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Document 21998A0817(01)
Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia - Final Act - Joint Declarations
Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia - Final Act - Joint Declarations
Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia - Final Act - Joint Declarations
OJ L 229, 17.8.1998, p. 3–60
(ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 11 Volume 029 P. 99 - 156
Special edition in Estonian: Chapter 11 Volume 029 P. 99 - 156
Special edition in Latvian: Chapter 11 Volume 029 P. 99 - 156
Special edition in Lithuanian: Chapter 11 Volume 029 P. 99 - 156
Special edition in Hungarian Chapter 11 Volume 029 P. 99 - 156
Special edition in Maltese: Chapter 11 Volume 029 P. 99 - 156
Special edition in Polish: Chapter 11 Volume 029 P. 99 - 156
Special edition in Slovak: Chapter 11 Volume 029 P. 99 - 156
Special edition in Slovene: Chapter 11 Volume 029 P. 99 - 156
Special edition in Bulgarian: Chapter 11 Volume 017 P. 131 - 188
Special edition in Romanian: Chapter 11 Volume 017 P. 131 - 188
Special edition in Croatian: Chapter 11 Volume 021 P. 119 - 176
In force: This act has been changed. Current consolidated version: 01/01/2013
ELI: http://data.europa.eu/eli/agree_internation/1998/508/oj
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17.8.1998 |
EN |
Official Journal of the European Communities |
L 229/3 |
AGREEMENT
on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
THE EUROPEAN COMMUNITY and the GOVERNMENT OF AUSTRALIA, hereinafter referred to as ‘the Parties’,
CONSIDERING the traditional links of friendship that exist between them,
CONSIDERING their shared commitment to promoting the enhancement of product quality, with a view to ensuring the health, safety and environment of their citizens,
DESIRING to conclude an agreement providing for the mutual recognition of the respective conformity assessment procedures required for market access to the territory of the Parties,
TAKING INTO ACCOUNT the improved conditions of trade between the Parties which the mutual recognition of test reports and certificates of conformity will bring about,
AWARE of the positive contribution that mutual recognition can have in encouraging greater international harmonisation of standards and regulations,
NOTING the close relationship between Australia and New Zealand as confirmed in the Australian and New Zealand Closer Economic Relations Trade Agreement and the Trans-Tasman Mutual Recognition Arrangement as well as the growing level of integration of the Australian and New Zealand conformity assessment infrastructures through the Agreement concerning the establishment of the Council of the Joint Accreditation System of Australia and New Zealand (JAS-ANZ),
NOTING the close relationship between the European Community and Iceland, Liechtenstein and Norway through the Agreement on the European Economic Area, which makes it appropriate to consider the conclusion of a parallel mutual recognition agreement between Australia and these countries equivalent to this Agreement,
BEARING IN MIND their status as Contracting Parties to the Agreement establishing the World Trade Organisation, and conscious in particular of their obligations under the World Trade Organisation Agreement on Technical Barriers to Trade,
HAVE AGREED AS FOLLOWS:
Article 1
Definitions
1. General terms used in this Agreement and its Annexes shall have the meaning given in the definitions contained in ISO/IEC Guide 2 (1991) ‘General terms and their definitions concerning standardisation and related activities’ and in EN 45020 (1993 edition) unless the context requires otherwise. In addition, the following terms and definitions shall apply for the purpose of this Agreement:
‘Conformity assessment’ means systematic examination to determine the extent to which a product, process or service fulfils specified requirements;
‘Conformity assessment body’ means a body whose activities and expertise include performance of all or any stage of the conformity assessment process;
‘Designation’ means the authorisation by a designating authority of a conformity assessment body to perform conformity assessment activities; ‘designated’ has a corresponding meaning;
‘Designating authority’ means a body with the legal power to designate, suspend or withdraw designation of conformity assessment bodies under its jurisdiction.
2. The terms ‘conformity assessment body’ and ‘designating authority’ apply mutatis mutandis to other bodies and authorities with corresponding functions referred to in some Sectoral Annexes.
Article 2
General obligations
1. The Government of Australia shall accept attestations of conformity including test reports, certificates, authorisations and marks of conformity as required by legislation and regulations identified in the Sectoral Annexes issued by designated conformity assessment bodies in the European Community in accordance with this Agreement.
2. The European Community shall accept attestations of conformity including test reports, certificates, authorisations and marks of conformity as required by legislation and regulations identified in the Sectoral Annexes, issued by designated conformity assessment bodies in Australia in accordance with this Agreement.
3. This Agreement shall not entail mutual acceptance of the standards or technical regulations of the Parties or mutual recognition of the equivalence of such standards or technical regulations.
Article 3
Sectoral coverage
1. This Agreement concerns the conformity assessment procedures to satisfy mandatory requirements covered by the Sectoral Annexes.
2. Each Sectoral Annex shall, in general, contain the following information:
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(a) |
a statement of its scope and coverage; |
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(b) |
the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures (Section I); |
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(c) |
a list of the designated conformity assessment bodies (Section II); |
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(d) |
the designating authorities (Section III); |
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(e) |
a set of procedures for the designation of conformity assessment bodies (Section IV), and |
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(f) |
additional provisions as required (Section V). |
Article 4
Origin
1. This Agreement shall apply to products originating in the Parties to the Agreement according to the non-preferential rules of origin.
2. In case of conflicting rules, the non-preferential rules of the Party on whose territory the goods are marketed are determinative.
3. To the extent that the products referred to in paragraph 1 are also covered in a Sectoral Annex to the Agreement on Mutual Recognition in relation to conformity assessment between the European Community and New Zealand, this Agreement shall also apply to products of New Zealand origin.
4. To the extent that the products referred to in paragraph 1 are also covered in a Sectoral Annex to an Agreement on Mutual Recognition in relation to conformity assessment between Australia and States Contracting Parties to both the Convention of the European Free Trade Association (EFTA) and the Agreement on the European Economic Area (EEA), this Agreement shall also apply to products originating in any of these EFTA States.
Article 5
Conformity assessment bodies
In accordance with the terms of the Annex and the Sectoral Annexes, each Party recognises that the conformity assessment bodies designated by the other Party fulfil the conditions of eligibility to assess conformity in relation to their requirements as specified in the Sectoral Annexes. In designating such bodies, the Parties shall specify the scope of the conformity assessment activities for which they have been designated.
Article 6
Designating authorities
1. The Parties shall ensure that the designating authorities responsible for designating the conformity assessment bodies specified in the Sectoral Annexes shall have the necessary power and competence to designate, suspend, remove suspension and withdraw the designation of such bodies.
2. In making such designations and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.
3. In case of suspension of a designation or removal of such a suspension, the designating authority of the Party concerned shall immediately inform the other Party and the Joint Committee. Conformity assessment carried out by a suspended conformity assessment body before its suspension shall remain valid unless otherwise determined by its designating authority.
