 3. The coordination group shall draw up its own rules of procedure, which shall enter into force after a favourable opinion has been given by the Commission. These rules of procedure shall be made public. Article 32 1. With a view to the granting of a marketing authorisation for a veterinary medicinal product in more than one Member State, the applicant shall submit an application based on an identical dossier in those Member States. The dossier shall contain all the administrative information and scientific and technical documentation described in Articles 12 to 14. The documents submitted shall include a list of Member States concerned by the application. The applicant shall request one Member State to act as reference Member State and to prepare an assessment report in respect of the veterinary medicinal product in accordance with paragraphs 2 or 3. Where appropriate, the assessment report shall contain an evaluation for the purposes of Article 13(5) or Article 13a(3). 2. If the veterinary medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report in respect of the veterinary medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be forwarded to the concerned Member States and the applicant. 3. If the veterinary medicinal product has not received authorisation by the time of application, the applicant shall request the reference Member State to prepare a draft assessment report and drafts of the summary of product characteristics, labelling and package leaflet. The reference Member State shall prepare these drafts within 120 days of the receipt of a valid application and shall send them to the concerned Member States and the applicant. 4. Within 90 days after receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and the package leaflet and inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly. 5. Each Member State in which an application following paragraph 1 has been submitted shall adopt a decision in conformity with the approved assessment report, summary of product characteristics, labelling and package leaflet within 30 days after acknowledgement of the agreement. Article 33 1. If a Member State cannot, within the period allowed in Article 32(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant. The points of disagreement shall be referred without delay to the coordination group. If a Member State to which an application has been submitted invokes the reasons referred to in Article 71(1), it shall no longer be regarded as a Member State concerned by this Chapter. 2. The Commission shall adopt guidelines defining a potential serious risk for human or animal health or for the environment. 3. Within the coordination group, all Member States referred to in paragraph 1 shall use their best endeavours to reach agreement on the action to be taken. They shall provide the applicant with the opportunity to make his point of view known orally or in writing. If, within 60 days of the communication of the reasons for disagreement to the coordination group the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Article 32(5) shall apply. 4. If within the period of 60 days the Member States fail to reach an agreement, the Agency shall be immediately informed with a view to application of the procedure laid down in Articles 36, 37 and 38. The Agency shall be provided with a detailed description of the matters on which agreement could not be reached and the reasons for the disagreement. The applicant shall be provided with a copy of this information. 5. As soon as the applicant has been informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of Article 32(1). 6. In the case referred to in paragraph 4, the Member States that have approved the assessment report, summary of product characteristics, labelling and package leaflet of the reference Member State may, on request by the applicant, grant a marketing authorisation for the veterinary medicinal product without waiting for the outcome of the procedure laid down in Article 36. In that case, the authorisation granted shall be without prejudice to the outcome of that procedure. Article 34 1. If two or more applications submitted in accordance with Articles 12 to 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or revocation of authorisation, a Member State, or the Commission, or the marketingauthorisation holder may refer the matter to the Committee for Medicinal Products for Veterinary Use, hereinafter referred to as “the Committee”, for the application of the procedure laid down in Articles 36, 37 and 38. 2. With a view to promoting the harmonisation of veterinary medicinal products authorised in the Community, and to strengthening the efficiency of the provisions of Articles 10 and 11, Member States shall send to the coordination group, no later than ... (16), a list of veterinary medicinal products for which a harmonised summary of product characteristics should be prepared. The coordination group shall agree on a list of medicinal products, on the basis of proposals sent by Member States, and shall forward the list to the Commission. The medicinal products on the list shall be subject to the provisions in paragraph 1 in accordance with a timetable established in cooperation with the Agency. The Commission, acting in collaboration with the Agency, and taking into consideration the views of the interested parties, shall agree the final list and timetable. Article 35 1. Member States or the Commission or the applicant or marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Articles 36, 37 and 38 before a decision is reached on a request for a marketing authorisation or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appear necessary, so as to take account in particular of the information collected in accordance with Title VII. The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder. The Member State and the applicant or the marketing authorisation holder shall forward to the Committee all available information relating to the matter in question. 2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to specific parts of the authorisation. In that case, Article 39 shall apply to those medicinal products only if they are covered by the marketing authorisation procedure referred to in this Chapter. Article 36 1. When reference is made to the procedure laid down in this Article, the Committee shall consider the matter concerned and shall issue a reasoned opinion within 60 days of the date on which the matter was referred to it. However, in cases submitted to the Committee in accordance with Articles 34 and 35, this period may be extended by the Committee for a further period of up to 90 days, taking into account the views of the marketing authorisation holders concerned. In an emergency, and on a proposal from its Chairman, the Committee may agree to a shorter deadline. 2. In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint independent experts to advise it on specific questions. When appointing such experts, the Committee shall define their tasks and specify the time limit for the completion of these tasks. 3. Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit that it will specify. The opinion of the Committee shall include the draft summary of product characteristics and the drafts of the labelling and package leaflet. If it considers appropriate, the Committee may invite any other person to provide information relating to the matter before it. The Committee may suspend the time limit referred to in paragraph 1 to allow the applicant or the marketing authorisation holder to prepare the explanations. 4. The Agency shall forthwith inform the applicant or the marketing authorisation holder when the opinion of the Committee is that:
Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No .../2004 (17). The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5 of this Article. 5. Within 15 days after its adoption, the Agency shall forward the final opinion of the Committee to Member States, the Commission and the applicant or the marketing authorisation holder, together with a report describing the assessment of the veterinary medicinal product and the reasons for its conclusions. In the event of an opinion in favour of granting or maintaining a marketing authorisation, the following documents shall be annexed to the opinion:
Article 37 Within 15 days after receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law. In the event of a draft decision that envisages the granting of a marketing authorisation, the documents referred to in the second subparagraph of Article 36(5) shall be annexed. If, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences. The draft decision shall be forwarded to Member States and the applicant or marketing authorisation holder. (16) One year after the entry into force of this Directive." (17) Note for OJ. Regulation No as in footnote to Recital 5.’" |
|
21) |
Article 38 shall be amended as follows:
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|
22) |
in Article 39, the third subparagraph of paragraph 1 shall be deleted; |
|
23) |
in Article 42, paragraph 2 shall be replaced by the following: ‘2. At least every ten years the Commission shall publish a report on experience gained on the basis of the procedures provided for in this chapter and shall propose any amendments necessary to improve the procedures. The Commission shall submit this report to the European Parliament and the Council.’ |
|
24) |
Article 43 shall be replaced by the following: ‘Article 43 Articles 33(4), (5) and (6) and 34 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in Article 17. Articles 32 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in Article 19(2).’ |
|
25) |
in Article 44, the following paragraph shall be added: ‘4. The Member State shall forward to the Agency a copy of the manufacturing authorisations referred to in paragraph 1. The Agency shall enter that information in the Community database referred to in Article 80(6).’ |
|
26) |
in Article 50, point (f) shall be replaced by the following:
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|
27) |
the following Article shall be inserted: ‘Article 50a 1. For the purposes of this Directive, manufacturing active substances for use as starting materials shall include the complete or partial manufacture or the import of an active substance used as a starting material, as defined in Part 2, Section C of Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation in a veterinary medicinal product, including repackaging or re-labelling, such as carried out by a starting material distributor. 2. Any amendments which may be necessary to adapt the provisions of this Article to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 89(2).’ |
|
28) |
in Article 51, the following paragraphs shall be added: ‘The principles of good manufacturing practice as regards the manufacturing of active substances for use as starting materials as referred to in Article 50(f) shall be adopted in the form of detailed guidelines. The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 44(1), the reports referred to in Article 80(3) and the form and content of the certificate of good manufacturing practice referred to in Article 80(5).’ |
|
29) |
in Article 53, paragraph 1 shall be replaced by the following: ‘1. Member States shall ensure that the qualified person referred to in Article 52(1) fulfils the conditions of qualification referred to in paragraphs 2 and 3.’ |
|
30) |
in Article 54, paragraph 1 shall be replaced by the following: ‘1. A person engaging, in a Member State, in the activities of the person referred to in Article 52(1) on the date on which Directive 81/851/EEC became applicable, without complying with the provisions of Article 53, shall be eligible to continue to engage in those activities within the Community.’ |
|
31) |
in Article 55, paragraph 1(b) shall be replaced by the following:
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|
32) |
Article 58 shall be amended as follows:
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|
33) |
Article 59 shall be amended as follows:
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|
34) |
Article 60 shall be replaced by the following: ‘Article 60 Where there is no outer package, all the particulars which should feature on such a package pursuant to Articles 58 and 59 shall be shown on the immediate packaging.’ |
|
35) |
Article 61 shall be amended as follows:
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|
36) |
Article 62 shall be replaced by the following: ‘Article 62 Where the provisions of this Title are not observed and a formal notice addressed to the person concerned has been ineffectual, Member States' competent authorities may suspend or revoke the marketing authorisation.’ |
|
37) |
Article 64(2) shall be amended as follows:
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|
38) |
the title of Title VI shall be replaced by the following: ‘TITLE VI POSSESSION, DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS’ |
|
39) |
Article 65 shall be amended as follows:
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|
40) |
Article 66 shall be amended as follows:
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|
41) |
Article 67 shall be amended as follows:
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|
42) |
the first paragraph of Article 69 shall be replaced by the following: ‘Member States shall ensure that the owners or keepers of food-producing animals can provide proof of purchase, possession and administration of veterinary medicinal products to such animals for five years after their administration, including when the animal is slaughtered during the five-year period.’ |
|
43) |
the introductory wording of Article 70 shall be replaced by the following: ‘By way of derogation from Article 9 and without prejudice to Article 67, Member States shall ensure that veterinarians providing services in another Member State can take with them and administer to animals small quantities of veterinary medicinal products not exceeding daily requirements other than immunological veterinary medicinal products which are not authorised for use in the Member State in which the services are provided (hereinafter: “host Member State”), provided that the following conditions are satisfied:’ |
|
44) |
the following subparagraph shall be added to Article 71(1): ‘The Member State may also invoke the provisions of the first subparagraph in order to withhold marketing authorisation in accordance with a decentralised procedure as provided for in Articles 31 to 43.’ |
|
45) |
in Article 72, paragraph 2 shall be replaced by the following: ‘2. Member States may impose specific requirements on veterinary practitioners and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions.’ |
|
46) |
Article 73 shall be amended as follows:
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|
47) |
The following article shall be inserted: ‘Article 73a The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee their independence.’ |
|
48) |
The introductory wording of the second paragraph of Article 74 shall be replaced by the following: ‘That qualified person shall reside in the Community and shall be responsible for the following:’ |
|
49) |
Article 75 shall be replaced by the following: ‘Article 75 1. The marketing authorisation holder shall maintain detailed records of all suspected adverse reactions occurring within the Community or in a third country. Save in exceptional circumstances, these reactions shall be communicated electronically in the form of a report in accordance with the guidelines referred to in Article 77(1). 2. The marketing authorisation holder shall record all suspected serious adverse reactions and human adverse reactions relating to the use of veterinary medicinal products that are brought to his attention, and report them promptly to the competent authority of the Member State on whose territory the incident occurred, and no later than 15 days following receipt of the information. The marketing authorisation holder shall also record all suspected serious adverse reactions and human adverse reactions related to the use of veterinary medicinal products of which he can reasonably be expected to have knowledge, and report them promptly to the competent authority of Member State on whose territory the incident occurred, and no later than 15 days following receipt of the information. 3. The marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions, human adverse reactions and any suspected transmission via a veterinary medicinal product of any infectious agent occurring on the territory of a third country are reported promptly in accordance with the guidelines referred to in Article 77(1), so that they are available to the Agency and the competent authorities of the Member States in which the veterinary medicinal product is authorised, and no later than 15 days following the receipt of the information. 4. By way of derogation from paragraphs 2 and 3, in the case of veterinary medicinal products which are covered by Directive 87/22/EEC, have benefited from the authorisation procedures under Articles 31 and 32 of this Directive or have been the subject of the procedures provided for in Articles 36, 37 and 38 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions and human adverse reactions occurring in the Community are reported in such a way so as to be accessible to the reference Member State or a competent authority designated as reference Member State. The reference Member State shall assume responsibility for the analysis and follow-up of any such adverse reactions. 5. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation or subsequently as indicated in the guidelines referred to in Article 77(1), reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request. The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product. 6. Amendments to paragraph 5 may be adopted in accordance with the procedure referred to in Article 89(2) in the light of the experience gained from its operation. 7. Following the granting of a marketing authorisation, the holder of such authorisation may request the amendment of the periods referred to in paragraph 5 of this Article in accordance with the procedure laid down by Commission Regulation (EC) No 1084/2003 (21). 8. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised veterinary medicinal product without giving prior or simultaneous notification to the competent authority. In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading. Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties. |
|
50) |
Article 76(1) shall be replaced by the following: ‘1. The Agency, in collaboration with Member States and the Commission, shall set up a dataprocessing network to facilitate the exchange of pharmacovigilance information regarding veterinary medicinal products marketed in the Community in order to allow the competent authorities to share the information at the same time.’ |
|
51) |
in Article 77(1), the second subparagraph shall be replaced by the following: ‘In accordance with those guidelines, the marketing authorisation holder shall use internationally agreed veterinary medical terminology for the transmission of reports on adverse reactions. The Commission shall publish the guidelines, which shall take account of international harmonisation work achieved in the field of pharmacovigilance.’ |
|
52) |
Article 78 shall be amended as follows:
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|
53) |
Article 80 shall be amended as follows:
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54) |
Article 82 shall be replaced by the following: ‘Article 82 1. Where it considers it necessary for reasons of human or animal health, a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the bulk product and/or veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation. 2. On request by the competent authorities, the marketing authorisation holder shall promptly supply the samples referred to in paragraph 1, together with the reports of the control referred to in Article 81(2). The competent authority shall inform all the other Member States in which the veterinary medicinal product is authorised as well as the European Directorate for the Quality of Medicines of its intention to control batches or the batch in question. In such cases, the competent authorities of another Member State shall not apply the provisions of paragraph 1. 3. After studying the control reports referred to in Article 81(2), the laboratory responsible for the control shall repeat, on the samples provided, all the tests carried out by the manufacturer on the finished product, in accordance with the relevant provisions shown in the dossier for marketing authorisation. The list of tests to be repeated by the laboratory responsible for the control shall be restricted to justified tests, provided that all Member States concerned, and if appropriate the European Directorate for the Quality of Medicines, agree to this. For immunological veterinary medicinal products authorised under Regulation (EC) No .../2004 (23), the list of tests to be repeated by the control laboratory may be reduced only after agreement by the Agency. 4. All Member States concerned shall recognise the results of the tests. 5. Unless the Commission is informed that a longer period is necessary to conduct the tests, Member States shall ensure that this control is completed within 60 days of receipt of the samples. The competent authority shall notify the other Member States concerned, the European Directorate for the Quality of Medicines, the marketing authorisation holder and, if appropriate, the manufacturer, of the results of the tests within the same period of time. If a competent authority concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take all the necessary measures vis-à-vis the marketing authorisation holder and the manufacturer, where appropriate, and shall inform accordingly the other Member States in which the veterinary medicinal product is authorised. (23) Note for OJ. Regulation No as in footnote to Recital 5.’" |
|
55) |
Article 83 shall be amended as follows:
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|
56) |
in Article 84, point (a) of paragraph 1 shall be replaced by the following:
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|
57) |
in Article 85, the following paragraph shall be added: ‘3. Member States shall prohibit the advertising to the general public of veterinary medicinal products that:
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|
58) |
in Article 89, paragraphs 2 and 3 shall be replaced by the following: ‘2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month. 4. The Standing Committee shall adopt its rules of procedure. These rules of procedure shall be made public.’ |
|
59) |
Article 90 shall be replaced by the following: ‘Article 90 Member States shall take all necessary measures to ensure that the competent authorities concerned communicate the appropriate information to each other, particularly regarding compliance with the requirements adopted for the authorisations referred to in Article 44, for the certificates referred to in Article 80(5) or for authorisation to place products on the market. Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 80(3) to the competent authorities of another Member State. The conclusions reached following an inspection as referred to in Article 80(1) carried out by the inspectors of the Member State concerned shall be valid for the Community. However, by way of exception, if a Member State has not been able, for serious reasons of human or animal health, to accept the conclusions of an inspection as referred to in Article 80(1), that Member State shall forthwith inform the Commission and the Agency. The Agency shall inform the Member States concerned. When the Commission is informed of such serious reasons, it may, after consulting the Member States concerned, ask the inspector of the competent supervisory authority to carry out a new inspection; the inspector may be accompanied by two other inspectors from Member States that are not parties to the disagreement.’ |
|
60) |
in Article 94, the third subparagraph shall be replaced by the following: ‘Decisions to grant or revoke a marketing authorisation shall be made publicly available.’ |
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61) |
Article 95 shall be replaced by the following: ‘Article 95 Member States shall not permit foodstuffs for human consumption to be taken from test animals unless the competent authorities have established an appropriate withdrawal period. The withdrawal period shall either:
|
|
62) |
the following articles shall be inserted: ‘Article 95a Member States shall ensure that appropriate collection systems are in place for veterinary medicinal products that are unused or expired. Article 95b When a veterinary medicinal product is to be authorised in accordance with Regulation (EC) No .../2004 (24) and the Scientific Committee in its opinion refers to recommended conditions or restrictions with regard to the safe and effective use of the veterinary medicinal product as provided for in Article 34(4)(d) of that Regulation, a decision addressed to Member States shall be adopted in accordance with the procedure laid down in Articles 37 and 38 of this Directive, for the implementation of those conditions or restrictions. (24) Note for OJ. Regulation No as in footnote to Recital 5.’" |
Article 2
The periods of protection provided for in Article 1, point 6, which amends Article 13 of Directive 2001/82/EC, shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date of transposition referred to in Article 3 first paragraph.
Article 3
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... (25) at the latest. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 5
This Directive is addressed to the Member States.
Done at ...,
For the European Parliament
The President
For the Council
The President
(1) OJ C 75E, 26.3.2002, p. 234.
(3) Position of the European Parliament of 23 October 2002 (OJ C 300 E, 11.12.2003, p. 390), Council Common Position of 29 September 2003 (OJ C 297 E, 9.12.2003, p. 72), Position of the European Parliament of 17 December 2003.
(4) OJ L 311, 28.11.2001, p. 1.
(5) OJ L 214, 24.8.1993, p. 1. Regulation repealed by Regulation (EC) No /2004 (see p. of this Official Journal). (Note to the OJ. Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.)
(6) OJ L 184, 17.7.1999, p. 23.
(13) Note to OJ. Regulation No as in footnote to Recital 5.
(14) The date of the entry into force of this Directive.’
(21) OJ L 159, 27.6.2003, p. 1.’
(25) 18 months after entry into force of the Directive.
P5_TA(2003)0579
Traditional herbal medicinal products ***II
European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (12754/1/2003 — C5-0519/2003 — 2002/0008(COD))
(Codecision procedure: second reading)
The European Parliament,
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— |
having regard to the Council common position (12754/1/2003 — C5-0519/2003) (1), |
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— |
having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2002) 1) (3), |
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— |
having regard to the amended proposal (COM(2003) 161) (1), |
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— |
having regard to Article 251(2) of the EC Treaty, |
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— |
having regard to Rule 80 of its Rules of Procedure, |
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— |
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0452/2003), |
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1. |
Amends the common position as follows; |
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2. |
Instructs its President to forward its position to the Council and the Commission. |
(1) Not yet published in OJ.
(2) Texts Adopted, 21.11.2002, P5_TA(2002)0561.
P5_TC2-COD(2002)0008
Position of the European Parliament adopted at second reading on 17 December 2003 with a view to the adoption of European Parliament and Council Directive 2004/.../EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the Opinion of the European Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
Whereas:
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(1) |
Directive 2001/83/EC (4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy. |
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(2) |
Where the applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal product have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC, he should not be required to provide the results of pre-clinical tests or the results of clinical trials. |
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(3) |
A significant number of medicinal products, despite their long tradition, do not fulfil the requirements of having a well-established medicinal use with recognised efficacy and an acceptable level of safety and are not eligible for a marketing authorisation. To maintain these products on the market, the Member States have enacted differing procedures and provisions. The differences that currently exist between the provisions laid down in the Member States may hinder trade in traditional medicinal products within the Community and lead to discrimination and distortion of competition between manufacturers of these products. They may also have an impact on the protection of public health, since the necessary guarantees of quality, safety and efficacy are not always provided at present. |
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(4) |
Having regard to the particular characteristics of these medicinal products, especially their long tradition, it is desirable to provide a special, simplified registration procedure for certain traditional medicinal products. However, this simplified procedure should be used only where no marketing authorisation can be obtained under Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety. It should likewise not apply to homeopathic medicinal products eligible for marketing authorisation or for registration under Directive 2001/83/EC. |
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(5) |
The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, insofar as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary where the medicinal product, on the basis of the information on its traditional use, proves not to be harmful in specified conditions of use. However, even a long tradition does not exclude the possibility that there may be concerns with regard to the product's safety, and therefore the competent authorities should be entitled to ask for all data necessary for assessing the safety. The quality aspect of the medicinal product is independent of its traditional use so that no derogation should be made with regard to the necessary physico-chemical, biological and microbiological tests. Products should comply with quality standards in relevant European Pharmacopoeia monographs or those in the pharmacopoeia of a Member State. |
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(6) |
The vast majority of medicinal products with a sufficiently long and coherent tradition are based on herbal substances. It therefore seems appropriate to limit the scope of the simplified registration in a first step to traditional herbal medicinal products. |
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(7) |
The simplified registration should be acceptable only where the herbal medicinal product may rely on a sufficiently long medicinal use in the Community. Medicinal use outside the Community should be taken into account only if the medicinal product has been used within the Community for a certain time. Where there is limited evidence of use within the Community, it is necessary to assess carefully the validity and relevance of use outside the Community. |
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(8) |
With the objective of further facilitating the registration of certain traditional herbal medicinal products and of further enhancing harmonisation, there should be the possibility of establishing a Community list of herbal substances that fulfil certain criteria, such as having been in medicinal use for a sufficiently long time, and hence are considered not to be harmful under normal conditions of use. |
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(9) |
Having regard to the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products should be established within the European Agency for the Evaluation of Medicinal Products set up by Council Regulation (EEC) No 2309/93 (5) (hereinafter ‘the Agency’). The Committee should carry out tasks concerning the simplified registration and authorisation of medicinal products as provided for in this Directive. Its tasks should relate in particular to establishing Community herbal monographs relevant for the registration as well as the authorisation of herbal medicinal products. It should be composed of experts in the field of herbal medicinal products. |
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(10) |
It is important to ensure full consistency between the new committee and the Committee for Human Medicinal Products already existing within the Agency. |
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(11) |
In order to promote harmonisation, Member States should recognise registrations of traditional herbal medicinal products granted by another Member State based on Community herbal monographs or consisting of substances, preparations or combinations thereof contained in a list to be established. For other products, Member States should take due account of such registrations. |
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(12) |
This Directive allows non-medicinal herbal products, fulfilling the criteria of food legislation, to be regulated under food legislation in the Community. |
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(13) |
The Commission should present a report on the application of the Chapter on traditional herbal medicinal products to the European Parliament and to the Council, including an assessment on the possible extension of traditional-use registration to other categories of medicinal products. |
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(14) |
It is therefore appropriate to amend Directive 2001/83/CE accordingly, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Directive 2001/83/EC is hereby amended as follows:
|
(1) |
In Article 1 the following points shall be added:
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|
(2) |
The following Chapter shall be inserted in Title III: ‘CHAPTER 2a: Specific provisions applicable to traditional herbal medicinal products Article 16a 1. A simplified registration procedure (hereinafter “traditional-use registration”) is hereby established for herbal medicinal products which fulfil all of the following criteria:
2. Notwithstanding Article 1(30), the presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for registration in accordance with paragraph 1, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). 3. However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this Chapter shall not apply. Article 16b 1. The applicant and registration holder shall be established in the Community. 2. In order to obtain traditional-use registration, the applicant shall submit an application to the competent authority of the Member State concerned. Article 16c 1. The application shall be accompanied by:
Annex I shall apply by analogy to the particulars and documents specified in point (a). 2. A corresponding product, as referred to in paragraph 1(c), is characterised by having the same active ingredients, irrespective of the excipients used, the same or similar intended purpose, equivalent strength and posology and the same or similar route of administration as the medicinal product applied for. 3. The requirement to show medicinal use throughout the period of thirty years, referred to in paragraph 1(c), is satisfied even where the marketing of the product has not been based on a specific authorisation. It is likewise satisfied if the number or quantity of ingredients of the medicinal product has been reduced during that period. 4. Where the product has been used in the Community for less than 15 years, but is otherwise eligible for simplified registration, the Member State where the application for traditional-use registration has been submitted shall refer the product to the Committee for Herbal Medicinal Products. The Member State shall submit relevant documentation supporting the referral. The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be taken into account by the Member State when taking its final decision. Article 16d 1. Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that:
2. For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this Chapter. Article 16e 1. Traditional-use registration shall be refused if the application does not comply with Articles 16a, 16b or 16c or if at least one of the following conditions is fulfilled:
2. The competent authorities of the Member States shall notify the applicant, the Commission and any competent authority that requests it, of any decision they take to refuse traditional-use registration and the reasons for refusal. Article 16f 1. A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products shall be established in accordance with the procedure referred to in Article 121(2). The list shall contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product. 2. If an application for traditional-use registration relates to a herbal substance, preparation or a combination thereof contained in the list referred to in paragraph 1, the data specified in Article 16c(1)(b)(c) and (d) do not need to be provided. Article 16e(1)(c) and (d) shall not apply. 3. If a herbal substance, preparation or a combination thereof ceases to be included in the list referred to in paragraph 1, registrations pursuant to paragraph 2 for herbal medicinal products containing this substance shall be revoked unless the particulars and documents referred to in Article 16c(1) are submitted within three months. Article 16g 1. Articles 3(1) and (2), 4(4), 6(1), 12, 17(1), 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3), 112, 116 to 118, 122, 123, 125, 126 second subparagraph, 127 of this Directive as well as Commission Directive 91/356/EEC (6) shall apply, by analogy, to traditional-use registration granted under this Chapter. 2. In addition to the requirements of Articles 54 to 65 any labelling and user package leaflet shall contain a statement to the effect that:
A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question. 3. In addition to the requirements of Articles 86 to 99 any advertisement for a medicinal product registered under this Chapter shall contain the following statement: “Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use”. Article 16h 1. A Committee for Herbal Medicinal Products is hereby established. That Committee shall be part of the Agency and shall have the following competence:
Finally, the Committee for Herbal Medicinal Products shall perform any other task conferred upon it by Community law. The appropriate coordination with the Committee for Human Medicinal Products shall be ensured by a procedure to be determined by the Executive Director of the Agency in accordance with Article 57(2) of Regulation (EEC) No 2309/93. 2. Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Herbal Medicinal Products. The alternates shall represent and vote for the members in their absence. Members and alternates shall be chosen for their role and experience in the evaluation of herbal medicinal products and shall represent the competent national authorities. The said Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. With a view to the co-opting of such members, the said Committee shall identify the specific complementary scientific competence of the additional member(s). Co-opted members shall be chosen among experts nominated by Member States or the Agency. The members of the said Committee may be accompanied by experts in specific scientific or technical fields. 3. The Committee for Herbal Medicinal Products shall establish Community herbal monographs for herbal medicinal products with regard to the application of Article 10(1)(a)(ii) as well as traditional herbal medicinal products. The said Committee shall fulfil further responsibilities conferred upon it by provisions of this Chapter and other Community law. When Community herbal monographs within the meaning of this paragraph have been established, they shall be taken into account by the Member States when examining an application. Where no such Community herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to. When new Community herbal monographs are established, the registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The registration holder shall notify any such modification to the competent authority of the Member State concerned. The herbal monographs shall be published. 4. The general provisions of Regulation (EEC) No 2309/93 relating to the Committee for Human Medicinal Products shall apply by analogy to the Committee for Herbal Medicinal Products. Article 16i Before ... (7) the Commission shall present a report to the European Parliament and the Council concerning the application of the provisions of this Chapter. The report shall include an assessment on the possible extension of traditional-use registration to other categories of medicinal products. (6) OJ L 193, 17.7.1991, p. 30." (7) Three years after the date of entry into force of this Directive.’" |
Article 2
1. The Member States shall take the necessary measures to comply with this Directive by ... (8). They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. For the traditional herbal medicinal products as referred to in Article 1, which are already on the market on the entry into force of this Directive, the competent authorities shall apply the provisions of this Directive within seven years after its entry into force.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at
For the European Parliament
The President
For the Council
The President
(1) OJ C 126 E, 28.5.2002, p. 263.
