[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: 21CFR26.62]

[Page 277]
 
                        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. 26.62   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.