Article 7
Verification of designation procedures
1. The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility and specified in the Sectoral Annexes comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.
2. The Parties shall compare methods used to verify that the designated conformity assessment bodies comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex. Existing systems for the accreditation of conformity assessment bodies in the two Parties may be used for such comparison procedures.
3. Such comparison shall be carried out in accordance with the procedures to be determined by the Joint Committee established under Article 12.
Article 8
Verification of compliance of conformity assessment bodies
1. Each Party shall ensure that conformity assessment bodies designated by a designating authority will be available for verification of their technical competence and compliance with other relevant requirements.
2. Each Party has the right to contest the technical competence and compliance of conformity assessment bodies under the jurisdiction of the other Party. This right will be exercised under exceptional circumstances only.
3. Such contestation has to be justified in an objective and argued manner and in writing to the other Party and the Chair of the Joint Committee.
4. Where the Joint Committee decides that verification of technical competence or compliance is required, it will be carried out in a timely manner jointly by the Parties with the participation of the relevant designating authorities.
5. The result of this verification will be discussed in the Joint Committee with a view to resolving the issue as soon as possible.
6. Except when decided otherwise by the Joint Committee, the contested conformity assessment body, where it is included in Section II of a Sectoral Annex, shall be suspended by the competent designating authority from the time disagreement has been established in the Joint Committee until agreement has been reached in the Joint Committee on the status of that body.
Article 9
Exchange of information
1. The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes.
2. Consistent with their obligations under the World Trade Organisation Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except where considerations of safety, health and environmental protection warrant more urgent action, notify the other Party of the new provisions at least 60 days before their entry into force.
Article 10
Uniformity of conformity assessment procedures
In the interests of promoting a uniform application of the conformity assessment procedures provided for in the laws and regulations of the Parties, the designated conformity assessment bodies shall take part, as appropriate, in coordination and comparison exercises conducted by each of the Parties in the relevant areas covered by the Sectoral Annexes.
Article 11
Agreements with other countries
The Parties agree that mutual recognition agreements concluded by either Party with a country which is not a party to this Agreement shall in no way entail an obligation upon the other Party to accept test reports, certificates, authorisations and marks of conformity issued by conformity assessment bodies in that third country, save where there is an express agreement between the Parties.
Article 12
Joint Committee
1. A Joint Committee made up of representatives of the two Parties shall be established. It is responsible for the effective functioning of the Agreement.
2. The Joint Committee shall determine its own rules of procedure. It shall take its decisions and adopt its recommendations by consensus. It can decide to delegate specific tasks to subcommittees.
3. The Joint Committee shall meet at least once a year unless it decides otherwise. If required for the effective functioning of this Agreement, and at the request of either Party, an additional meeting or meetings shall be held.
4. A Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for:
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(a) |
amending the Sectoral Annexes to give effect to the decision by a designating authority to designate a particular conformity assessment body; |
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(b) |
amending the Sectoral Annexes to give effect to the decision by a designating authority to withdraw designation of a particular conformity assessment body; |
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(c) |
exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies specified in the Sectoral Annexes maintain the necessary level of competence; |
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(d) |
in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements; |
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(e) |
exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes including those which require modification of the Sectoral Annexes; |
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(f) |
resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and |
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(g) |
facilitating the extension of this Agreement to further sectors. |
5. Any amendments to Sectoral Annexes made in accordance with the provisions of this Article shall be notified promptly in writing by the Chair of the Joint Committee to each Party.
6. The following procedure shall apply in relation to the inclusion in or withdrawal from a Sectoral Annex of a conformity assessment body:
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(a) |
a Party proposing an amendment to a Sectoral Annex to give effect to a decision by a designating authority to designate or withdraw designation of a conformity assessment body shall forward its proposal to the other Party in writing, adding supporting documentation to the request; |
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(b) |
a copy of the proposal and documentation shall be sent to the Chair of the Joint Committee; |
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(c) |
in the event that the other Party consents to the proposal or upon the expiry of 60 days without an objection having been lodged, the inclusion in or withdrawal from the Sectoral Annex of the conformity assessment body shall take effect, and |
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(d) |
in the event that, under Article 8, the other Party contests the technical competence or compliance of a conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with that Article. |
7. In the event that a designated conformity assessment body is withdrawn from a Sectoral Annex, conformity assessment carried out by that conformity assessment body before the date of effect of its withdrawal shall remain valid unless otherwise determined by the Joint Committee. In the case of the inclusion of a new conformity assessment body, conformity assessment carried out by such a conformity assessment body shall be valid from the date the Parties agree to its inclusion in the Sectoral Annex.
8. Where a Party introduces new or additional conformity assessment procedures affecting a sector covered by a Sectoral Annex, the Joint Committee shall, unless the Parties agree otherwise, bring such procedures within the mutual recognition implementing arrangements established by this Agreement.
Article 13
Territorial application
This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty and, on the other hand, to the territory of Australia.
Article 14
Entry into force and duration
1. This Agreement shall enter into force on the first day of the second month following the date on which the Parties have exchanged Notes confirming the completion of their respective procedures for the entry into force of this Agreement.
2. Either Party may terminate this Agreement by giving the other Party six months notice in writing.
Article 15
Final provisions
1. The Annex to this Agreement forms an integral part thereof.
2. Any amendment to this Agreement shall be done by mutual agreement.
3. The Parties shall conclude Sectoral Annexes, to which Article 2 applies, which will provide the implementing arrangements for this Agreement.
4. Amendments to the Sectoral Annexes shall be determined by the Parties through the Joint Committee.
5. This Agreement and the Sectoral Annexes are drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic.
Hecho en Canberra, el veinticuatro de junio de mil novecientos noventa y ocho.
Udfærdiget i Canberra den fireogtyvende juni nitten hundrede og otteoghalvfems.
Geschehen zu Canberra am vierundzwanzigsten Juni neunzehnhundertachtundneunzig.
Έγινε στην Καμπέρα, στις είκοσι τέσσερις Ιουνίου χίλια εννιακόσια ενενήντα οκτώ.
Done at Canberra on the twenty-fourth day of June in the year one thousand nine hundred and ninety-eight.
Fait à Canberra, le vingt-quatre juin mil neuf cent quatre-vingt-dix-huit.
Fatto a Canberra, addì ventiquattro giugno millenovecentonovantotto.
Gedaan te Canberra, de vierentwintigste juni negentienhonderd achtennegentig.
Feito em Camberra, em vinte e quatro de Junho de mil novecentos e noventa e oito.
Tehty Canberrassa kahdentenakymmenentenäneljäntenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.
Som skedde i Canberra den tjugofjärde juni nittonhundranittioåtta.
