[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: 21CFR26.63]
[Page 273-274]
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. 26.63 General coverage of this part.
(a) This part applies to conformity assessment procedures for
products and/or processes and to other related cooperative activities as
described in this part.
(b) Subparts A and B of this part may include:
(1) A description of the relevant legislative, regulatory, and
administrative provisions pertaining to the conformity assessment
procedures and technical regulations;
(2) A statement on the product scope and coverage;
(3) A list of designating authorities;
(4) A list of agreed conformity assessment bodies (CAB's) or
authorities or a source from which to obtain a list of such bodies or
authorities and a statement of the scope of the conformity assessment
procedures for which each has been agreed;
(5) The procedures and criteria for designating the CAB's;
(6) A description of the mutual recognition obligations;
(7) A sectoral transition arrangement;
(8) The identity of a sectoral contact point in each party's
territory; and
(9) A statement regarding the establishment of a Joint Sectoral
Committee.
(c) This part shall not be construed to entail mutual acceptance of
standards or technical regulations of the parties and, unless otherwise
specified in subpart A or B of this part, shall not entail the mutual
recognition of the
[[Page 274]]
equivalence of standards or technical regulations.
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