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Title 21 - Food and Drugs
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
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| 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. | ||