(3) Opinion of the European Parliament of 21 November 2002 (OJ C 25 E, 29.1.2004, p. 222), Council Common Position of 4 November 2003 (OJ C 305 E, 16.12.2003, p. 52), Position of the European Parliament of 17 December 2003.
(4) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).
(5) OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regulation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).
(8) 18 months after the date of entry into force of this Directive
P5_TA(2003)0580
Measuring instruments ***II
European Parliament legislative resolution on the Council common position adopting a European Parliament and Council directive on measuring instruments (9681/4/2003 — C5-0417/2003 — 2000/0233(COD))
(Codecision procedure: second reading),
The European Parliament,
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— |
having regard to the Council common position (9681/4/2003 — C5-0417/2003) (1), |
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— |
having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2000) 566) (3), |
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— |
having regard to the amended proposal (COM(2002) 37) (4), |
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— |
having regard to Article 251(2) of the EC Treaty, |
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— |
having regard to Rule 80 of its Rules of Procedure, |
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— |
having regard to the recommendation for second reading of the Committee on Industry, External Trade, Research and Energy (A5-0458/2003), |
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1. |
Amends the common position as follows; |
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2. |
Instructs its President to forward its position to the Council and the Commission. |
(1) OJ C 252 E, 21.10.2003, p. 1.
(2) OJ C 65 E, 14.3.2002, p. 34.
P5_TC2-COD(2000)0233
Position of the European Parliament adopted at second reading on 17 December 2003 with a view to the adoption of European Parliament and Council Directive 2004/.../EC on measuring instruments
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the Opinion of the European Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
Whereas:
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(1) |
A number of measuring instruments are covered by specific Directives, adopted on the basis of Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control (4). Specific Directives that are technically outdated should be repealed and replaced by an independent Directive reflecting the spirit of the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (5). |
|
(2) |
Correct and traceable measuring instruments can be used for a variety of measurement tasks. Those responding to reasons of public interest, public health, safety and order, protection of the environment and the consumer, of levying taxes and duties and of fair trading, which directly and indirectly affect the daily life of citizens in many ways, may require the use of legally controlled measuring instruments. |
|
(3) |
Legal metrological control should not lead to barriers to the free movement of measuring instruments. The provisions concerned should be the same in all Member States and proof of conformity accepted throughout the Community. |
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(4) |
Legal metrological control requires conformity with specified performance requirements. The performance requirements that the measuring instruments must meet should provide a high level of protection. The conformity assessment should provide a high level of confidence. |
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(5) |
Member States should as a general rule prescribe legal metrological control. Where legal metrological control is prescribed, only measuring instruments complying with common performance requirements should be used. |
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(6) |
The principle of optionality introduced by this Directive, whereby Member States may exercise their right to decide whether or not to regulate any of the instruments covered by this Directive, should be applicable only to the extent that this will not cause unfair competition. |
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(7) |
The responsibilities of the manufacturer for compliance with the requirements of this Directive should be specifically stated. |
|
(8) |
The performance of measuring instruments is particularly sensitive to the environment, particular the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference forms an integral part of this Directive and the immunity requirements of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (6) should therefore not apply. |
|
(9) |
Community legislation should specify essential requirements that do not impede technical progress, preferably performance requirements. Provisions to remove technical barriers to trade should follow the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards. |
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(10) |
In order to take account of differences in climatic conditions or of different levels of consumer protection that may apply at national level, essential requirements may give rise to the establishment of environmental or accuracy classes. |
|
(11) |
In order to ease the task of proving conformity with the essential requirements and to enable conformity to be assessed, it is desirable to have harmonised standards. Such harmonised standards are drawn up by private-law bodies and should retain their status as non-mandatory texts. To this end, the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines on cooperation between the Commission and the European Standardisation bodies signed on 13 November 1984. |
|
(12) |
The technical and performance specifications of internationally agreed normative documents may also comply, in part or in full, with the essential requirements laid down by this Directive. In those cases the use of these internationally agreed normative documents can be an alternative to the use of harmonised standards and, under specific conditions, give rise to a presumption of conformity. |
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(13) |
Conformity with the essential requirements laid down by this Directive can also be provided by specifications that are not supplied by a European technical standard or an internationally agreed normative document. The use of European technical standards or internationally agreed normative documents should therefore be optional. |
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(14) |
The conformity assessment of sub-assemblies should respect the provisions of this Directive. If subassemblies are traded separately and independently of an instrument, the exercise of conformity assessment should be undertaken independently of the instrument concerned. |
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(15) |
The state of the art in measurement technology is subject to constant evolution which may lead to changes in the needs for conformity assessments. Therefore, for each category of measurement and, where appropriate, sub-assemblies, there must be an appropriate procedure or a choice between different procedures of equivalent stringency. The procedures adopted are as required by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the ‘CE’ marking, which are intended to be used in the technical harmonisation Directives (7). However, derogations may have to be made for these modules in order to reflect specific aspects of metrological control. Provision should be made for the ‘CE’ marking to be affixed during the fabrication process. |
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(16) |
Continued development in measurement technology as well as concerns expressed by stakeholders about certification, stress the need to ensure consistent conformity assessment procedures for industrial products, as requested by the Council Resolution adopted on 10 November 2003 (8). |
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(17) |
Member States should not impede the placing on the market and/or putting into use of measuring instruments that carry the ‘CE’ marking and supplementary metrology marking in accordance with the provisions of this Directive. |
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(18) |
Member States should take appropriate action to prevent non-complying measuring instruments from being placed on the market and/or put into use. Adequate cooperation between the competent authorities of the Member States is therefore necessary to ensure a Community-wide effect of this objective. |
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(19) |
Manufacturers should be informed of the grounds on which negative decisions in respect of their products were taken, and of the legal remedies available to them. |
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(20) |
Manufacturers should be offered the possibility to exercise the rights obtained before the entry into force of this Directive, during a reasonable transitional period. |
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(21) |
National specifications concerning the appropriate national requirements in use should not interfere with the provisions of this Directive on ‘putting into use’. |
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(22) |
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9). |
|
(23) |
The activity of the Measuring Instruments Commmittee should include proper consultations with representatives of interested parties. |
|
(24) |
Directives 71/318/EEC, 71/319/EEC, 71/348/EEC, 73/362/EEC, 75/33/EEC, as concerns the meters defined in Annex MI-001 of this Directive, 75/410/EEC, 76/891/EEC, 77/95/EEC, 77/313/EEC, 78/1031/EEC and 79/830/EEC should therefore be repealed, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Scope
This Directive applies to the devices and systems with a measuring function defined in the instrument-specific annexes concerning water meters (MI-001), gas meters and volume conversion devices (MI-002), active electrical energy meters (MI-003), heat meters (MI-004), measuring systems for continuous and dynamic measurement of quantities of liquids other then water (MI-005), automatic weighing instruments (MI-006), taximeters (MI-007), material measures (MI-008), dimensional measuring instruments (MI-009) and exhaust gas analysers (MI-010).
Article 2
1. Member States may prescribe the use of measuring instruments mentioned in Article 1 for measuring tasks for reasons of public interest, public health, public safety, public order, protection of the environment, protection of consumers, levying of taxes and duties and fair trading, where they consider it justified.
2. Where Member States do not prescribe such use, they shall communicate the reasons therefor to the Commission and the other Member States.
Article 3
Object
This Directive establishes the requirements that the devices and systems referred to in Article 1 have to satisfy with a view to their being placed on the market and/or put into use for those tasks mentioned in Article 2(1).
This Directive is a specific Directive in respect of requirements for electromagnetic immunity in the sense of Article 2(2) of Directive 89/336/EEC. Directive 89/336/EEC continues to apply with regard to emission requirements.
Article 4
Definitions
For the purposes of this Directive:
|
a) |
‘measuring instrument’ means any device or system with a measurement function that is covered by Articles 1 and 3; |
|
b) |
‘sub-assembly’ means a hardware device, mentioned as such in the specific annexes, that functions independently and makes up a measuring instrument together
|
|
c) |
‘legal metrological control’ means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading; |
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d) |
‘manufacturer’ means a natural or legal person responsible for the conformity of the measuring instrument with this Directive with a view to either placing it on the market under his own name and/or putting it into use for his own purposes; |
|
e) |
‘placing on the market’ means making available for the first time in the Community an instrument intended for an end user, whether for reward or free of charge; |
|
f) |
‘putting into use’ means the first use of an instrument intended for the end user for the purposes for which it was intended; |
|
g) |
‘authorised representative’ means a natural or legal person who is established within the Community and authorised by a manufacturer, in writing, to act on his behalf for specified tasks within the meaning of this Directive; |
|
h) |
‘harmonised standard’ means a technical specification adopted by CEN, CENELEC or ETSI or jointly by two or all of these organisations, at the request of the Commission pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (10) and prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations; |
|
i) |
‘normative document’ means a document containing technical specifications adopted by the Organisation Internationale de Métrologie Légale (OIML), subject to the procedure stipulated in Article 16(1). |
Article 5
Applicability to sub-assemblies
Where specific annexes exist, laying down the essential requirements for sub-assemblies, the provisions of this Directive shall apply mutatis mutandis to such sub-assemblies.
Sub-assemblies and measuring instruments may be assessed independently and separately for the purpose of establishing conformity.
Article 6
Essential requirements and assessment of conformity
1. A measuring instrument shall meet the essential requirements laid down in Annex I and in the relevant instrument-specific Annex.
Member States may require, if it is needed for correct use of the instrument, the information referred to in Annex I or in the relevant instrument-specific annexes to be provided in the official language(s) of the Member State in which the instrument is placed on the market.
2. The conformity of a measuring instrument with the essential requirements shall be assessed in accordance with Article 9.
Article 7
Conformity marking
1. The conformity of a measuring instrument with all the provisions of this Directive shall be indicated by the presence on it of the ‘CE’ marking and the supplementary metrology marking as specified in Article 17.
2. The ‘CE’ marking and supplementary metrology marking shall be affixed by, or under the responsibility of, the manufacturer. These markings may be affixed to the instrument during the fabrication process, if justified.
3. The affixing of markings on a measuring instrument that are likely to deceive third parties as to the meaning and/or form of the ‘CE’ marking and the supplementary metrology marking shall be prohibited. Any other marking may be affixed on a measuring instrument, provided that the visibility and legibility of the ‘CE’ marking and the supplementary metrology marking is not thereby reduced.
4. Where the measuring instrument is subject to measures adopted under other Directives covering other aspects which require the affixing of the ‘CE’ marking, the marking shall indicate that the instrument in question is also presumed to conform to the requirements of those other Directives. In such a case, the publication reference of the said Directives, in the Official Journal of the European Union, must be given in the documents, notices or instructions required by those Directives and accompanying the measuring instrument.
Article 8
Placing on the market and putting into use
1. Member States shall not impede for reasons covered by this Directive the placing on the market and/or putting into use of any measuring instrument that carries the ‘CE’ marking and supplementary metrology marking in accordance with Article 7.
2. Member States shall take all appropriate measures to ensure that measuring instruments be placed on the market and/or put into use only if they satisfy the requirements of this Directive.
3. A Member State may require a measuring instrument to satisfy provisions governing its putting into use that are justified by local climatic conditions. In such a case, the Member State shall choose appropriate upper and lower temperature limits from Table 1 of Annex I and, in addition, may specify humidity conditions (condensing or non-condensing) and whether the intended location of use is open or closed.
4. When different accuracy classes are defined for a measuring instrument:
|
a) |
the instrument-specific annexes under the heading ‘Putting into use’ may indicate the accuracy classes to be used for specific applications; |
|
b) |
in all other cases a Member State may determine the accuracy classes to be used for specific applications within the classes defined, subject to allowing the use of all accuracy classes on its territory. |
In either case falling under (a) or (b), measuring instruments of a better accuracy class may be used if the owner so chooses.
5. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of instruments not in conformity with this Directive, provided that a visible sign clearly indicates their nonconformity and their non-availability for placing on the market and/or putting into use until brought into conformity.
Article 9
Conformity assessment
Conformity assessment of a measuring instrument with the relevant essential requirements shall be carried out by the application, at the choice of the manufacturer, of one of the conformity assessment procedures listed in the instrument-specific annex. The manufacturer shall provide, where appropriate, technical documentation for specific instruments or groups of instruments as set out in Article 10.
The conformity assessment modules making up the procedures are described in Annexes A to H1.
Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Member State where the notified body carrying out the Conformity assessment procedures is established, or in a language accepted by that body.
Article 10
Technical Documentation
1. The technical documentation shall render the design, manufacture and operation of the measuring instrument intelligible and shall permit an assessment of its conformity with the appropriate requirements of this Directive.
2. The technical documentation shall be sufficiently detailed to ensure:
|
— |
the definition of the metrological characteristics, |
|
— |
the reproducibility of the metrological performances of produced instruments when properly adjusted using appropriate intended means, and |
|
— |
the integrity of the instrument. |
3. The technical documentation shall include insofar as relevant for assessment and identification of the type and/or instrument:
|
a) |
a general description of the instrument; |
|
b) |
conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits, etc; |
|
c) |
manufacturing procedures to ensure consistent production; |
|
d) |
if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation; |
|
e) |
descriptions and explanations necessary for the understanding of paragraphs (b), (c) and (d), including the operation of the instrument; |
|
f) |
a list of the standards and/or normative documents referred to in Article 13, applied in full or in part; |
|
g) |
descriptions of the solutions adopted to meet the essential requirements where the standards and/or normative documents referred to in Article 13 have not been applied; |
|
h) |
results of design calculations, examinations, etc; |
|
i) |
the appropriate test results, where necessary, to demonstrate that the type and/or instruments comply with:
|
|
j) |
the EC-type examination certificates or EC design examination certificates in respect of instruments containing parts identical to those in the design. |
4. The manufacturer shall specify where seals and markings have been applied.
5. The manufacturer shall indicate the conditions for compatibility with interfaces and sub-assemblies, where relevant.
Article 11
Notification
1. Member States shall notify to the other Member States and the Commission the bodies under their jurisdiction, which they have designated to carry out the tasks pertaining to the conformity assessment modules referred to in Article 9, together with the identification numbers given to them by the Commission in accordance with paragraph 4 of this Article, the kind(s) of measuring instrument for which each body has been designated and in addition, where relevant, the instrument accuracy classes, the measuring range, the measurement technology, and any other instrument characteristic limiting the scope of the notification.
2. Member States shall apply the criteria set out in Article 12 for the designation of such bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to meet the corresponding criteria. Member States shall publish the references to these national standards. If a Member State has not introduced national legislation for tasks mentioned under Article 2, it shall retain the right to designate and notify a body for tasks relating to that instrument.
3. A Member State that has notified a body shall:
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— |
ensure that the body continues to meet the criteria set out in Article 12, |
|
— |
withdraw such notification if it finds that the body no longer meets those criteria. |
It shall forthwith inform the other Member States and the Commission of any such withdrawal.
4. Each of the bodies to be notified shall be given an identification number by the Commission. The Commission shall publish the list of notified bodies, together with the information in respect of the scope of the notification referred to in paragraph 1, in the Official Journal of the European Union, C series, and shall ensure that the list is kept up to date.
Article 12
Criteria to be satisfied by designated bodies
Member States shall apply the following criteria for the designation of bodies in accordance with Article 11(1).
1. The body, its director and staff involved in conformity assessment tasks shall not be the designer, manufacturer, supplier, installer or user of the measuring instruments that they inspect, nor the authorised representative of any of them. In addition, they may not be not directly involved in the design, manufacture, marketing or maintenance of the instruments, nor represent the parties engaged in these activities. The preceding criterion does not, however, preclude in any way the possibility of exchanges of technical information between the manufacturer and the body for the purposes of conformity assessment.
2. The body, its director and staff involved in conformity assessment tasks shall be free from all pressures and inducements, in particular financial inducements, that might influence their judgement or the results of their conformity assessment, especially from persons or groups of persons with an interest in the results of the assessments.
3. The conformity assessment shall be carried out with the highest degree of professional integrity and requisite competence in the field of metrology. Should the body subcontract specific tasks, it shall first ensure that the subcontractor meets the requirements of this Directive, and in particular of this Article. The body shall keep the relevant documents assessing the subcontractor's qualifications and the work carried out by him under this Directive at the disposal of the notifying authority.
4. The body shall be capable of carrying out all the conformity assessment tasks for which it has been designated, whether those tasks are carried out by the body itself or on its behalf and under its responsibility. It shall have at its disposal the necessary staff and shall have access to the necessary facilities for carrying out in a proper manner the technical and administrative tasks entailed in conformity assessment.
5. The body's staff shall have:
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— |
sound technical and vocational training, covering all conformity assessment tasks for which the body was designated; |
|
— |
satisfactory knowledge of the rules governing the tasks which it carries out, and adequate experience of such tasks; |
|
— |
the requisite ability to draw up the certificates, records and reports demonstrating that the tasks have been carried out. |
6. The impartiality of the body, its director and staff shall be guaranteed. The remuneration of the body shall not depend on the results of the tasks it carries out. The remuneration of the body's director and staff shall not depend on the number of tasks carried out or on the results of such tasks.
7. The body shall take out civil liability insurance if its civil liability is not covered by the Member State concerned under national law.
8. The body's director and staff shall be bound to observe professional secrecy with regard to all information obtained in the performance of their duties pursuant to this Directive, except vis-à-vis the authority of the Member State which has designated it.
Article 13
Harmonised standards and normative documents
1. Member States shall presume conformity with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes in respect of a measuring instrument that complies with the elements of the national standards implementing the European harmonised standard for that measuring instrument that correspond to those elements of this European harmonised standard the references in respect of which have been published in the Official Journal of the European Union, C series
Where a measuring instrument complies only in part with the elements of the national standards referred to in the first subparagraph, Member States shall presume conformity with the essential requirements corresponding to the elements of the national standards with which the instrument complies.
Member States shall publish the references to the national standards referred to in the first subparagraph.
2. Member States shall presume conformity with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes in respect of a measuring instrument that complies with the corresponding parts of the normative documents and lists referred to in Article 16(1)(a), the references in respect of which have been published in the Official Journal of the European Union, C series.
Where a measuring instrument complies only in part with the normative document referred to in the first subparagraph, Member States shall presume conformity with the essential requirements corresponding to the normative elements with which the instrument complies.
Member States shall publish the references of the normative document referred to in the first subparagraph.
3. A manufacturer may choose to use any technical solution that complies with the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes (MI-001 to MI-010). In addition, to benefit from the presumption of conformity, the manufacturer must correctly apply solutions mentioned either in the relevant European harmonised standards, or in the corresponding parts of the normative documents and lists as referred to in paragraphs 1 and 2.
4. Member States shall presume compliance with the appropriate tests mentioned in point (i) of Article 10 if the corresponding test programme has been performed in accordance with the relevant documents mentioned in paragraphs 1 to 3 and if the test results ensure compliance with the essential requirements.
Article 14
Standing Committee
Where a Member State or the Commission considers that a European harmonised standard as referred to in Article 13(1) does not fully meet the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes, the Member State or the Commission shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC, giving its reasons for doing so. The Committee shall deliver an opinion without delay.
In the light of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw the references to the national standards from the publication referred to in the third subparagraph of Article 13(1).
Article 15
Measuring Instruments Committee
1. The Commission shall be assisted by the Measuring Instruments Committee.
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4. The Committee shall adopt its Rules of Procedure.
5. The Commission shall ensure that relevant information about envisaged measures, as referred to in Article 16, is made available to interested parties in due time.
Article 16
Functions of the Measuring Instruments Committee
1. On request by a Member State or on its own initiative, the Commission, acting in accordance with the procedure referred to in Article 15(2), may take any appropriate measure to:
|
a) |
identify normative documents drawn up by OIML and, in a list, indicate the parts thereof compliance with which gives rise to a presumption of conformity with the corresponding essential requirements of this Directive; |
|
b) |
publish the references of the normative documents and the list referred to in point (a) in the Official Journal of the European Union, C series. |
2. On request by a Member State or on its own initiative, the Commission, acting in accordance with the procedure referred to in Article 15(3), may take any appropriate measure to amend instrument-specific annexes (MI-001 to MI-010) in respect of:
|
— |
the maximum permissible errors (MPEs) and accuracy classes, |
|
— |
the rated operating conditions, |
|
— |
the critical change values, |
|
— |
disturbances, |
3. Where a Member State or the Commission considers that a normative document whose references have been published in the Official Journal of the European Union, C series, in accordance with paragraph 1(b), does not fully meet the essential requirements referred to in Annex I and in the relevant instrument-specific Annexes, that Member State or the Commission shall bring the matter before the Measuring Instruments Committee, giving the reasons for doing so.
The Commission, acting in accordance with the procedure referred to in Article 15(2), shall inform the Member States whether or not it is necessary to withdraw the references to the normative document concerned from publication in the Official Journal.
4. Member States may take appropriate measures to consult interested parties at national level about OIML work relating to the scope of this Directive.
Article 17
Markings
1. The ‘CE’ marking referred to in Article 7 consists of the symbol ‘CE’ according to the design laid down in paragraph I.B(d) of the Annex to Decision 93/465/EEC. The ‘CE’ marking shall be at least 5 mm high.
2. The supplementary metrology marking consists of the capital letter ‘M’ and the last two digits of the year of its affixing, surrounded by a rectangle. The height of the rectangle shall be equal to the height of the ‘CE’ marking. The supplementary metrology marking shall immediately follow the ‘CE’ marking.
3. The identification number of the notified body concerned referred to in Article 11, if prescribed by the conformity assessment procedure, shall follow the ‘CE’ marking and supplementary metrology marking.
4. When a measuring instrument consists of a set of devices, not being sub-assemblies, operating together, the markings shall be affixed on the instrument's main device.
When a measuring instrument is too small or too sensitive to carry the ‘CE’ marking and supplementary metrology marking, the markings shall be carried by the packaging, if any, and by the accompanying documents required by this Directive.
5. The ‘CE’ marking and supplementary metrology marking shall be indelible. The identification number of the notified body concerned shall be indelible or self destructive upon removal. All markings shall be clearly visible or easily accessible.
Article 18
Market surveillance and administrative cooperation
1. Member States shall take all appropriate measures to ensure that measuring instruments that are subject to legal metrological control but do not comply with applicable provisions of this Directive are neither placed on the market nor put into use.
2. The competent authorities of the Member States shall assist each other in the fulfilment of their obligations to carry out market surveillance.
