[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.16]

[Page 254-255]
 
                        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 REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
     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

[[Page 255]]

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.