Agreement on mutual recognition in relation to conformity assessment, certifi... (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
- 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
- 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
- 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
- SECTION I
- LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
- SECTION II
- DESIGNATED CONFORMITY ASSESSMENT BODIES
- SECTION III
- THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
- SECTION IV
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- 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
- SECTION I
- LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
- SECTION II
- DESIGNATED CONFORMITY ASSESSMENT BODIES
- SECTION III
- THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
- SECTION IV
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- SECTION V
- ADDITIONAL PROVISIONS
- 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
- SECTION II
- DESIGNATED CONFORMITY ASSESSMENT BODIES
- SECTION III
- THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
- SECTION IV
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- 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
- SECTION II
- DESIGNATED CONFORMITY ASSESSMENT BODIES
- SECTION III
- THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
- SECTION IV
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- 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
- SECTION II
- DESIGNATED CONFORMITY ASSESSMENT BODIES
- SECTION III
- THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
- SECTION IV
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- 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
- SECTION I
- LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
- SECTION II
- DESIGNATED CONFORMITY ASSESSMENT BODIES
- SECTION III
- THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II
- SECTION IV
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- 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
- SECTION II
- DESIGNATED CONFORMITY ASSESSMENT BODIES
- SECTION III
- AUTHORITIES RESPONSIBLE FOR DESIGNATING CONFORMITY OF ASSESSMENT BODIES
- SECTION IV
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- SECTION V
- ADDITIONAL PROVISIONS
- 1.
- Lighting
- 2.
- Standstill
- 3.
- Review
- 4.
- Extension
- FINAL ACT
- ANNEX
- Joint Declaration relating to future work on implementing arrangements for this Agreement
- 1.
- Pressure Equipment
- 2.
- Aircraft certification and continued airworthiness
- 3.
- Inclusion of other Sectoral Annexes
- Joint Declaration on mutual recognition in the voluntary sphere
- Joint Declaration relating to further developing harmonisation of technical regulations and conformity assessment procedures
- Joint Declaration relating to the review of Article 4 of the Agreement
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