[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: 21CFR26.80]

[Page 282]
 
                        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 C--``Framework'' Provisions
 
Sec. 26.80   Entry into force, amendment, and termination.

    (a) The ``Agreement on Mutual Recognition Between the United States 
of America and the European Community,'' from which this part is 
derived, including its sectoral annexes on telecommunication equipment, 
electromagnetic compatibility, electrical safety, recreational craft, 
pharmaceutical Good Manufacturing Practices (GMP) inspections, and 
medical devices shall enter into force on the first day of the second 
month following the date on which the parties have exchanged letters 
confirming the completion of their respective procedures for the entry 
into force of that agreement.
    (b) That agreement including any sectoral annex may, through the 
Joint Committee, be amended in writing by the parties to that agreement. 
Those parties may add a sectoral annex upon the exchange of letters. 
Such annex shall enter into force 30 days following the date on which 
those parties have exchanged letters confirming the completion of their 
respective procedures for the entry into force of the sectoral annex.
    (c) Either party to that agreement may terminate that agreement in 
its entirety or any individual sectoral annex thereof by giving the 
other party to that agreement 6-months notice in writing. In the case of 
termination of one or more sectoral annexes, the parties to that 
agreement will seek to achieve by consensus to amend that agreement, 
with a view to preserving the remaining Sectoral Annexes, in accordance 
with the procedures in this section. Failing such consensus, that 
agreement shall terminate at the end of 6 months from the date of 
notice.
    (d) Following termination of that agreement in its entirety or any 
individual sectoral annex thereof, a party to that agreement shall 
continue to accept the results of conformity assessment procedures 
performed by conformity assessment bodies under that agreement prior to 
termination, unless a regulatory authority in the party decides 
otherwise based on health, safety and environmental considerations or 
failure to satisfy other requirements within the scope of the applicable 
sectoral annex.