Por la Comunidad Europea
For Det Europæiske Fællesskab
Für die Europäische Gemeinschaft
Για την Ευρωπαϊκή Κοινότητα
For the European Community
Pour la Communauté européenne
Per la Comunità europea
Voor de Europese Gemeenschap
Pela Comunidade Europeia
Euroopan yhteisön puolesta
På Europeiska gemenskapens vägnar
Por Australia
For Australien
Für Australien
Για την Αυστραλία
For Australia
Pour l'Australie
Per l'Australia
Voor Australië
Pela Austrália
Australian puolesta
För Australien
ANNEX
PROCEDURES FOR THE DESIGNATION AND MONITORING OF CONFORMITY ASSESSMENT BODIES
A. GENERAL REQUIREMENTS AND CONDITIONS
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1. |
Designating authorities shall only designate legally identifiable entities as conformity assessment bodies. |
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2. |
Designating authorities shall only designate conformity assessment bodies able to demonstrate that they understand, have experience relevant to, and are competent to apply the conformity assessment requirements and procedures of the legislative, regulatory and administrative provisions of the other Party for which they are designated. |
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3. |
Demonstration of technical competence shall be based on:
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4. |
The technical competence criteria shall be based on internationally-accepted documents supplemented by specific interpretative documents developed as appropriate from time to time. |
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5. |
The Parties shall encourage harmonisation of designation and conformity assessment procedures through cooperation between designating authorities and conformity assessment bodies by means of coordination meetings, participation in mutual recognition arrangements, and working group meetings. Where accreditation bodies participate in the designation process they should be encouraged to participate in mutual recognition arrangements. |
B. SYSTEM TO DETERMINE CONFORMITY ASSESSMENT BODIES' COMPETENCE
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6. |
The designating authorities may apply the following processes to determine the technical competence of conformity assessment bodies. If necessary, a Party will indicate to the designating authority the possible ways to demonstrate competence.
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C. EVALUATION OF THE DESIGNATION SYSTEM
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7. |
Once the designation systems to evaluate the competence of conformity assessment bodies have been defined by each Party, the other Party may, in consultation with the designating authorities, check that the systems give sufficient assurance that the designation of the conformity assessment bodies satisfies its requirements. |
D. FORMAL DESIGNATION
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8. |
Designating authorities shall consult the conformity assessment bodies within their jurisdiction in order to determine their willingness to be designated under the terms of this Agreement. Such consultation should include those conformity assessment bodies who do not operate under the respective legislative, regulatory and administrative requirements of their own Party but which may, nevertheless, be interested and capable of working to the legislative, regulatory and administrative requirements of the other Party. |
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9. |
Designating authorities shall inform their Party's representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be included in or withdrawn from Section II of the Sectoral Annexes. Designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with the provisions of this Agreement and the rules of procedure of the Joint Committee. |
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10. |
When advising their Party's representative on the Joint Committee established under this Agreement, of the conformity assessment bodies to be included in the Sectoral Annexes, the designating authority shall provide the following details in respect of each conformity assessment body:
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E. MONITORING
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11. |
Designating authorities shall maintain, or cause to maintain, ongoing surveillance over designated conformity assessment bodies by means of regular audit or assessment. The frequency and nature of such activities shall be consistent with international best practices or as agreed by the Joint Committee. |
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12. |
Designating authorities shall require designated conformity assessment bodies to participate in proficiency testing or other appropriate comparison exercises where such exercises are technically possible within reasonable cost. |
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13. |
Designating authorities shall consult as necessary with their counterparts to ensure the maintenance of confidence in conformity assessment processes and procedures. This consultation may include joint participation in audits related to conformity assessment activities or other assessments of designated conformity assessment bodies, where such participation is appropriate and technically possible within reasonable cost. |
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14. |
Designating authorities shall consult, as necessary, with the relevant regulatory authorities of the other Party to ensure that all regulatory requirements are identified and are satisfactorily addressed. |
SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
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1. |
The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in Australia and the European Community, and to which Good Manufacturing Practice (GMP) requirements apply. For medicinal products covered by this Sectoral Annex, each Party shall recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party. In addition, the manufacturer's certification of the conformity of each batch to its specifications shall be recognised by the other Party without re-control at import. ‘Medicinal products’ means all products regulated by the pharmaceutical legislation in the European Community and Australia as listed in the Appendix to this Annex. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs, and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products. ‘GMP’ is that part of quality assurance which ensures that products are consistently produced and controlled during manufacture to the quality standards appropriate to their intended use and as required by the marketing authorisation granted by the importing Party. For the purpose of this Sectoral Annex it includes the system whereby the manufacturer receives the specification of the product and/or process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification (equivalent to qualified person certification in the European Community). |
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2. |
With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request that, for the purpose of this Agreement, an inspection be made by the locally competent inspection service. This provision will apply inter alia to the manufacture of active pharmaceutical ingredients and intermediate products and products intended for use in clinical trials, as well as agreed pre-marketing inspections. Operational arrangements are detailed under Section III, item 3b. |
Certification of manufacturers
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3. |
At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of manufacturers of medicinal products shall certify that the manufacturer:
The certificates shall also identify the site(s) of manufacture (and contract testing laboratories, if any). The format of certificate is attached as Appendix 2; it may be modified by the Joint Committee, as established in Article 12 of the Agreement. Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, such as when a new inspection has to be carried out, this period may be extended to 60 days. |
Batch certification
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4. |
Each batch exported shall be accompanied by a batch certificate prepared by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch. It will be made available upon request of the competent authority. When issuing a certificate, the manufacturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It shall contain a statement that the batch processing and packaging records were reviewed and found to be in conformity with GMP. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Community the ‘qualified person’ referred to in Article 21 of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. In Australia, the responsible persons are for manufacturing quality control as specified in the Therapeutic Goods Regulation 19(b) under the Therapeutic Goods Act 1989. |
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
Subject to Section III ‘Operational provisions’, general GMP inspections shall be carried out in accordance with the GMP requirements of the exporting Party. The legislative, regulatory and administrative requirements are listed in Appendix 1.
However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, shall be those of the relevant product marketing authorisation granted by the importing Party.
