02007R0658 — EN — 02.07.2012 — 001.002
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COMMISSION REGULATION (EC) No 658/2007 of 14 June 2007 (OJ L 155 15.6.2007, p. 10) |
Amended by:
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Official Journal |
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No |
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L 150 |
68 |
9.6.2012 |
Corrected by:
COMMISSION REGULATION (EC) No 658/2007
of 14 June 2007
concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
This Regulation lays down rules concerning the application of financial penalties to the holders of marketing authorisations, granted under Regulation (EC) No 726/2004, in respect of infringements of the following obligations, in cases where the infringement concerned may have significant public health implications in the Union, or where it has a Union dimension by taking place or having its effects in more than one Member State, or where interests of the Union are involved:
the obligation to submit complete and accurate particulars and documents in an application for marketing authorisation under Regulation (EC) No 726/2004 submitted to the European Medicines Agency established by that Regulation, (hereinafter ‘the Agency’), or in response to obligations laid down in that Regulation and Regulation (EC) No 1901/2006 to the extent that the infringement concerns a material particular;
the obligation to comply with conditions or restrictions included in the marketing authorisation and concerning the supply or use of the medicinal product, as referred to in Article 9(4)(b), the second subparagraph of Article 10(1), Article 34(4)(c) and the second subparagraph of Article 35(1) of Regulation (EC) No 726/2004;
the obligation to comply with conditions or restrictions included in the marketing authorisation with regard to the safe and effective use of the medicinal product as referred to in Article 9(4)(aa), (c), (ca), (cb) and (cc), Article 10(1), Article 34(4)(d) and Article 35(1) of Regulation (EC) No 726/2004 taking account of any deadlines set in accordance with the third subparagraph of Article 10(1) of Regulation (EC) No 726/2004;
the obligation to introduce any necessary variation to the terms of the marketing authorisation to take account of technical and scientific progress and enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods, as provided for in Article 16(1) and Article 41(1) of Regulation (EC) No 726/2004;
the obligation to supply any new information which may entail a variation to the terms of the marketing authorisation, to notify any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product is marketed, or to supply any information that may influence the evaluation of the risks and benefits of the product, as provided for in Article 16(2) and Article 41(4) of Regulation (EC) No 726/2004;
the obligation to keep product information up to date with current scientific knowledge, including the conclusions of the assessment and recommendations made public on the European medicines web-portal, as provided for in Article 16(3) of Regulation (EC) No 726/2004;
►C1 the obligation to provide, at the request of the Agency, any data demonstrating that the risk-benefit balance remains favourable, as provided for in Articles 16(3a) and 41(4) of Regulation (EC) No 726/2004; ◄
the obligation to place the medicinal product on the market in accordance with the content of the summary of the product characteristics and the labelling and package leaflet as contained in the marketing authorisation;
the obligation to comply with the conditions referred to in Article 14(7) and (8) of Regulation (EC) No 726/2004 or to introduce the specific procedures referred to in Article 39(7) of Regulation (EC) No 726/2004;
the obligation to notify the Agency of the dates of actual marketing and of the date when the product ceases to be on the market, and to provide to the Agency data relating to the volume of sales and the volume of prescriptions of the product, as provided in Article 13(4) and Article 38(4) of Regulation (EC) No 726/2004;
the obligation to operate a comprehensive pharmacovigilance system for the fulfilment of pharmacovigilance tasks, including the operation of a quality system, maintenance of a pharmacovigilance system master file and performance of regular audits, in accordance with Article 21 of Regulation (EC) No 726/2004 read together with Article 104 of Directive 2001/83/EC;
►C1 the obligation to submit, at the request of the Agency, a copy of the pharmacovigilance system master file, as provided for in Article 16(3a) of Regulation (EC) No 726/2004; ◄
the obligation to operate a risk management system as provided for in Article 14a and Article 21(2) of Regulation (EC) No 726/2004 read together with Article 104(3) of Directive 2001/83/EC and Article 34(2) of Regulation (EC) No 1901/2006;
