[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: 21CFR26.80]
[Page 278]
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. 26.80 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.
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