[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.11]

[Page 253]
 
                        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--Table of Contents
 
     Subpart A--Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices
 
Sec. 26.11   Start of operational period.

    (a) The operational period shall start at the end of the transition 
period and its provisions apply to inspection reports generated by 
authorities listed as equivalent for the inspections performed in their 
territory.
    (b) In addition, when an authority is not listed as equivalent based 
on adequate experience gained during the transition period, the Food and 
Drug Administration (FDA) will accept for normal endorsement (as 
provided in Sec. 26.12) inspection reports generated as a result of 
inspections conducted jointly by that authority on its territory and 
another authority listed as equivalent, provided that the authority of 
the Member State in which the inspection is performed can guarantee 
enforcement of the findings of the inspection report and require that 
corrective measures be taken when necessary. FDA has the option to 
participate in these inspections, and based on experience gained during 
the transition period, the parties will agree on procedures for 
exercising this option.
    (c) In the European Community (EC), the qualified person will be 
relieved of responsibility for carrying the controls laid down in 
Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix 
A of this subpart) provided that these controls have been carried out in 
the United States and that each batch/lot is accompanied by a batch 
certificate (in accordance with the World Health Organization 
Certification Scheme on the Quality of Medicinal Products) issued by the 
manufacturer certifying that the product complies with requirements of 
the marketing authorization and signed by the person responsible for 
releasing the batch/lot.

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