In particular, the competent authorities shall exchange:
|
— |
information concerning the extent to which instruments they examine comply with the provisions of this Directive, and the results of such examinations; |
|
— |
EC-type examination and design examination certificates and their annexes issued by notified bodies as well as additions, amendments and withdrawals relating to certificates already issued; |
|
— |
quality system approvals issued by notified bodies, as well as information on quality systems refused or withdrawn; |
|
— |
evaluation reports established by notified bodies, when demanded by other authorities. |
3. The Member States shall ensure that all necessary information relating to the certificates and quality system approvals is made available to bodies they have notified.
4. Each Member State shall inform the other Member States and the Commission which competent authorities it has designated for such exchange of information.
Article 19
Safeguard clause
1. Where a Member State establishes that all or part of the measuring instruments of a particular model that bear the ‘CE’ marking and the supplementary metrology marking do not satisfy the essential requirements relating to metrological performance set out in this Directive, when correctly installed and used in accordance with the manufacturer's instructions, it shall take all appropriate measures to withdraw these instruments from the market, prohibit or restrict their further being placed on the market, or prohibit or restrict their further being used.
When deciding on the above measures, the Member State shall take account of the systematic or incidental nature of the non-compliance. Where the Member State has established that the noncompliance is of a systematic nature, it shall immediately inform the Commission of the measures taken, indicating the reasons for its decision.
2. The Commission shall enter into consultation with the parties concerned as soon as possible.
(a) Should the Commission find that the measures taken by the Member State concerned are justified, it shall immediately inform that Member State thereof, as well as the other Member States.
The competent Member State shall take appropriate action against any person who affixed the markings and shall inform the Commission and the other Member States thereof.
If the non-compliance is attributed to shortcomings in the standards or normative documents, the Commission shall, after consulting the parties concerned, bring the matter as soon as possible before the appropriate Committee referred to in Articles 14 or 15.
(b) Should the Commission find that the measures taken by the Member State concerned are not justified, it shall immediately inform that Member State thereof, as well as the manufacturer concerned or his authorised representative.
The Commission shall ensure that the Member States are kept informed of the progress and outcome of the procedure.
Article 20
Unduly fixed markings
1. Where a Member State establishes that the ‘CE’ marking and supplementary metrology marking have been affixed unduly, the manufacturer or his authorised representative shall be obliged:
|
— |
to make the instrument conform as regards those provisions concerning the ‘CE’ marking and supplementary metrology marking not covered by Article 19(1) and |
|
— |
to end the infringement under the conditions imposed by the Member State. |
2. Should the infringement described above persist, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the instrument in question or to ensure that it is withdrawn from the market or prohibit or restrict its further use in accordance with the procedures laid down in Article 19.
Article 21
Decisions entailing refusal or restriction
Any decision taken pursuant to this Directive entailing the withdrawal from the market of a measuring instrument, or prohibiting or restricting the placing on the market or putting into use of an instrument, shall state the exact grounds on which it is based. The decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available to him under the law of the Member State concerned and of the time limits to which such remedies are subject.
Article 22
Repeals
The following Directives shall be repealed as from ... (11) without prejudice to Article 23:
|
— |
Council Directive 71/318/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to gas meters (12), |
|
— |
Directive 71/319/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to meters for liquids other than water (13), |
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— |
Directive 71/348/EEC of 12 October 1971 on the approximation of the laws of the Member States relating to ancillary equipment for meters for liquids other than water (14), |
|
— |
Directive 73/362/EEC of 19 November 1973 on the approximation of the laws of the Member States relating to material measures of length (15), |
|
— |
Directive 75/33/EEC of 17 December 1974 on the approximation of the laws of the Member States relating to cold water meters, as concerns the meters defined in Annex MI-001 of this Directive (16), |
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— |
Directive 75/410/EEC of 24 June 1975 on the approximation of the laws of the Member States relating to continuous totalising weighing machines (17), |
|
— |
Directive 76/891/EEC of 4 November 1976 on the approximation of the laws of the Member States relating to electrical energy meters (18), |
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— |
Directive 77/95/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to taximeters (19), |
|
— |
Directive 77/313/EEC of 5 April 1977 on the approximation of the laws of the Member States relating to measuring systems for liquids other than water (20), |
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— |
Directive 78/1031/EEC of 5 December 1978 on the approximation of the laws of the Member States relating to automatic checkweighing and weight grading machines (21), |
|
— |
Directive 79/830/EEC of 11 September 1979 on the approximation of the laws of the Member States relating to hot-water meters (22). |
Article 23
Transitional provisions
By way of derogation from Article 8(2), Member States shall permit, for measurement tasks for which they have prescribed the use of a legally controlled measuring instrument, the placing on the market and putting into use of measuring instruments that satisfy the rules applicable before ... (23) until the expiry of the validity of the type approval of those measuring instruments or, in the case of a type approval of indefinite validity, for a period of a maximum of ten years from ... (23)
Article 24
Transposition
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before ... (24). They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States
Member States shall apply these provisions from ... (23).
2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.
Article 25
Revision clause
The European Parliament and the Council invite the Commission to report, before ... (25), on the implementation of this Directive, inter alia, on the basis of reports provided by the Member States, and, where appropriate, to submit a proposal for amendments.
The European Parliament and Council invite the Commission to evaluate whether conformity assessment procedures for industrial products are properly applied and, where appropriate, to propose amendments in order to ensure consistent certification.
Article 26
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 27
Addressees
This Directive is addressed to the Member States.
Done at
For the European Parliament
The President
For the Council
The President
(1) OJ C 62 E, 27.2.2001, p. 1, andOJ C 126 E, 28.5.2002, p. 368.
(2) OJ C 139, 11.5.2001, p. 4.
(3) Opinion of the European Parliament of 3 July 2001 (OJ C 65 E, 14.3.2002, p. 34). Council Common Position of 22 July 2003 (OJ C 252 E, 21.10.2003, p. 1) and Position of the European Parliament of 17 December 2003.
(4) OJ L 202, 6.9.1971, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
(6) OJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).
(7) OJ L 220, 30.8.1993, p. 23.
(8) OJ C 282, 25.11.2003, p. 3.
(9) OJ L 184, 17.7.1999, p. 23.
(10) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).
(11) 30 months after the date of entry into force of this Directive.
(12) OJ L 202, 6.9.1971, p. 21. Directive as last amended by Commission Directive 82/623/EEC (OJ L 252, 27.8.1982, p. 5).
(13) OJ L 202, 6.9.1971, p. 32.
(14) OJ L 239, 25.10.1971, p. 9. Directive as last amended by the 1994 Act of Accession.
(15) OJ L 335, 5.12.1973, p. 56. Directive as last amended by Commission Directive 85/146/EEC (OJ L 54, 23.2.1985, p. 29).
(16) OJ L 14, 20.1.1975, p. 1.
(17) OJ L 183, 14.7.1975, p. 25.
(18) OJ L 336, 4.12.1976, p. 30.
(19) OJ L 26, 31.1.1977, p. 59.
(20) OJ L 105, 28.4.1977, p. 18. Directive as amended by Commission Directive 82/625/EEC (OJ L 252, 27.8.1982, p. 10).
(21) OJ L 364, 27.12.1978, p. 1.
(22) OJ L 259, 15.10.1979, p. 1.
(23) 30 months after the date of entry into force of this Directive.
(24) 24 months after the date of entry into force of this Directive.
(25) 7 years after the date of entry into force of this Directive.
ANNEX I
ESSENTIAL REQUIREMENTS
A measuring instrument shall provide a high level of metrological protection in order that any party affected can have confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of the measurement technology and security of the measurement data.
The requirements that shall be met by measuring instruments are set out below and are supplemented, where appropriate, by specific instrument requirements in Annexes MI-001 to MI-010 that provide more detail on certain aspects of the general requirements.
The solutions adopted in the pursuit of the requirements shall take account of the intended use of the instrument and any foreseeable misuse thereof.
DEFINITIONS
Measurand
The measurand is the particular quantity subject to measurement.
Influence quantity
An influence quantity is a quantity that is not the measurand but that affects the result of measurement.
Rated Operating Conditions
The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument.
Disturbance
An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified.
Critical change value
The critical change value is the value at which the change in the measurement result is considered undesirable.
Material Measure
A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity.
Direct sales
A trading transaction is direct sales if:
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— |
the measurement result serves as the basis for the price to pay and; |
|
— |
at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection and; |
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— |
all the parties in the transaction accept the measurement result at that time and place. |
Climatic environments
Climatic environments are the conditions in which measuring instruments may be used. To cope with climatic differences between the Member States, a range of temperature limits has been defined.
Utility
A utility is regarded as a supplier of electricity, gas, heat or water.
REQUIREMENTS
1. Allowable Errors
1.1. Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error(MPE) value as laid down in the appropriate instrument-specific requirements.
Unless stated otherwise in the instrument-specific annexes, MPE is expressed as a bilateral value of the deviation from the true measurement value.
1.2. Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as laid down in the appropriate instrument-specific requirements.
Where the instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE.
1.3. The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements laid down in the appropriate instrument-specific annexes.
1.3.1. Climatic environments
The manufacturer shall specify the upper temperature limit and the lower temperature limit from any of the values in Table 1 unless otherwise specified in the annexes MI-001 to MI-010, and indicate whether the instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed.
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|
Temperature Limits |
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Upper temperature limit |
30 °C |
40 °C |
55 °C |
70 °C |
|
Lower temperature limit |
5 °C |
-10 °C |
-25 °C |
-40 °C |
Table 1
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(a) |
Mechanical environments are classified into classes M1 to M3 as described below.
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|
(b) |
The following influence quantities shall be considered in relation with mechanical environments:
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|
(a) |
Electromagnetic environments are classified into classes E1, E2 or E3 as described below, unless otherwise laid down in the appropriate instrument-specific annexes.
|
|
(b) |
The following influence quantities shall be considered in relation with electromagnetic environments:
|
1.3.4. Other influence quantities to be considered, where appropriate, are:
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— |
Voltage variation, |
|
— |
Mains frequency variation, |
|
— |
Power frequency magnetic fields, |
|
— |
any other quantity likely to influence in a significant way the accuracy of the instrument. |
1.4. When carrying out the tests as envisaged in this Directive, the following paragraphs apply:
1.4.1. Basic rules for testing and the determination of errors
Essential requirements specified in 1.1 and 1.2 shall be verified for each relevant influence quantity. Unless otherwise specified in the appropriate instrument-specific annex, these essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value.
Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur.
1.4.2. Ambient humidity
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— |
According to the climatic operating environment in which the instrument is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate. |
|
— |
The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate. |
2. Reproducibility
The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.
3. Repeatability
The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.
4. Discrimination and Sensitivity
A measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task.
5. Durability
A measuring instrument shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer's instruction when in the environmental conditions for which it is intended.
6. Reliability
A measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.
7. Suitability
7.1. A measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.
7.2. A measuring instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.
7.3. The errors of a utility measuring instrument at flows or currents outside the controlled range shall not be unduly biased.
7.4. Where a measuring instrument is designed for the measurement of values of the measurand that are constant over time, the measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.
7.5. A measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.
7.6. A measuring instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual.
When a measuring instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software.
8. Protection against corruption
8.1. The metrological characteristics of a measuring instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the measuring instrument.
8.2. A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.
8.3. Software that is critical for metrological characteristics shall be identified as such and shall be secured.
Software identification shall be easily provided by the measuring instrument.
Evidence of an intervention shall be available for a reasonable period of time.
8.4. Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.
8.5. For utility measuring instruments the display of the total quantity supplied or the displays from which the total quantity supplied can be derived, whole or partial reference to which is the basis for payment, shall not be able to be reset during use.
9. Information to be borne by and to accompany the instrument
9.1. A measuring instrument shall bear the following inscriptions:
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— |
manufacturer's mark or name; |
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— |
information in respect of its accuracy, plus, when applicable: |
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— |
information in respect of the conditions of use; |
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— |
measuring capacity; |
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— |
measuring range; |
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— |
identity marking; |
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— |
number of the EC-type examination certificate or the EC design examination certificate; |
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— |
information whether or not additional devices providing metrological results comply with the provisions of this Directive on legal metrological control. |
9.2. An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of this Directive suitably marked.
9.3. The instrument shall be accompanied by information on its operation, unless the simplicity of the measuring instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant:
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— |
rated operating conditions; |
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— |
mechanical and electromagnetic environment classes; |
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— |
the upper and lower temperature limit, whether condensation is possible or not, open or closed location; |
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— |
instructions for installation, maintenance, repairs, permissible adjustments; |
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— |
instructions for correct operation and any special conditions of use; |
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— |
conditions for compatibility with interfaces, sub-assemblies or measuring instruments. |
9.4. Groups of identical measuring instruments used in the same location or used for utility measurements do not necessarily require individual instruction manuals.
9.5. Unless specified otherwise in an instrument-specific annex, the scale interval for a measured value shall be in the form 1×10n, 2×10n, or 5×10n, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.
9.6. A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement used.
9.7. The units of measurement used and their symbols shall be in accordance with the provisions of Community legislation on units of measurement and their symbols.
9.8. All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable.
10. Indication of result
10.1. Indication of the result shall be by means of a display or hard copy.
10.2. The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.
10.3. In the case of hard copy the print or record shall also be easily legible and non-erasable.
10.4. A measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sales, any ticket provided to the consumer by an ancillary device not complying with the appropriate requirements of this Directive shall bear an appropriate restrictive information.
10.5. Whether or not a measuring instrument intended for utility measurement purposes can be remotely read it shall in any case be fitted with a metrologically controlled display accessible without tools to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay.
11. Further processing of data to conclude the trading transaction
11.1. A measuring instrument other than a utility measuring instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when:
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— |
the measurement is non-repeatable and; |
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— |
the measuring instrument is normally intended for use in the absence of one of the trading parties; |
11.2. Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.
12. Conformity evaluation
A measuring instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of this Directive.
ANNEX A
DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION CONTROL
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1. |
The ‘declaration of conformity based on internal production control’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive. |
Technical documentation
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2. |
The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument. |
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3. |
The manufacturer shall keep the technical documentation at the disposal of the national authorities for ten years after the last instrument has been manufactured. |
Manufacturing
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4. |
The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the appropriate requirements of this Directive. |
Written declaration of conformity
|
5.1. |
The manufacturer shall affix the ‘CE’ marking and the supplementary metrology marking to each measuring instrument that satisfies the appropriate requirements of this Directive. |
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5.2. |
A declaration of conformity is drawn up for an instrument model and shall be kept at the disposal of the national authorities for ten years after the last instrument has been manufactured. It shall identify the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
Authorised representative
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6. |
The manufacturer's obligations contained in paragraphs 3 and 5.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligations contained in paragraphs 3 and 5.2 shall be the responsibility of the person who places the instrument on the market. |
ANNEX A1
DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION CONTROL PLUS PRODUCT TESTING BY A NOTIFIED BODY
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1. |
‘Declaration of conformity based on internal production control plus product testing by a notified body’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex, and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive. |
Technical documentation
|
2. |
The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument. |
|
3. |
The manufacturer shall keep the technical documentation at the disposal of the national authorities for ten years after the last instrument has been manufactured. |
Manufacturing
|
4. |
The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the appropriate requirements of this Directive. |
Product checks
|
5. |
A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out in appropriate intervals determined by it, in order to verify the quality of the internal checks of the product, taking into account inter alia the technological complexity of the instruments and the quantity of production. An adequate sample of the final products, taken by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant document(s) referred to in Article 13, or equivalent tests, shall be carried out to check the conformity of the instruments with the appropriate requirements of this Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the notified body shall take appropriate measures. |
Written declaration of conformity
|
6.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 5, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive. |
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6.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for ten years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
Authorised representative
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7. |
The manufacturer's obligations contained in paragraphs 3 and 6.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligations contained in paragraphs 3 and 6.2 shall be the responsibility of the person who places the instrument on the market. |
ANNEX B
TYPE EXAMINATION
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1. |
‘Type examination’ is the part of a conformity assessment procedure whereby a notified body examines the technical design of a measuring instrument and ensures and declares that the technical design meets the appropriate requirements of this Directive. |
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2. |
Type examination may be carried out in either of the following manners. The notified body decides on the appropriate manner and the specimens required:
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3. |
The application for type examination shall be lodged by the manufacturer with a notified body of his choice. The application shall include:
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|
4. |
The notified body shall: For the specimens:
For the other parts of the measuring instrument:
For the manufacturing process:
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|
5.1. |
The notified body shall draw up an evaluation report that records the activities as undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to Article 12(8), the notified body shall release the content of this report, in full or in part, only with the agreement of the manufacturer. |
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5.2. |
Where the technical design meets the requirements of this Directive that apply to the measuring instrument, the notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer and, if appropriate, of his authorised representative, conclusions of the examination, conditions (if any) for its validity and the necessary data for identification of the instrument. The certificate may have one or more annexes attached. The certificate and its annexes shall contain all relevant information for conformity evaluation and inservice control. In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include:
The certificate shall have a validity of ten years from the date of its issue, and may be renewed for subsequent periods of ten years each. |
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5.3. |
The notified body shall establish an evaluation report in this regard and keep it at the disposal of the Member State that designated it. |
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6. |
The manufacturer shall inform the notified body that holds the technical documentation concerning the EC-type examination certificate of all modifications to the instrument that may affect the conformity of the instrument with the essential requirements or the conditions for validity of the certificate. Such modifications require additional approval in the form of an addition to the original EC-type examination certificate. |
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7. |
Each notified body shall immediately inform the Member State that designated it about:
Each notified body shall immediately inform the Member State that designated it of the withdrawal of an EC-type examination certificate. The notified body shall hold the technical file including the documentation submitted by the manufacturer for a period up to the end of the validity of the certificate. |
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8. |
The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions with the technical documentation for 10 years after the last measuring instrument has been manufactured. |
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9. |
The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and carry out the obligations mentioned in paragraphs 6 and 8. Where the manufacturer is not established within the Communities and where he does not have an authorised representative, the obligation to make the technical documentation available on request shall be the responsibility of the person designated by the manufacturer. |
ANNEX C
DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
|
1. |
‘Declaration of conformity to type based on internal production control’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive. |
Manufacturing
|
2. |
The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the type as described in the EC-type examination certificate and with the appropriate requirements of this Directive. |
Written declaration of conformity
|
3.1. |
The manufacturer shall affix the ‘CE’ marking and the supplementary metrology marking to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive. |
|
3.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the instrument model for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
Authorised representative
|
4. |
The manufacturer's obligations contained in paragraph 3.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligation mentioned in paragraph 3.2 shall be the responsibility of the person who places the instrument on the market. |
ANNEX C1
DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS PRODUCT TESTING BY A NOTIFIED BODY
|
1. |
‘Declaration of conformity to type based on internal production control plus product testing by a notified body’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive. |
Manufacturing
|
2. |
The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the type as described in the EC-type examination certificate and with the appropriate requirements of this Directive. |
Product checks
|
3. |
A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out in appropriate intervals determined by it, in order to verify the quality of the internal checks of the product, taking into account inter alia the technological complexity of the instruments and the quantity of production. An adequate sample of the final products, taken by the notified body before the placing on the market, shall be examined and appropriate tests, as identified by the relevant documents referred to in Article 13, or equivalent tests, shall be carried out to check the conformity of the product with the type as described in the EC-type examination certificate and the appropriate requirements of the Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the notified body shall take appropriate measures. |
Written declaration of conformity
|
4.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3, the latter's identification number, to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive. |
|
4.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
Authorised representative
|
5. |
The manufacturer's obligations contained in paragraph 4.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. Where the manufacturer is not established within the Community and where he does not have an authorised representative, the obligations mentioned in paragraph 4.2 shall be the responsibility of the person who places the instrument on the market. |
ANNEX D
DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
|
1. |
‘Declaration of conformity to type based on quality assurance of the production process’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive. |
Manufacturing
|
2. |
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instrument concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4. |
Quality system
|
3.1. |
The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. The application shall include:
|
|
3.2. |
The quality system shall ensure compliance of the instruments with the type as described in the ECtype examination certificate and the appropriate requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall contain in particular an adequate description of:
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|
3.3. |
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published. In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
|
3.4. |
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
|
3.5. |
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate the modifications proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required. It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
Surveillance under the responsibility of the notified body
|
4.1. |
The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system. |
|
4.2. |
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:
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|
4.3. |
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. |
|
4.4. |
Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
Written declaration of conformity
|
5.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive. |
|
5.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
|
6. |
The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:
|
|
7. |
Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval. |
Authorised representative
|
8. |
The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. |
ANNEX D1
DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
|
1. |
‘Declaration of conformity based on quality assurance of the production process’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive. |
Technical documentation
|
2. |
The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design and operation of the instrument. |
|
3. |
The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the last instrument has been manufactured. |
Manufacturing
|
4. |
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instrument concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6. |
Quality system
|
5.1. |
The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. The application shall include:
|
|
5.2. |
The quality system shall ensure compliance of the instruments with the appropriate requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall contain, in particular, an adequate description of:
|
|
5.3. |
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published. In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
|
5.4. |
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
|
5.5. |
The manufacturer shall keep the notified body that has approved the quality system periodically informed of any intended change of the quality system. The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is required. It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
Surveillance under the responsibility of the notified body
|
6.1. |
The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system. |
|
6.2. |
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:
|
|
6.3. |
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. |
|
6.4. |
Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
Written declaration of conformity
|
7.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 5.1, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive. |
|
7.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
|
8. |
The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:
|
|
9. |
Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval. |
Authorised representative
|
10. |
The manufacturer's obligations contained in paragraphs 3, 5.1, 5.5, 7.2 and 8 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. |
ANNEX E
DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF FINAL PRODUCT INSPECTION AND TESTING
|
1. |
‘Declaration of conformity to type based on quality assurance of final product inspection and testing’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive. |
Manufacturing
|
2. |
The manufacturer shall operate an approved quality system as specified in paragraph 3 for final product inspection and testing of the measuring instrument concerned and shall be subject to surveillance, as specified in paragraph 4. |
Quality system
|
3.1. |
The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. The application shall include:
|
|
3.2. |
The quality system shall ensure compliance of the instruments with the type as described in the EC-type examination certificate and the appropriate requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall contain in particular an adequate description of:
|
|
3.3. |
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published. In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
|
3.4. |
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
|
3.5. |
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required. It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
Surveillance under the responsibility of the notified body
|
4.1. |
The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system. |
|
4.2. |
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of inspection, testing and storage, and shall provide it with all necessary information, in particular:
|
|
4.3. |
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. |
|
4.4. |
Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
Written declaration of conformity
|
5.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive. |
|
5.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the instrument model for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
|
6. |
The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:
|
|
7. |
Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval. |
Authorised representative
|
8. |
The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. |
ANNEX E1
DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF FINAL PRODUCT INSPECTION AND TESTING
|
1. |
‘Declaration of conformity based on quality assurance of final product inspection and testing’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the appropriate requirements of this Directive. |
Technical documentation
|
2. |
The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument. |