SECTION II
OFFICIAL INSPECTION SERVICES
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FOR AUSTRALIA: |
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FOR THE EUROPEAN COMMUNITY: |
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BELGIUM |
Inspection générale de la pharmacie Algemene Farmaceutische Inspectie |
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DENMARK |
Lægemiddelstyrelsen |
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GERMANY |
Bundesministeriumfür Gesundheit |
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GREECE |
Εθνικός Οργανισμός Φαρμάκου Ministry of Health and Welfare National Drug Organisation (EOF) |
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SPAIN |
For medicinal products for human use: Ministerio de Sanidad y Consumo Subdirección General de Control Farmacéutico For medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentación (MAPA) Dirección General de la Producción Agraria |
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FRANCE |
For medicinal products for human use: Agence du médicament For veterinary medicinal products: CNEVA, Agence nationale du médicament vétérinaire, unité inspections For cosmetics: Ministère de l'emploi et de la solidarité Direction générale de la santé Sous direction pharmacie |
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IRELAND |
Irish Medicines Board |
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ITALY |
For medicinal products for human use: Ministero della Sanità Dipartimento Farmaci e Farmacovigilanza For medicinal products for veterinary use: Ministero della Sanità Dipartimento alimenti e nutrizione e sanità pubblica veterinaria — Div. IX |
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LUXEMBOURG |
Division de la pharmacie et des médicaments |
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NETHERLANDS |
Staat der Nederlanden |
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AUSTRIA |
Bundesministerium für Arbeit, Gesundheit und Soziales |
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PORTUGAL |
For human and veterinary (non immunologicals): Instituto Nacional da Farmácia e do Medicamento — Infarmed For veterinary immunologicals: Direcção-Geral de Veterinaria |
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FINLAND |
Lääkelaitos/Läkemedelsverket National Agency for Medicines |
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SWEDEN |
Läkemedelsverket — Medicinal Products Agency |
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UNITED KINGDOM |
For human and veterinary (non immunologicals): Medicines Control Agency For veterinary immunologicals: Veterinary Medicines Directorate |
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EUROPEAN COMMUNITY |
Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) |
SECTION III
OPERATIONAL PROVISIONS
1. Transmission of inspection reports
Upon reasoned request, the relevant inspection services shall forward a copy of the last inspection report of the manufacturing site or control site, in the case where analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see item 2 below). Each Party shall deal with these inspection reports with the degree of confidentiality requested by the Party of origin.
If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties shall ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 days should a new inspection be carried out.
2. Inspection reports
A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party.
3. Reference GMP
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(a) |
Manufacturers shall be inspected in accordance with the applicable GMP of the exporting country (see Appendix 1). |
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(b) |
With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations shall inspect in accordance with its own GMP or, in the absence of specific GMP requirements, in accordance with the applicable GMP of the importing country. This will also be the case when the locally applicable GMP are not considered equivalent, in terms of quality assurance of the finished product, to the GMP of the importing Party. Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) shall be determined according to a procedure established by the Joint Committee. |
4. Nature of inspections
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(a) |
Inspections shall routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections). |
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(b) |
‘Product- or process-oriented’ inspections (which may be ‘pre-marketing’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) shall be provided in confidence to the inspectorate. |
5. Inspection/establishment fees
The regime of inspection/establishment fees is determined by the manufacturer's location. Inspection/establishment fees will not be charged to manufacturers located on the territory of the other Party for products covered by this Agreement, except as provided for in paragraph 6 below.
6. Safeguard clause for inspections
Each Party reserves the right to conduct its own inspection for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the option of joining the inspection. Recourse to this safeguard clause should be an exception. Should such an inspection take place, inspection costs may be recovered.
7. Exchange of information between authorities and approximation of quality requirements
In accordance with the general provisions of the Agreement, the Parties shall exchange any information necessary for the mutual recognition of inspections.
In addition, the relevant authorities in Australia and in the European Community shall keep each other informed of any new technical guidance or inspection procedure. Each Party shall consult the other before their adoption and will endeavour to proceed towards their approximation.
8. Official batch release
The official batch release procedure is an additional verification of the safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement does not encompass this mutual recognition of official batch releases. However, when an official batch release procedure applies, the manufacturer shall provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party.
For the European Community, the official batch release procedure for medicinal products for human use is specified in document ‘Administrative EC Batch Release Procedure III/3859/92’ and different specific batch release procedures. For Australia, the official batch release procedure is specified in document ‘WHO Technical Report Series, No 822, 1992’.
9. Inspectors training
In accordance with the general provisions of the Agreement, training sessions for inspectors, organised by the authorities, shall be accessible to inspectors of the other Party. The Parties to the Agreement will keep each other informed on these sessions.
10. Joint inspections
In accordance with the general provisions of the Agreement, and by mutual agreement between the Parties, joint inspections may be authorised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form shall be agreed through procedures approved by the Joint Committee.
11. Alert system
Contact points will be agreed between the Parties to permit competent authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure will be agreed.
The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, is communicated to each other with the appropriate degree of urgency.
12. Contact points
For the purpose of this Agreement, the contact points for any technical question, such as exchange of inspection reports, inspectors training sessions, technical requirements, will be:
|
FOR AUSTRALIA: |
For medicinal products for human use:
For medicinal products for use in animals:
|
|||||||||||||||
|
FOR THE EUROPEAN COMMUNITY: |
|
13. Divergence of views
Both Parties shall use their best endeavours to resolve any divergence of views concerning inter alia compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Joint Committee.
SECTION IV
TRANSITIONAL ARRANGEMENTS FOR VETERINARY MEDICINAL PRODUCTS
The Parties note that the current GMP requirements for veterinary medicinal products in Australia are not equivalent to those that apply in the European Community. Therefore, Australian veterinary medicinal products manufacturers will be inspected by Therapeutic Goods Administration (TGA) on behalf of the veterinary National Registration Authority, according to the TGA reference GMP and relevant additional EC GMP for veterinary medicinal products.
During a two-year transitional period, TGA inspection reports will be routinely sent to the importing Party, which may accept them or decide to carry out an inspection itself. If accepted, the European Community will recognise Australian manufacturers' certifications of batch conformity.
Two years after the entry into force of the Agreement, the European Community shall, subject to satisfactory verification of Australia's GMP inspection programme, recognise the conclusions of inspections carried out by the TGA and Australian manufacturers' certifications of batch conformity.
Should the National Registration Authority (NRA) begin to carry out inspections itself, inspection reports will also be routinely transmitted to the importing Party until there has been a satisfactory verification of the NRA GMP inspection programme.
