Code of Federal Regulations Title 21. Food and Drugs 21 CFR Pt. 26, Subpt. A, App. B 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 générale de la Pharmacie, Algemene Farmaceutische Inspectie.

Denmark:  Laegemiddelstyrelsen.

Germany:  Bundesministerium für Gesundheit for immunologicals:  Paul–Ehrlich–Institut, Federal Agency for Sera and Vaccines.

Greece:  (?sym?), Ministry of Health and Welfare, National Drug Organization (E.O.F).

Spain:  For medicinal products for human use:  Ministerio de Sanidad y Consumo, Subdirección General de Control Farmacéutico. For medicinal products for veterinary use:  Ministerio de Agricultura, Pesca y Alimentación (MAPA), Dirección General de la Producción Agraria.

France:  For medicinal products for human use:  Agence du Médicament. For veterinary medicinal products:  Agence Nationale du Médicament Vétérinaire.

Ireland:  Irish Medicines Board.

Italy:  For medicinal products for human use:  Ministero della Sanità, Dipartimento Farmaci e Farmacovigilanza. For medicinal products for veterinary use:  Ministero della Sanità, Dipartimento alimenti e nutrizione e sanitàpubblica veterinaria–Div. IX.

Luxembourg:  Division de la Pharmacie et des Médicaments.

Netherlands:  Staat der Nederlanden.

Austria:  Bundesministerium für Arbeit, Gesundheit und Soziales.

Portugal:  Instituto da Farmácia e do Medicamento (INFARMED).

Finland:  Lääkelaitos/Läkemedelsverket (National Agency for Medicines).

Sweden:  Läkemedelsverket–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).