|
3. |
The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the last instrument has been manufactured. |
Manufacturing
|
4. |
The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instrument concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6. |
Quality system
|
5.1. |
The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. The application shall include:
|
|
5.2. |
The quality system shall ensure compliance of the instruments with the appropriate requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. This documentation shall contain in particular an adequate description of:
|
|
5.3. |
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published. In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
|
5.4. |
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
|
5.5. |
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is required. It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
Surveillance under the responsibility of the notified body
|
6.1. |
The purpose is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system. |
|
6.2. |
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of inspection, testing and storage, and shall provide it with all necessary information, in particular:
|
|
6.3. |
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. |
|
6.4. |
Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
Written declaration of conformity
|
7.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 5.1, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive. |
|
7.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
|
8. |
The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:
|
|
9. |
Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval. |
Authorised representative
|
10. |
The manufacturer's obligations contained in paragraphs 3, 5.1, 5.5, 7.2 and 8 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. |
ANNEX F
DECLARATION OF CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
|
1. |
‘Declaration of conformity to type based on product verification’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments that have been subjected to the provisions of paragraph 3 are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive. |
Manufacturing
|
2. |
The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the approved type as described in the EC-type examination certificate and the appropriate requirements of this Directive. |
Verification
|
3. |
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to check the conformity of the instruments with the type as described in the EC-type examination certificate and the appropriate requirements of this Directive. The examinations and tests to check the conformity with the metrological requirements will be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in paragraph 4, or by examination and testing of the instruments on a statistical basis as specified in paragraph 5. |
|
4. |
Verification of conformity with the metrological requirements by examination and testing of every instrument. |
|
4.1. |
All instruments shall be individually examined and appropriate tests as set out in the relevant documents referred to in Article 13, or equivalent tests, shall be carried out to verify their conformity with the metrological requirements that apply to them. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. |
|
4.2. |
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the certification of the instrument. |
|
5. |
Statistical verification of conformity with the metrological requirements. |
|
5.1. |
The manufacturer shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced, and shall present his instruments for verification in the form of homogeneous lots. |
|
5.2. |
A random sample shall be drawn from each lot according to the requirements of paragraph 5.3. All instruments in the sample shall be individually examined and appropriate tests as set out in the relevant documents referred to in Article 13, or equivalent tests, to establish their conformity with the metrological requirements that apply to them shall be carried out to determine whether the lot is accepted or rejected. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. |
|
5.3. |
The statistical procedure shall meet the following requirements: The statistical control will be based on attributes. The sampling system shall ensure:
|
|
5.4. |
If a lot is accepted, all instruments of the lot are approved, except for those instruments from the sample that were found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the certification of the instrument. |
|
5.5. |
If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures. |
Written declaration of conformity
|
6.1. |
The manufacturer shall affix the ‘CE’ marking and the supplementary metrology marking to each measuring instrument that is in conformity with the approved type and satisfies the appropriate requirements of this Directive. |
|
6.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. If agreed upon by the notified body referred to in paragraph 3, the manufacturer shall also affix the notified body's identification number to the measuring instruments under the notified body's responsibility. |
|
7. |
The manufacturer may, if agreed upon by the notified body and under its responsibility, affix the notified body's identification number to the measuring instruments during the manufacturing process. |
Authorised representative
|
8. |
The manufacturer's obligations may be fulfilled, on his behalf and under his responsibility, by his authorised representative except for the obligations contained in paragraphs 2 and 5.1. |
ANNEX F1
DECLARATION OF CONFORMITY BASED ON PRODUCT VERIFICATION
|
1. |
‘Declaration of conformity based on product verification’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments that have been subjected to the provisions of paragraph 5 are in conformity with the appropriate requirements of this Directive. |
Technical documentation
|
2. |
The manufacturer shall establish the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument. |
|
3. |
The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the last instrument has been manufactured. |
Manufacturing
|
4. |
The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with the appropriate requirements of this Directive. |
Verification
|
5. |
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to check the conformity of the instruments with the appropriate requirements of this Directive. The examinations and tests to check the conformity with the metrological requirements will be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in paragraph 6, or by examination and testing of the instruments on a statistical basis as specified in paragraph 7. |
|
6. |
Verification of conformity with the metrological requirements by examination and testing of every instrument. |
|
6.1. |
All instruments shall be individually examined and appropriate tests, as set out in the relevant documents referred to in Article 13, or equivalent tests, shall be carried out to verify their conformity with the metrological requirements that apply to them. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. |
|
6.2. |
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the certification of the instrument. |
|
7. |
Statistical verification of conformity with the metrological requirements. |
|
7.1. |
The manufacturer shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced, and shall present his instruments for verification in the form of homogeneous lots. |
|
7.2. |
A random sample shall be drawn from each lot according to the requirements of paragraph 7.3. All instruments in the sample shall be individually examined and appropriate tests as set out in the relevant documents referred to in Article 13, or equivalent tests, to establish their conformity with the metrological requirements that apply to them, shall be carried out to determine whether the lot is accepted or rejected. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. |
|
7.3. |
The statistical procedure shall meet the following requirements: The statistical control will be based on attributes. The sampling system shall ensure:
|
|
7.4. |
If a lot is accepted all instruments of the lot are approved, except for those instruments from the sample that were found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the certification of the instrument. |
|
7.5. |
If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures. |
Written declaration of conformity
|
8.1. |
The manufacturer shall affix the ‘CE’ marking and the supplementary metrology marking to each measuring instrument that satisfies the appropriate requirements of this Directive. |
|
8.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. If agreed upon by the notified body referred to in paragraph 5, the manufacturer shall also affix the notified body's identification number to the measuring instruments under the notified body's responsibility. |
|
9. |
The manufacturer may, if agreed upon by the notified body and under its responsibility, affix the notified body's identification number to the measuring instruments during the manufacturing process. |
Authorised representative
|
10. |
The manufacturer's obligations may be fulfilled, on his behalf and under his responsibility, by his authorised representative, except for the obligations contained in paragraphs 4 and 7.1. |
ANNEX G
DECLARATION OF CONFORMITY BASED ON UNIT VERIFICATION
|
1. |
‘Declaration of conformity based on unit verification’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that a measuring instrument that has been subjected to the provisions of paragraph 4, is in conformity with the appropriate requirements of this Directive. |
Technical documentation
|
2. |
The manufacturer shall establish the technical documentation as described in Article 10 and make it available to the notified body referred to in paragraph 4. The technical documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive and shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument. The manufacturer shall keep the technical documentation at the disposal of the national authorities for ten years. |
Manufacturing
|
3. |
The manufacturer shall take all measures necessary to ensure conformity of the manufactured instrument with the appropriate requirements of this Directive. |
Verification
|
4. |
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests as set out in the relevant documents referred to in Article 13, or equivalent tests, to check the conformity of the instrument with the appropriate requirements of this Directive, or have them carried out. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and affix its identification number to the approved instrument, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the certification of the instrument. |
Written declaration of conformity
|
5.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 4, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive. |
|
5.2. |
A declaration of conformity shall be drawn up and kept at the disposal of the national authorities for 10 years after the instrument has been manufactured. It shall identify the instrument for which it was drawn up. A copy of the declaration shall be supplied with the measuring instrument. |
Authorised representative
|
6. |
The manufacturer's obligations contained in paragraphs 2 and 4.2 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. |
ANNEX H
DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE
|
1. |
‘Declaration of conformity based on full quality assurance’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive. |
Manufacturing
|
2. |
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the measuring instrument concerned as specified in paragraph 3, and shall be subject to surveillance as specified in paragraph 4. |
Quality system
|
3.1. |
The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. The application shall include:
|
|
3.2. |
The quality system shall ensure compliance of the instruments with the appropriate requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall contain in particular an adequate description of:
|
|
3.3. |
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published. In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
|
3.4. |
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
|
3.5. |
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required. It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
Surveillance under the responsibility of the notified body
|
4.1. |
The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system. |
|
4.2. |
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:
|
|
4.3. |
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. |
|
4.4. |
Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out under its responsibility, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
Written declaration of conformity
|
5.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive. |
|
5.2. |
A declaration of conformity is drawn up for an instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the instrument model for which it was drawn up. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
|
6. |
The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:
|
|
7. |
Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval. |
Authorised representative
|
8. |
The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. |
ANNEX H1
DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
|
1. |
‘Declaration of conformity based on full quality assurance plus design examination’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive. |
Manufacturing
|
2. |
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the measuring instrument concerned as specified in paragraph 3, and shall be subject to surveillance as specified in paragraph 5. The adequacy of the technical design of the measuring instrument shall have been examined according to the provisions of paragraph 4. |
Quality system
|
3.1. |
The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. The application shall include:
|
|
3.2. |
The quality system shall ensure compliance of the instruments with the appropriate requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall contain in particular an adequate description of:
|
|
3.3. |
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published in the Official Journal. In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
|
3.4. |
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
|
3.5. |
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required. It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
|
3.6. |
Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval. |
Design examination
|
4.1. |
The manufacturer shall lodge an application for examination of the design with the notified body referred to in paragraph 3.1. |
|
4.2. |
The application shall enable understanding of the design, manufacture and operation of the instrument, and shall enable assessment of conformity with the appropriate requirements of this Directive. It shall include:
|
|
4.3. |
The notified body shall examine the application, and where the design meets the provisions of the Directive that apply to the measuring instrument it shall issue an EC design examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, any conditions for its validity and the necessary data for identification of the approved instrument. |
|
4.3.1. |
All relevant parts of the technical documentation shall be annexed to the certificate. |
|
4.3.2. |
The certificate or its annexes shall contain all relevant information for conformity evaluation and in-service control. It shall to allow the evaluation of conformity of the manufactured instruments with the examined design regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, including:
|
|
4.3.3. |
The notified body shall establish an evaluation report in this regard and keep it at the disposal of the Member State that designated it. Without prejudice to Article 12(8), the notified body shall release the content of this report, in full or in part, only with the agreement of the manufacturer. The certificate shall have a validity of ten years from the date of its issue, and may be renewed for subsequent periods of ten years each. If the manufacturer is denied a design examination certificate, the notified body shall provide detailed reasons for the denial. |
|
4.4. |
The manufacturer shall keep the notified body that has issued the ‘EC’ design examination certificate informed of any fundamental modification to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the ‘EC’ design examination certificate where such changes may affect the conformity with the essential requirements of this Directive, the conditions for validity of the certificate or the prescribed conditions for use of the instrument. This additional approval is given in the form of an addition to the original ‘EC’ design examination certificate. |
|
4.5. |
Each notified body shall periodically make available to the Member State that designated it:
Each notified body shall immediately inform the Member State that designated it of the withdrawal of an EC design examination certificate. |
|
4.6. |
The manufacturer or his authorised representative shall keep a copy of the ‘EC’ design examination certificate, its annexes and additions with the technical documentation for 10 years after the last measuring instrument has been manufactured. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to make the technical documentation available on request shall be the responsibility of the person designated by the manufacturer. |
Surveillance under the responsibility of the notified body
|
5.1. |
The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system. |
|
5.2. |
The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:
|
|
5.3. |
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. |
|
5.4. |
Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out under its responsibility, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
Written declaration of conformity
|
6.1. |
The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Directive. |
|
6.2. |
A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the model of the instrument for which it was drawn up and shall mention the number of the design examination certificate. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
|
7. |
The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities:
|
Authorised representative
|
8. |
The manufacturer's obligations contained in paragraphs 3.1, 3.5, 6.2 and 7 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. |
ANNEX MI-001
WATER METERS
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to water meters intended for the measurement of volumes of clean, cold or heated water in residential, commercial and light industrial use.
Definitions
Water Meter
An instrument designed to measure, memorise and display the volume at metering conditions of water passing through the measurement transducer.
Minimum Flowrate (Q1)
The lowest flowrate at which the water meter provides indications that satisfy the requirements concerning the maximum permissible errors (MPEs.)
Transitional Flowrate (Q2)
The transitional flowrate is the flowrate value occurring between the permanent and minimum flowrates, at which the flowrate range is divided into two zones, the ‘upper zone’ and the ‘lower zone’. Each zone has a characteristic MPE.
Permanent Flowrate (Q3)
The highest flowrate at which the water meter operates in a satisfactory manner under normal conditions of use, i.e. under steady or intermittent flow conditions.
Overload Flowrate (Q4)
The overload flowrate is the highest flowrate at which the meter operates in a satisfactory manner for a short period of time without deteriorating.
Specific Requirements
Rated Operating Conditions
The manufacturer shall specify the rated operating conditions for the instrument, in particular;
|
1. |
The flowrate range of the water. The values for the flowrate range shall fulfil the following conditions: Q3/Q1 ≥ 10 Q2/Q1 = 1.6 Q4/Q3 = 1.25 For 5 years from the date of entry into force of this Directive the ratio Q2/Q1 may be: 1,5, 2,5, 4, or 6,3. |
|
2. |
The temperature range of the water. The values for the temperature range shall fulfil the following conditions: 0,1 °C to at least 30 °C, or 30 °C to at least 90 °C. The meter may be designed to operate over both ranges. |
|
3. |
The relative pressure range of the water, the range being 0.3 bar to at least 10 bar at Q3. |
|
4. |
For the power supply: the nominal value of the AC voltage supply and/or the limits of DC supply. |
MPE
|
5. |
The MPE, positive or negative, on volumes delivered at flowrates between the transitional flowrate (Q2) (included) and the overload flowrate (Q4) is: 2 % for water having a temperature ≤ 30 °C, 3 % for water having a temperature > 30 °C. |
|
6. |
The MPE, positive or negative, on volumes delivered at flowrates between the minimum flowrate (Q1) and the transitional flowrate (Q2) (excluded) is 5 % for water having any temperature. |
Permissible Effect of Disturbances
|
7.1. |
Electromagnetic immunity |
|
7.1.1. |
The effect of an electromagnetic disturbance on a water meter shall be such that:
|
|
7.1.2. |
After undergoing an electromagnetic disturbance the water meter shall:
|
|
7.1.3. |
The critical change value is the smaller of the two following values:
|
|
7.2. |
Durability After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:
|
Suitability
|
8.1. |
The meter shall be able to be installed to operate in any position unless clearly marked otherwise. |
|
8.2. |
The manufacturer shall specify whether the meter is designed to measure reverse flow. In such a case, the reverse flow volume shall either be subtracted from the cumulated volume or shall be separately recorded. The same MPE shall apply to both forward and reverse flow. Water meters not designed to measure reverse flow shall either prevent reverse flow or shall withstand an accidental reverse flow without any deterioration or change in metrological properties. |
Units of Measurement
|
9. |
Metered volume shall be displayed in cubic metres. |
Putting into Use
|
10. |
The Member State shall ensure that the requirements under 1, 2 and 3 are determined by the distributor or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable. |
Conformity assessment
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
B+F or B+D or H1.
ANNEX MI-002
GAS METERS AND VOLUME CONVERSION DEVICES
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to gas meters and volume conversion devices defined below, intended for residential, commercial and light industrial use.
Definitions
Gas meter
An instrument designed to measure, memorise and display the quantity of fuel gas (volume or mass) that has passed it.
Conversion device
A device fitted to a gas meter that automatically converts the quantity measured at metering conditions into a quantity at base conditions.
Minimum flowrate (Qmin)
The lowest flowrate at which the gas meter provides indications that satisfy the requirements regarding maximum permissible error (MPE.)
Maximum flowrate (Qmax)
The highest flowrate at which the gas meter provides indications that satisfy the requirements regarding MPE.
Transitional flowrate (Qt)
The transitional flowrate is the flowrate occurring between the maximum and minimum flowrates at which the flowrate range is divided into two zones, the ‘upper zone’ and the ‘lower zone’. Each zone has a characteristic MPE.
Overload Flowrate (Qr)
The overload flowrate is the highest flowrate at which the meter operates for a short period of time without deteriorating.
Base conditions
The specified conditions to which the measured quantity of fluid is converted.
PART I — SPECIFIC REQUIREMENTS — GAS METERS
1. Rated operating conditions
The manufacturer shall specify the rated operating conditions of the gas meter, taking into account:
1.1. The flowrate range of the gas shall fulfil at least the following conditions:
|
Class |
Qmax/Qmin |
Qmax/Qt |
Qr/Qmax |
|
1.5 |
≥ 150 |
≥ 10 |
1.2 |
|
1.0 |
≥ 20 |
≥ 5 |
1.2 |
1.2. The temperature range of the gas, with a minimum range of 40 °C.
1.3. The fuel/gas related conditions.
The gas meter shall be designed for the range of gases and supply pressures of the country of destination. In particular the manufacturer shall indicate:
|
— |
the gas family or group; |
|
— |
the maximum operating pressure. |
1.4. A minimum temperature range of 50 °C for the climatic environment.
1.5. The nominal value of the AC voltage supply and/or the limits of DC supply
2. Maximum permissible error (MPEs)
2.1. Gas meter indicating the volume at metering conditions or mass
|
Class |
1.5 |
1.0 |
|
Qmin ≤ Q < Qt |
3 % |
2 % |
|
Qt ≤ Q ≤ Qmax |
1,5 % |
1 % |
Table 1
When the errors between Qt and Qmax all have the same sign, they shall all not exceed 1 % for class 1.5 and 0,5 % for Class 1.0.
2.2. For a gas meter with temperature conversion, which only indicates the converted volume, the MPE of the meter is increased by 0,5 % in a range of 30 °C extending symmetrically around the temperature specified by the manufacturer that lies between 15 °C and 25 °C. Outside this range, an additional increase of 0,5 % is permitted in each interval of 10 °C.
3. Permissible effect of disturbances
3.1. Electromagnetic immunity
3.1.1. The effect of an electromagnetic disturbance on a gas meter or volume conversion device shall be such that:
|
— |
the change in the measurement result is no greater than the critical change value as defined in 3.1.3, or |
|
— |
the indication of the measurement result is such that it cannot be interpreted as a valid result, such as a momentary variation that cannot be interpreted, memorised or transmitted as a measuring result. |
3.1.2. After undergoing a disturbance, the gas meter shall:
|
— |
recover to operate within MPE, and |
|
— |
have all measurement functions safeguarded, and |
|
— |
allow recovery of all measurement data present just before the disturbance. |
3.1.3. The critical change value is the smaller of the two following values:
|
— |
the quantity corresponding to half of the magnitude of the MPE in the upper zone on the measured volume; |
|
— |
the quantity corresponding to the MPE on the quantity corresponding to one minute at maximum flowrate. |
3.2. Effect of upstream-downstream flow disturbances
Under installation conditions specified by the manufacturer, the effect of the flow disturbances shall not exceed one third of the MPE.
4. Durability
After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:
4.1. Class 1.5 meters
4.1.1. The variation of the measurement result after the durability test when compared with the initial measurement result for the flow rates in the range Qt to Qmax shall not exceed the measurement result by more than 2 %.
4.1.2. The error of indication after the durability test shall not exceed twice the MPE in paragraph 2.
4.2. Class 1.0 meters
4.2.1. The variation of the measurement result after the durability test when compared with the initial measurement result shall not exceed one-third of the MPE in paragraph 2.
4.2.2. The error of indication after the durability test shall not exceed the MPE in paragraph 2.
5. Suitability
5.1. A gas meter powered from the mains (AC or DC) shall be provided with an emergency power supply device or other means to ensure, during a failure of the principal power source, that all measuring functions are safeguarded.
5.2. A dedicated power source shall have a lifetime of at least five years. After 90 % of its lifetime an appropriate warning shall be shown.
5.3. An indicating device shall have a sufficient number of digits to ensure that the quantity passed during 8 000 hours at Qmax does not return the digits to their initial values.
5.4. The gas meter shall be able to be installed to operate in any position declared by the manufacturer in its installation instruction.
5.5. The gas meter shall have a test element, which shall enable tests to be carried out in a reasonable time.
5.6. The gas meter shall respect the MPE in any flow direction or only in one flow direction clearly marked.
6. Units
Metered quantity shall be displayed in cubic metre, or in kilogram.
PART II — SPECIFIC REQUIREMENTS — VOLUME CONVERSION DEVICES
A volume conversion device constitutes a sub-assembly according to Article 4, definition (b), second indent.
For a volume conversion device, the essential requirements for the gas meter shall apply, if applicable. In addition, the following requirements shall apply:
7. Base conditions for converted quantities
The manufacturer shall specify the base conditions for converted quantities.
8. MPE
|
— |
0,5 % at ambient temperature 20 °C +/- 3 °C, ambient humidity 60 % +/- 15 %, nominal values for power supply; |
|
— |
0,7 % for temperature conversion devices at rated operating conditions; |
|
— |
1 % for other conversion devices at rated operating conditions. |
Note: The error of the gas meter is not taken into account.
9. Suitability
9.1. An electronic conversion device shall be capable of detecting when it is operating outside the operating range(s) stated by the manufacturer for parameters that are relevant for measurement accuracy. In such a case, the conversion device must stop integrating the converted quantity, and may totalise separately the converted quantity for the time it is operating outside the operating range(s).
9.2. An electronic conversion device shall be capable to display all relevant data for the measurement without additional equipment.
PART III — PUTTING INTO USE AND CONFORMITY ASSESSMENT
PUTTING INTO USE
|
(a) |
Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class 1.5 meter, and by Class 1.0 meters which have a Qmax/Qmin ratio equal or greater than 150. |
|
(b) |
Where a Member State imposes measurement of commercial and/or light industrial use, it shall allow such measurement to be performed by any Class 1.5 meter. |
|
(c) |
As regards the requirements under paragraphs 1.2 and 1.3, Member States shall ensure that the properties be determined by the distributor or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable. |
Conformity assessment
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are
B+F or B+D or H1.
ANNEX MI-003
ACTIVE ELECTRICAL ENERGY METERS
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to active electrical energy meters intended for residential, commercial and light industrial use.
Note: Electrical energy meters may be used in combination with external instrument transformers, depending upon the measurement technique applied. However, this Annex covers only electrical energy meters but not instrument transformers.
DEFINITIONS
An active electrical energy meter is a device which measures the active electrical energy consumed in a circuit.
I = the electrical current flowing through the meter;
In = the specified reference current for which the transformer operated meter has been designed;
Ist = the lowest declared value of I at which the meter registers active electrical energy at unity power factor (polyphase meters with balanced load);
Imin = the value of I above which the error lies within maximum permissible errors (MPEs) (polyphase meters with balanced load);
Itr = the value of I above which the error lies within the smallest MPE corresponding to the class index of the meter;
Imax = the maximum value of I for which the error lies within the MPEs;
U = the voltage of the electricity supplied to the meter;
Un = the specified reference voltage;
f = the frequency of the voltage supplied to the meter;
fn = the specified reference frequency;
PF = power factor = cosΦ = the cosine of the phase difference Φ between I and U.
SPECIFIC REQUIREMENTS
1. Accuracy
The manufacturer shall specify the class index of the meter. The class indices are defined as: Class A, B and C.
2. Rated operating conditions
The manufacturer shall specify the rated operating conditions of the meter; in particular: The values of fn , Un , In, Ist, Imin , Itr and Imax that apply to the meter.
For the current values specified, the meter shall satisfy the conditions given in Table 1.
|
|
Class A |
Class B |
Class C |
|
For direct-connected meters |
|||
|
Ist |
≤ 0,05 · Itr |
≤ 0,04 · Itr |
≤ 0,04 · Itr |
|
Imin |
≤ 0,5 · Itr |
≤ 0,5 · Itr |
≤ 0,3 · Itr |
|
Imax |
≥ 50 · Itr |
≥ 50 · Itr |
≥ 50 · Itr |
|
For transformer-operated meters |
|||
|
Ist |
≤ 0,06 · Itr |
≤ 0,04 · Itr |
≤ 0,02 · Itr |
|
Imin |
≤ 0,4 · Itr |
≤ 0,2 · Itr (1) |
≤ 0,2 · Itr |
|
In |
= 20 · Itr |
= 20 · Itr |
= 20 · Itr |
|
Imax |
≥ 1,2 · In |
≥ 1,2 · In |
≥ 1,2 · In |
Table 1
The voltage, frequency and power factor ranges within which the meter shall satisfy the MPE requirements are specified in Table 2. These ranges shall recognise the typical characteristics of electricity supplied by public distribution systems.
The voltage and frequency ranges shall be at least:
0,9 · Un ≤ U ≤ 1,1 · Un
0,98 · fn ≤ f ≤ 1,02 · fn
power factor range at least:
from cosφ = 0,5 inductive to cosφ = 0,8 capacitive.
3. MPEs
The effects of the various measurands and influence quantities (a,b,c,...) are evaluated separately, all other measurands and influence quantities being kept relatively constant at their reference values. The error of measurement, that shall not exceed the MPE stated in Table 2, is calculated as:
Error of measurement = √ a2+b2+c2...
When the meter is operating under varying-load current, the percentage errors shall not exceed the limits given in Table 2.
|
|
Operating temperatures |
Operating temperatures |
Operating temperatures |
Operating temperatures |
||||||||
|
|
+5 °C ... +30 °C |
-10 °C ... +5 °C or +30 °C ... +40 °C |
-25 °C ... -10 °C or +40 °C ... +55 °C |
-40 °C ... -25 °C or +55 °C ... +70 °C |
||||||||
|
Meter class |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
|
Single phase meter; polyphase meter if operating with balanced loads |
||||||||||||
|
Imin ≤ I < Itr |
3.5 |
2 |
1 |
5 |
2.5 |
1.3 |
7 |
3.5 |
1.7 |
9 |
4 |
2 |
|
Itr ≤ I ≤ Imax |
3.5 |
2 |
0.7 |
4.5 |
2.5 |
1 |
7 |
3.5 |
1.3 |
9 |
4 |
1.5 |
|
Polyphase meter if operating with single phase load |
||||||||||||
|
Itr ≤ I ≤ Imax, see exception below |
4 |
2.5 |
1 |
5 |
3 |
1.3 |
7 |
4 |
1.7 |
9 |
4.5 |
2 |
For electromechanical polyphase meters the current range for single-phase load is limited to 5Itr ≤ I ≤ Imax
Table 2 — MPEs in percent at rated operating conditions and defined load current levels and operating temperature. When a meter operates in different temperature ranges the relevant MPE values shall apply.
4. Permissible effect of disturbances
4.1. General
As electrical energy meters are directly connected to the mains supply and as mains current is also one of the measurands, a special electromagnetic environment is used for electricity meters.
The meter shall comply with the electromagnetic environment E2 and the additional requirements in 4.2. and 4.3.
The electromagnetic environment and permissible effects reflect the situation that there are disturbances of long duration which shall not affect the accuracy beyond the critical change values and transient disturbances, which may cause a temporary degradation or loss of function or performance but from which the meter shall recover and shall not affect the accuracy beyond the critical change values.
When there is a foreseeable high risk due to lightning or where overhead supply networks are predominant, the metrological characteristics of the meter shall be protected.
4.2. Effect of disturbances of long duration
|
Disturbance |
Critical change values in percent for meters of class |
||
|
|
A |
B |
C |
|
Reversed phase sequence |
1,5 |
1,5 |
0,3 |
|
Voltage unbalance (only applicable to polyphase meters) |
4 |
2 |
1 |
|
Harmonic contents in the current circuits (2), |
1 |
0,8 |
0,5 |
|
DC and harmonics in the current circuit (2), |
6 |
3 |
1,5 |
|
Fast transient bursts |
6 |
4 |
2 |
|
Magnetic fields; HF (radiated RF) electromagnetic field; Conducted disturbances introduced by radio-frequency fields; and Oscillatory waves immunity |
3 |
2 |
1 |
Table 3 — Critical change values for disturbances of long duration
4.3. Permissible effect of transient electromagnetic phenomena
4.3.1. The effect of an electromagnetic disturbance on an electrical energy meter shall be such that during and immediately after a disturbance
|
— |
any output intended for testing the accuracy of the meter does not produce pulses or signals corresponding to an energy of more than the critical change value and in reasonable time after the disturbance the meter shall |
|
— |
recover to operate within the MPE limits, and |
|
— |
have all measurement functions safeguarded, and |
|
— |
allow recovery of all measurement data present prior to the disturbance, and |
|
— |
not indicate a change in the registered energy of more than the critical change value. |
The critical change value in kWh is m · Un · Imax · 10-6
(m being the number of measuring elements of the meter, Un in Volts and Imax in Amps).
4.3.2. For overcurrent the critical change value is 1,5 %.
5. Suitability
5.1. Below the rated operating voltage the positive error of the meter shall not exceed 10 %.
5.2. The display of the total energy shall have a sufficient number of digits to ensure that when the meter is operated for 4 000 hours at full load (I = Imax, U = Un and PF = 1) the indication does not return to its initial value and shall not be able to be reset during use.
