[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: 21CFR26.14]

[Page 254]
 
                        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. 26.14   Transmission of preapproval inspection reports.

    (a) A preliminary notification that an inspection may have to take 
place will be made as soon as possible.
    (b) Within 15-calendar days, the relevant authority will acknowledge 
receipt of the request and confirm its ability to carry out the 
inspection. In the European Community (EC), requests will be sent 
directly to the relevant authority, with a copy to the European Agency 
for the Evaluation of Medicinal Products (EMEA). If the authority 
receiving the request cannot carry out the inspection as requested, the 
requesting authority shall have the right to conduct the inspection.
    (c) Reports of preapproval inspections will be sent within 45-
calendar days of the request that transmitted the appropriate 
information and detailed the precise issues to be addressed during the 
inspection. A shorter time may be necessary in exceptional cases and 
these will be described in the request.