the obligation to record and report suspected adverse reactions for medicinal products for human use, in accordance with Article 28(1) of Regulation (EC) No 726/2004 read together with Article 107 of Directive 2001/83/EC;
the obligation to submit periodic safety update reports, in accordance with Article 28(2) of Regulation (EC) No 726/2004 read together with Article 107b of Directive 2001/83/EC;
the obligation to conduct post-marketing studies, including post-authorisation safety studies and post-authorisation efficacy studies, and to submit them for review, as provided for in Article 10a of Regulation (EC) No 726/2004 and Article 34(2) of Regulation (EC) No 1901/2006;
the obligation to record and report all suspected serious adverse reactions and adverse human reactions to a veterinary medicinal product as well as all suspected serious unexpected adverse reactions and human adverse reactions or suspected transmission of infectious agents, as provided for in Article 49(1) and (2) of Regulation (EC) No 726/2004;
the obligation to record in detail all suspected adverse reactions and to submit these records in the form of periodic safety update reports, as provided for in Article 49(3) of Regulation (EC) No 726/2004;
the obligation to notify the Agency prior or simultaneously to any communication of information on pharmacovigilance concerns to the general public, as provided for in Article 49(5) of Regulation (EC) No 726/2004;
the obligation to collate and assess specific pharmacovigilance data, as provided for in the fourth paragraph of Article 51 of Regulation (EC) No 726/2004;
the obligation to have permanently and continuously at disposal an appropriately qualified person responsible for pharmacovigilance, as provided for in Article 48 of Regulation (EC) No 726/2004;
the obligation to detect residues in the case of veterinary medicinal products, as provided for in Article 41(2) and (3) of Regulation (EC) No 726/2004;
the obligation to ensure that public announcements relating to information on pharmacovigilance concerns are presented objectively and are not misleading and to notify them to the Agency, as provided for in Article 22 of Regulation (EC) No 726/2004 read together with Article 106a(1) of Directive 2001/83/EC;
the obligation to comply with the time limits for initiating or completing measures specified in the Agency’s decision on deferral following the initial marketing authorisation of the medicinal product concerned and in accordance with the definitive opinion referred to in Article 25(5) of Regulation (EC) No 1901/2006;
the obligation to place the medicinal product on the market within two years of the date on which the paediatric indication is authorised, as provided for in Article 33 of Regulation (EC) No 1901/2006;
the obligation to transfer the marketing authorisation or to allow a third party to use documentation contained in the marketing authorisation dossier, as provided for in the first subparagraph of Article 35 of Regulation (EC) No 1901/2006;
the obligation to submit paediatric studies to the Agency, including the obligation to enter information into the European database on third country clinical trials, as provided for in Article 41(1) and (2), Article 45(1) and Article 46(1) of Regulation (EC) No 1901/2006;
the obligation to submit an annual report to the Agency as provided for in Article 34(4) of Regulation (EC) No 1901/2006 and to inform the Agency in accordance with the second subparagraph of Article 35 of that Regulation.
Article 2
Complementarity of procedures
For the purposes of the initiation and conduct of the infringement procedure provided for in Chapter II, the Agency and the Commission shall take into account any infringement procedure by a Member State against the same marketing authorisation holder and based on the same legal grounds and the same facts.
Article 3
Cooperation by the competent authorities of the Member States
Information provided by the national competent authorities in response to a request from the Agency or the Commission under this Regulation shall be used by the Agency and the Commission only for the following purposes:
as evidence for the purposes of applying this Regulation;
for carrying out the tasks entrusted to them for the authorisation and supervision of medicinal products under Regulation (EC) No 726/2004.
Article 4
Burden of proof
In any infringement procedure under this Regulation, the burden of proving an infringement shall rest on the Commission.
CHAPTER II
INFRINGEMENT PROCEDURE
SECTION 1
Inquiry
Subsection 1
Initiation of procedure
Article 5
Initiation of the infringement procedure
The Agency shall inform the Commission that it intends to initiate the infringement procedure.
