AGREEMENT
on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
Article 1
Definitions
Article 2
General obligations
Article 3
Sectoral coverage
Article 4
Origin
Article 5
Conformity assessment bodies
Article 6
Designating authorities
Article 7
Verification of designation procedures
Article 8
Verification of compliance of conformity assessment bodies
Article 9
Exchange of information
Article 10
Uniformity of conformity assessment procedures
Article 11
Agreements with other countries
Article 12
Joint Committee
Article 13
Territorial application
Article 14
Entry into force and duration
Article 15
Final provisions
ANNEX
PROCEDURES FOR THE DESIGNATION AND MONITORING OF CONFORMITY ASSESSMENT BODIES
A. GENERAL REQUIREMENTS AND CONDITIONS
B. SYSTEM TO DETERMINE CONFORMITY ASSESSMENT BODIES' COMPETENCE
C. EVALUATION OF THE DESIGNATION SYSTEM
D. FORMAL DESIGNATION
E.
MONITORING
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
Certification of manufacturers
Batch certification
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
SECTION II
OFFICIAL INSPECTION SERVICES
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
2.
Inspection reports
3.
Reference GMP
4.
Nature of inspections
5.
Inspection/establishment fees
6.
Safeguard clause for inspections
7.
Exchange of information between authorities and approximation of quality requirements
8.
Official batch release
9.
Inspectors training
10.
Joint inspections
11.
Alert system
12.
Contact points
FOR AUSTRALIA: |
For medicinal products for human use:
For medicinal products for use in animals:
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FOR THE EUROPEAN COMMUNITY: |
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13.
Divergence of views
SECTION IV
TRANSITIONAL ARRANGEMENTS FOR VETERINARY MEDICINAL PRODUCTS
Appendix 1
List of applicable legislative, regulatory and administrative provisions
For the European Community:
For Australia:
For products for human use:
For products for veterinary use:
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
Products for export to the European Community |
Products for export to Australia |
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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:
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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:
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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 |
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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 |
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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 |
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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:
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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
2.
Medical devices incorporating medicinal substances
3.
Registration and listing procedures
4.
Exchange of information
6.
New legislation
7.
Divergence of views
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
Products for export to the European Community |
Products for export to Australia |
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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 |
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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 |
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Under the authority of the Government of Australia:
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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 |
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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 be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
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The procedures for designating conformity assessment bodies will be consistent with the principles and procedures set out in the Annex to the Agreement.
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SECTION V
ADDITIONAL PROVISIONS
TS 001 |
TS 002 |
TS 003 |
TS 004 |
TS 005 |
TS 006 |
TS 007 |
TS 008 |
TS 009 |
TS 0012 |
TS 0013.1 |
TS 0013.2 |
TS 0014 |
TS 0015 |
TS 0016 |
TS 0018 |
TS 0019 |
TS 0020 |
TS 0021.1 |
TS 0021.2 |
TS 0021.3 |
TS 0023 |
TS 0024 |
TS 0028 |
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
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 |
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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
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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 |
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Under the authority of the Government of Australia:
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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 |
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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 be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through:
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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
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
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 |
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Under the authority of the Government of Australia:
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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 |
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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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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
SECTORAL ANNEX ON MACHINERY TO THE EUROPEAN COMMUNITY-AUSTRALIA AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
SCOPE AND COVERAGE
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 |
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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
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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 |
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Under the authority of the Government of Australia:
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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 |
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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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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: |
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SECTION V
ADDITIONAL PROVISIONS
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
Products for export to the European Community |
Products for export to Australia |
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
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
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: |
[Names and details to be inserted] |
[Names and details to be inserted] |
[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
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
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
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
SECTION I
REGULATORY REQUIREMENTS
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
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
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
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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