|
Section 26.0
|
Definitions |
|
Section 26.1
|
Purpose |
|
Section 26.2
|
Scope |
|
Section 26.3
|
Product coverage |
|
Section 26.4
|
Length of transition period |
|
Section 26.5
|
Equivalence assessment |
|
Section 26.6
|
Participation in the equivalence assessment and determination |
|
Section 26.7
|
Other transition activities |
|
Section 26.8
|
Equivalence determination |
|
Section 26.9
|
Regulatory authorities not listed as currently equivalent |
|
Section 26.10
|
Start of operational period |
|
Section 26.11
|
Nature of recognition of inspection reports |
|
Section 26.12
|
Transmission of postapproval inspection reports |
|
Section 26.13
|
Transmission of preapproval inspection reports |
|
Section 26.14
|
Monitoring continued equivalence |
|
Section 26.15
|
Suspension |
|
Section 26.16
|
Role and composition of the Joint Sectoral Committee |
|
Section 26.17
|
Regulatory collaboration |
|
Section 26.18
|
Information relating to quality aspects |
|
Section 26.19
|
Alert system |
|
Section 26.20
|
Safeguard clause |
|
Section 26.21
|
Purpose |
|
Section 26.31
|
Scope |
|
Section 26.32
|
Product coverage |
|
Section 26.33
|
Regulatory authorities |
|
Section 26.34
|
Length and purpose of transition period |
|
Section 26.35
|
Listing of CAB's |
|
Section 26.36
|
Confidence building activities |
|
Section 26.37
|
Other transition period activities |
|
Section 26.38
|
Equivalence assessment |
|
Section 26.39
|
Start of the operational period |
|
Section 26.40
|
Exchange and endorsement of quality system evaluation reports |
|
Section 26.41
|
Exchange and endorsement of product evaluation reports |
|
Section 26.42
|
Transmission of quality system evaluation reports |
|
Section 26.43
|
Transmission of product evaluation reports |
|
Section 26.44
|
Monitoring continued equivalence |
|
Section 26.45
|
Listing of additional CAB's |
|
Section 26.46
|
Role and composition of the Joint Sectoral Committee |
|
Section 26.47
|
Harmonization |
|
Section 26.48
|
Regulatory cooperation |
|
Section 26.49
|
Alert system and exchange of postmarket vigilance reports |
|
Section 26.50
|
Definitions |
|
Section 26.60
|
Purpose of this part |
|
Section 26.61
|
General obligations |
|
Section 26.62
|
General coverage of this part |
|
Section 26.63
|
Transitional arrangements |
|
Section 26.64
|
Designating authorities |
|
Section 26.65
|
Designation and listing procedures |
|
Section 26.66
|
Suspension of listed conformity assessment bodies |
|
Section 26.67
|
Withdrawal of listed conformity assessment bodies |
|
Section 26.68
|
Monitoring of conformity assessment bodies |
|
Section 26.69
|
Conformity assessment bodies |
|
Section 26.70
|
Exchange of information |
|
Section 26.71
|
Sectoral contact points |
|
Section 26.72
|
Joint Committee |
|
Section 26.73
|
Preservation of regulatory authority |
|
Section 26.74
|
Suspension of recognition obligations |
|
Section 26.75
|
Confidentiality |
|
Section 26.76
|
Fees |
|
Section 26.77
|
Agreements with other countries |
|
Section 26.78
|
Territorial application |
|
Section 26.79
|
Entry into force, amendment, and termination |
|
Section 26.80
|
Final provisions |
|
Section 26.81
|
Scope |