Article 6
Request for information
Prior to initiating an infringement procedure, the Agency may request from the marketing authorisation holder concerned any information relating to the alleged infringement.
The Agency shall state the purpose of the request and the fact that it is made under this Regulation, and indicate a time-limit for the submission of the reply by the marketing authorisation holder, which shall be at least four weeks.
Where the request is in response to a request from a Member State under Article 5(1), that Member State shall be informed by the Agency.
Article 7
Notification
The Agency shall send written notification of the initiation of an infringement procedure to the marketing authorisation holder concerned, to the Member States and to the Commission.
The notification shall set out the allegations against the marketing authorisation holder, specifying the provision allegedly infringed, and the evidence on which those allegations are founded.
It shall give notice to the marketing authorisation holder that fines or periodic penalty payments may be imposed.
Subsection 2
Measures of inquiry
Article 8
Requests by the Agency
Requests shall be addressed in writing to the marketing authorisation holder. The Agency shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for in Article 19(1)(a) and (b) for failing to comply with the request or for supplying incorrect or misleading information.
The Agency may request national competent authorities to cooperate in the investigation in the following ways:
by performing any of the tasks entrusted to the supervisory authorities by Articles 19(1) and 44(1) of Regulation (EC) No 726/2004;
by performing inspections or other supervisory measures in accordance with Articles 111 to 115 of Directive 2001/83/EC and Articles 80, 81 and 82 of Directive 2001/82/EC.
Requests shall be addressed in writing and shall state the legal basis and the purpose of the request. The time-limit for the submission of the reply or the conduct of the measure of inquiry shall be determined by agreement between the Agency and the national competent authority to which the request is addressed, having regard to the specific circumstances of the case.
Requests shall be addressed in writing and shall state the legal basis and the purpose of the request, and shall fix a time-limit by which the information should be provided, which shall be at least four weeks.
Article 9
Right to be heard
Before adoption of the report provided for in Article 10, the Agency shall invite the marketing authorisation holder to submit written observations.
It shall do so in writing, indicating a time-limit for the submission of those observations, which shall be at least four weeks.
Subsection 3
Report
Article 10
Content and time-limits
SECTION 2
Decision-making stage
Subsection 1
Procedure
Article 11
Statement of objections
Where, following a request from the Agency pursuant to Article 10(2), the Commission decides to continue with the infringement procedure, it shall notify in writing to the marketing authorisation holder a statement of objections containing the following:
the allegations against the marketing authorisation holder, including a precise indication of which provision has allegedly been infringed, and the evidence on which those allegations are founded;
notice that fines or periodic penalty payments may be imposed.
Article 12
Right to reply
That time-limit shall be at least four weeks.
The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.
Article 13
Oral hearing
The date for the oral hearing shall be set by the Commission.
Article 14
Requests for information
Requests shall be addressed in writing to the marketing authorisation holder. The Commission shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for in Article 19(1)(c) and (d) for failing to comply with the request or supplying incorrect or misleading information.
Requests shall be addressed in writing and shall state the legal basis and the purpose of the request. Where the request is addressed to the Agency or a national competent authority, the time-limit by which the information is to be provided shall be determined by the Commission after consultation of the Agency or the national competent authority to which the request is addressed, having regard to the specific circumstances of the case. Where the request is addressed to other natural or legal persons, it shall fix a time-limit by which the information is to be provided, which shall be at least four weeks.
Article 15
New period of inquiry
The Commission shall clearly indicate to the Agency the points of fact which it should further examine and, if appropriate, suggest possible measures of inquiry to that effect.
Subsection 2
Decision and financial penalties
Article 16
Forms of financial penalty and maximum amounts
Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the infringement has been brought to an end.
