Agreement on mutual recognition between the European Community and Canada (21998A1016(01))
Agreement on mutual recognition between the European Community and Canada
- AGREEMENT
- on mutual recognition between the European Community and Canada
- Article I
- Definitions
- Article II
- General obligations
- Article III
- General coverage of the Agreement
- Article IV
- Transitional arrangements
- Article V
- Civil liability
- Article VI
- Designating authorities
- Article VII
- Conformity assessment bodies
- Article VIII
- Verification and suspension of conformity assessment bodies
- Article IX
- Exchange of information
- Article X
- Monitoring of the Agreement
- Article XI
- Joint Committee
- Article XII
- Joint sectoral groups
- Article XIII
- Sectoral contact point, management of information, assistance and emergency action
- Article XIV
- Safeguards
- Article XV
- Market access
- Article XVI
- Fees
- Article XVII
- Agreements with other countries
- Artide XVIII
- Territorial application
- Article XIX
- Entry into force, modification and duration
- Article XX
- Final provisions
- SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT, INFORMATION TECHNOLOGY EQUIPMENT AND RADIO TRANSMITTERS
- 1. PURPOSE
- 2. SCOPE AND COVERAGE
- 3. THE APPROVAL REQUIREMENTS
- 4. CONFORMITY ASSESSMENT ACTIVITIES
- 5. INSTITUTIONS
- 6. TRANSITIONAL ARRANGEMENT
- 7. ADDITIONAL PROVISIONS
- Subcontracting
- Post-market surveillance
- Joint Telecommunications Group
- Exchange of information and mutual assistance
- Regulatory changes and updating the Annex
- Cross-referencing
- Attachment 1
- Legislative, regulatory and administrative provisions
- Attachment 2
- Coverage
- Attachment 3
- Designating authorities
- Attachment 4
- Designated conformity assessment bodies
- Attachment 5
- Approval authorities
- Appendix 1
- RADIO TRANSMITTERS STANDARDS LIST UNDER RADIOCOMMUNICATION REGULATIONS
- SECTORAL ANNEX ON ELECTROMAGNETIC COMPATIBILITY (EMC)
- 1. SCOPE AND COVERAGE
- 2. THE REQUIREMENTS
- 3. CONFORMITY ASSESSMENT ACTIVITIES
- 4. INSTITUTIONS
- 4.1.
- Designating authorities
- 4.2.
- Designated conformity assessment bodies
- 5. TRANSITIONAL ARRANGEMENT
- 6. ADDITIONAL PROVISIONS
- Subcontracting
- Post-market surveillance
- Exchange of information and mutual assistance
- Regulatory changes and updating the Annex
- Cross-referencing
- Attachment 1
- Legislative, regulatory and administrative provisions
- Attachment 2
- Designating authorities
- Attachment 3
- Designated conformity assessment bodies
- Appendix 1
- Interference-causing equipment standards
- SECTORAL ANNEX ON ELECTRICAL SAFETY
- 1. PURPOSE
- 2. SCOPE AND COVERAGE
- 3. RESPONSIBLE/DESIGNATING AUTHORITIES
- 4. TRANSITION PHASE
- 5. OPERATION OF THE TRANSITION PHASE
- 6. MARKING OF CONFORMITY
- 7. OPERATIONAL PHASE
- 8. LIMITED SCOPE OR DENIAL OF RECOGNITION FOR THE PURPOSES OF CERTIFICATION
- 9. FOLLOW UP OF CERTIFICATION ACTIVITIES
- 10. JOINT ELECTRICAL SAFETY GROUP
- Attachment 1
- Legislative, regulatory and administrative requirements and regulatory authorities
- (
- re
- Articles 2(3) and 9(1))
- Attachment 2
- Designating authorities
- SECTORAL ANNEX ON RECREATIONAL CRAFT
- SECTION I
- Scope and coverage
- SECTION II
- Legislative, regulatory and administrative requirements
- SECTION III
- Authorities responsible for designating the conformity assessment bodies as specified by conformity assessment modules
- SECTION IV
- Procedures for designating conformity bodies
- SECTION V
- Transitional arrangement
- SECTION VI
- Additional provisions
- Attachment 1
- Designating authorities
- Attachment 2
- Designated conformity assessment bodies
- SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)
- 1. PURPOSE
- 2. GENERAL CONSIDERATIONS
- 3. SCOPE AND COVERAGE
- 4. CONFIDENTIALITY
- 5. MANAGEMENT MECHANISMS
- 6. RESOLUTION OF DIVERGENT VIEWS
- 7. TRANSITION PERIOD
- 7.1.
