[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: 21CFR26.71]
[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. 26.71 Exchange of information.
(a) The parties shall exchange information concerning the
implementation of the legislative, regulatory, and administrative
provisions identified in subparts A and B of this part.
(b) Each party shall notify the other party of legislative,
regulatory, and administrative changes related to the subject matter of
this part at least 60 days before their entry into force. Where
considerations of safety, health or environmental protection require
more urgent action, a party shall notify the other party as soon as
practicable.
(c) Each party shall promptly notify the other party of any changes
to its designating authorities and/or conformity assessment bodies
(CAB's).
(d) The parties shall exchange information concerning the procedures
used to ensure that the listed CAB's under their responsibility comply
with the legislative, regulatory, and administrative provisions outlined
in subpart B of this part.
(e) Regulatory authorities identified in subparts A and B of this
part shall consult as necessary with their counterparts, to ensure the
maintenance of confidence in conformity assessment procedures and to
ensure that all technical requirements are identified and are
satisfactorily addressed.
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