[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: 21CFR26.68]
[Page 275]
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. 26.68 Withdrawal of listed conformity assessment bodies.
The following procedures shall apply with regard to the withdrawal
from subpart B of this part of a conformity assessment body (CAB):
(a) A party proposing to withdraw a CAB listed in subpart B of this
part shall forward its proposal in writing to the other party;
(b) Such CAB shall be promptly notified by the other party and shall
be provided a period of at least 30 days from receipt to provide
information in order to refute or to correct the deficiencies which form
the basis of the proposed withdrawal;
(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 withdrawal from the list in
subpart B of this part of the CAB shall take effect;
(d) In the event the other party opposes the proposal to withdraw by
supporting the technical competence and compliance of the CAB, the CAB
shall not at that time be withdrawn from the list of CAB's in subpart B
of this part. In this instance, the Joint Sectoral Committee or the
Joint Committee may decide to carry out a joint verification of the body
concerned. After the completion of such verification, the proposal for
withdrawal of the CAB may be resubmitted to the other party; and
(e) Subsequent to the withdrawal of a CAB listed in subpart B of
this part, a party shall continue to accept the results of conformity
assessment procedures performed by that CAB prior to withdrawal, unless
a regulatory authority of the party decides otherwise based on health,
safety, and environmental considerations or failure to satisfy other
requirements within the scope of subpart B of this part.
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