[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: 21CFR26.66]
[Page 274]
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. 26.66 Designation and listing procedures.
The following procedures shall apply with regard to the designation
of conformity assessment bodies (CAB's) and the inclusion of such bodies
in the list of CAB's in subpart B of this part:
(a) The designating authority identified in subpart B of this part
shall designate CAB's in accordance with the procedures and criteria set
forth in subpart B of this part;
(b) A party proposing to add a CAB to the list of such bodies in
subpart B of this part shall forward its proposal of one or more
designated CAB's in writing to the other party with a view to a decision
by the Joint Committee;
(c) Within 60 days following receipt of the proposal, the other
party shall indicate its position regarding either its confirmation or
its opposition. Upon confirmation, the inclusion in subpart B of this
part of the proposed CAB or CAB's shall take effect; and
(d) In the event that the other party contests on the basis of
documented evidence the technical competence or compliance of a proposed
CAB, or indicates in writing that it requires an additional 30 days to
more fully verify such evidence, such CAB shall not be included on the
list of CAB's in subpart B of this part. In this instance, the Joint
Committee may decide that the body concerned be verified. After the
completion of such verification, the proposal to list the CAB in subpart
B may be resubmitted to the other party.
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