2012/828/EU: Council Decision of 13 November 2012 on the conclusion of the Agreem... (32012D0828)
2012/828/EU: Council Decision of 13 November 2012 on the conclusion of the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
- COUNCIL DECISION
- of 13 November 2012
- on the conclusion of the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
- (2012/828/EU)
- Article 1
- Article 2
- Article 3
- AGREEMENT
- between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
- Article 1
- Amendments to the Agreement on Mutual Recognition
- ‘Article 4
- Scope and coverage
- ‘Article 6
- Designating authorities
- ‘Article 9
- Exchange of information
- ‘SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY – NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT
- 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.
- Joint Sectoral Group
- 14.
- Divergence of views
- SECTION IV
- CHANGES TO THE LIST OF OFFICIAL INSPECTION SERVICES
- SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY — NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT
- SCOPE AND COVERAGE
- SECTION I
- LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
- SECTION II
- THE AUTHORITIES RESPONSIBLE FOR DESIGNATING CONFORMITY ASSESSMENT BODIES UNDER THIS SECTORAL ANNEX
- SECTION III
- PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES
- SECTION IV
- ADDITIONAL PROVISIONS
- 1.
- New legislation
- 2.
- Exchange of information
- 3.
- Subcontracting
- 4.
- Recording of approvals granted
- 5.
- Confidence-building with respect to high-risk devices
- 6.
- Joint Sectoral Group
- 7.
- Divergence of views
- Appendix
- Article 2
- Entry into force
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