[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 B]

[Page 252-253]

                        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 B to Subpart A of Part 26--List of Authorities

1. For the United States: In the United States, the regulatory authority
                  is the Food and Drug Administration.

2. For the European Community: In the European Community, the regulatory
                     authorities are the following:

Belgium: Inspection g[eacute]n[eacute]rale de la Pharmacie, Algemene
Farmaceutische Inspectie.
Denmark: Laegemiddelstyrelsen.
Germany: Bundesministerium f[uuml]r Gesundheit for immunologicals: Paul-
Ehrlich-Institut, Federal Agency for Sera and Vaccines.
Greece: [Egr][theta][nu][iota][kappa][omega][sigmav]
[Omega][rho][gamma][alpha][nu][iota][sigma][mu][omega][sigmav]
[Phi][alpha][rho][mu][alpha][kappa][omega][ugr], Ministry of Health and
Welfare, National Drug Organization (E.O.F).
Spain: For medicinal products for human use: Ministerio de Sanidad y
Consumo, Subdirecci[oacute]n General de Control Farmac[eacute]utico. For
medicinal products for

[[Page 253]]

veterinary use: Ministerio de Agricultura, Pesca y Alimentaci[oacute]n
(MAPA), Direcci[oacute]n General de la Producci[oacute]n Agraria.

France: For medicinal products for human use: Agence du
M[eacute]dicament. For veterinary medicinal products: Agence Nationale
du M[eacute]dicament V[eacute]t[eacute]rinaire.
Ireland: Irish Medicines Board.
Italy: For medicinal products for human use: Ministero della
Sanit[agrave], Dipartimento Farmaci e Farmacovigilanza. For medicinal
products for veterinary use: Ministero della Sanit[agrave], Dipartimento
alimenti e nutrizione e sanit[agrave] pubblica veterinaria-Div. IX.
Luxembourg: Division de la Pharmacie et des M[eacute]dicaments.
Netherlands: Staat der Nederlanden.
Austria: Bundesministerium f[uuml]r Arbeit, Gesundheit und Soziales.
Portugal: Instituto da Farm[aacute]cia e do Medicamento (INFARMED).
Finland: L[auml][auml]kelaitos/L[auml]kemedelsverket (National Agency
for Medicines).
Sweden: L[auml]kemedelsverket-Medical Products Agency.
United Kingdom: For human use and veterinary (non-immunologicals):
Medicines Control Agency. For veterinary immunologicals: Veterinary
Medicines Directorate.
European Community: Commission of the European Communities. European
Agency for the Evaluation of Medicinal Products (EMEA).