Appendix 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: Εθνικως Ωργανισμως Φαρμακωυ, 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 sanità pubblica 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).