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[2007 Index Page]
 



[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.75]

[Page 277]
 
                        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 
 
                   Subpart C_``Framework'' Provisions
 
Sec.  26.75  Suspension of recognition obligations.

    Either party may suspend its obligations under subpart A or B of 
this part, in whole or in part, if:
    (a) A party suffers a loss of market access for the party's products 
within the scope of subpart A or B of this part as a result of the 
failure of the other party to fulfill its obligations under this part;
    (b) The adoption of new or additional conformity assessment 
requirements as referenced in Sec.  26.73(e) results in a loss of market 
access for the party's products within the scope of subpart B of this 
part because conformity assessment bodies (CAB's) designated by the 
party in order to meet such requirements have not been recognized by the 
party implementing the requirements; or
    (c) The other party fails to maintain legal and regulatory 
authorities capable of implementing the provisions of this part.




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