[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.20]

[Page 258]
 
                        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 A--Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices
 
Sec. 26.20   Alert system.

    (a) The details of an alert system will be developed during the 
transitional period. The system will be maintained in place at all 
times. Elements to be considered in developing such a system are 
described in Appendix E of this subpart.
    (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, recalls, counterfeiting, and other problems concerning 
quality, which could necessitate additional controls or suspension of 
the distribution of the product.