[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: 21CFR26.62]
[Page 273]
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. 26.62 General obligations.
(a) The United States shall, as specified in subparts A and B of
this part, accept or recognize results of specified procedures, used in
assessing conformity to specified legislative, regulatory, and
administrative provisions of the United States, produced by the other
party's conformity assessment bodies (CAB's) and/or authorities.
(b) The European Community (EC) and its Member States shall, as
specified in subparts A and B of this part, accept or recognize results
of specified procedures, used in assessing conformity to specified
legislative, regulatory, and administrative provisions of the EC and its
Member States, produced by the other party's CAB's and/or authorities.
(c) Where sectoral transition arrangements have been specified in
subparts A and B of this part, the obligations in paragraphs (a) and (b)
of this section will apply following the successful completion of those
sectoral transition arrangements, with the understanding that the
conformity assessment procedures utilized assure conformity to the
satisfaction of the receiving party, with applicable legislative,
regulatory, and administrative provisions of that party, equivalent to
the assurance offered by the receiving party's own procedures.
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