INHALT

Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand - Final Act - Joint Declarations

AGREEMENT
on mutual recognition in relation to conformity assessment between the European Community and New Zealand
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
(a)
Accreditation
(b)
Other means
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-NEW ZEALAND 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 New Zealand:
Appendix 2
SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITYASSESSMENT, 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.
Medical devices incorporating medicinal substances
2.
New legislation
3.
Exchange of information
4.
Subcontracting
5.
Recording of approvals granted
6.
Divergence of views
SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT TO THE EUROPEAN COMMUNITY-NEW ZEALAND 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-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITYASSESSMENT, 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-NEW ZEALAND 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-NEW ZEALAND 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-NEW ZEALAND 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
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