Appendix 1
List of applicable legislative, regulatory and administrative provisions
For the European Community:
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as extended, widened and amended
Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as extended, widened and amended
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
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
Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use
Guide to Good Distribution Practice (94/C63/03)
Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV
For Australia:
For products for human use:
Therapeutic Goods Act 1989, and Regulations, Orders and Determinations thereunder, including Orders setting standards such as labelling, the Determination establishing manufacturing Principles
|
— |
Therapeutic Goods Act 1989, |
|
— |
Therapeutic Goods Regulations, |
|
— |
Therapeutic Goods (Charges) Act 1989, |
|
— |
Therapeutic Goods (Charges) Regulations, |
|
— |
Therapeutic Goods (Excluded Goods) Order No 1 of 1992, |
|
— |
Therapeutic Goods (Goods that are not Therapeutic Devices) Order No 1 of 1992, |
|
— |
Therapeutic Goods (Manufacturing Principles) Determinations, |
|
— |
Australian Code of Good Manufacturing Practice for Therapeutic Goods — Medicinal Products, August 1990, including:
|
|
— |
Australian Code of Good Manufacturing Practice for Therapeutic Goods — Sunscreen Products, February 1994 |
|
— |
Australian Code of Good Manufacturing Practice for Therapeutic Goods — Medicinal Gases, July 1992 |
For products for veterinary use:
Legislation — Commonwealth:
|
— |
Agricultural and Veterinary Chemicals (Administration) Act, 1992, |
|
— |
Agricultural and Veterinary Chemicals Act, 1993, |
|
— |
Agricultural and Veterinary Chemicals Code Act, 1993, |
|
— |
Agricultural and Veterinary Chemicals (Consequential Amendments) Act, 1993. |
Legislation — New South Wales:
|
— |
Stock Foods and Medicines Act, 1940, |
|
— |
Public Health Act, 1961, |
|
— |
Poison Act, 1966, |
|
— |
Pesticides and Allied Chemicals Act, 1979. |
Legislation — Victoria:
|
— |
Animal Preparations Act, 1987, |
|
— |
Health Act, 1958, |
|
— |
Drugs, Poisons and Controlled Substances Act, 1981. |
Legislation — Queensland:
|
— |
Agricultural Standards Act, 1952-1981, |
|
— |
Stock Act, 1915-1976, |
|
— |
Health Act, 1937-1987. |
Legislation — South Australia:
|
— |
Stock Medicines Act, 1939-1978, |
|
— |
Stock Foods Act, 1941, |
|
— |
Dangerous Drugs Act, 1986, |
|
— |
Controlled Substances Act, 1984, |
|
— |
Stock Diseases Act, 1934. |
Legislation — Western Australia:
|
— |
Veterinary Preparations and Animal Feeding Stuffs Act, 1976-1982, |
|
— |
Poisons Act, 1964-1981, |
|
— |
Health (Pesticides) Regulations, 1956. |
Legislation — Tasmania:
|
— |
Veterinary Medicines Act, 1987, |
|
— |
Poisons Act, 1971, |
|
— |
Public Health Act, 1962, |
|
— |
Pesticides Act, 1968. |
Legislation — Northern Territory:
|
— |
Poisons and Dangerous Drugs Act, 1983, |
|
— |
Therapeutic Goods and Cosmetics Act, 1986, |
|
— |
Stock Diseases Act, 1954. |
Appendix 2
SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
The provisions of this Sectoral Annex shall apply to the following products:
|
Products for export to the European Community |
Products for export to Australia |
||||||||||||||||
|
All medical devices subject to third party conformity assessment procedures, both product related and quality system related, provided for in Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, but excluding the following products:
|
All medical devices subject under the Australian Therapeutic Goods Act 1989 and Therapeutic Goods Regulations, to third party conformity assessment procedures, both product related and quality systems related, apply, but excluding the following products:
|
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
|
The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance |
The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance |
||||||||||||||||||
|
|
SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
|
The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements |
The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements |
|
The Therapeutic Goods Administration of the Department of Health and Family Services, in respect of the conformity assessment procedures required under the Community legislation cited in Section I, for all medical devices and for all modules for the various phases of the conformity assessment procedures applicable to such devices |
The designated conformity assessment bodies are: [Name and details to be inserted] [Further names to be added as required] |
SECTION III
THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
|
For the conformity assessment bodies designated by Australia |
For the conformity assessment bodies designated by the European Community |
||||||||||||||||||||||||||||||||
|
|
SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
|
The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements |
The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements |
||||||
|
The conformity assessment bodies listed in Section II must meet the requirements of the Directives listed in Section I, taking into account 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 conformity marking, which are intended to be used in the technical harmonisation directives and be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
|
Conformity assessment bodies will be designated in accordance with the procedures set out in the Annex to the Agreement. Conformity assessment bodies which are Notified Bodies under Annex XI of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices or Annex VIII of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medicinal devices in conjunction with 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 conformity marking, which are intended to be used in the technical harmonisation directives shall be presumed competent to carry out conformity assessment to Australian requirements for those devices and procedures for which they have been correspondingly notified by their competent authorities in Europe. |
SECTION V
ADDITIONAL PROVISIONS
1. Transitional period for certain high-risk devices
|
1.1. |
A transitional period, for the purpose of strengthening confidence in the designating systems of each of the Parties will apply for the Medical Devices specified in Schedule 3 of the Therapeutic Goods Regulation and Medical Devices Directives (90/385/EEC and 93/42/EEC) and listed below:
|
|
1.2. |
The Parties will establish a detailed programme to this effect involving the Therapeutic Goods Administration and the European Community's competent authorities. |
|
1.3. |
This confidence-building period will be completed within 18 months from the date of entry into force of the Agreement. |
2. Medical devices incorporating medicinal substances
|
2.1. |
In order to meet European Community requirements, the following procedures shall apply to medical devices incorporating medicinal substances referred to in Article 1(4) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices:
|
|
2.2. |
In order to meet Australian requirements, the following procedures shall apply to medical devices incorporating medicinal substances referred to in Article 1(4) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices:
|
3. Registration and listing procedures
|
3.1. |
The Parties recognise that Australian procedures under the Therapeutic Goods Act for the registration or listing of products for market surveillance purposes, and corresponding European Community procedures, are unaffected by this Agreement. |
|
3.2. |
Within the framework of this Agreement, the Australian Regulatory Authority will within five (5) working days register a product from the European Community upon receipt of an application accompanied by the designated fee without further assessment of the product. |
|
3.3. |
Any fees attached to registration by either Party will be related only to the costs of medical device registration, enforcement and post-market surveillance activities of the Parties in this sector. |
4. Exchange of information
The Parties agree to inform each other of incidents in the context of medical device vigilance procedure, or with regard to matters concerning product safety, and shall establish contact points for this purpose.
5. In order to facilitate the application of this Sectoral Annex, the Parties will establish a guidance document setting out the procedures and requirements which are equivalent under the legislation of the two Parties, as well as modalities to facilitate registration requirements.
6. New legislation
The Parties note the possibility of Australia introducing new legislation concerning medical devices, and agree that any new arrangements will respect the principles on which the Mutual Recognition Agreement is based, notably Article 2 of the Agreement.
7. Divergence of views
Both Parties shall use their best endeavours to resolve any divergence of views concerning compliance of manufacturers and conclusions of conformity assessment reports. Unresolved divergencies of view will be referred to the Joint Committee.
SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
The provisions of this Sectoral Annex shall apply to the following:
|
Products for export to the European Community |
Products for export to Australia |
||||
|
Any product falling under the scope of Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition of their conformity. In general terms, that Council Directive covers:
This list of product groups may be extended to include other European Community common technical regulations in this sector as they become available. |
Any product defined as customer equipment in the Telecommunications Act 1997. In general this is equipment whose parameters are defined in the Australian Communications Authority Technical Standards as determined under the above Act. These requirements are set out in the Telecommunications Labelling (Customer Equipment and Customer Cabling) Notice No 2 of 1997. |
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
|
The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance |
The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance |
||||||||||||||||||||||
|
|
||||||||||||||||||||||
|
|
||||||||||||||||||||||
|
|
SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
|
The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements |
The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements |
|
The designated conformity assessment bodies are: |
The designated conformity assessment bodies are: |
|
[Name and details to be inserted] |
[Name and details to be inserted] |
|
[Note: Further names to be added as required] |
[Note: Further names to be added as required] |
SECTION III
THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
|
For the conformity assessment bodies designated by Australia |
For the conformity assessment bodies designated by the European Community |
||||||||||||||||||||||||||||||||||||||
|
Under the authority of the Government of Australia:
|
|
SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
|
The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements |
The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements |
||||||||||||||||||||
|
The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account 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 conformity marking, which are intended to be used in the technical harmonisation directives and be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
|
The procedures for designating conformity assessment bodies will be consistent with the principles and procedures set out in the Annex to the Agreement.
|
||||||||||||||||||||
|
|
SECTION V
ADDITIONAL PROVISIONS
|
1. |
In accordance with Part 21 of the Telecommunications Act 1997, the Australian Communications Authority (ACA) is required to authorise a manufacturer or importer to apply a label to customer equipment prior to placing that customer equipment on the Australian market. Within the framework of this Agreement, the ACA will use its best endeavours, within five (5) working days and in any case no longer than 10 days, to issue such an authorisation in accordance with procedures set out in the Telecommunications Labelling (Customer Equipment and Customer Cabling) Notice No 2 of 1997. |
|
2. |
It is agreed by both Parties that the relevant Council Directives and Australian legislative and regulatory requirements allow mutual recognition of separate elements of the conformity assessment process. Accordingly each Party shall accept test reports issued by conformity assessment bodies designated by the other Party as meeting its requirements in this regard. |
|
3. |
Where the legislative, regulatory or administrative provisions of either Party require it, conformity assessment bodies subcontracting all or part of the testing must subcontract only to testing laboratories accredited in accordance with clause (a) in Section IV above. |
|
4. |
In respect of telecommunications terminal equipment which is subject to the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, the relevant provisions of the Sectoral Annexes on, respectively, Low Voltage Equipment and Electromagnetic Compatibility shall apply. ACA technical standards
|
SECTORAL ANNEX ON LOW VOLTAGE EQUIPMENT TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
The provisions of this Sectoral Annex shall apply to the following types of low voltage equipment:
|
— |
All products falling within the scope of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits. |
|
— |
Electrical products which are within the scope of Australian State and Territory legislation for the safety of low voltage electrical equipment. |
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
|
The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance |
The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance |
||||||||||||||||||||||||||
|
Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits, as amended |
New South Wales
Victoria
Queensland
Western Australia
South Australia
Tasmania
Australian Capital Territory
Northern Territory
|
SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
|
The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements |
The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements |
|
The designated conformity assessment bodies are: |
The designated conformity assessment bodies are: |
|
[Name and details to be inserted] |
[Name and details to be inserted] |
|
[Note: Further names to be added as required] |
[Note: Further names to be added as required] |
SECTION III
THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
|
For the conformity assessment bodies designated by Australia |
For the conformity assessment bodies designated by the European Community |
||||||||||||||||||||||||||||||||||||||
|
Under the authority of the Government of Australia:
|
|
SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
|
The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements |
The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements |
||||||||||||||||||||||||||||||
|
The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account 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 conformity marking, which are intended to be used in the technical harmonisation directives and be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
|
The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement:
|
SECTION V
ADDITIONAL PROVISIONS
|
1. |
In accordance with Australian legislation set out in Section I of this Annex, certain types of electrical equipment (the Declared Articles list) are required to be registered before they can be placed on the market. Within the framework of this Agreement, the Australian State and Territory Regulatory Authorities will within five (5) working days register a product from the European Community upon receipt of an application accompanied by the designated fee without further assessment of the product. The designated fee will be related to the costs of the electrical equipment registration, enforcement and post-market surveillance activities of the Australian regulatory authorities. |
|
2. |
The Parties note that a Regulatory Compliance Mark (RCM) is to be introduced in Australia in August 1996. The adoption of the RCM, together with changes to Australian regulatory requirements, may result in due course in the removal of the arrangements described in paragraph 1 above. Any conditions for use of the RCM will respect the principles of the Mutual Recognition Agreement, notably Article 2 of the Agreement. |
|
3. |
Where the legislative, regulatory or administrative provisions of either Party require it, conformity assessment bodies subcontracting all or part of the testing must subcontract only to testing laboratories accredited in accordance with clause (a) in Section IV above. |
|
4. |
In the event of a challenge within the European Community under Article 8(2) of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits, test reports issued by designated conformity assessment bodies in Australia will be accepted by European Community authorities in the same way that reports from European Community notified bodies are accepted. That is, conformity assessment bodies in Australia will be recognised under Article 11 of that Council Directive as ‘bodies which may make a report in accordance with Article 8’. |
SECTORAL ANNEX ON ELECTROMAGNETIC COMPATIBILITY TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
The provisions of this Sectoral Annex shall apply to the following:
|
— |
Electromagnetic compatibility of equipment as defined in Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, but excluding radiocommunications equipment which is not connected to the public switched telecommunication networks, and |
|
— |
Electromagnetic compatibility of equipment regulated under the Australian Radiocommunications Act 1992. |
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
|
The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance |
The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance |
|
Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, as amended |
Radiocommunications Act 1992 |
SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
|
The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements |
The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements |
|
The designated conformity assessment bodies are: |
The designated conformity assessment bodies are: |
|
[Name and details to be inserted] |
[Name and details to be inserted] |
|
[Further names to be added as required] |
[Further names to be added as required] |
SECTION III
THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
|
For the conformity assessment bodies designated by Australia |
For the conformity assessment bodies designated by the European Community |
||||||||||||||||||||||||||||||||||||||
|
Under the authority of the Government of Australia:
|
|
SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
|
The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements |
The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements |
||||||||||||||||||||||||
|
The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account 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 conformity marking, which are intended to be used in the technical harmonisation directives, and are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
|
The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement:
|
SECTION V
ADDITIONAL PROVISIONS
The European Community and Australia agree that
|
1. |
Reports and certificates prepared by European Community competent bodies will be accepted by Australian regulatory authorities. |
|
2. |
Reports and certificates prepared by designated conformity assessment bodies in Australia will also be accepted by European Community authorities on the same basis as reports and certificates prepared by European Community competent bodies. |
|
3. |
Where the legislative, regulatory or administrative provisions in either Party require it, conformity assessment bodies subcontracting all or part of the testing must subcontract only to testing laboratories accredited in accordance with clause (a) in Section IV above. |
|
4. |
The Parties note the Australian requirement for its competent bodies to be members of the Australian Association of Competent Bodies and the Commission's current consideration of a proposal to establish a Technical Secretariat for Notified Bodies and Competent Bodies under Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility to promote the coordination activities of these Bodies under this Directive. The Parties also note the European Commission's intention to encourage competent bodies to participate in coordination activities. |
SECTORAL ANNEX ON MACHINERY TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
The provisions of this Sectoral Annex shall apply to the products listed in Annex IV to Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery and to tower cranes and mobile cranes.
