[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: 21CFR26.61]

[Page 273]
 
                        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.  26.61  Purpose of this part.

    This part specifies the conditions by which each party will accept 
or recognize results of conformity assessment procedures, produced by 
the other party's conformity assessment bodies (CAB's) or authorities, 
in assessing conformity to the importing party's requirements, as 
specified on a sector-specific basis in subparts A and B of this part, 
and to provide for other related cooperative activities. The objective 
of such mutual recognition is to provide effective market access 
throughout the territories of the parties with regard to conformity 
assessment for all products covered under this part. If any obstacles to 
such access arise, consultations will promptly be held. In the absence 
of a satisfactory outcome of such consultations, the party alleging its 
market access has been denied may, within 90 days of such consultation, 
invoke its right to terminate the ``Agreement on Mutual Recognition 
Between the United States of America and the European Community,'' from 
which this part is derived, in accordance with Sec.  26.80.