Article 17
Decision
Article 18
Principles governing the application and quantification of financial penalties
In each case, the Commission shall take into consideration, where relevant, the following circumstances:
the seriousness and the effects of the infringement, and, in particular, the following:
the way in which the infringement adversely affects the rights, safety or well-being of patients;
its effects on animal health and welfare and the impact on animal owners;
whether it poses or could pose a risk to public health, animal health or the environment;
the gravity of the infringement in relation to public health, animal health and the environment;
on the one hand, the good faith of the marketing authorisation holder in the interpretation and fulfilment of the obligations connected with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 or, on the other hand, any evidence of wilful deceit on the part of the marketing authorisation holder;
on the one hand, the degree of diligence and cooperation shown by the marketing authorisation holder in the detection of the infringement and the application of corrective action, or during the course of the infringement procedure or, on the other hand, any obstruction by the marketing authorisation holder of the detection of an infringement and the conduct of an infringement procedure, or any non-compliance by the marketing authorisation holder with requests made by the Agency, the Commission or a national competent authority in application of this Regulation;
the turnover of the medicinal product concerned;
the need to adopt provisional measures by the Commission or urgent action by a Member State in accordance with Articles 20 or 45 of Regulation (EC) No 726/2004 as a result of an infringement;
the repetition, frequency or duration of the infringement by that marketing authorisation holder;
prior sanctions, including penalties, imposed on the same marketing authorisation holder.
SECTION 3
Non-cooperation
Article 19
Financial penalties
The Commission may by decision impose on marketing authorisation holders fines not exceeding 0,5 % of their Community turnover in the preceding business year where, intentionally or negligently:
they do not comply with a measure of inquiry adopted pursuant to Article 8(1);
they supply incorrect or misleading information in response to a measure of inquiry adopted pursuant to Article 8(1);
they do not comply with a request for information pursuant to Article 14;
they supply incorrect or misleading information in response to a request for information pursuant to Article 14.
Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the non-cooperation has ceased.
Article 20
Procedure
When the Commission intends to adopt a decision as referred to in Article 19(1), it shall first notify in writing the marketing authorisation holder, setting a time-limit within which the marketing authorisation holder may submit to the Commission his written observations. That time-limit shall be at least four weeks.
The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.
CHAPTER III
ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY AND TEMPORAL PROVISIONS
Article 21
Access to the file
Following notification under Article 7, the marketing authorisation holder shall have the right, on request, to access the documents and other materials compiled by the Agency and the Commission which serve as evidence of an alleged infringement.
Documents obtained through access to the file shall be used only for the purposes of judicial or administrative proceedings for the application of this Regulation.
Article 22
Legal representation
The marketing authorisation holder shall have the right to legal representation during the infringement procedure.
Article 23
Confidentiality and professional secrecy
The Agency and the Commission may also require marketing authorisation holders and other persons to identify any part of a report by the Agency, of a statement of objections or of a decision adopted by the Commission which in their view contains business secrets.
The Agency and Commission may set a time-limit within which the marketing authorisation holder and other persons are to:
substantiate their claim for confidentiality with regard to each individual document or part of document;
provide the Commission with a non-confidential version of the documents, in which the confidential passages are deleted;
provide a concise description of each piece of deleted information.
The time-limit referred to in the third subparagraph shall be at least two weeks.
Article 24
Application of time-limits
In the case of a communication from the marketing authorisation holder, it shall be sufficient for the purposes of the relevant time-limits for the communication to have been dispatched by registered post before the relevant time-limit has expired.
Article 25
Limitation periods for the imposition of financial penalties
In the case of the financial penalties provided for in Article 19, the right of the Commission to adopt a decision imposing such a penalty shall expire after three years.
Time shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, time shall begin to run on the day on which the infringement ceases.
Article 26
Limitation periods for the collection of financial penalties
The limitation period for the recovery of financial penalties shall be suspended for so long as:
time to pay is allowed;
enforcement of payment is suspended pursuant to a decision of the Court of Justice of the European Communities.
CHAPTER IV
FINAL PROVISIONS
Article 27
Transitional provision
In the case of infringements which began before its entry into force, this Regulation shall apply to the part of the infringement which takes place after that date.
Article 28
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
( 1 ) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).
( 2 ) OJ L 311, 28.11.2001, p. 1. Directive as amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).
( 3 ) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006.