[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: 21CFR26.67]
[Page 274-275]
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. 26.67 Suspension of listed conformity assessment bodies.
The following procedures shall apply with regard to the suspension
of a conformity assessment body (CAB) listed in subpart B of this part.
(a) A party shall notify the other party of its contestation of the
technical competence or compliance of a CAB listed in subpart B of this
part and the contesting party's intent to suspend such CAB. Such
contestation shall be exercised when justified in an objective and
reasoned manner in writing to the other party;
(b) The CAB shall be given prompt notice by the other party and an
opportunity to present information in order to refute the contestation
or to correct the deficiencies which form the basis of the contestation;
(c) Any such contestation shall be discussed between the parties in
the Joint Sectoral Committee described in subpart B of this part. If
there is no Joint Sectoral Committee, the contesting party shall refer
the matter directly to the Joint Committee. If agreement to suspend is
reached by the Joint Sectoral Committee or, if there is no Joint
Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
(d) Where the Joint Sectoral Committee or Joint Committee decides
that verification of technical competence or compliance is required, it
shall normally be carried out in a timely manner by the party in whose
territory the body in question is located, but may be carried out
jointly by the parties in justified cases;
(e) If the matter has not been resolved by the Joint Sectoral
Committee within 10 days of the notice of
[[Page 275]]
contestation, the matter shall be referred to the Joint Committee for a
decision. If there is no Joint Sectoral Committee, the matter shall be
referred directly to the Joint Committee. If no decision is reached by
the Joint Committee within 10 days of the referral to it, the CAB shall
be suspended upon the request of the contesting party;
(f) Upon the suspension of a CAB listed in subpart B of this part, a
party is no longer obligated to accept or recognize the results of
conformity assessment procedures performed by that CAB subsequent to
suspension. A party shall continue to accept the results of conformity
assessment procedures performed by that CAB prior to suspension, unless
a regulatory authority of the party decides otherwise based on health,
safety or environmental considerations or failure to satisfy other
requirements within the scope of subpart B of this part; and
(g) The suspension shall remain in effect until agreement has been
reached by the parties upon the future status of that body.
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