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
|
The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance |
The legislative, regulatory and administrative requirements of Australia with which European Community designated conformity assessment bodies shall assess compliance |
||||||||||||||||||||||||||||||||||||||
|
The following legislative, regulatory and administrative requirements cover the conformity assessment procedures for the use of products covered by this Annex. New South Wales Victoria
Queensland
Western Australia
South Australia
Tasmania
Australian Capital Territory Northern Territory
|
SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
|
The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements |
The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements |
|
The designated conformity assessment bodies are: |
The designated conformity assessment bodies are: |
|
[Name and details to be inserted] |
[Name and details to be inserted] |
|
[Further names and details to be added as required] |
[Further names and details to be added as required] |
SECTION III
THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
|
For the conformity assessment bodies designated by Australia |
For the conformity assessment bodies designated by the European Commission |
||||||||||||||||||||||||||||||||||||||
|
Under the authority of the Government of Australia:
|
|
SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
|
The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements |
The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements |
||||||||||||||
|
The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account 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 conformity marking, which are intended to be used in the technical harmonisation directives, and are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
|
In accordance with the specific requirements set out in the legislation, regulations and administrative provisions listed in Section I, and where these make compliance with Australian standards for plant mandatory, the conformity assessment bodies listed in Section II are designated by the designating authorities specified in Section III in accordance with the following criteria:
Where the designer and design verifier are employed or engaged by the same person the whole of the design process must, if the legislation requires, operate: |
||||||||||||||
|
|
SECTION V
ADDITIONAL PROVISIONS
|
1. |
In respect of machinery which is subject to the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, the relevant provisions of the Sectoral Annexes on, respectively, Low Voltage Equipment and Electromagnetic Compatibility shall apply. |
|
2. |
Upon the date of application of the provisions of the Directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery, at present European Commission proposal COM(95) 350, bodies in Australia which have been designated to issue type-approvals according to this Directive shall, either directly or through the authority responsible for their designation, fulfil the notification and other obligations placed upon approval authorities under the relevant provisions of this Directive. |
|
3. |
It is noted further that this proposed Directive makes reference to the conformity assessment requirements set out in Council Directive 92/53/EEC of 18 June 1992 amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers. It is recognised that under the provisions of this Directive a manufacturer cannot be accredited as a testing laboratory. However, it is permissible for a testing laboratory to use outside equipment, subject to the approval of the designating authority. |
(1) There are no mandatory conformity assessment requirements under this legislation.
SECTORAL ANNEX ON PRESSURE EQUIPMENT TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
The provisions of this Sectoral Annex shall apply to the following products:
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Products for export to the European Community |
Products for export to Australia |
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Products falling within the scope of Council Directive 87/404/EEC of 25 June 1987 on the harmonisation of the laws of the Member States relating to simple pressure vessels. |
Products falling within the scope of Council Directive 87/404/EEC of 25 June 1987 on the harmonisation of the laws of the Member States relating to simple pressure vessels and which are subject to the Australian legislative and regulatory requirements listed in Section I of this Sectoral Annex. |
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
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The legislative, regulatory and administrative requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance |
The legislative, regulatory and administrative requirements of Australia with which the European Community designated Conformity Assessment Bodies shall assess compliance |
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Council Directive 87/404/EEC of 25 June 1987 on the harmonisation of the laws of the Member States relating to simple pressure vessels, as amended. |
The following legislative, regulatory and administrative requirements cover the conformity assessment procedures for the use of products covered by this Sectoral Annex. New South Wales Victoria
Queensland
Western Australia
South Australia
Tasmania
Australian Capital Territory Northern Territory
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SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
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The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements |
The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements |
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The designated conformity assessment bodies are: |
The designated conformity assessment bodies are: |
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[Names and details to be inserted] |
[Names and details to be inserted] |
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[Note: Further names and details to be added as required] |
[Note: Further names and details to be added as required] |
SECTION III
THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
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For the conformity assessment bodies designated by Australia |
For the conformity assessment bodies designated by the European Commission |
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Under the authority of the Government of Australia:
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SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
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The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's requirements |
The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's requirements |
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The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account 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 conformity marking, which are intended to be used in the technical harmonisation directives, and are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
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SECTION V
ADDITIONAL PROVISIONS
In respect of pressure equipment which is subject to the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, the relevant provisions of the Sectoral Annexes on, respectively, Low Voltage Equipment and Electromagnetic Compatibility shall apply.
(1) There are no mandatory conformity assessment requirements under this legislation.
SECTORAL ANNEX ON AUTOMOTIVE PRODUCTS TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
In accordance with the terms of this Annex, Australia shall recognise and accept results of testing, conformity of production and approval procedures according to Regulations adopted in the context of the UN/ECE 1958 Agreement (UN/ECE Regulations), deemed to be equivalent to EC Directives, carried out in the European Community, where these Regulations are substantially equivalent to Australian regulatory provisions.
In accordance with the terms of this Annex, the European Community shall accept results of testing and conformity of production procedures carried out in Australia in accordance with the Council Directives for which there is a UN/ECE Regulation, which is fully or partially/conditionally applied by Australia and is recognised as substantially equivalent in Annex IV, Part 2 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, as last amended.
In accordance with the terms of this Annex, Parties shall recognise and accept results of testing and conformity of production procedures carried out by the other Party to that Party's requirements in areas where substantial equivalence between regulatory provisions of both Parties is established.
The provision of this Sectoral Annex shall apply to automotive products and vehicle components as specified in the following Regulations from the Economic Commission for Europe: 1, 3-8, 11, 12, 13 for N and O-category vehicles, 14, 16-21, 23-25, 30, 37, 38, 43, 46, 48, 49, 51 and 83, in their latest applicable version as well as to EC Directives/ADRs on speed-limiting devices, defrosting and demisting systems and windscreen wiper/washer systems, as last amended.
The scope and coverage of this Sectoral Annex will be adapted according to changes in the position on substantial equivalence between UN/ECE Regulations and the regulatory provisions in force in Australia and the European Community.