5.3. In the event of loss of electricity in the circuit, the amounts of electrical energy measured shall remain available for reading during a period of at least 4 months.
5.4. Running with no load
When the voltage is applied with no current flowing in the current circuit (current circuit shall be open circuit), the meter shall not register energy at any voltage between 0,8 · Un and 1,1 Un .
5.5. Starting
The meter shall start and continue to register at Un, PF = 1 (polyphase meter with balanced loads) and a current which is equal to Ist .
6. Units
The electrical energy measured shall be displayed in kilowatt-hours or in megawatt-hours.
7. Putting into use
|
(a) |
Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class A meter. For specified purposes the Member State is authorised to require any Class B meter. |
|
(b) |
Where a Member State imposes measurement of commercial and/or light industrial use, it shall allow such measurement to be performed by any Class B meter. For specified purposes the Member State is authorised to require any Class C meter. |
|
(c) |
The Member State shall ensure that the current range be determined by the distributor or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable. |
Conformity assessment
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
B+F or B+D or H1.
(1) For Class B electromechanical meters Imin ≤ 0,4 · Itr shall apply.
(2) In the case of electromechanical electricity meters, no critical change values are defined for harmonic contents in the current circuits and for DC and harmonics in the current circuit
ANNEX MI-004
HEAT METERS
The relevant requirements of Annex I, the specific requirements and the conformity assessment procedures listed in this Annex, apply to heat meters defined below, intended for residential, commercial and light industrial use.
DEFINITIONS
A heat meter is an instrument designed to measure the heat which, in a heat exchange circuit, isgiven up by a liquid called the heat-conveying liquid.
A heat meter is either a complete instrument or a combined instrument consisting of the sub-assemblies, flow sensor, temperature sensor pair, and calculator, as defined in Article 4(b), or a combination thereof
θ = the temperature of the heat-conveying liquid
θin = the value of θ at the inlet of the heat exchange circuit
θout = the value of θ at the outlet of the heat exchange circuit
Δθ = the temperature difference θ in - θ out with Δθ ≥ 0
θmax = the upper limit of θ for the heat meter to function correctly within the MPEs
θmin = the lower limit of θ for the heat meter to function correctly within the MPEs
Δθmax = the upper limit of Δθ for the heat meter to function correctly within the MPEs
Δθmin = the lower limit of Δθ for the heat meter to function correctly within the MPEs
q = the flow rate of the heat conveying liquid
qs = the highest value of q that is permitted for short periods of time for the heat meter to function correctly
qp = the highest value of q that is permitted permanently for the heat meter to function correctly
qi = the lowest value of q that is permitted for the heat meter to function correctly
P = the thermal power of the heat exchange
Ps = the upper limit of P that is permitted for the heat meter to function correctly.
SPECIFIC REQUIREMENTS
1. Rated operating conditions
The values of the rated operating conditions shall be specified by the manufacturer as follows:
1.1. For the temperature of the liquid: θmax, θmin,
|
— |
for the temperature differences: Δθmax, Δθmin, subject to the following restrictions: Δθmax/Δθmin ≥ 10; Δθmin = 3 K or 5 K or 10 K. |
1.2. For the pressure of the liquid: The maximum positive internal pressure that the heat meter can withstand permanently at the upper limit of the temperature.
1.3. For the flow rates of the liquid: qs, qp, qi, where the values of qp and qi are subject to the following restriction: qp/qi ≥ 10.
1.4. For the thermal power: Ps.
2. Accuracy classes
The following accuracy classes are defined for heat meters: 1, 2, 3.
3. MPEs applicable to complete heat meters
The maximum permissible relative errors applicable to a complete heat meter, expressed in percent of the true value for each accuracy class, are:
|
— |
For class 1: E = Ef + Et + Ec, with Ef , Et , Ec according to paragraphs 7.1 to 7.3. |
|
— |
For class 2: E = Ef + Et + Ec, with Ef , Et , Ec according to paragraphs 7.1 to 7.3. |
|
— |
For class 3: E = Ef + Et + Ec, with Ef , Et , Ec according to paragraphs 7.1 to 7.3. |
4. Permissible influences of electromagnetic disturbances
4.1. The instrument shall not be influenced by static magnetic fields and by electromagnetic fields at mains frequency.
4.2. The influence of an electromagnetic disturbance shall be such that the change in the measurement result is not greater than the critical change value as laid down in requirement 4.3 or the indication of the measurement result is such that it cannot be interpreted as a valid result.
4.3. The critical change value for a complete heat meter is equal to the absolute value of the MPE applicable to that heat meter (see paragraph 3).
5. Durability
After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:
5.1. Flow sensors: The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed the critical change value.
5.2. Temperature sensors: The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed 0,1 °C.
6. Inscriptions on a heat meter:
|
— |
Accuracy class |
|
— |
Limits of flow rate |
|
— |
Limits of temperature |
|
— |
Limits of temperature difference |
|
— |
Place of the flow sensor installation — flow or return |
|
— |
Indication of the direction of flow |
7. Sub-assemblies:
The provisions for sub-assemblies may apply to sub-assemblies manufactured by the same or different manufacturers. Where a heat meter consists of sub-assemblies, the essential requirements for the heat meter apply to the sub-assemblies as relevant. In addition, the following apply:
7.1. The relative MPE of the flow sensor, expressed in %, for accuracy classes:
|
— |
Class 1: Ef = (1 + 0,01 qp/q), but not more than 5 %, |
|
— |
Class 2: Ef = (2 + 0,02 qp/q), but not more than 5 %, |
|
— |
Class 3: Ef = (3 + 0,05 qp/q), but not more than 5 %, |
where the error Ef relates the indicated value to the true value of the relationship between flow sensor output signal and the mass or the volume.
7.2. The relative MPE of the temperature sensor pair, expressed in %:
|
— |
Et = (0,5 + 3·Δθmin/Δθ), |
|
— |
where the error Et relates the indicated value to the true value of the relationship between temperature sensor pair output and temperature difference. |
7.3. The relative MPE of the calculator, expressed in %:
|
— |
Ec = (0,5 + Δθmin/Δθ), |
|
— |
where the error Ec relates the value of the heat indicated to the true value of the heat. |
7.4. The critical change value for a sub-assembly of a heat meter is equal to the respective absolute value of the MPE applicable to the sub-assembly (see paragraphs 7.1, 7.2 or 7.3).
7.5. Inscriptions on the sub-assemblies
Flow sensor:
Accuracy class
Limits of flow rate
Limits of temperature
Nominal meter factor (e.g. litres/pulse) or corresponding output signal
Indication of the direction of flow
Temperature sensor pair:
Type identification (e.g. Pt 100)
Limits of temperature
Limits of temperature difference
Calculator:
Type of temperature sensors
|
— |
Limits of temperature |
|
— |
Limits of temperature difference |
|
— |
Required nominal meter factor (e.g. litres/pulse) or corresponding input signal coming from the flow sensor |
|
— |
Place of the flow sensor installation: flow or return |
PUTTING INTO USE
|
(a) |
Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class 3 meter. |
|
(b) |
Where a Member State imposes measurement of commercial and/or light industrial use, it is authorised to require any Class 2 meter. |
|
(c) |
As regards the requirements under paragraphs 1.1 to 1.4, Member States shall ensure that the properties be determined by the distributor or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable. |
9. Conformity assessment
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
B+F or B + D or H 1.
ANNEX MI-005
MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC MEASUREMENT OF QUANTITIES OF LIQUIDS OTHER THAN WATER
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to measuring systems intended for the continuous and dynamic measurement of quantities (volumes or masses) of liquids other than water. If appropriate, the terms ‘volume, and L’ in this Annex can be read as: ‘mass and kg’.
DEFINITIONS
Meter
An instrument designed to measure continuously, memorise and display the quantity at metering conditions of liquid flowing through the measurement transducer in a closed, fully charged conduit.
Calculator
A part of a meter that receives the output signals from the measurement transducer(s) and possibly, from associated measuring instruments and displays the measurement results.
Associated measuring instrument
An instrument connected to the calculator for measuring certain quantities which are characteristic of the liquid, with a view to make a correction and/or conversion.
Conversion Device
A part of the calculator which by taking account of the characteristics of the liquid (temperature, density, etc.) measured using associated measuring instruments, or stored in a memory, automatically converts:
|
— |
the volume of the liquid measured at metering conditions into a volume at base conditions and/or into mass, or |
|
— |
the mass of the liquid measured at metering conditions into a volume at metering conditions and/or into a volume at base conditions |
Note: A conversion device includes the relevant associated measuring instruments.
Base conditions
The specified conditions to which the measured quantity of liquid at metering conditions is converted.
Measuring System
A system that comprises the meter itself and all devices required to ensure correct measurement or intended to facilitate the measuring operations.
Fuel dispenser
A measuring system intended for the refuelling of motor vehicles, small boats and small aircraft.
Self-service arrangement
An arrangement that allows the customer to use a measuring system for the purpose of obtaining liquid for his own use.
Self-service device
A specific device that is part of a self-service arrangement and which allows one of more measuring systems to perform in this self-service arrangement.
Minimum measured quantity (MMQ)
The smallest quantity of liquid for which the measurement is metrologically acceptable for the measuring system.
Direct indication
The indication, either volume or mass, corresponding to the measure and that the meter is physically capable of measuring.
Note: the direct indication may be converted into another quantity using a conversion device.
Interruptible/non interruptible
A measuring system is considered as interruptible/non interruptible when the liquid flow can/cannot be stopped easily and rapidly.
Flowrate range
The range between the minimum flowrate (Qmin) and maximum flowrate (Qmax).
SPECIFIC REQUIREMENTS
1. RATED OPERATING CONDITIONS
The manufacturer shall specify the rated operating conditions for the instrument, in particular;
1.1. The flowrate range
The flowrate range is subject to the following conditions:
|
i) |
the flowrate range of a measuring system shall be within the flowrate range of each of its elements, in particular the meter. |
|
ii) |
meter and measuring system: |
|
Specific measuring system |
Characteristic of liquid |
Minimum ratio of Qmax: Qmin |
|
Fuel dispensers |
Not Liquefied gases |
10 : 1 |
|
Liquefied gases |
5 : 1 |
|
|
Measuring system |
Cryogenic liquids |
5 : 1 |
|
Measuring systems on pipeline and systems for loading ships |
All liquids |
Suitable for use |
|
All other measuring systems |
All liquids |
4 : 1 |
Table 1
1.2. The properties of the liquid to be measured by the instrument by specifying the name or type of the liquid or its relevant characteristics, for example:
|
— |
Temperature range; |
|
— |
Pressure range; |
|
— |
Density range; |
|
— |
Viscosity range. |
1.3. The nominal value of the AC voltage supply and/or limits of the DC voltage supply.
1.4. The base conditions for converted values.
Note: Paragraph 1.4 is without prejudice to the Member States' obligations to require use of a temperature of either 15°C in accordance with Article 3(1) of Council Directive 92/81/EEC of 19 October 1992 on the harmonisation of the structures of excise duties on mineral oils (1) or, for heavy fuel oils, LPG and methane, another temperature pursuant to Article 3(2) of that Directive.
2. ACCURACY CLASSIFICATION AND MAXIMUM PERMISSIBLE ERRORS (MPEs)
2.1. For quantities equal to or greater than 2 litres the MPE on indications is:
|
|
Accuracy Class |
||||
|
|
0,3 |
0,5 |
1,0 |
1,5 |
2,5 |
|
Measuring systems (A) |
0,3 % |
0,5 % |
1,0 % |
1,5 % |
2,5 % |
|
Meters (B) |
0,2 % |
0,3 % |
0,6 % |
1,0 % |
1,5 % |
Table 2
2.2. For quantities less than two litres the MPE on indications is:
|
Measured volume V |
MPE |
|
V < 0,1 L |
4 × value in Table 2, applied to 0,1 L |
|
0,1 L ≤ V < 0,2 L |
4 × value in Table 2 |
|
0,2 L ≤ V < 0,4 L |
2 × value in Table 2, applied to 0,4 L |
|
0,4 L ≤V < 1 L |
2 × value in Table 2 |
|
1 L ≤ V < 2 L |
Value in Table 2, applied to 2 L |
Table 3
2.3. However, no matter what the measured quantity may be, the magnitude of the MPE is given by the greater of the following two values:
|
— |
the absolute value of the MPE given in Table 2 or Table 3, |
|
— |
the absolute value of the MPE for the minimum measured quantity (Emin). |
2.4.1. For minimum measured quantities greater than or equal to 2 litres the following conditions apply:
Condition 1
Emin shall fulfil the condition: Emin ≥ 2R, where R is the smallest scale interval of the indication device.
Condition 2
Emin is given by the formula: Emin = (2 MMQ) × (A/100), where:
|
— |
MMQ is the minimum measured quantity, |
|
— |
A is the numerical value specified in line A of Table 2. |
2.4.2. For minimum measured quantities of less than two litres, the above mentioned condition 1 applies and Emin is twice the value specified in Table 3, and related to line A of Table 2.
2.5. Converted indication
In the case of a converted indication the MPEs are as in line A of Table 2.
2.6. Conversion devices
MPEs on converted indications due to a conversion device are equal to ± (A - B), A and B being the values specified in Table 2.
Parts of conversion devices that can be tested separately
|
(a) |
Calculator MPEs on quantities of liquid indications applicable to calculation, positive or negative, are equal to one-tenth of the MPEs as defined in line A of Table 2. |
|
(b) |
Associated measuring instruments Associated measuring instruments shall have an accuracy at least as good as the values in Table 4:
Table 4 These values apply to the indication of the characteristic quantities of the liquid displayed by the conversion device. |
|||||||||||||||||||||||||||||
|
(c) |
Accuracy for calculating function The MPE for the calculation of each characteristic quantity of the liquid, positive or negative, is equal to two fifths of the value fixed in (b). |
2.7. The requirement (a) in paragraph 2.6 applies to any calculation, not only conversion.
3. MAXIMUM PERMISSIBLE EFFECT OF DISTURBANCES
3.1. The effect of an electromagnetic disturbance on a measuring system shall be one of the following;
|
— |
the change in the measurement result is not greater than the critical change value as defined in paragraph 3.2, or |
|
— |
the indication of the measurement result shows a momentary variation that cannot be interpreted, memorised or transmitted as a measuring result. Furthermore, in the case of an interruptible system, this can also mean the impossibility to perform any measurement, or |
|
— |
the change in the measurement result is greater than the critical change value, in which case the measuring system shall permit the retrieval of the measuring result just before the critical change value occurred and cut off the flow. |
3.2. The critical change value is the greater of MPE/5 for a particular measured quantity or Emin.
4. DURABILITY
After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criterion shall be satisfied:
The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed the value for meters specified in line B of table 2.
5. SUITABILITY
5.1. For any measured quantity relating to the same measurement, the indications provided by various devices shall not deviate one from another by more than one scale interval where devices have the same scale interval. In the case where the devices have different scale intervals, the deviation shall not be more than that of the greatest scale interval.
However, in the case of a self-service arrangement the scale intervals of the main indicating device on the measuring system and the scale intervals of the self-service device shall be the same and results of measurement shall not deviate one from another.
5.2. It shall not be possible to divert the measured quantity in normal conditions of use unless it is readily apparent.
5.3. Any percentage of air or gas not easily detectable in the liquid shall not lead to a variation of error greater than:
|
— |
0,5 % for liquids other than potable liquids and for liquids of a viscosity not exceeding 1 mPa.s, or |
|
— |
1 % for potable liquids and for liquids of a viscosity exceeding 1 mPa.s. However, the allowed variation shall never be smaller than 1 % of MMQ. This value applies in the case of air or gas pockets. |
5.4. Instruments for direct sales.
5.4.1. A measuring system for direct sales shall be provided with means for resetting the display to zero.
It shall not be possible to divert the measured quantity.
5.4.2. The display of the quantity on which the transaction is based shall be permanent until all parties in the transaction have accepted the measurement result.
5.4.3. Measuring systems for direct sales shall be interruptible.
5.4.4. Any percentage of air or gas in the liquid shall not lead to a variation of error greater than the values specified in paragraph 5.3.
5.5. Fuel Dispensers
5.5.1. Displays on fuel dispensers shall not be capable of being reset to zero during a measurement.
5.5.2. The start of a new measurement shall be inhibited until the display has been reset to zero.
5.5.3. Where a measuring system is fitted with a price display, the difference between the indicated price and the price calculated from the unit price and the indicated quantity shall not exceed the price corresponding to Emin. However this difference need not be less than the smallest monetary value.
6. POWER SUPPLY FAILURE
A measuring system shall either be provided with an emergency power supply device that will safeguard all measuring functions during the failure of the main power supply device or be equipped with means to save and display the data present in order to permit the conclusion of the transaction in progress and with means to stop the flow at the moment of the failure of the main power supply device.
7. PUTTING INTO USE
|
Accuracy Class |
Types of Measuring system |
||||||||||
|
0,3 |
— Measuring systems on pipeline |
||||||||||
|
0,5 |
All measuring systems if not differently stated elsewhere in this Table, in particular:
|
||||||||||
|
1,0 |
|
||||||||||
|
1,5 |
Measuring systems for liquefied carbon dioxide. Measuring systems for liquefied gases under pressure measured at a temperature below -10 °C (other than cryogenic liquids). |
||||||||||
|
2,5 |
measuring systems for cryogenic liquids (temperature below -153 °C) |
Note: However, the manufacturer may specify a better accuracy for a certain type of measuring system.
Table 5
8. UNITS OF MEASUREMENT
The metered quantity shall be displayed in millilitres, cubic centimetres, litres, cubic metres, grams, kilograms or tonnes.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
B+F or B+D or H1 or G.
(1) OJ L 316, 31.10.1992, p. 12. Directive repealed by Directive 2003/96/EC (OJ L 283, 31.10.2003, p. 51).
(2) However, Member States may require measuring systems of accuracy class 0.3 or 0.5 when used for the levying of duties on mineral oils when (un)loading ships and rail and road tankers.
ANNEX MI-006
AUTOMATIC WEIGHING INSTRUMENTS
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in Chapter I of this Annex, apply to automatic weighing instruments defined below, intended to determine the mass of a body by using the action of gravity on that body.
DEFINITIONS
Automatic weighing instrument
An instrument that determines the mass of a product without the intervention of an operator and follows a predetermined programme of automatic processes characteristic of the instrument.
Automatic catchweigher
An automatic weighing instrument that determines the mass of pre-assembled discrete loads (for example prepackages) or single loads of loose material.
Automatic checkweigher
An automatic catchweigher that subdivides articles of different mass into two or more subgroups according to the value of the difference of their mass and a nominal set-point.
Weight labeller
An automatic catchweigher that labels individual articles with the weight value.
Weight/price labeller
An automatic catchweigher that labels individual articles with the weight value, and price information.
Automatic gravimetric filling instrument
An automatic weighing instrument that fills containers with a predetermined and virtually constant mass of product from bulk.
Discontinuous totaliser (totalising hopper weigher)
An automatic weighing instrument that determines the mass of a bulk product by dividing it into discrete loads. The mass of each discrete load is determined in sequence and summed. Each discrete load is then delivered to bulk.
Continuous totaliser
An automatic weighing instrument that continuously determines the mass of a bulk product on a conveyor belt, without systematic subdivision of the product and without interrupting the movement of the conveyor belt.
Rail-weighbridge
An automatic weighing instrument having a load receptor inclusive of rails for conveying railway vehicles.
SPECIFIC REQUIREMENTS
Chapter I — Requirements common to all types of automatic weighing instruments
1. Rated Operating Conditions
The manufacturer shall specify the rated operating conditions for the instrument as follows:
1.1. For the measurand:
The measuring range in terms of its maximum and minimum capacity.
1.2. For the electrical supply influence quantities:
In case of AC voltage supply: the nominal AC voltage supply, or the AC voltage limits.
In case of DC voltage supply: the nominal and minimum DC voltage supply, or the DC voltage limits.
1.3. For the mechanical and climatic influence quantities:
The minimum temperature range is 30°C unless specified otherwise in the following chapters of this Annex.
The mechanical environment classes according to Annex I, paragraph 1.3.2 are not applicable. For instruments which are used under special mechanical strain, e.g. instruments incorporated into vehicles, the manufacturer shall define the mechanical conditions of use.
1.4. For other influence quantities (if applicable):
The rate(s) of operation.
The characteristics of the product(s) to be weighed.
2. Permissible effect of disturbances — Electromagnetic environment
The required performance and the critical change value are given in the relevant Chapter of this Annex for each type of instrument.
3. Suitability
3.1. Means shall be provided to limit the effects of tilt, loading and rate of operation such that maximum permissible errors (MPEs) are not exceeded in normal operation.
3.2. Adequate material handling facilities shall be provided to enable the instrument to respect the MPEs during normal operation.
3.3. Any operator control interface shall be clear and effective.
3.4. The integrity of the display (where present) shall be verifiable by the operator.
3.5. Adequate zero setting capability shall be provided to enable the instrument to respect the MPEs during normal operation.
3.6. Any result outside the measurement range shall be identified as such, where a printout is possible.
4. Conformity assessment
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
For mechanical systems: B+D or B+E or B+F or D1 or F1 or G or H1.
For electromechanical instruments: B+D or B+E or B+F or G or H1.
For electronic systems or systems containing software: B+D or B+F or G or H1.
Chapter II — Automatic Catchweighers
1. Accuracy Classes
1.1. Instruments are divided into primary categories designated by:
X or Y
as specified by the manufacturer.
1.2. These primary categories are further divided into four accuracy classes:
XI, XII, XIII & XIV
and
Y(I), Y(II), Y(a) & Y(b)
which shall be specified by the manufacturer
2. Category X Instruments
2.1. Category X applies to instruments used to check prepackages made up in accordance with the requirements of Council Directive 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids (1) and of Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products (2) .
2.2. The accuracy classes are supplemented by a factor (x) that quantifies the maximum permissible standard deviation as specified in paragraph 4.2.
The manufacturer shall specify the factor (x), where (x) shall be ≤ 2 and in the form 1 × 10k, 2 × 10k or 5 × 10k , where k is a negative whole number or zero.
3. Category Y Instruments
Category Y applies to all other automatic catchweighers.
4. MPE
4.1. Mean error Category X/MPE Category Y instruments
|
Table 1 |
|||||||||
|
Net Load (m) in verification scale intervals (e) |
Maximum permissible mean error |
Maximum permissible error |
|||||||
|
XI |
Y(I) |
XII |
Y(II) |
XIII |
Y(a) |
XIV |
Y(b) |
X |
Y |
|
0 < m ≤ 50 000 |
0 < m ≤ 5 000 |
0 < m ≤ 500 |
0 < m ≤ 50 |
± 0,5 e |
± 1 e |
||||
|
50 000 < m ≤ 200 000 |
5 000 < m ≤ 20 000 |
500 < m ≤ 2 000 |
50 < m ≤ 200 |
± 1,0 e |
± 1,5 e |
||||
|
200 000 < m |
20 000 < m ≤ 100 000 |
2 000 < m ≤ 10 000 |
200 < m ≤ 1 000 |
± 1,5 e |
± 2 e |
||||
4.2. Standard deviation
Maximum permissible value for the standard deviation of a class X (x) instrument is the result of the multiplication of the factor (x) by the value in Table 2 below.
|
Table 2 |
|
|
Net Load (m) |
Maximum permissible standard deviation for class X(1) |
|
m ≤ 50 g |
0,48 % |
|
50 g < m ≤ 100 g |
0,24 g |
|
100 g < m ≤ 200 g |
0,24 % |
|
200 g < m ≤ 300 g |
0,48 g |
|
300 g < m ≤ 500 g |
0,16 % |
|
500 g < m ≤ 1 000 g |
0,8 g |
|
1 000 g < m ≤ 10 000 g |
0,08 % |
|
10 000 g < m ≤ 15 000 g |
8 g |
|
15 000 g < m |
0,053 % |
|
For class XI and XII, (x) shall be less than 1 For class XIII, (x) shall be not greater than 1 For class XIV, (x) shall be greater than 1 |
|
4.3. Verification scale interval — single interval instruments
|
Table 3 |
||||
|
Accuracy classes |
Verification scale interval |
Number of verification scale intervals n = Max/e |
||
|
Minimum |
Maximum |
|||
|
XI |
Y(I) |
0,001 g ≤ e |
50 000 |
— |
|
XII |
Y(II) |
0,001 g ≤ e ≤ 0,05 g |
100 |
100 000 |
|
0,1 g ≤ e |
5 000 |
100 000 |
||
|
XIII |
Y(a) |
0,1 g ≤ e ≤ 2 g |
100 |
10 000 |
|
5 g ≤ e |
500 |
10 000 |
||
|
XIV |
Y(b) |
5 g ≤ e |
100 |
1 000 |
4.4. Verification scale interval — multi-interval instruments
|
Table 4 |
||||
|
Accuracy classes |
Verification scale interval |
Number of verification scale intervals n = Max/e |
||
|
Minimum value (3) n = Max/e(i+1) |
Maximum value n = Maxi/ei |
|||
|
XI |
Y(I) |
0,001 g ≤ ei |
50 000 |
- |
|
XII |
Y(II) |
0,001 g ≤ ei ≤ 0,05 g |
5 000 |
100 000 |
|
0,1 g ≤ ei |
5 000 |
100 000 |
||
|
XIII |
Y(a) |
0,1 g ≤ ei |
500 |
10 000 |
|
XIV |
Y(b) |
5 g ≤ ei |
50 |
1 000 |
Where:
|
i |
= |
1, 2, ...r |
|
i |
= |
partial weighing range |
|
r |
= |
total number of partial ranges |
5. Measurement Range
In specifying the measurement range for class Y instruments the manufacturer shall take account that the minimum capacity shall not be less than:
class Y(I): 100 e
class Y(II): 20 e for 0,001 g ≤ e ≤ 0,05 g, and 50 e for 0,1 g ≤ e
class Y(a): 20 e
class Y(b): 10 e
Scales used for grading, e.g. postal scales and garbage weighers: 5 e
6. Dynamic Setting
6.1. The dynamic setting facility shall operate within a load range specified by the manufacturer.
6.2. When fitted, a dynamic setting facility that compensates for the dynamic effects of the load in motion shall be inhibited from operating outside the load range, and shall be capable of being secured.
