[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: 21CFR26.16]
[Page 250]
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 A Specific Sector Provisions for Pharmaceutical Good
Manufacturing Practices
Sec. 26.16 Suspension.
(a) Each party has the right to contest the equivalence of a
regulatory authority. This right will be exercised in an objective and
reasoned manner in writing to the other party.
(b) The issue shall be discussed in the Joint Sectoral Committee
promptly upon such notification. Where the Joint Sectoral Committee
determines that verification of equivalence is required, it may be
carried out jointly by the parties in a timely manner, under Sec. 26.6.
(c) Efforts will be made by the Joint Sectoral Committee to reach
unanimous consent on the appropriate action. If agreement to suspend is
reached in the Joint Sectoral Committee, an authority may be suspended
immediately thereafter. If no agreement is reached in the Joint Sectoral
Committee, the matter is referred to the Joint Committee as described in
Sec. 26.73. If no unanimous consent is reached within 30 days after
such notification, the contested authority will be suspended.
(d) Upon the suspension of authority previously listed as
equivalent, a party is no longer obligated to normally endorse the
inspection reports of the suspended authority. A party shall continue to
normally endorse the inspection reports of that authority prior to
suspension, unless the authority of the receiving party decides
otherwise based on health or safety considerations. The suspension will
remain in effect until unanimous consent has been reached by the parties
on the future status of that authority.
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