[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: 21CFR26.64]

[Page 278]
 
                        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. 26.64   Transitional arrangements.

    The parties agree to implement the transitional commitments on 
confidence building as specified in subparts A and B of this part.
    (a) The parties agree that each sectoral transitional arrangement 
shall specify a time period for completion.
    (b) The parties may amend any transitional arrangement by mutual 
agreement.
    (c) Passage from the transitional phase to the operational phase 
shall proceed as specified in subparts A and B of this part, unless 
either party documents that the conditions provided in such subpart for 
a successful transition are not met.