[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26A App A]

[Page 252]

                        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. Appendix A to Subpart A of Part 26--List of Applicable Laws,
               Regulations, and Administrative Provisions

                   1. For the European Community (EC):

    [Copies of EC documents may be obtained from the European Document
Research, 1100 17th St. NW., suite 301, Washington, DC 20036. EC
documents may be viewed on the European Commission Pharmaceuticals Units
web site at http://dg3.eudra.org.]
Council Directive 65/65/EEC of 26 January 1965 on the approximation of
provisions laid down by law, regulation, or administrative action
relating to proprietary medicinal products as extended, widened, and
amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of
provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products as extended, widened and
amended.
Council Directive 81/851/EEC of 28 September 1981 on the approximation
of the laws of the Member States relating to veterinary medicinal
products, as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the
principles and guidelines of good manufacturing practice for medicinal
products for human use.
Commission Directive 91/412/EEC of 23 July 1991 laying down the
principles and guidelines of good manufacturing practice for veterinary
medicinal products.
Council Regulation EEC No 2309/93 of 22 July 1993 laying down Community
procedures for the authorization and supervision of medicinal products
for human and veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale
distribution of medicinal products for human use.
Guide to Good Distribution Practice (94/C 63/03).
Current version of the Guide to Good Manufacturing Practice, Rules
Governing Medicinal Products in the European Community, Volume IV.

                        2. For the United States:

    [Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents,
except the FDA Compliance Program Guidance Manual, may be viewed on
FDA's Internet web site at http://www.fda.gov.]
Relevant sections of the United States Federal Food, Drug, and Cosmetic
Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal Regulations
(CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799.
Relevant sections of the FDA Investigations Operations Manual, the FDA
Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual,
the FDA Compliance Program Guidance Manual, and other FDA guidances.