Individuals & Families
Small Businesses
Nonprofits
Employers
Employee Benefits Brokers
PEOs
Credit Unions
Membership Groups
Legal Information
Sign In
/
U.S. Code of Federal Regula...
/
Title 21-Food and Drugs
/
CHAPTER I—FOOD AND DRUG ADM...
/
PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GO...
PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
§ 26.0 - General.
§ 26.1 - Definitions.
§ 26.2 - Purpose.
§ 26.3 - Scope.
§ 26.4 - Product coverage.
§ 26.5 - Length of transition period.
§ 26.6 - Equivalence assessment.
§ 26.7 - Participation in the equivalence assessment and determination.
§ 26.8 - Other transition activities.
§ 26.9 - Equivalence determination.
§ 26.10 - Regulatory authorities not listed as currently equivalent.
§ 26.11 - Start of operational period.
§ 26.12 - Nature of recognition of inspection reports.
§ 26.13 - Transmission of postapproval inspection reports.
§ 26.14 - Transmission of preapproval inspection reports.
§ 26.15 - Monitoring continued equivalence.
§ 26.16 - Suspension.
§ 26.17 - Role and composition of the Joint Sectoral Committee.
§ 26.18 - Regulatory collaboration.
§ 26.19 - Information relating to quality aspects.
§ 26.20 - Alert system.
§ 26.21 - Safeguard clause.
§ 26.31 - Purpose.
§ 26.32 - Scope.
§ 26.33 - Product coverage.
§ 26.34 - Regulatory authorities.
§ 26.35 - Length and purpose of transition period.
§ 26.36 - Listing of CAB's.
§ 26.37 - Confidence building activities.
§ 26.38 - Other transition period activities.
§ 26.39 - Equivalence assessment.
§ 26.40 - Start of the operational period.
§ 26.41 - Exchange and endorsement of quality system evaluation reports.
§ 26.42 - Exchange and endorsement of product evaluation reports.
§ 26.43 - Transmission of quality system evaluation reports.
§ 26.44 - Transmission of product evaluation reports.
§ 26.45 - Monitoring continued equivalence.
§ 26.46 - Listing of additional CAB's.
§ 26.47 - Role and composition of the Joint Sectoral Committee.
§ 26.48 - Harmonization.
§ 26.49 - Regulatory cooperation.
§ 26.50 - Alert system and exchange of postmarket vigilance reports.
§ 26.60 - Definitions.
§ 26.61 - Purpose of this part.
§ 26.62 - General obligations.
§ 26.63 - General coverage of this part.
§ 26.64 - Transitional arrangements.
§ 26.65 - Designating authorities.
§ 26.66 - Designation and listing procedures.
§ 26.67 - Suspension of listed conformity assessment bodies.
§ 26.68 - Withdrawal of listed conformity assessment bodies.
§ 26.69 - Monitoring of conformity assessment bodies.
§ 26.70 - Conformity assessment bodies.
§ 26.71 - Exchange of information.
§ 26.72 - Sectoral contact points.
§ 26.73 - Joint Committee.
§ 26.74 - Preservation of regulatory authority.
§ 26.75 - Suspension of recognition obligations.
§ 26.76 - Confidentiality.
§ 26.77 - Fees.
§ 26.78 - Agreements with other countries.
§ 26.79 - Territorial application.
§ 26.80 - Entry into force, amendment, and termination.
§ 26.81 - Final provisions.