2013/1/EU: Council Decision of 20 November 2012 on the conclusion of a Protocol t... (32013D0001)
2013/1/EU: Council Decision of 20 November 2012 on the conclusion of a Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA)
- COUNCIL DECISION
- of 20 November 2012
- on the conclusion of a Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA)
- (2013/1/EU)
- Article 1
- Article 2
- Article 3
- Article 4
- PROTOCOL
- to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA)
- Article 1
- Purpose and means
- Article 2
- Definitions
- Article 3
- Alignment of legislation
- Article 4
- Technical infrastructure
- Article 5
- Mutual acceptance of industrial products including their conformity assessment
- Article 6
- Safeguard clause
- Article 7
- Extension of coverage
- Article 8
- Obligations of parties as regards their responsible authorities and notified bodies
- Article 9
- Procedures for the recognition of responsible authorities and the notification of notified bodies
- Article 10
- Verification of notified bodies
- Article 11
- Exchange of information and cooperation
- Article 12
- Confidentiality
- Article 13
- Management of this Protocol
- Article 14
- Technical cooperation
- Article 15
- Agreements with other countries
- Article 16
- Entry into force
- Article 17
- Duration
- Article 18
- Languages
- ANNEX
- ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS
- Pharmaceutical Good Manufacturing Practice (GMP)
- SECTION I
- EU and national law
- SECTION II
- Scope and coverage
- 1. Scope
- 2. Exclusions
- 3. Maintenance, publication and extension of coverage and exclusion
- SECTION III
- Responsible authorities
- EU
- Israel
- SECTION IV
- Specific arrangements
- 1. Definitions
- 2. Obligations of the Parties
- 3. Exchange of manufacturing/import authorisations and GMP compliance information
- 4. Exchange of inspection reports
- 5. Exchange of results of laboratory testing performed by OMCLs
- 6. Exchange of results of Official Control Authority Batch Release (OCABR)
- 7. Format of Information exchange
- 8. Safeguard clause
- 9. Alert System
- 10. Information and Cooperation
- 11. Contact points
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