7. Performance Under Influence Factors And Electromagnetic Disturbances
7.1. The MPEs due to influence factors are:
7.1.1. For category X instruments:
|
— |
For automatic operation; as specified in Tables 1, and 2, |
|
— |
For static weighing in non-automatic operation; as specified in Table 1. |
7.1.2. For category Y instruments
|
— |
For each load in automatic operation; as specified in Table 1, |
|
— |
For static weighing in non-automatic operation; as specified for category X in Table 1. |
7.2. The critical change value due to a disturbance is one verification scale interval.
7.3. Temperature range:
|
— |
For class XI and Y(I) the minimum range is 5° C, |
|
— |
For class XII and Y(II) the minimum range is 15° C. |
Chapter III — Automatic Gravimetric Filling Instruments
1. Accuracy classes
1.1. The manufacturer shall specify both the reference accuracy class Ref(x) and the operational accuracy class(es) X(x).
1.2. An instrument type is designated a reference accuracy class, Ref(x), corresponding to the best possible accuracy for instruments of the type. After installation, individual instruments are designated for one or more operational accuracy classes, X(x), having taken account of the specific products to be weighed. The class designation factor (x) shall be ≤ 2, and in the form 1 × 10k , 2 × 10k or 5 × 10k where k is a negative whole number or zero.
1.3. The reference accuracy class, Ref(x) is applicable for static loads.
1.4. For the operational accuracy class X(x), X is a regime relating accuracy to load weight and (x) is a multiplier for the limits of error specified for class X(1) in 2.2.
2. MPE
2.1. Static weighing error.
2.1.1. For static loads under rated operating conditions, the MPE for reference accuracy class Ref(x), shall be 0,312 of the maximum permissible deviation of each fill from the average; as specified in Table 5; multiplied by the class designation factor (x).
2.1.2. For instruments where the fill may be made up from more than one load (e.g. cumulative or selective combination weighers) the MPE for static loads shall be the accuracy required for the fill as specified in 2.2 (i.e. not the sum of the maximum permissible deviation for the individual loads).
2.2. Deviation from average fill.
|
Table 5 |
|
|
Value of the mass, m (g), of the fills |
Maximum permissible deviation of each fill from the average for class X(1) |
|
m ≤ 50 |
7,2 % |
|
50 < m ≤ 100 |
3,6 g |
|
100 < m ≤ 200 |
3,6 % |
|
200 < m ≤ 300 |
7,2 g |
|
300 < m ≤ 500 |
2,4 % |
|
500 < m ≤ 1 000 |
12 g |
|
1 000 < m ≤ 10 000 |
1,2 % |
|
10 000 < m ≤ 15 000 |
120 g |
|
15 000 < m |
0,8 % |
|
Note: The calculated deviation of each fill from the average may be adjusted to take account for the effect of material particle size. |
|
2.3. Error relative to pre-set value (setting error).
For instruments where it is possible to pre-set a fill weight; the maximum difference between the pre-set value and the average mass of the fills shall not exceed 0,312 of the maximum permissible deviation of each fill from the average, as specified in Table 5.
3. Performance Under Influence Factor And Electromagnetic Disturbance
3.1. The MPE due to influence factors shall be as specified in paragraph 2.1.
3.2. The critical change value due to a disturbance is a change of the static weight indication equal to the MPE as specified in paragraph 2.1 calculated for the rated minimum fill, or a change that would give equivalent effect on the fill in the case of instruments where the fill consists of multiple loads. The calculated critical change value shall be rounded to the next higher scale interval (d).
3.3. The manufacturer shall specify the value of the rated minimum fill.
Chapter IV — Discontinuous Totalisers
1. Accuracy Classes
Instruments are divided into four accuracy classes as follows: 0.2, 0.5, 1, 2.
2. MPEs
|
Table 6 |
|
|
Accuracy class |
MPE of totalised load |
|
0.2 |
± 0,10 % |
|
0.5 |
± 0,25 % |
|
1 |
± 0,50 % |
|
2 |
± 1,00 % |
3. Totalisation scale interval
The totalisation scale interval (dt) shall be in the range: 0,01 % Max ≤ dt ≤ 0,2 % Max
4. Minimum Totalised Load (Σmin)
The minimum totalised load (Σmin) shall be not less than the load at which the MPE is equal to the totalisation scale interval (dt) and not less than the minimum load as specified by the manufacturer.
5. Zero Setting
Instruments that do not tare weigh after each discharge shall have a zero setting device. Automatic operation shall be inhibited if zero indication varies by:
|
— |
1 dt on instruments with automatic zero setting device; |
|
— |
0,5 dt on instruments with a semi-automatic, or non-automatic, zero setting device. |
6. Operator Interface
Operator adjustments and reset function shall be inhibited during automatic operation.
7. Printout
On instruments equipped with a printing device, the reset of the total shall be inhibited until the total is printed. The printout of the total shall occur if automatic operation is interrupted.
8. Performance under influence factors and electromagnetic disturbances
8.1. The MPEs due to influence factors shall be as specified in Table 7.
|
Table 7 |
|
|
Load (m) in totalisation scale intervals (dt) |
MPE |
|
0 < m ≤ 500 |
± 0,5 dt |
|
500 < m ≤ 2 000 |
± 1,0 dt |
|
2 000 < m ≤ 10 000 |
± 1,5 dt |
8.2. The critical change value due to a disturbance is one totalisation scale interval for any weight indication and any stored total.
Chapter V — Continuous Totalisers
1. Accuracy classes
Instruments are divided into three accuracy classes as follows: 0.5, 1, 2
2. Measurement Range
2.1. The manufacturer shall specify the measurement range, the ratio between the minimum net load on the weighing unit and the maximum capacity, and the minimum totalised load.
2.2. The minimum totalised load Σmin shall not be less than
800 d for class 0.5,
400 d for class 1,
200 d for class 2.
Where d is the totalisation scale interval of the general totalisation device.
3. MPE
|
Table 8 |
|
|
Accuracy class |
MPE for totalised load |
|
0,5 |
± 0,25 % |
|
1 |
± 0,5 % |
|
2 |
± 1,0 % |
4. Speed of the belt
The speed of the belt shall be specified by the manufacturer. For single-speed beltweighers, and variable-speed beltweighers having a manual speed setting control, the speed shall not vary by more than 5 % of the nominal value. The product shall not have a different speed than the speed of the belt.
5. General Totalisation Device
It shall not be possible to reset the general totalisation device to zero.
6. Performance under influence factors and electromagnetic disturbances
6.1. The MPE due to influence factor, for a load not less than the Σmin, shall be 0,7 times the appropriate value specified in Table 8, rounded to the nearest totalisation scale interval (d).
6.2. The critical change value due to a disturbance shall be 0,7 times the appropriate value specified in Table 8, for a load equal to Σmin, for the designated class of the beltweigher; rounded up to the next higher totalisation scale interval (d).
Chapter VI — Automatic Rail Weighbridges
1. Accuracy classes
Instruments are divided into four accuracy classes as follows: 0.2, 0.5, 1, 2.
2. MPE
2.1. The MPEs for weighing-in-motion of a single wagon or a total train are shown in table 9.
|
Table 9 |
|
|
Accuracy class |
MPE |
|
0.2 |
± 0,1 % |
|
0.5 |
± 0,25 % |
|
1 |
± 0,5 % |
|
2 |
± 1,0 % |
2.2. The MPEs for the weight of coupled or uncoupled wagons weighing-in-motion shall be one of the following values, whichever is the greatest:
|
— |
the value calculated according to Table 9, rounded to the nearest scale interval; |
|
— |
the value calculated according to Table 9, rounded to the nearest scale interval for a weight equal to 35 % of the maximum wagon weight (as inscribed on the descriptive markings); |
|
— |
one scale interval (d) |
2.3. The MPEs for the weight of train weighing-in-motion shall be one of the following values, whichever is the greatest:
|
— |
the value calculated according to Table 9, rounded to the nearest scale interval; |
|
— |
the value calculated according to Table 9, for the weight of a single wagon equal to 35 % of the maximum wagon weight (as inscribed on the descriptive markings) multiplied by the number of reference wagons (not exceeding 10) in the train, and rounded to the nearest scale interval; |
|
— |
one scale interval (d) for each wagon in the train, but not exceeding 10 d. |
2.4. When weighing coupled wagons; the errors of not more than 10 % of the weighing results taken from one or more passes of the train may exceed the appropriate MPE given in paragraph 2.2, but shall not exceed twice the MPE.
3. Scale interval (d)
The relationship between the accuracy class and the scale interval shall be as specified in Table 10.
|
Table 10 |
|
|
Accuracy class |
Scale interval (d) |
|
0.2 |
d ≤ 50 kg |
|
0.5 |
d ≤ 100 kg |
|
1 |
d≤ 200 kg |
|
2 |
d≤ 500 kg |
4. Measurement range
4.1. The minimum capacity shall not be less than 1 t, and not greater than the value of the result of the minimum wagon weight divided by the number of partial weighings.
4.2. The minimum wagon weight shall not be less than 50 d.
5. Performance under influence factor and electromagnetic disturbance
5.1. The MPE due to an influence factor shall be as specified in Table 11.
|
Table 11 |
|
|
Load (m) in verification scale intervals (d) |
MPE |
|
0 < m ≤ 500 |
± 0,5 d |
|
500 < m ≤ 2 000 |
± 1,0 d |
|
2 000 < m ≤ 10 000 |
± 1,5 d |
5.2. The critical change value due to a disturbance is one scale interval.
(1) OJ L 42, 15.2.1975, p. 1. Directive as last amended by Directive 89/676/EEC (OJ L 398, 30.12.1989, p. 18).
(2) OJ L 46, 21.2.1976, p. 1. Directive as last amended by the EEA Agreeement.
(3) For i = r the corresponding column of Table 3 applies with e replaced by er
ANNEX MI-007
TAXIMETERS
The relevant requirements of Annex 1, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex apply to taximeters.
DEFINITIONS
Taximeter
A device that works together with a signal generator (1) to make a measuring instrument. This device measures duration, calculates distance on the basis of a signal delivered by the distance signal generator. Additionally, it calculates and displays the fare to be paid for a trip on the basis of the calculated distance and/or the measured duration of the trip.
Fare
The total amount of money due for a trip based on a fixed initial hire fee and/or the length and/or the duration of the trip. The fare does not include a supplement charged for extra services.
Cross—over speed
The speed value found by division of a time tariff value by a distance tariff value.
Normal calculation mode S (single application of tariff)
Fare calculation based on application of the time tariff below the cross-over speed and application of the distance tariff above the cross-over speed.
Normal calculation mode D (double application of tariff)
Fare calculation based on simultaneous application of time tariff and distance tariff over the whole trip.
Operating position
The different modes in which a taximeter fulfils the different parts of its functioning. The operating positions are distinguished by the following indications:
‘For Hire’: The operating position in which the fare calculation is disabled
‘Hired’: The operating position in which the fare calculation takes place on the basis of a possible initial charge and a tariff for distance travelled and/or time of the trip
‘Stopped’: The operating position in which the fare due for the trip is indicated and at least the fare calculation based on time is disabled.
Design requirements
1. The taximeter shall be designed to calculate the distance and to measure the duration of a trip.
2. The taximeter shall be designed to calculate and display the fare, incrementing in steps equal to the resolution fixed by the Member State in the operation position ‘Hired’. The taximeter shall also be designed to display the final value for the trip in the operating position ‘Stopped’.
3. A taximeter shall be able to apply the normal calculation modes S and D. It shall be possible to choose between these calculation modes by a secured setting.
4. A taximeter shall be able to supply the following data through an appropriate secured interface(s):
|
— |
operation position: ‘For Hire’, ‘Hired’ or ‘Stopped’; |
|
— |
totaliser data according to paragraph 15.1; |
|
— |
general information: constant of the distance signal generator, date of securing, taxi identifier, real time, identification of the tariff; |
|
— |
fare information for a trip: total charged, fare, calculation of the fare, supplement charge, date, start time, finish time, distance travelled; |
|
— |
tariff(s) information: parameters of tariff(s). |
National legislation may require certain devices to be connected to the interface(s) of a taximeter. Where such a device is required; it shall be possible, by secured setting, to inhibit automatically the operation of the taximeter for reasons of the non-presence or improper functioning of the required device.
5. If relevant, it shall be possible to adjust a taximeter for the constant of the distance signal generator to which it is to be connected and to secure the adjustment.
Rated operating conditions
6.1. The mechanical environment class that applies is M3.
6.2. The manufacturer shall specify the rated operating conditions for the instrument, in particular:
|
— |
a minimum temperature range of 80 °C for the climatic environment; |
|
— |
the limits of the DC power supply for which the instrument has been designed. |
Maximum permissible errors (MPEs)
7. The MPE, excluding any errors due to application of the taximeter in a taxi, are:
|
— |
For the time elapsed: +/- 0,1 % minimum value of mpe: 0,2 s; |
|
— |
For the distance travelled: +/- 0,2 % minimum value of mpe: 4 m; |
|
— |
For the calculation of the fare: +/- 0,1 % minimum, including rounding: corresponding to the least significant digit of the fare indication. |
Permissible effect of disturbances
8. Electromagnetic immunity
8.1. The electromagnetic class that applies is E3.
8.2. The MPE laid down in paragraph 7 shall also be respected in the presence of an electromagnetic disturbance.
Power supply failure
9. In case of a reduction of the voltage supply to a value below the lower operating limit as specified by the manufacturer, the taximeter shall:
|
— |
continue to work correctly or resume its correct functioning without loss of data available before the voltage drop if the voltage drop is temporary, i.e. due to restarting the engine; |
|
— |
abort an existing measurement and return to the position ‘For Hire’ if the voltage drop is for a longer period. |
Other requirements
10. The conditions for the compatibility between the taximeter and the distance signal generator shall be specified by the manufacturer of the taximeter.
11. If there is a supplement charge for an extra service, entered by the driver on manual command, this shall be excluded from the fare displayed. However, in that case a taximeter may display temporarily the value of the fare including the supplementary charge.
12. If the fare is calculated according to calculation mode D a taximeter may have an additional display mode in which only the total distance and duration of the trip are displayed in real time.
13. All values displayed for the passenger shall be suitably identified. These values as well as their identification shall be clearly readable under daylight and night conditions.
14.1. If the fare to be paid or the measures to be taken against fraudulent use can be affected by the choice of functionality from a pre-programmed setting or by free data setting, it shall be possible to secure the instrument settings and data entered.
14.2. The securing possibilities available in a taximeter shall be such that separate securing of the settings is possible.
14.3. The provisions in paragraph 8.3 of Annex I apply also to the tariffs.
15.1. A taximeter shall be fitted with non-resettable totalisers for all of the following values:
|
— |
The total distance travelled by the taxi; |
|
— |
The total distance travelled when hired; |
|
— |
The total number of hirings; |
|
— |
The total amount of money charged as supplements; |
|
— |
The total amount of money charged as fare. |
The totalised values shall include the values saved according to paragraph 9 under conditions of loss of power supply.
15.2. If disconnected from power, a taximeter shall allow the totalised values to be stored for one year for the purpose of reading out the values from the taximeter to another medium.
15.3. Adequate measures shall be taken to prevent the display of totalised values from being used to deceive passengers.
16. Automatic change of tariffs is allowed due to the:
|
— |
distance of the trip; |
|
— |
duration of the trip; |
|
— |
time of the day; |
|
— |
date; |
|
— |
day of the week. |
17. If properties of the taxi are important for the correctness of the taximeter, the taximeter shall provide means to secure the connection of the taximeter to the taxi in which it is installed.
18. For the purpose of testing after installation, the taximeter shall be equipped with the possibility to test separately the accuracy of time and distance measurement and the accuracy of the calculation.
19. A taximeter and its installation instructions specified by the manufacturer shall be such that, if installed according to the manufacturer's instructions, fraudulent alterations of the measurement signal representing the distance travelled are sufficiently excluded.
20. The general essential requirement dealing with fraudulent use shall be fulfilled in such a way that the interests of the customer, the driver, the driver's employer and the fiscal authorities are protected.
21. A taximeter shall be designed so that it can respect the MPEs without adjustment during a period of one year of normal use.
22. The taximeter shall be equipped with a real-timeclock by means of which the time of the day and the date are kept, one or both can be used for automatic change of tariffs. The requirements for the real-time clock are:
|
— |
The timekeeping shall have an accuracy of 0,02 %; |
|
— |
The correction possibility of the clock shall be not more than 2 minutes per week. Correction for summer and wintertime shall be performed automatically; |
|
— |
Correction, automatic or manually, during a trip shall be prevented. |
23. The values of distance travelled and time elapsed, when displayed or printed in accordance with this Directive, shall use the following units:
Distance travelled:
|
— |
in the United Kingdom and Ireland: until the date which will be fixed by these Member States according to Article (1)(b) of Directive 80/181/EEC: kilometres or miles; |
|
— |
in all other Member States: kilometres. |
Time elapsed:
|
— |
seconds, minutes or hours, as may be suitable; keeping in mind the necessary resolution and the need to prevent misunderstandings. |
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
B+F or B+D or H1.
(1) the distance signal generator is outside the scope of this Directive.
ANNEX MI-008
MATERIAL MEASURES
CHAPTER I — MATERIAL MEASURES OF LENGTH
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this chapter, apply to material measures of length defined below. However, the requirement for the supply of a copy of declarations of conformity may be interpreted as applying to a batch or consignment rather than each individual instruments.
DEFINITIONS
Material measure of length
An instrument comprising scale marks whose distances are given in legal units of length.
SPECIFIC REQUIREMENTS
Reference Conditions
1.1. For tapes of length equal to or greater than five metres, the maximum permissible errors (MPEs) are to be met when a tractive force of fifty newtons or other force values as specified by the manufacturer and marked on the tape accordingly, or in the case of rigid or semi-rigid measures no tractive force is needed, is applied.
1.2. The reference temperature is 20 °C unless otherwise specified by the manufacturer and marked on the measure accordingly.
MPEs
2. The MPE, positive or negative in mm, between two non-consecutive scale marks is (a + bL), where:
|
— |
L is the value of the length rounded up to the next whole metre; and |
|
— |
a and b are given in Table 1 below. |
When a terminal interval is bounded by a surface, the MPE for any distance beginning at this point is increased by the value c given in Table 1.
|
Accuracy Class |
a (mm) |
b |
c (mm) |
|
I |
0,1 |
0,1 |
0,1 |
|
II |
0,3 |
0,2 |
0,2 |
|
III |
0,6 |
0,4 |
0,3 |
|
D— special class for dipping tapes (1). Up to and including 30m (2) |
1,5 |
zero |
zero |
|
S— special class for tank strapping tapes. For each 30 m length when the tape is supported on a flat surface |
1,5 |
zero |
zero |
Table 1
Dip tapes may also be of Classes I or II in which case for any length between two scale marks, one of which is on the sinker and the other on the tape, the mpe is ± 0,6 mm when application of the formula gives a value of less than 0,6 mm.
The MPE for the length between consecutive scale marks, and the maximum permissible difference between two consecutive intervals, are given in Table 2 below.
|
Length i of the interval |
MPE or difference in millimetres according to accuracy class |
||
|
I |
II |
III |
|
|
i ≤ 1 mm |
0,1 |
0,2 |
0,3 |
|
1 mm < i ≤ 1 cm |
0,2 |
0,4 |
0,6 |
Table 2
Where a rule is of the folding type, the jointing shall be such as not to cause any errors, supplementary to those above, exceeding: 0.3 mm for Class II, and 0.5 mm for Class III.
Materials
3.1. Materials used for material measures shall be such that length variations due to temperature excursions up to ±8 °C about the reference temperature do not exceed the MPE. This does not apply to Class S and Class D measures where the manufacturer intends that thermal expansion corrections shall be applied to observed readings where necessary.
3.2. Measures made from material whose dimensions may alter materially when subjected to a wide range of relative humidity, may only be included in Classes II or III.
Markings
4. The nominal value shall be marked on the measure. Millimetre scales shall be numbered every centimetre and measures with a scale interval greater than 2 cm shall have all scale marks numbered.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
F 1 or D1 or B+D or H or G.
CHAPTER II — CAPACITY SERVING MEASURES
The relevant essential requirements of Annex I, and the specific requirements and the conformity assessment procedures listed in this chapter, apply to capacity serving measures defined below. However, the requirement for the supply of a copy of declarations of conformity may be interpreted as applying to a batch or consignment rather than each individual instrument. Also, the requirement for the instrument to bear information in respect of its accuracy shall not apply.
DEFINITIONS
Capacity serving measure
A capacity measure (such as a drinking glass, jug or thimble measure) designed to determine a specified volume of a liquid (other than a pharmaceutical product) which is sold for immediate consumption.
Line measure
A capacity serving measure marked with a line to indicate nominal capacity.
Brim measure
A capacity serving measure for which the internal volume is equal to the nominal capacity.
Transfer measure
A capacity serving measure from which it is intended that the liquid is decanted prior to consumption.
Capacity
The capacity is the internal volume for brim measures or internal volume to a filling mark for line measures.
SPECIFIC REQUIREMENTS
1. Reference Conditions
1.1. Temperature: the reference temperature for measurement of capacity is 20°C.
1.2. Position for correct indication: free standing on a level surface.
2. MPEs
|
|
line |
brim |
|
Transfer measures |
|
|
|
< 100 mL |
± 2 mL |
- 0 + 4 mL |
|
≥ 100 mL |
± 3 % |
- 0 + 6 % |
|
Serving measures |
|
|
|
< 200 mL |
± 5 % |
- 0 + 10 % |
|
≥ 200 mL |
± 5mL + 2,5 % |
- 0 + 10 mL + 5 % |
Table 1
3. Materials
Capacity serving measures shall be made of material which is sufficiently rigid and dimensionally stable to maintain capacity within the MPE.
4. Shape
4.1. Transfer measures shall be designed so that a change of contents equal to the MPE causes a change in level of at least 2 mm at the brim or filling mark.
4.2. Transfer measures shall be designed so that the complete discharge of the liquid being measured will not be impeded.
5. Marking
5.1. The nominal capacity declared shall be clearly and indelibly marked on the measure.
5.2. Capacity serving measures may also be marked with up to three clearly distinguishable capacities, none of which shall lead to confusion one to the other.
5.3. All filling marks shall be sufficiently clear and durable to ensure that MPEs are not exceeded in use.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
A1 or F1 or D1 or E1 or B+E or B+D or H.
(1) Applies to the tape/dip weight combinations.
(2) If the nominal tape length exceeds 30 m, an additional mpe of 0,75 mm shall be permitted for each 30 m of tape length.
ANNEX MI-009
DIMENSIONAL MEASURING INSTRUMENTS
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to dimensional measuring instruments of the types defined below.
Definitions
Length measuring instrument
A length measuring instrument serves for the determination of the length of rope-type materials (e.g. textiles, bands, cables) during feed motion of the product to be measured.
Area Measuring Instruments
An area measuring instrument serves for the determination of the area of irregular shaped objects, e.g. for leather.
Multi-dimensional Measuring Instruments
A multi-dimensional measuring instrument serves for the determination of the edge length (length, height, width) of the smallest enclosing rectangular parallelepiped of a product.
CHAPTER I — EQUIREMENTS COMMON TO ALL DIMENSIONAL MEASURING INSTRUMENTS
Electromagnetic immunity
1. The effect of an electromagnetic disturbance on a dimensional measuring instrument shall be such that:
|
— |
the change in measurement result is no greater than the critical change value as defined in paragraph 2.3; or |
|
— |
it is impossible to perform any measurement; or |
|
— |
there are momentary variations in the measurement result that cannot be interpreted, memorised or transmitted as a measuring result; or |
|
— |
there are variations in the measurement result severe enough to be noticed by all those interested in the measurement result. |
2. The critical change value is equal to one scale interval.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
For mechanical or electromechanical instruments:
F1 or E1 or D1 or B+F or B+E or B+D or H or H 1 or G.
For electronic instruments or instruments containing software:
B+F or B+D or H1 or G.
CHAPTER II — LENGTH MEASURING INSTRUMENTS
Characteristics of the product to be measured
1. Textiles are characterised by the characteristic factor K. This factor takes the stretchability and force per unit area of the product measured into account and is defined by the following formula:
K = ε.(GA + 2,2 N/m2), where
ε is the relative elongation of a cloth specimen 1 m wide at a tensile force of 10 N,
GA is the weight force per unit area of a cloth specimen in N/m2.
Operating conditions
2.1. Range
Dimensions and K-factor, where applicable, within the range specified by the manufacturer for the instrument. The ranges of K-factor are given in Table 1:
|
Group |
Range of K |
Product |
|
I |
0 < K < 2×10-2 N/m2 |
low stretchability |
|
II |
2×10-2 N/m2 < K < 8×10-2 N/m2 |
medium stretchability |
|
III |
8×10-2 N/m2 < K < 24×10-2 N/m2 |
high stretchability |
|
IV |
24×10-2 N/m2 < K |
very high stretchability |
Table 1
2.2. Where the measured object is not transported by the measuring instrument, its speed must be within the range specified by the manufacturer for the instrument.
