Code of Federal Regulations > Title 21 > Chapter I > Part 26 > Subpart A > Appendix Appendix B - Appendix B to Subpart A of Part 26

Regulations last checked for updates: Nov 24, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

Appendix 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).

authority: 5 U.S.C. 552; 15 U.S.C. 1453,1454,1455; 18 U.S.C. 1905; 21 U.S.C. 321,331,351,352,355,360,360b,360c,360d,360e,360f,360g,360h,360i,360j,360l,360m,371,374,381,382,383,393; 42 U.S.C. 216,241,242l,262,264,265

source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.