Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Country/Territory European Union Document type Legislation Date 1991 Source FAO, FAOLEX Original source CELEX-EUR Official Journal L 228, 17 August 1991, pp. 70-73. Subject Livestock Keyword Drugs Authorization/permit Registration Internal trade International trade Animal health Processing/handling Geographical area European Union Countries Abstract This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products whose manufacture requires the authorization referred to in article 24 of Directive 81/851/EC. The manufacturers shall ensure that the manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorization. The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different services involved. At each manufacturing site, the manufacturer shall have competent and appropriately qualified personnel. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations. Full text English Website europa.eu References - Legislation Implements Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products. Legislation | European Union | 1981 Keyword: Drugs, Authorization/permit, Registration, Internal trade, International trade, Animal health, Institution Source: FAO, FAOLEX Implemented by Decree No. 6 of 2006 containing rules relative to veterinary medicinal products. Legislation | Netherlands | 2005 Keyword: Fish disease, Animal health, Drugs, Internal trade, International trade, Registration Source: FAO, FAOLEX Ministerial Joint Decree No. 313314 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Legislation | Greece | 1994 Keyword: Animal production, Drugs, Inspection, Animal health Source: FAO, FAOLEX Veterinary Medicines Regulations 2011 (S.I. No. 2159 of 2011). Legislation | United Kingdom | 2011 Keyword: Fish disease, Animal feed/feedstuffs, Animal health, Drugs, Institution, Authorization/permit, Residues, Inspection, International trade, Offences/penalties Source: FAO, FAOLEX Ministerial Decree implementing Directive 91/412/CEE of the Commission on the production of veterinary drugs. Legislation | Italy | 1993 Keyword: Animal health, Drugs, Authorization/permit, International trade, Inspection Source: FAO, FAOLEX Animal Remedies Regulations, 1996. Legislation | Ireland | 1996 Keyword: Animal health, Drugs, Authorization/permit, Internal trade, International trade, Inspection Source: FAO, FAOLEX Veterinary Medicines Regulations 2013 (S.I. No. 2033 of 2013). Legislation | United Kingdom | 2013 Keyword: Fish disease, Animal feed/feedstuffs, Animal health, Drugs, Institution, Authorization/permit, Residues, Inspection, International trade, Offences/penalties Source: FAO, FAOLEX Good Manufacturing Practice for Veterinary Medicinal Products Rules, 2018 (L.N. 3 of 2018). Legislation | Malta | 2018 Keyword: Drugs, Animal health, Authorization/permit, Inspection Source: FAO, FAOLEX Cabinet Regulation No. 319 of 2007 on Manufacture and Control of Veterinary Medicinal Products, the Procedure for the Issuance of a Good Manufacturing Practice Certificate to a Manufacturer of Veterinary Medicinal Products and Regarding the Requirements for the Qualification and Professional Experience of the Official Responsible for the Manufacture of Veterinary Medicinal Products Legislation | Latvia | 2007 (2011) Keyword: Drugs, Animal health, Certification, Business/industry/corporations Source: FAO, FAOLEX Décision no 2015-03-076 du 11 mars 2015 relative aux bonnes pratiques de fabrication des médicaments vétérinaires Legislation | France | 2015 (2017) Keyword: Drugs, Animal health, Internal trade, Authorization/permit, Hygiene/sanitary procedures, Transport/storage, Fraud, Inspection, International trade Source: FAO, FAOLEX