- Time frame
- 7.2.
- Confidence building programme
- 7.3.
- Budget
- 7.4.
- Administrative provision
- 7.5.
- End of transitional period
- 8. OPERATIONAL PHASE
- 8.1.
- General provisions
- 8.1.5.
- Certification of manufacturers
- 8.1.6.
- Batch certification
- 8.1.7.
- Fees
- 8.2.
- Information sharing
- 8.3.
- Two-way alert system
- 9. MONITORING OF THE AGREEMENT
- 10. APPENDICES
- Appendix 1
- 1.
- List of applicable legislation
- 2.
- Indicative list of products
- Appendix 2
- Authorities
- Appendix 3
- Joint sectoral group
- Appendix 4
- Components of a GMP compliance programme
- 1.
- Legislative and regulatory requirements and scope
- 2.
- Regulatory directives and policies
- 3.
- Good manufacturing practices (GMP) standards
- 4.
- Inspection resources
- 5.
- Inspection procedures (pre-inspection, inspection, and post-inspection activities)
- 6.
- Inspection performance standards
- 7.
- Enforcement powers and procedures
- 8.
- Alert and crisis systems
- 9.
- Analytical capability
- 10.
- Surveillance programme/measures (used by firms and by regulatory authority)
- 11.
- Quality management systems
- Appendix 5
- Components of a ‘two-way’ alert programme
- 1.
- Documentation
- 2. Crisis
- management system
- 3.
- Enforcement procedures
- 4.
- Quality assurance system
- Contact points
- Appendix 6
- Phases of a confidence building period
- Appendix 7
- Certificate of pharmaceutical manufacturer in the framework of the Agreement on mutual recognition between Canada and the European Community, Sectoral Annex on medicinal products GMP inspection and batch certification
- SECTORAL ANNEX ON MEDICAL DEVICES
- 1. PURPOSE
- 2. SCOPE AND COVERAGE
- 3. CONFIDENTIALITY
- 4. RESOLUTION OF DIVERGENT VIEWS
- 5. MANAGEMENT MECHANISM
- 6. TRANSITION PERIOD
- 7. OPERATIONAL PHASE
- 8. ATTACHMENTS
- Attachment I
- Attachment II
- Designated conformity assessment bodies and their respective designating authorities
- Attachment III
- Phases and elements of a confidence building programme
- A. REVIEW AND EVALUATION OF ELEMENTS OF CONFORMITY ASSESSMENT (EXCHANGE OF DOCUMENTATION)
- 1.
- Legislative and regulatory requirements and scope
- 2.
- Regulatory directives and policies
- 3.
- Quality audit management, methodology and practices
- 4.
- Scientific technical evaluation methodology and practices
- 5.
- Evaluation and auditing reports
- 6.
- Auditing and evaluation procedures
- 7.
- Auditing and evaluation performance standards
- 8.
- Enforcement powers and procedures
- 9.
- Alert and crisis systems
- 10.
- Analytical capability
- 11.
- Surveillance programme/measures (used by manufacturers and by regulatory authorities)
- 12.
- Quality management systems
- B. INTER-COMPARISON EXERCISE
- C. DECISION MAKING ON THE SUCCESS OF THE INTER-COMPARISON STUDY
- Attachment IV
- Components of a ‘two-way’ alert programme
- 1.
- Documentation
- 2.
- Crisis management system
- 3.
- Enforcement procedures
- 4.
- Quality assurance system
- Attachment V
- Guidelines: procedures for the designation and monitoring of conformity assessment bodies
- A. GENERAL REQUIREMENTS AND CONDITIONS
- B. SYSTEM TO DETERMINE CONFORMITY ASSESSMENT BODIES' CAPABILITIES
- C. EVALUATION OF THE DESIGNATION SYSTEM
- D. FORMAL DESIGNATION
- E. MONITORING
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