INHALT

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