[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.
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