2.3. If the measurement result depends on the thickness, the surface condition and the kind of delivery (e.g. from a big roll or from a pile), corresponding limitations are specified by the manufacturer.
MPEs
3. Instrument
|
Accuracy class |
MPE |
|
I |
0,125 %, but not less than 0,005 Lm |
|
II |
0,25 %, but not less than 0,01 Lm |
|
III |
0,5 %, but not less than 0,02 Lm |
Table 2
Where Lm is the minimum measurable length, that is to say the smallest length specified by the manufacturer for which the instrument is intended to be used.
The true length value of the different types of materials should be measured using suitable instruments (e.g. tapes of length). Thereby, the material which is going to be measured should be laid out on a suitable underlay (e.g. a suitable table) straight and unstretched.
Other requirements
4. The instruments must ensure that the product is measured unstretched according to the intended stretchability for which the instrument is designed.
CHAPTER III — AREA MEASURING INSTRUMENTS
Operating conditions
1.1. Range
Dimensions within the range specified by the manufacturer for the instrument.
1.2. Condition of the product
The manufacturer shall specify the limitations of the instruments due to the speed, and thickness of the surface conditions if relevant, of the product.
MPEs
2. Instrument
The MPE is 1,0 %, but not less than 1 dm2.
Other requirements
3. Presentation of the product
In the case of pulling back or stopping the product, it should not be possible to have an error of measurement or the display must be blanked.
4. Scale interval
The instruments must have a scale interval of 1,0 dm2. In addition, it must be possible to have a scale interval of 0,1 dm2 for testing purposes.
CHAPTER IV — MULTIDIMENSIONAL MEASURING INSTRUMENTS
Operating conditions
1.1. Range
Dimensions within the range specified by the manufacturer for the instrument.
1.2. Minimum dimension
The lower limit of the minimum dimension for all values of the scale interval is given in Table 1.
|
Scale interval (d) |
Minimum dimension (min) (lower limit) |
|
d ≤ 2 cm |
10 d |
|
2 cm < d ≤ 10 cm |
20 d |
|
10 cm < d |
50 d |
Table 1
1.3. Speed of the product
The speed must be within the range specified by the manufacturer for the instrument.
MPE
2. Instrument:
The MPE is ± 1,0 d.
ANNEX MI-010
EXHAUST GAS ANALYSERS
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to exhaust gas analysers defined below intended for inspection and professional maintenance of motor vehicles in use.
DEFINITIONS
Exhaust gas analyser
An exhaust gas analyser is a measuring instrument that serves to determine the volume fractions of specified components of the exhaust gas of a motor vehicle engine with spark ignition at the moisture level of the sample analysed.
These gas components are:
carbon monoxide (CO), carbon dioxide (CO2), oxygen (O2) and hydrocarbons (HC).
The content of hydrocarbons has to be expressed as concentration of n-hexane (C6 H14), measured with near-infrared absorption techniques.
The volume fractions of the gas components are expressed as a percentage (% vol) for CO, CO2 and O2 and in parts per million (ppm vol).
Moreover, an exhaust gas analyser calculates the lambda value from the volume fractions of the components of the exhaust gas.
Lambda
Lambda is a dimensionless value representative of the burning efficiency of an engine in terms of air/fuel ratio in the exhaust gases. It is determined with a reference standardised formula.
SPECIFIC REQUIREMENTS
Instrument Classes
1. Two classes (0 and I) are being defined for exhaust gas analysers. The relevant minimum measuring ranges for these classes are shown in Table 1.
|
Parameter |
Classes 0 and I |
|
CO fraction |
from 0 to 5 % vol |
|
CO2 fraction |
from 0 to16 % vol |
|
HC fraction |
from 0 to 2 000 ppm vol |
|
O2 fraction |
from 0 to 21 % vol |
|
λ |
from 0,8 to 1,2 |
Table 1 — Classes and measuring ranges
Rated operating conditions
2. The values of the operating conditions shall be specified by the manufacturer as follows:
2.1. For the climatic and mechanical influence quantities:
|
— |
A minimum temperature range of 35 °C for the climatic environment; |
|
— |
The mechanical environment class that applies is M1. |
2.2. For the electrical power influence quantities:
|
— |
The voltage and frequency range for the AC voltage supply; |
|
— |
The limits of the DC voltage supply. |
2.3. For the ambient pressure:
|
— |
The minimum and the maximum values of the ambient pressure are for both classes: pmin ≤ 860 hPa, pmax ≥1 060 hPa. |
Maximum permissible errors (MPEs)
3. The MPEs are defined as follows:
3.1. For each of the fractions measured, the maximum error value permitted under rated operating conditions according to paragraph 1.1 of Annex I is the greater of the two values shown in Table 2. Absolute values are expressed in % vol or ppm vol, percentage values are percent of the true value.
|
Parameter |
Class 0 |
Class I |
|
CO fraction |
± 0,03 % vol ± 5 % |
± 0,06 % vol ± 5 % |
|
CO2 fraction |
± 0,5 % vol ± 5 % |
± 0,5 % vol ± 5 % |
|
HC fraction |
± 10 ppm vol ± 5 % |
± 12 ppm vol ± 5 % |
|
O2 fraction |
± 0,1 % vol ± 5 % |
± 0,1 % vol ± 5 % |
Table 2 — MPEs
3.2. The MPE on lambda calculation is 0,3 %. The conventional true value is calculated according to the formula defined in point 5.3.7.3 of Annex I of Directive 98/69/EC of the EP and the Council relating to measures to be taken against air pollution by emissions from motor vehicles and amending Council Directive 70/220/EEC. (1). For this purpose, the values displayed by the instrument are used for calculation.
Permissible effect of disturbances
4. For each of the volume fractions measured by the instrument, the critical change value is equal to the MPE for the parameter concerned.
5. The effect of an electromagnetic disturbance shall be such that:
|
— |
either the change in the measurement result is not greater than the critical change value laid down in paragraph 4; |
|
— |
or the presentation of the measurement result is such that it cannot be taken for a valid result. |
Other requirements
6. The resolution shall be equal to or of one order of magnitude higher than the values shown in Table 3.
|
|
CO |
CO2 |
O2 |
HC |
|
Class 0 and class I |
0,01 % vol |
0,1 % vol |
1 ppm vol |
Table 3 — Resolution
The lambda value shall be displayed with a resolution of 0,001.
7. The standard deviation of 20 measurements shall not be greater than one third of the modulus of the MPE for each applicable gas volume fraction.
8. For measuring CO, CO2 and HC, the instrument, including the specified gas handling system, must indicate 95 % of the final value as determined with calibration gases within 15 seconds after changing from a gas with zero content, e.g. fresh air. For measuring O2, the instrument under similar conditions must indicate a value differing less than 0,1 % vol from zero within 60 seconds after changing from fresh air to an oxygen-free gas.
9. The components in the exhaust gas, other than the components whose values are subject to the measurement, shall not affect the measurement results by more than the half of the modulus of the MPEs when those components are present in the following maximum volume fractions:
6 % vol CO,
16 % vol CO2,
10 % vol O2,
5 % vol H2,
0,3 % vol NO,
2 000 ppm vol HC (as n-hexane),
water vapor up to saturation.
10. An exhaust gas analyser shall have an adjustment facility that provides operations for zero-setting, gas calibration and internal adjustment. The adjustment facility for zero-setting and internal adjustment shall be automatic.
11. For automatic or semi-automatic adjustment facilities, the instrument shall be unable to make a measurement as long as the adjustments have not been made.
12. An exhaust gas analyser shall detect hydrocarbon residues in the gas handling system. It shall not be possible to carry out a measurement if the hydrocarbon residues, present before any measurement, exceeds 20 ppm vol.
13. An exhaust gas analyser shall have a device for automatically recognising any malfunctioning of the sensor of the oxygen channel due to wear or a break in the connecting line.
14. If the exhaust gas analyser is capable to operate with different fuels (e.g. petrol or liquefied gas), there shall be the possibility to select the suitable coefficients for the Lambda calculation without ambiguity concerning the appropriate formula.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 9 that the manufacturer can choose between are:
B+F or B+D or H1.
(1) OJ L 350, 28.12.1998, p. 17.
(2) 0,01 % vol for measured values below or equal to 4 % vol, otherwise 0,1 % vol.
P5_TA(2003)0581
Motor vehicles: seats, their anchorages and head restraints ***I
European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending Council directive 74/408/EEC relating to motor vehicles with regards to the seats, their anchorages and head restraints (COM(2003) 361 — C5-0283/2003 — 2003/0128(COD))
(Codecision procedure: first reading)
The European Parliament,
|
— |
having regard to the Commission proposal to the European Parliament and the Council (COM(2003) 361) (1), |
|
— |
having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission proposal was submitted to the European Parliament (C5-0283/2003), |
|
— |
having regard to Rule 67 of the Rules of Procedure, |
|
— |
having regard to the report of the Committee on Regional Policy, Transport and Tourism (A5-0418/2003), |
|
1. |
Approves the Commission proposal as amended; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council and Commission. |
(1) Not yet published in OJ.
P5_TC1-COD(2003)0128
Position of the European Parliament adopted at first reading on 17 December 2003 with a view to the adoption of Directive 2004/.../EC of the European Parliament and of the Council amending Council Directive 74/408/EEC relating to motor vehicles with regards to the seats, their anchorages and head restraints
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
|
(1) |
Research has shown that the use of safety belts and restraint systems can contribute to a substantial reduction in the number of fatalities and the severity of injury in the event of an accident, even due to rollover. Their fitting in all categories of vehicles will certainly constitute an important step forward to provide an increase in road safety and a consequent saving of lives. |
|
(2) |
A substantial benefit to society can be accrued if all vehicles are provided with safety belts. |
|
(3) |
In its resolution of 18 February 1986 on common measures to reduce road accidents, as part of the Community's programme for road safety (3), the European Parliament stressed the need for making the wearing of safety belts compulsory for all passengers, including children, except in public service vehicles. Therefore, a distinction has to be made between public service buses and other vehicles as regards the compulsory installation of safety belts and/or restraint systems. |
|
(4) |
Pursuant to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), the Community type-approval system has been implemented for all new vehicles of category M1 from 1 January 1998. Consequently, only these vehicles have to be fitted with seats, seat anchorages and head restraints, in compliance with the provisions of Directive 74/408/EEC (5). |
|
(5) |
Until the Community type-approval system is extended to all categories of vehicles, the installation of seats and seat anchorages compatible with the installation of seat belt anchorages should be required in the interests of road safety in vehicles belonging to categories other than M1. |
|
(6) |
Directive 74/408/EEC already provides for all technical and administrative provisions allowing the type-approval of vehicles of categories other than M1. Therefore, the Member States do not need to introduce further provisions. |
|
(7) |
Since the entry into force of Directive 96/37/EC, several Member States have already made compulsory the provisions contained therein in respect of certain categories of vehicles other than M1. Manufacturers and their suppliers have thus developed the appropriate technology. |
|
(8) |
Research work have shown that it is not possible to provide side-facing seats with safety belts ensuring the same level of safety to the occupants as front-facing seats. For safety reasons, it is necessary to ban those seats in certain categories of vehicles. |
|
(9) |
Research shows that the risks of side-facing seats for passengers in category M3 vehicles have not been sufficiently assessed. It is necessary to examine these risks using methods such as those used for testing car safety in order to arrive at a balanced risk assessment. The Commission should commission such tests and forward the results to the European Parliament by 31 December 2004. |
|
(10) |
Directive 74/408/EEC should be amended accordingly. |
|
(11) |
Since the objectives of the proposed action, namely the improvement of road safety by the introduction of the compulsory fitting of safety belts in certain categories of vehicles, cannot be sufficiently achieved by the Member States and can, therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary for that purpose, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Amendment of Directive 74/408/EEC
Directive 74/408/EEC is hereby amended as follows:
|
1. |
Article 1 shall be amended as follows:
|
|
2. |
The following Article 3a shall be inserted: ‘Article 3a 1. With effect from [1 July 2004], Member States shall prohibit the installation of side-facing seats on new types of vehicles of categories M1 and N1 as well as category M2 of class B . 2. With effect from [1 January 2006], Member States shall prohibit the installation of side-facing seats on new vehicles of categories M1 and N1 as well as category M2 of class B . 3. Paragraphs 1 and 2 shall not apply to ambulances, the vehicles listed in Article 8(1) first indent to Directive 70/156/EEC or to the seating of motor caravans intended solely for use when the vehicle is stationary.’ |
|
3. |
In Annex IV, item 1.1. shall be replaced by the following:
|
Article 2
Implementation
1. With effect from [1 January 2004],
|
(a) |
refuse to grant EC type-approval, or national type-approval, in respect of a type of vehicle; |
|
(b) |
prohibit the registration, sale or entry into service of new vehicles. |
with respect to the seats, their anchorages and head restraints which comply with the requirements set out in Directive 74/408/EEC as amended by this Directive, Member States shall not:
2. With effect from [1 July 2004], with respect to the seats,
|
(a) |
no longer grant EC type-approval; |
|
(b) |
refuse to grant national type-approval. |
their anchorages and head restraints which do not comply with the requirements set out in Directive 74/408/EEC as amended by this Directive, Member States shall, in respect of a new type of vehicle:
3. With effect from [1 January 2006],
|
(a) |
consider certificates of conformity which accompany new vehicles as no longer valid for the purpose of Article 7(1) of Directive 70/156/EEC; |
|
(b) |
refuse the registration, sale or entry into service of new vehicles, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked. |
with respect to the seats, their anchorages and head restraints which do not comply with the requirements set out in Directive 74/408/EEC as amended by this Directive, Member States shall:
Article 3
Transposition
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before ... (7). They shall forthwith inform the Commission thereof.
2. They shall apply these provisions from ... (8).
3. When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
4. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 4
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 5
Addressees
This Directive is addressed to the Member States
Done at ...,
For the European Parliament
The President
For the Council
The President
(1) OJ C ...
(2) Position of the European Parliament of 17 December 2003.
(4) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
(5) OJ L 221, 12.8.1974, p. 1. Directive as last amended by Commission Directive 96/37/EC (OJ L 186, 25.7.1996, p. 28).
(7) Six months after the date of adoption of this Directive.
(8) Six months after the date of adoption of this Directive.
P5_TA(2003)0582
Motor vehicles: safety belts and restraint systems ***I
European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending Council Directive 77/541/EEC on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (COM(2003) 363 — C5-0282/2003 — 2003/0130(COD))
(Codecision procedure: first reading)
The European Parliament,
|
— |
having regard to the Commission proposal to the European Parliament and the Council (COM(2003) 363) (1), |
|
— |
having regard to Articles 251(2) and 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0282/2003), |
|
— |
having regard to Rule 67 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Regional Policy, Transport and Tourism (A5-0304/2003), |
|
1. |
Approves the Commission proposal as amended; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council and Commission. |
(1) Not yet published in OJ.
P5_TC1-COD(2003)0130
Position of the European Parliament adopted at first reading on 17 December 2003 with a view to the adoption of Directive 2004/.../EC of the European Parliament and of the Council amending Council Directive 77/541/EEC on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (1),
Acting in accordance with the procedure referred to in Article 251 of the Treaty (2),
Whereas:
|
(1) |
Research has shown that the use of safety belts and restraint systems can contribute to a substantial reduction in the number of fatalities and the severity of injury in the event of an accident, even due to rollover. Their fitting in all categories of vehicles will certainly constitute an important step forward to provide an increase in road safety and a consequent saving of lives. |
|
(2) |
A substantial benefit to society can be accrued if all vehicles are provided with safety belts. |
|
(3) |
In its resolution of 18 February 1986 on common measures to reduce road accidents, as part of the Community's programme for road safety (3), the European Parliament stressed the need for making the wearing of safety belts compulsory for all passengers, including children, except in public service vehicles. Therefore, a distinction has to be made between public service buses and other vehicles as regards the compulsory installation of safety belts and/or restraint systems. |
|
(4) |
Pursuant to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4) , the Community type-approval system has only been implemented for all new vehicles of category M1 from 1 January 1998. Consequently, only these vehicles have to be fitted with safety belts and/or restraint systems fulfilling the provisions of Directive 77/541/EEC (5). |
|
(5) |
Until the Community type-approval system is extended to all categories of vehicles, the installation of safety belts and/or restraint systems should be required in the interests of road safety in vehicles belonging to categories other than M1. |
|
(6) |
Directive 77/541/EEC already provides for all technical and administrative provisions allowing the type-approval of vehicles of categories other than M1. Therefore, the Member States do not need to introduce further provisions. |
|
(7) |
Since the entry into force of Commission Directive 96/36/EC (6) adapting to technical progress Directive 77/541/EEC, several Member States have already made compulsory the provisions contained therein in respect of certain categories of vehicles other than M1. Manufacturers and their suppliers have thus developed the appropriate technology. |
|
(8) |
Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001 relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver's seat, and amending Directives 70/156/EEC and 97/27/EC (7) makes provision for allowing disabled people or persons of reduced mobility to access more easily vehicles used for the carriage of passengers comprising more than eight seats. It is necessary to allow Member States to permit the installation of safety belts and/or restraint systems, which do not comply with the technical specifications of Directive 77/541/EEC, but were specifically designed for the purposes of securing those people in such vehicles. |
|
(9) |
Directive 77/541/EEC should be amended accordingly. |
|
(10) |
Since the objectives of the proposed action, namely the improvement of road safety by the introduction of the compulsory fitting of safety belts in certain categories of vehicles, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the proposed action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary for that purpose, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Amendment of Directive 77/541/EEC
Directive 77/541/EEC is hereby amended as follows:
|
1. |
The following Article 2a shall be inserted: ‘Article 2a 1. Member States may, under national law, allow the installation of safety belts or restraint systems other than those covered by this Directive provided they are intended for disabled people. 2. Member States may also exempt restrains systems designed to comply with the provisions of Annex VII to Directive 2001/85/EC from the provisions of this Directive. 3. The safety belts or restraint systems covered in paragraphs 1 and 2 shall be designed and constructed in order to provide at least the same level of safety as the safety belts or restraint systems covered by this Directive.’ |
|
2. |
In Article 9 the following paragraph shall be added: ‘Vehicles of category M2 and M3 are subdivided in class as defined in section 2 of Annex I to Directive 2001/85/EC of the European Parliament and of the Council (8) |
|
3. |
Annex I shall be amended as follows:
|
|
4. |
The table in Annex XV shall be replaced by the following:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Article 2
Implementation
1. With effect from [1 January 2004], Member States
|
a) |
refuse to grant EC type-approval, or national type-approval in respect of a type of vehicle; |
|
b) |
prohibit the registration, sale or entry into service of new vehicles. |
shall not with respect to the installation of safety belts and/or the installation of restraint systems, which comply with the requirements set out in Directive 77/541/EEC as amended by this Directive:
2. With effect from [1 July 2004],
|
a) |
no longer grant EC type-approval; |
|
b) |
refuse to grant national type-approval. |
with respect to the installation of safety belts and/or the installation of restraint systems, which do not comply with the requirements set out in Directive 77/541/EEC as amended by this Directive, Member States shall in respect of a new type of vehicle:
3. With effect from [1 January 2006], Member States shall:
|
a) |
consider certificates of conformity which accompany new vehicles as no longer valid for the purpose of Article 7(1) of Directive 70/156/EEC; |
|
b) |
refuse the registration, sale or entry into service of new vehicles, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, |
with respect to the installation of safety belts and/or the installation of restraint systems, which do not comply with the requirements set out in Directive 77/541/EEC as amended by this Directive.
Article 3
Transposition
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before ... (9). They shall forthwith inform the Commission thereof.
2. They shall apply these provisions from ... (9).
3. When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
4. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive.
Article 4
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 5
Addressees
This Directive is addressed to the Member States
Done at ...,
For the European Parliament
The President
For the Council
The President
(1) OJ C ...
(2) Position of the European Parliament of 17 December 2003.
(3) OJ C 68, 24.3.1986, p. 35.
(4) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
(5) OJ L 220, 29.8.1977, p. 95. Directive as last amended by Commission Directive 2000/3/EC (OJ L 53, 25.2.2000, p. 1).
(6) OJ L 178, 17.7.1996, p. 15.
(9) Six months after the adoption of this Directive.
P5_TA(2003)0583
Motor vehicles: anchorages for safety-belts ***I
European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts (COM(2003) 362 — C5-0286/2003 — 2003/0136(COD))
(Codecision procedure: first reading)
The European Parliament,
|
— |
having regard to the Commission proposal to the European Parliament and the Council (COM(2003) 362) (1), |
|
— |
having regard to Articles 251(2) and 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0286/2003), |
|
— |
having regard to Rule 67 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Regional Policy, Transport and Tourism (A5-0305/2003), |
|
1. |
Approves the Commission proposal as amended; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council and Commission. |
(1) Not yet published in OJ.
P5_TC1-COD(2003)0136
Position of the European Parliament adopted at first reading on 17 December 2003 with a view to the adoption of Directive 2004/.../EC of the European Parliament and of the Council amending Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (1),
Acting in accordance with the procedure referred to in Article 251 of the Treaty (2),
Whereas:
|
(1) |
Research has shown that the use of safety belts and restraint systems can contribute to a substantial reduction in the number of fatalities and the severity of injury in the event of an accident, even due to rollover. Their fitting in all categories of vehicles will certainly constitute an important step forward to provide an increase in road safety and a consequent saving of lives. |
|
(2) |
A substantial benefit to society can be accrued if all vehicles are provided with safety belts. |
|
(3) |
In its resolution of 18 February 1986 on common measures to reduce road accidents, as part of the Community's programme for road safety (3), the European Parliament stressed the need for making the wearing of safety belts compulsory for all passengers, including children, except in public service vehicles. Therefore, a distinction has to be made between public service buses and other vehicles as regards the compulsory installation of safety belts and/or restraint systems. |
|
(4) |
Pursuant to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4) , the Community type-approval system has been implemented for all new vehicles of category M1 from 1 January 1998. Consequently, only these vehicles have to be fitted with anchorages intended for safety belts and/or restraint systems fulfilling the provisions of Directive 76/115/EEC (5). |
|
(5) |
Until the Community type-approval system is extended to all categories of vehicles, the installation of anchorages intended for safety belts and/or restraint systems should be required in the interests of road safety, in vehicles belonging to categories other than M1. |
|
(6) |
Directive 76/115/EEC already provides for all technical and administrative provisions allowing the type-approval of vehicles of categories other than M1. Therefore, the Member States do not need to introduce further provisions. |
|
(7) |
Since the entry into force of Directive 96/38/EC, several Member States have already made compulsory the provisions contained therein in respect of certain categories of vehicle other than M1. Manufacturers and their suppliers have thus developed appropriate technology. |
|
(8) |
Directive 76/115/EEC should be amended accordingly. |
|
(9) |
Since the objectives of the proposed action, namely the improvement of road safety by the introduction of the compulsory fitting of safety belts in certain categories of vehicles, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the proposed action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary for that purpose, |
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Amendment of Directive 76/115/EEC
Directive 76/115/EEC is hereby amended as follows:
|
1. |
In Article 2 the following paragraph shall be added: ‘Vehicles of category M2 and M3 are subdivided in class as defined in section 2 of Annex I to Directive 2001/85/EC of the European Parliament and of the Council (6). |
|
2. |
Annex I is amended as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Article 2
Implementation
1. With effect from [1 January 2004], Member States shall:
|
a) |
refuse to grant EC type-approval, or national type-approval, in respect of a type of vehicle; |
|
b) |
prohibit the registration, sale or entry into service of new vehicles, |
not with respect to the anchorages for safety belts, which comply with the requirements set out in Directive 76/115/EEC as amended by this Directive.
2. With effect from [1 July 2004], Member States shall in respect of a new type of vehicle:
|
a) |
no longer grant EC type-approval; |
|
b) |
refuse to grant national type-approval, |
with respect to the anchorages for safety belts, which do not comply with the requirements set out in Directive 76/115/EEC as amended by this Directive.
3. With effect from [1 January 2006], Member States shall:
|
a) |
consider certificates of conformity which accompany new vehicles as no longer valid for the purpose of Article 7(1) of Directive 70/156/EEC; |
|
b) |
refuse the registration, sale or entry into service of new vehicles, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, |
with respect to the anchorages for safety belts, which do not comply with the requirements set out in Directive 76/115/EEC as amended by this Directive.
Article 3
Transposition
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before ... (7) . They shall forthwith inform the Commission thereof.
2. They shall apply these provisions from ... (8) .
3. When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
4. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive.
Article 4
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 5
Addressees
This Directive is addressed to the Member States
Done at ...,
For the European Parliament
The President
For the Council
The President
(1) OJ C ...
(2) Position of the European Parliament of 17 December 2003.
(3) OJ C 68, 24.3.1986, p. 35.
(4) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
(5) OJ L 24, 30.1.1976, p. 6. Directive as last amended by Commission Directive 96/38/EC (OJ L 187, 26.7.1996, p. 95).
(7) Six months after the adoption of this Directive.
(8) Six months after the adoption of this Directive.