SECTION I
REGULATORY REQUIREMENTS
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The regulatory requirements of the European Community with which Australian designated conformity assessment bodies shall assess compliance |
The regulatory requirements of Australia with which the European Community designated conformity assessment bodies shall assess compliance |
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The relevant testing and conformity of production procedures for the purpose of this Annex are those defined in the following Council Directives in amended form, as appropriate: |
The relevant testing, conformity of production and approval procedures for the purpose of this Annex are those defined in the following law, Regulations and Australian Design Rules in their latest applicable version: |
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SECTION II
DESIGNATED CONFORMITY ASSESSMENT BODIES
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The conformity assessment bodies designated by Australia to assess products against the European Community's legislative, regulatory and administrative requirements |
The conformity assessment bodies designated by the European Community to assess products against Australia's legislative, regulatory and administrative requirements |
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The designated conformity assessment bodies are: [Name and details to be inserted] [Further names to be added as required] |
SECTION III
AUTHORITIES RESPONSIBLE FOR DESIGNATING CONFORMITY OF ASSESSMENT BODIES
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For the conformity assessment bodies designated by Australia |
For the conformity assessment bodies designated by the European Community |
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The Administrator of Vehicle Standards delegated by the Australian Minister for Transport under the provisions of the Motor Vehicle Standards Act 1989 |
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SECTION IV
PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
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The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community's regulatory requirements |
The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia's regulatory requirements |
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The principles set out in the Annex to the Agreement |
The principles set out in the Annex to the Agreement |
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For testing laboratories:
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For testing laboratories: The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement.
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Conformity of Production: |
Conformity of Production: |
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The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement.
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The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement.
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SECTION V
ADDITIONAL PROVISIONS
1. Lighting
The Parties note that for certain Australian design rules concerned with vehicle lighting and included in Section I of this Sect oral Annex, i.e. Australian Design Rules 49/00, 6/00, 48/00, 50/00, 52/00 and 1/00, it is a requirement to test with filament globes complying with Australian Design Rule 51/00 which is considered equivalent to UN/ECE Regulation 37.
2. Standstill
In areas not covered by the Sectoral Annex, the Parties agree not to introduce changes to their certification arrangements other than those introduced by the establishment of this Agreement, which would make these arrangements less favourable in their effect than those currently prevailing.
3. Review
This Sectoral Annex shall be reviewed two years after its entry into force in the light of developments in relation to international standardisation in the area of vehicles and parts, in particular as far as Australia and the European Community are concerned.
4. Extension
The Parties shall advise one another of adoption of requirements that align with regulations from the Economic Commission for Europe. Where notification has been received that both Australia and the European Community have adopted a UN/ECE Regulation, the Joint Committee shall adopt appropriate amendments for inclusion in the listing given in Section I of this Sectoral Annex.
FINAL ACT
The plenipotentiaries of:
the EUROPEAN COMMUNITY, hereinafter referred to as ‘the Community’,
of the one part, and
the plenipotentiary of AUSTRALIA,
of the other part,
meeting for the signature of the Agreement on Mutual Recognition in relation to Conformity Assessment between the European Community and Australia, hereinafter referred to as the ‘Agreement’, have adopted the following texts:
the Agreement including its Annex and the following Sectoral Annexes relating to:
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1. |
Medicinal Products GMP Inspection and Batch Certification |
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2. |
Medical Devices |
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3. |
Telecommunications Terminal Equipment |
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4. |
Low Voltage Equipment |
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5. |
Electromagnetic Compatibility |
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6. |
Machinery |
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7. |
Pressure Equipment |
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8. |
Automotive Products |
The plenipotentiaries of the Community and the plenipotentiary of Australia have adopted the texts of the Joint Declarations listed below and annexed to this Final Act:
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Joint Declaration relating to future work on implementing arrangements for this Agreement, |
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Joint Declaration on mutual recognition in the voluntary sphere, |
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Joint Declaration relating to further developing harmonisation of technical regulations and conformity assessment procedures, |
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Joint Declaration relating to the review of Article 4 of the Agreement. |
Hecho en Canberra, el veinticuatro de junio de mil novecientos noventa y ocho.
Udfærdiget i Canberra den fireogtyvende juni nitten hundrede og otteoghalvfems.
Geschehen zu Canberra am vierundzwanzigsten Juni neunzehnhundertachtundneunzig.
Έγινε στην Καμπέρα, στις είκοσι τέσσερις Ιουνίου χίλια εννιακόσια ενενήντα οκτώ.
Done at Canberra on the twenty-fourth day of June in the year one thousand nine hundred and ninety-eight.
Fait à Canberra, le vingt-quatre juin mil neuf cent quatre-vingt-dix-huit.
Fatto a Canberra, addì ventiquattro giugno millenovecentonovantotto.
Gedaan te Canberra, de vierentwintigste juni negentienhonderd achtennegentig.
Feito em Camberra, em vinte e quatro de Junho de mil novecentos e noventa e oito.
Tehty Canberrassa kahdentenakymmenentenäneljäntenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.
Som skedde i Canberra den tjugofjärde juni nittonhundranittioåtta.
Por la Comunidad Europea
For Det Europæiske Fællesskab
Für die Europäische Gemeinschaft
Για την Ευρωπαϊκή Κοινότητα
For the European Community
Pour la Communauté européenne
Per la Comunità europea
Voor de Europese Gemeenschap
Pela Comunidade Europeia
Euroopan yhteisön puolesta
På Europeiska gemenskapens vägnar
Por Australia
For Australien
Für Australien
Για την Αυστραλία
For Australia
Pour l'Australie
Per l'Australia
Voor Australië
Pela Austrália
Australian puolesta
För Australien
ANNEX
Joint Declaration relating to future work on implementing arrangements for this Agreement
1. Pressure Equipment
The Parties will extend the scope of the Sectoral Annex on Pressure Equipment and start negotiations to that effect once the new Directive on this subject, at present being examined in the Council of the European Union and the European Parliament on the basis of a European Commission proposal, has entered into force.
2. Aircraft certification and continued airworthiness
The Parties confirm their intention to continue negotiations in order to complete the Sectoral Annex in respect of aircraft certification and continued airworthiness, with view its establishment as an implementing arrangement for this Agreement no later than two years following its entry into force.
3. Inclusion of other Sectoral Annexes
To build on this Agreement, Australia and the European Community will commence negotiations on the further extension of the sectoral coverage of the Agreement two years from the date that the Agreement enters into force.
Joint Declaration on mutual recognition in the voluntary sphere
The Parties will encourage their non-governmental bodies to cooperate with the view to establishing mutual recognition arrangements in the voluntary sphere.
Joint Declaration relating to further developing harmonisation of technical regulations and conformity assessment procedures
The Parties will give consideration to increasing the degree of harmonisation or equivalence of their respective technical regulations and conformity assessment procedures, where appropriate and where consistent with good regulatory practice. The Parties acknowledge that one objective could be the establishment where feasible of a single submission and evaluation procedure, applicable in both Parties, for the products covered by the Agreement.
Joint Declaration relating to the review of Article 4 of the Agreement
The Parties will consider a broadening of the provisions of Article 4 to include other countries once the Parties have concluded equivalent Agreements on Mutual Recognition in relation to conformity assessment in the same sectors with those other countries.