[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: 21CFR26.73]
[Page 276]
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. 26.73 Joint Committee.
(a) A Joint Committee consisting of representatives of the United
States and the European Community (EC) will be established. The Joint
Committee shall be responsible for the effective functioning of the
``Agreement on Mutual Recognition Between the United States of America
and the European Community,'' from which this part is derived.
(b) The Joint Committee may establish Joint Sectoral Committees
comprised of appropriate regulatory authorities and others deemed
necessary.
(c) The United States and the EC shall each have one vote in the
Joint Committee. The Joint Committee shall make its decisions by
unanimous consent. The Joint Committee shall determine its own rules and
procedures.
(d) The Joint Committee may consider any matter relating to the
effective functioning of that agreement. In particular it shall be
responsible for:
(1) Listing, suspension, withdrawal and verification of conformity
assessment bodies (CAB's) in accordance with that agreement;
(2) Amending transitional arrangements in the sectoral annexes to
that agreement;
(3) Resolving any questions relating to the application of that
agreement not otherwise resolved in the respective Joint Sectoral
Committees;
(4) Providing a forum for discussion of issues that may arise
concerning the implementation of that agreement;
(5) Considering ways to enhance the operation of that agreement;
(6) Coordinating the negotiation of additional sectoral annexes to
that agreement; and
(7) Considering whether to amend that agreement in accordance with
Sec. 26.80.
(e) When a party introduces new or additional conformity assessment
procedures affecting a sectoral annex to that agreement, the parties
shall discuss the matter in the Joint Committee with a view to bringing
such new or additional procedures within the scope of that agreement and
the relevant sectoral annex.
[[Page 277]]
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