[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.71]

[Page 280]
 
                        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 REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
                   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.