Agreement on mutual recognition between the European Community and the United... (21999A0204(01))
Agreement on mutual recognition between the European Community and the United States of America - Joint Declaration
- AGREEMENT
- on mutual recognition between the European Community and the United States of America
- Article 1
- Definitions
- Article 2
- Purpose of the Agreement
- Article 3
- General obligations
- Article 4
- General coverage of the Agreement
- Article 5
- Transitional arrangements
- Article 6
- Designating Authorities
- Article 7
- Designation and listing procedures
- Article 8
- Suspension of listed conformity assessment bodies
- Article 9
- Withdrawal of listed conformity assessment bodies
- Article 10
- Monitoring of conformity assessment bodies
- Article 11
- Conformity assessment bodies
- Article 12
- Exchange of information
- Article 13
- Sectoral contact points
- Article 14
- Joint Committee of the Parties
- Article 15
- Preservation of regulatory authority
- Article 16
- Suspension of recognition obligations
- Article 17
- Confidentiality
- Article 18
- Fees
- Article 19
- Agreements with other countries
- Article 20
- Territorial application
- Article 21
- Entry into force, amendment and termination
- Article 22
- Final provisions
- SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT
- PREAMBLE
- SECTION I
- LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
- SECTION II
- SCOPE AND COVERAGE
- SECTION III
- CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT
- 1.
- Description of Mutual Recognition Obligations
- 2.
- Conformity Assessment Procedures
- SECTION IV
- AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
- SECTION V
- CONFORMITY ASSESSMENT BODIES
- SECTION VI
- DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
- SECTION VII
- ADDITIONAL PROVISIONS
- 1.
- Sub-contracting
- 2.
- Post-market surveillance, border measures and internal movement
- 3.
- Joint Sectoral Committee
- 4.
- Contact point
- 5.
- Regulatory changes and updating the Sectoral Annex
- SECTION VIII
- TRANSITIONAL ARRANGEMENT
- Appendix 1
- Lists of acronyms and glossary
- SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC)
- PREAMBLE
- SECTION I
- LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
- SECTION II
- SCOPE AND COVERAGE
- SECTION III
- CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II
- 1.
- Description of Mutual Recognition Obligations
- 2.
- Conformity Assessment Procedures
- SECTION IV
- AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
- SECTION V
- CONFORMITY ASSESSMENT BODIES
- SECTION VI
- DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
- SECTION VII
- ADDITIONAL PROVISIONS
- 1.
- Sub-contracting
- 2.
- Post-market surveillance, border measures and internal movement
- 3.
- Joint Sectoral Committee
- 4.
- Contact point
- 5.
- Regulatory changes and updating the Sectoral Annex
- SECTION VIII
- TRANSITIONAL ARRANGEMENT
- SECTORAL ANNEXFOR ELECTRICAL SAFETY
- PREAMBLE
- SECTION I
- LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
- SECTION II
- SCOPE AND COVERAGE
- SECTION III
- DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS
- SECTION IV
- AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
- SECTION V
- CONFORMITY ASSESSMENT BODIES
- SECTION VI
- DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES
- SECTION VII
- JOINT SECTORAL COMMITTEEFORELECTRICAL SAFETY
- SECTORAL ANNEX FOR RECREATIONAL CRAFT
- PREAMBLE
- SECTION I
- LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS
- SECTION II
- SCOPE AND COVERAGE
- SECTION III
- AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES
- SECTION IV
- DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES
- SECTION V
- CONFORMITY ASSESSMENT BODIES
- SECTION VI
- TRANSITIONAL ARRANGEMENT
- SECTION VII
- ADDITIONAL PROVISIONS
- SECTION VIII
- DEFINITIONS
- SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs)
- PREAMBLE
- CHAPTER 1
- DEFINITIONS, PURPOSE, SCOPE AND COVERAGE
- Article 1
- Definitions
- Article 2
- Purpose
- Article 3
- Scope
- Article 4
- Product coverage
- CHAPTER 2
- TRANSITION PERIOD
- Article 5
- Length of transition period
- Article 6
- Equivalence assessment
- Article 7
- Participation in the equivalence assessment and determination
- Article 8
- Other transition activities
- CHAPTER 3
- END OF TRANSITION PERIOD
- Article 9
- Equivalence determination
- Article 10
- Authorities not currently listed as equivalent
- CHAPTER 4
- OPERATIONAL PERIOD
- Article 11
- Start of the operational period
- Article 12
- Nature of recognition of inspection reports
- Article 13
- Transmission of post-approval inspection reports
- Article 14
- Transmission of pre-approval inspection reports
- Article 15
- Monitoring continued equivalence
- Article 16
- Suspension
- CHAPTER 5
- JOINT SECTORAL COMMITTEE
- Article 17
- Role and composition of the Joint Sectoral Committee
- CHAPTER 6
- INFORMATION EXCHANGE
- Article 18
- Regulatory collaboration
- Article 19
- Information relating to quality aspects
- Article 20
- Alert System
- CHAPTER 7
- SAFEGUARD CLAUSE
- Article 21
- Appendix 1
- List of applicable laws, regulations and administrative provisions
- Appendix 2
- List of Authorities
- Appendix 3
- Indicative list of Products covered by the Sectoral Annex
- Appendix 4
- Criteria for Assessing Equivalence for Post- and Pre-Approval
- Appendix 5
- Elements to be Considered in Developing a Two-way Alert System
- 1.
- Documentation
- 2.
- Crisis Management System
- 3.
- Enforcement Procedures
- 4.
- Quality Assurance System
- 5.
- Contact points
- SECTORAL ANNEX ON MEDICAL DEVICES
- PREAMBLE
- CHAPTER 1
- PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX
- Article 1
- Purpose
- Article 2
- Scope
- Article 3
- Product Coverage
- Article 4
- Regulatory Authorities
- CHAPTER 2
- TRANSITION PERIOD
- Article 5
- Length and purpose of transition period
- Article 6
- Listing of CABs
- Article 7
- Confidence Building Activities
- Article 8
- Other transition period activities
- CHAPTER 3
- END OF TRANSITION PERIOD
- Article 9
- Equivalence Assessment
- CHAPTER 4
- OPERATIONAL PERIOD
- Article 10
- Start of the operational period
- Article 11
- Exchange and endorsement of quality system evaluation reports
- Article 12
- Exchange and endorsement of product evaluation reports
- Article 13
- Transmission of quality system evaluation reports
- Article 14
- Transmission of product evaluation reports
- Article 15
- Monitoring continued equivalence
- Article 16
- Listing of Additional CABs
- CHAPTER 5
- JOINT SPECIAL COMMITTEE
- Article 17
- Role and composition of the Joint Sectoral Committee
- CHAPTER 6
- HARMONISATION AND INFORMATION EXCHANGE
- Article 18
- Harmonisation
- Article 19
- Regulatory cooperation
- Article 20
- Alert system and exchange of post-market vigilance reports
- Appendix 1
- Relevant legislation, regulations and procedures
- Appendix 2
- Scope of product coverage
- Appendix 3
- Authorities responsible for designating conformity assessment bodies
- Appendix 4
- Conformity assessment bodies
- JOINT DECLARATION
- to the Agreement on Mutual Recognition between the European Community and the United States of America
Feedback