P5_TA(2003)0584
Freedom of movement and ownership of goods
European Parliament resolution on a legal framework for free movement within the internal market of goods whose ownership is likely to be contested (2002/2114(INI))
The European Parliament,
|
— |
having regard to its resolutions of 14 December 1995 on the return of plundered property to Jewish communities (1) and of 16 July 1998 on the restitution of property belonging to Holocaust victims (2), |
|
— |
having regard to the European Convention on Offences relating to Cultural Property of 23 June 1985 and Council Directive 93/7/EEC of 15 March 1993 on the return of cultural objects unlawfully removed from the territory of a Member State (3), |
|
— |
having regard to Rule 163 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0408/2003), |
|
A. |
whereas early moves were made following the end of the Second World War to find and return looted property to its country of origin, |
|
B. |
whereas a very considerable amount of property has not been recovered by its owners or their successors, |
|
C. |
whereas litigants have often been confronted with difficult problems due to conflicts of law, varying prescriptive periods and other difficulties, and that this hampers or prevents access to swift and efficient resolution of the interests of all parties affected, |
|
D. |
whereas this is an important human and legal problem as victims continue to encounter legal and technical problems, |
|
E. |
whereas a public hearing was held on 18 March 2003, |
|
F. |
whereas this is a widespread European legal problem, |
|
1. |
Welcomes the recognition among various governments that the unique problems associated with cultural goods (i.e. public or private property considered as constituting an artistic creation or cultural property) which were plundered in wartime through acts of violence, confiscation or by apparently legal transactions or auctions need to be addressed; |
|
2. |
Recognises that, although the problem of these goods is a matter of public knowledge, it has often proved remarkably difficult for private claimants to recover their property and to clarify their provenance; |
|
3. |
Welcomes the efforts being made by third countries (especially the United States of America and the Russian Federation) to take parallel or reciprocal action; |
|
4. |
Calls on the Commission, with due regard for Article 295 of the EC Treaty, to undertake a study by the end of 2004 on:
|
|
5. |
Calls on the Member States and the accession States to make all necessary efforts to adopt measures to ensure the creation of mechanisms which favour the return of the property referred to in this resolution and to be mindful that the return to rightful claimants of art objects looted as part of crimes against humanity is a matter of general interest for the purposes of Article 1 of Protocol 1 to the European Convention of Human Rights; |
|
6. |
Calls on the Presidency of the European Union to assign this issue to a working group of the Council; |
|
7. |
Instructs its President to forward this resolution to the Council, the Commission, the governments of the Member States and the accession States and the Council of Europe. |
(1) OJ C 17, 22.1.1996, p. 199.
P5_TA(2003)0585
Legislative and work programme of the Commission for 2004
European Parliament resolution on the Commission's legislative and work programme for 2004
The European Parliament,
|
— |
having regard to the conclusion of the interinstitutional agreement on better law-making between the European Parliament, the Council and the Commission, |
|
— |
having regard to the Commission's legislative and work programme (COM(2003) 645), |
|
— |
having regard to the presentation by the Commission of that programme on 18 November 2003 and the ensuing debate in the presence of Council, |
|
— |
having regard to the Brussels European Council of 12 and 13 December 2003, |
|
— |
having regard to Rule 57 and Rule 37(4) of the Rules of Procedure, |
|
A. |
whereas the annual legislative programme constitutes an indispensable interinstitutional instrument for coordinating, evaluating and monitoring the Union's activities in a transparent and efficient way, |
|
B. |
whereas transparency and predictability with regard to the European Union's legislative work are core principles of modern governance, |
|
C. |
whereas 2004 will be a significant and crucial year for the European Union, marked by major events, such as the most extensive enlargement the EU has ever known, the approval of a new Constitutional Treaty, the election of a new European Parliament in June, the arrival of Commissioners from the new Member States in May and the establishment of a new College of Commissioners in November, |
|
D. |
whereas more transparent and efficient legislative planning on the part of the European Union requires closer involvement of the Council in the interinstitutional legislative programming exercise; whereas the draft interinstitutional agreement on better law-making provides a basis for such enhanced interinstitutional coordination, |
|
E. |
whereas the Brussels European Council of 12-13 December 2003 opened the way for multiannual legislative programmation by adopting a first Council triannual strategic programme in accordance with the conclusions of the 2002 Seville European Council, |
General and institutional remarks
|
1. |
Takes note of the Commission's work and legislative programme and the political priorities outlined, namely the absorption of the accession of ten new Member States, stability and sustainable growth; |
|
2. |
Notes that in view of the special institutional character of the year 2004 the Commission has limited the number of key initiatives to be presented in 2004 to those it considers absolutely necessary and feasible; notes that the proposals to be put forward match the political priorities, but takes the view, nevertheless, that the Commission has taken too little action in response to the calls made by the parliamentary committees; |
|
3. |
Notes that the annual legislative and work programme contains a total of 275 legislative proposals and non-legislative acts, 128 of which directly correspond to the political priorities for 2004 but only 57 of which are legislative acts; notes that a substantial part of the programme for 2004 consists of proposals postponed from previous programmes; |
|
4. |
Regrets that only about half of the proposals announced in the legislative and work programme for 2003 have actually been adopted by the Commission; hopes that the programme for 2004 is based on more realistic assumptions; |
|
5. |
Notes that the European Parliament elections and the enlargement and subsequent renewal of the Commission in 2004 represent important challenges with regard to both the implementation of the legislative and work programme for 2004 and the interinstitutional dialogue on the preparation of the programme for 2005; |
|
6. |
Calls upon its parliamentary committees to examine closely the proposals contained in the legislative and work programme with a view to identifying those proposals that still need to be dealt with under the current legislature; |
|
7. |
Calls, in view of the imminent end of the current legislature, for close cooperation between the institutions with regard to the management of legislative procedures currently under examination; proposes, while fully respecting the Commission's and Council's rights and prerogatives, the following arrangements:
|
|
8. |
Takes the view that, in 2004, it will be necessary to reach agreement with the Commission on an ad hoc procedure governing the various stages in the preparation and presentation of the next legislative programme; |
|
9. |
Calls upon the Commission to comply with the timetables indicated in its legislative and work programme for the presentation of new proposals; insists, should the Commission envisage deviating from these timetables, on the need to consult the relevant parliamentary committee beforehand; |
|
10. |
Takes the view that application of the interinstitutional agreement on better law-making will clear the way for wider-ranging coordination of legislative work among the three institutions, and considers that the Council should be involved in an interinstitutional legislative programme; |
|
11. |
Takes the view that the links between the Commission's programme and the Council's multiannual strategic programme drawn up in December 2003 are as yet far from clear; calls on the Commission and Council to explain precisely how these two planning processes go together; |
|
12. |
Points out that the need to revise the institutional framework of the enlarged European Union and to continue the work of establishing a future Constitution for Europe represents one of the major challenges for 2004; |
|
13. |
Notes that discussions and work are in progress in the Commission on the subject of future priorities for a revised financial framework for post-2006; takes the view that this debate is relevant, but that no decision should be taken at this stage, particularly in view of the imminence of the enlargement of the Union (1 May 2004) and the European elections (June 2004); believes that the decision should be taken by the future Commission once it has been formed and has determined its priorities, and that the final decision must be taken by the budgetary authority; |
Enlargement, stability and the EU's role in the world
|
14. |
Welcomes the fact that on 1 May 2004 ten new Member States will join the European Union; agrees that this historic enlargement will provide a considerable boost to the EU's economic and political potential, but will also represent an enormous challenge for the EU and in particular for the Commission; |
|
15. |
Recalls in this context the Commission's role in ensuring that the acquis communautaire is adhered to in the new Member States, with regard inter alia to the rules on the internal market, in the areas of employment and social protection policy, the environment and justice and home affairs; |
|
16. |
Points to the importance of economic cohesion within the Union, and deplores the fact that the Commission has not yet presented Parliament with an Action Plan for after May 2004 concerning the efforts needed for the new Member States to catch up economically and converge with the EU 15; |
|
17. |
Takes the view that the accession of 10 new Member States, the ongoing negotiations with Romania and Bulgaria, the report on the situation in Turkey and the opinion on Croatia's membership application together form the key political priority for 2004, but emphasises that, in the current tense and unstable international situation, the new framework created by an enlarged Union with new neighbourhood relations with countries to the east and in the Mediterranean will make closer coordination and tangible progress in the sphere of the CFSP essential with a view to the establishment of an area of security, peace, stability and prosperity, chiefly involving the Union's new neighbours; welcomes the adoption of a security strategy for the Union and calls on the Commission to implement policies which are consistent with that document; |
|
18. |
Supports further development of the joint economic area, area of justice and security and research area with Russia, as well as the feasibility studies concerning stabilisation and association agreements with Bosnia-Herzegovina and Serbia-Montenegro; |
|
19. |
Invites the Commission to devote particular attention to further developments and the progress of reform in Turkey, in particular in the run-up to the progress report for the December 2004 Council; in the aftermath of the recent terrible bomb attacks invites the Commission to maintain and even foster its engagement in Turkey in order to express the full solidarity of the European Union; |
|
20. |
Welcomes the Commission's analysis regarding the need for a reinforced ESDP, and invites the Commission and Council to work ever more closely together and to follow the consultation and information procedures of the European Parliament; insists, furthermore, that the Commission inform the competent European Parliament committee regularly during the budget year about the ongoing implementation of the budget dedicated to external actions, and in particular provide information about specific problems of implementation, in order to avoid a repetition of the 2003 global transfer situation, which clearly demonstrates that political priorities set by Parliament in the budgetary procedure have not been implemented; |
|
21. |
Regrets the fact that the Israeli-Palestinian conflict has disrupted and hampered the Barcelona integration process and applauds the ongoing efforts of the Commission and the High Representative for the CFSP to bring about peace in the region; |
|
22. |
Emphasises the importance of the EU presence in Afghanistan; thanks the European Commission's delegation to Kabul for its efforts; calls for Community and Member State aid to be continued in order to meet the needs of the population; |
|
23. |
Welcomes the recent communication from the Commission on the budgetisation of the European Development Fund (EDF); reiterates its long-standing support for the budgetisation of the EDF, which will provide for parliamentary supervision and democratic scrutiny of the EU's financial and technical cooperation with the ACP countries; gives the ACP countries an assurance that, through the exercise of its powers as one arm of the budgetary authority, it will prevent the diversion of funds from previous EDFs to other areas of the EU budget, by means of ringfencing and other appropriate measures; |
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24. |
Calls on the Commission to give a firm undertaking to draw up a detailed, comprehensive strategy designed to achieve the UN's millennium development objectives, in particular the elimination of poverty, and the objectives in the spheres of health and education; |
|
25. |
Welcomes the Peace Facility set up by the European Union to finance peacekeeping operations by the African Union; calls on the Commission to take steps to ensure that prompt use is made of this instrument in the various conflict areas in Africa; |
|
26. |
Encourages the Commission to implement the Action Plan on communicable diseases and reproductive health; insists that concrete action be taken in this area in order to mark the tenth anniversary of the International Conference on Population and Development (ICPD+10) in 2004; |
|
27. |
Strongly recommends that the European policies aimed at progressing towards the establishment of an area of Freedom, Security and Justice (Tampere agenda) be implemented before the May 2004 deadline; points out that, following the Treaty of Nice, the next stage in the establishment of an area of freedom, security and justice provides for the application of the codecision procedure to most measures concerning asylum and immigration; |
|
28. |
Recalls the need for major progress towards overall implementation of a European immigration policy; supports the Commission's proposals aimed at achieving a balance between measures to counteract illegal immigration and measures designed to ensure fair treatment and integration of legal immigrants; |
|
29. |
Notes the Commission's determination to set up new cooperation programmes with third countries in the area of immigration, programmes which are part of the fight against clandestine immigration and trafficking in human beings; |
|
30. |
Stresses the need to develop efficient management of the Member States' common borders in the framework of a coherent common policy in collaboration with the European Parliament; draws attention to the need to establish a Community operational structure, with a view to stepping up cooperation on the protection of external frontiers, in particular ahead of the 2004 enlargement; |
|
31. |
Calls for the development of a new Schengen Information System (SIS) to be carried out in a transparent and democratic manner, which presupposes that Parliament should be consulted and that the provisions on data protection should be complied with; |
Sustainable development and social policy
|
32. |
Agrees that sustainable development should be one of the major work priorities of the Commission; insists, however, that more focus must be given to concrete actions developing this policy towards employment, investment in human resources, prosperity and quality of life for European citizens; |
|
33. |
Supports all additional efforts to enhance growth and sustainable development, including investment in European networks; stresses, however, that the beneficial effects of these measures will only be felt if the process of implementation is accelerated; insists that, alongside the TENs and R&D projects, investment in the human dimension and capital must be given the highest priority; recalls the importance of the Commission's role in this process and declares its own readiness to contribute to speedy decisionmaking where necessary; |
|
34. |
Takes the view that the establishment of an integrated electricity market in an enlarged Europe will improve security of supply, but that further efforts should be made to achieve a satisfactory level of electrical interconnectivity; calls for a new proposal on closer coordination in the sector with a view to preventing blackouts similar to those recently suffered by Italy, Sweden, Denmark and the United Kingdom; |
|
35. |
Welcomes the support for innovation, research and development, which are fundamental to European growth and the European Union's Lisbon strategy, in particular the action plan which aims to increase investment in research and development in line with the target of 3% of GDP and to attract more and more human resources to the research sector; points out that specific measures must be taken to meet the needs of innovative SMUs active in Europe; |
|
36. |
Acknowledges that consideration should be given to the idea of establishing a European Research Council, endowed with adequate resources, with a view to strengthening fundamental research in Europe; takes the view that such a body should give priority to bottom-up approaches, cover all scientific areas and be based on scientific criteria; |
|
37. |
Underlines the importance of smoothly functioning services of general interest; deplores in this context the fact that the Commission again does not intend to propose a framework directive on services of general interest, as requested by Parliament on several occasions and by the European Council meeting in Laeken; |
|
38. |
Notes that the extension of the ‘Lamfalussy’ approach to the banking, insurance and UCITS sectors is not included in the Commission's priorities for 2004; supports this extension in principle but reminds the Commission firmly that this support is conditional upon a guarantee of a call-back for the European Parliament on the implementing measures to be adopted in these areas; |
|
39. |
Underlines again the importance of an effective and dynamic follow-up and implementation of the Lisbon strategy in 2004; considers that the Lisbon structural reform agenda has to result in better, and sustainable, jobs, in order to create a knowledge-based economy; insists that economic, environmental and social reforms must be mutually supportive and must be achieved in close cooperation with all actors concerned; looks to the Commission to step up cooperation with the social partners with a view to drawing up joint strategies and measures to achieve the employment objectives laid down in Lisbon, in particular greater involvement for the elderly and women on the labour market; |
|
40. |
Deplores the absence of any reference to the European economic and social model; is of the opinion that one consequence of the specificity of the European economic and social model should be that the Commission considers more carefully possible social and environmental consequences of its proposals, in particular when putting forward initiatives to liberalise economic activities further; |
|
41. |
Calls on the Commission to regard as a priority measures to remedy the serious socio-economic effects of the various plans to reconstitute fish stocks on communities that are highly dependent on fishing; |
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42. |
Welcomes the thematic strategies incorporated into the legislative programme, such as those outlined in the sixth action programme on the environment; stresses the importance a Commission initiative aimed at drawing up a thematic strategy on the urban environment; |
|
43. |
Calls on the Commission to take practical steps to follow up the conclusions of the Thessaloniki European Council of 19 and 20 June 2003, which called for the establishment of ‘a European diplomacy on environment and sustainable development’, and urges the Commission to put forward a specific political strategy in this area; asks to be kept regularly informed, between now and June 2005, about the progress made towards establishing a network of experts, in keeping with the strategy, adopted in Barcelona, on integrating the environment into external policies; |
|
44. |
Notes the new measures presented by the Commission with a view to completing the internal market, liberalising the various transport sectors and guaranteeing passengers using all modes of transport increased safety; in that connection, points out that the onus is now on the Council to speed up its efforts to adopt common positions on extremely important matters, such as social provisions in the sphere of road transport, the introduction of a system imposing certain restrictions on the use of heavy good vehicles, public service requirements and the award of public service contracts in the sphere of the transport of passengers by rail, road and inland waterway, and EU-OPSs in civil aviation; |
|
45. |
Emphasises that the Commission must implement all the measures required to take account of the increase in life expectancy, a major challenge which the European Union will be required to meet in the near future, and to implement a large-scale information campaign on health and eating habits; |
|
46. |
Points out that, in Council Decision 2003/578/EC of 22 July 2003 on guidelines for the employment policies of the Member States (1), the need for an adequate labour supply and the promotion of active ageing is emphasised, with a view to encouraging enterprises to hire or retain older employees, strengthening access to training and changing employer attitudes; |
|
47. |
Calls on the Commission to put forward practical proposals to build on the momentum established by the European Year of People with Disabilities; |
|
48. |
Urges that the new generation of Community programmes in the areas of education, culture, youth and audiovisual policy for the post-2006 period should be programmed in good time in order to ensure continuity in terms of both policy and implementation; |
Eurostat
|
49. |
Calls on the Commission to address the Eurostat case and all its aspects with the utmost seriousness; deplores the fact that the action plan provides no proper explanation for the Commission's failure to react for so long to the crisis in Eurostat, despite the evidence which mounted up over the years; |
|
50. |
Draws the Commission's attention to the deficiencies within its internal communication system, in particular to the need to improve the flow of information at all levels within the Commission in order to ensure that it is in a position to exercise its tasks properly; in this context, however, warns against establishing new bureaucratic structures; is disappointed at the fact that, despite commitments to improve European governance, the Commission is not planning to come forward with a proposal for a code of good administrative behaviour or a regulation on administrative law; |
|
51. |
Welcomes the commitment expressed by the President of the Commission to strengthening OLAF's operational independence and capability, including internal investigations; expects the Commission to come up with concrete proposals with a view to having them adopted before the enlargement, i.e. by this Parliament; calls on OLAF to complete all its outstanding investigations concerning Eurostat and to submit its final reports to Parliament as soon as possible, and by 15 January 2004 at the latest; |
|
52. |
Demands that the Commission urgently take all necessary measures to change the culture of secrecy and complacency regarding financial control instruments, so that any wrongdoing can in future be quickly detected and dealt with, and that it take steps to address immediately the need for effective communication between Commissioners and their Directorates-General; calls for existing rules (such as the Commissioners' Code of Conduct and the rules governing the Commission's relationship with OLAF) to be implemented in full, and for the outstanding cases concerning whistle-blowers to be resolved as soon as possible and procedures developed for their protection; |
|
53. |
Calls on its committees responsible to hold hearings or similar meetings to scrutinise closely developments concerning the Commission's accounting system and calls for that step to be accompanied by an assessment of the overall stage reached in implementing the financial control instruments which form part of the reform package, in the light of the Eurostat affair; |
*
* *
|
54. |
Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States and the future Member States that will join the European Union in May 2004. |
P5_TA(2003)0586
Role of the Union in conflict prevention in Africa and in particular in the implementation of the Linas-Marcoussis Agreement in the Côte d'Ivoire
European Parliament resolution on the European Union's role in conflict prevention in Africa and particularly in the implementation of the Linas-Marcoussis Agreement in Côte d'Ivoire
The European Parliament,
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— |
having regard to its previous resolutions on Côte d'Ivoire, |
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— |
having regard to the Linas-Marcoussis Agreement, negotiated under the auspices of France with the participation of the UN, the Economic Community of West African States (ECOWAS) and the EU, and signed by all parties to the Côte d'Ivoire civil conflict on 24 January 2003, |
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— |
having regard to the fact that the EU is represented by both the Commission and the Council on the Monitoring Committee on the Linas-Marcoussis Agreement, |
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— |
having regard to the efforts made by ECOWAS to re-establish peace and security, thereby safeguarding the national integrity of Côte d'Ivoire, |
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— |
having regard to the declarations by the Presidency, on behalf of the European Union, of 22 September and 27 October 2003, |
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— |
having regard to the declaration by the President of the UN Security Council of 13 November 2003, |
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— |
having regard to its resolution of 15 March 2001 on developing the Union's capabilities in conflict prevention and civil crisis management (1), |
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— |
having regard to the Council's decision of 22 January 2001 setting up the permanent bodies of the Common European Security and Defence Policy (CESDP), |
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— |
having regard to the Italian Presidency's declaration of 9 December 2003 on behalf of the European Union, |
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— |
having regard to Rule 37(4) of its Rules of Procedure, |
|
A. |
whereas this conflict, which cannot be attributed to the ethnic factor alone, has complex and multidimensional origins, including in particular poverty, unequal distribution of wealth, social injustice, human rights violations, the oppression of minorities, religious discrimination and the dysfunctional State, |
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B. |
concerned at the failure to secure a peaceful resolution to the conflict in Côte d'Ivoire and at the suspension by rebel ministers of their participation in the government of national reconciliation, precipitating the inability to implement the Linas-Marcoussis Agreement and the freeze on disarmament plans and the commitment of European funds, |
|
C. |
whereas the mandate and role of the Monitoring Committee on the Linas-Marcoussis Agreement and the various actors engaged in the process have met with some criticism, |
|
D. |
mindful of the political, economic and humanitarian risks that a resumption of hostilities in Côte d'Ivoire poses to the whole subregion, and that conflict prevention mechanisms have clearly failed in the current crisis, |
|
E. |
whereas the Ivorian ‘rebel forces’ have so far opposed the demilitarisation of non-governmental armed groups, which was due to begin on 1 August 2003 under international supervision; and whereas all the military commanders of both government and rebel forces agreed on 10 December 2003, in the presence of the peace-keeping forces, that before Christmas they would withdraw all heavy artillery pieces from the frontline, gather in their weapons, confine their men to barracks and clear all roadblocks, |
|
F. |
whereas on 24 November 2003 Kofi Annan, speaking to the United Nations Security Council, expressed his fear of a resumption of the conflict between rebel and government forces in Côte d'Ivoire, |
|
G. |
whereas the Commission has decided to grant Côte d'Ivoire EUR 6 million in aid for victims of the conflict and EUR 30 million over three years for a rehabilitation programme additional to the programmes adopted in the framework of the 7th and 8th EDFs and the national indicative programme under the 9th EDF, |
|
H. |
alarmed at the Commission's position in favour of extending by one year the current fisheries agreement with Côte d'Ivoire despite the fact that the implementation of development cooperation under the Cotonou Agreement in fact remains suspended owing to the conflict, |
|
I. |
whereas the European Union Council decided on 17 November 2003 to allocate EUR 250 million from the European Development Fund to a Peace Facility for Africa which is intended to provide the African Union with the financial muscle to ensure stability and peace in Africa, |
|
J. |
whereas the implementation of the reforms envisaged by the various agreements concluded by the political and military forces must lead a unified and cohesive Côte d'Ivoire to credible, transparent and open elections in 2005, |
|
1. |
Deplores the lack of political goodwill and the slow progress of the implementation of the Linas-Marcoussis Agreement; nevertheless welcomes the consideration given by the Ivorian Council of Ministers to the texts deriving from the Linas-Marcoussis Agreement on the nationality code and naturalisation requirements, the electoral code, eligibility requirements, in particular concerning eligibility to seek election as President of the Republic, and the land ownership code, and hopes that these will be adopted by the parliament and, in the case of those texts requiring a referendum amending the constitution, by a majority of the electorate; |
|
2. |
Calls on all parties to ensure the scrupulous application of the Linas-Marcoussis Agreement and calls for a stronger commitment from the EU and other international actors in the peace process; |
|
3. |
Calls on the ministers from the rebel forces to take up their seats again in the government in order to work towards appeasement and national reconciliation in the spirit of the Linas-Marcoussis Agreement; |
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4. |
Condemns the human rights violations that have occurred, and calls for an international committee of inquiry to be set up to investigate the abuses committed by the government and the rebels; |
|
5. |
Calls on the UN Security Council to consider the possibility of increasing the strength of the ECOWAS mission in Côte d'Ivoire, within the context of the African Union Peace Facility, and of transforming it into a UN peace-keeping force; |
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6. |
Calls for the ECOWAS peace-keeping force to be given an extended mandate and to be reinforced, and for the costs to be borne by the international community; |
|
7. |
Calls for a rapid start to the programme of disarmament, demobilisation and reintegration of nongovernmental armed forces; welcomes the fact that prisoners of war have started to be released; |
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8. |
Calls for the authority of the State (administration and public services) to be restored throughout the country and welcomes the reinstatement of prefects and sub-prefects in the western part of the country; |
|
9. |
Welcomes the European Union's confirmation, via the Presidency of the Council, of its willingness to support the reunification and reconstruction of Côte d'Ivoire by all possible means; |
|
10. |
Strongly condemns the concept of ‘ivoirité’, which serves to exclude part of the population from playing any democratic part in political activity in the country, and calls on President Gbagbo to urge his government and the Ivorian military to guarantee the protection of civilians, whatever their ethnic origin or nationality; deplores the recent arbitrary arrests and detention without trial of politicians mainly from political parties other than the President's ruling party; |
|
11. |
Strongly condemns any attempt to make direct or indirect use of violence in the political process in Côte d'Ivoire, as well as any threats to law and order and stability in the country; strongly condemns, in this context, the attacks on UN personnel in Bouaké and Man on 24 and 25 October 2003; |
|
12. |
Condemns the murder of the journalist Jean Hélène, who worked as correspondent for Radio France International in Côte d'Ivoire, and calls on the Ivorian authorities to continue their action to fully investigate this crime; |
|
13. |
Regrets the lack of visibility and transparency with regard to the operations of the Monitoring Committee on the Linas-Marcoussis Agreement, and calls on France, which hosted the formal peace negotiations, to make, in due course, a provisional assessment of the implementation of the Agreement; |
|
14. |
Urges the Commission to evaluate systematically the impact of EC actions targeted at the prevention of conflict in specific regions of tension; |
|
15. |
Calls for conflict prevention and structural stability to be key objectives of EU development policy; considers that EU conflict-prevention policy must address the structural causes of conflicts linked to poverty, including unequal distribution of wealth, social injustice, human rights violations, the oppression of minorities and religious discrimination; |
|
16. |
Instructs its President to forward this resolution to the Council, the Commission, the ACP-EU Council, the African Union secretariat and the Government of Côte d'Ivoire. |