Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.

Subject

Livestock

Keyword

Basic legislation Animal health Drugs Authorization/permit Data collection/reporting Access-to-information Inspection Internal trade International trade Offences/penalties

Geographical area

European Union Countries

Entry into force notes

This Directive came into force on 18 December 2001.

Abstract

The primary purpose of the rules for the production and distribution of veterinary medicinal products is the safeguarding of public health. This Directive lays down the Community code relating to veterinary medicinal products. The Directive consists of eleven Titles and three Annexes.

Full text

English

Website

europa.eu

References - Legislation

Repeals

Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products.

Legislation | European Union | 1981

Keyword: Animal health, Drugs, Authorization/permit, Internal trade, Animal feed/feedstuffs

Source: FAO, FAOLEX

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

European Communities (Animal Remedies) (No. 2) Regulations, 2007 (S.I. No. 786 of 2007).

Legislation | Ireland | 2007

Keyword: Aquaculture, Fish disease, Animal health, Inspection, Food quality control/food safety, Residues, MRL-maximum residue limit, Drugs, Animal feed/feedstuffs

Source: FAO, FAOLEX

Act on animals health protection and fighting against infectious diseases of animals.

Legislation | Poland | 2004 (2023)

Keyword: Fish products, Aquaculture, Food quality control/food safety, Meat, Transport/storage, Basic legislation, Animal health, Pests/diseases, Internal trade, Equine-animals, Hormones/steroids, Hygiene/sanitary procedures, Animal by-products, Drugs

Source: FAO, FAOLEX

European Communities (Animal Remedies) Regulations, 2007 (S.I. No 144 of 2007).

Legislation | Ireland | 2007

Keyword: Aquaculture, Fish disease, Animal health, Inspection, Food quality control/food safety, Residues, MRL-maximum residue limit, Drugs

Source: FAO, FAOLEX

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

Commission Directive 2006/130/EC implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription.

Legislation | European Union | 2006

Keyword: Animal health, Drugs

Source: FAO, FAOLEX

Veterinary Medicines Regulations 2006 (S.I. No. 2407 of 2006).

Legislation | United Kingdom | 2006

Keyword: Animal health, Drugs, Classification/declassification, Inspection, Animal feed/feedstuffs

Source: FAO, FAOLEX

Veterinary Medicines Regulations 2007 (S.I. No. 2539 of 2007).

Legislation | United Kingdom | 2007

Keyword: Animal health, Drugs, Classification/declassification, Inspection, Animal feed/feedstuffs

Source: FAO, FAOLEX

Veterinary Act No. 166/1999.

Legislation | Czechia | 1999 (2018)

Keyword: Basic legislation, Institution, Quarantine, Hygiene/sanitary procedures, Vaccination, Animal welfare, Fish disease, Aquaculture, Animal health, Food quality control/food safety, Pests/diseases

Source: FAO, FAOLEX

Decree on the use, prescribing and dispensing of medicinal products for the veterinary care.

Legislation | Czechia | 2008

Keyword: Animal health, Animal production, Drugs, Registration, Data collection/reporting, Access-to-information

Source: FAO, FAOLEX

Regulation establishing categories of veterinary medicinal products.

Legislation | Poland | 2008

Keyword: Animal health, Drugs

Source: FAO, FAOLEX

Regulation on proceedings concerning use of medical products in the absence of appropriate veterinary medical product.

Legislation | Poland | 2008

Keyword: Animal health, Drugs, Authorization/permit

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

Veterinary Medicines Regulations 2005 (S.I. No. 2745 of 2005).

Legislation | United Kingdom | 2005

Keyword: Animal health, Drugs, Classification/declassification, Inspection, Animal feed/feedstuffs

Source: FAO, FAOLEX

Veterinary Medicinal Products Regulations, 2004 (L.N. 469 of 2004).

Legislation | Malta | 2004

Keyword: Animal health, Drugs, Authorization/permit, Data collection/reporting, Access-to-information, Inspection, Internal trade, International trade, Offences/penalties

Source: FAO, FAOLEX

Legislative Decree No. 71 implementing Directives 2000/37/EC and 2001/82/EC concerning veterinary medicinal products.

Legislation | Italy | 2003

Keyword: Animal health, Drugs

Source: FAO, FAOLEX

Veterinary Medicines Regulations 2008 (S.I. No. 2297 of 2008).

Legislation | United Kingdom | 2008

Keyword: Animal health, Drugs, Classification/declassification, Inspection, Animal feed/feedstuffs

Source: FAO, FAOLEX

Real Decreto Nº 1246/2008 - Procedimiento de autorización, registro y farmacovigilancia de los medicamentos veterinarios fabricados industrialmente.

Legislation | Spain | 2008

Keyword: Animal health, Hygiene/sanitary procedures, Drugs, Vaccination, Hormones/steroids, Legal proceedings/administrative proceedings, Authorization/permit, Registration, Toxicity/poisoning, Internal trade, Inspection

Source: FAO, FAOLEX

Regulation on the traceability of trade in and use of veterinary medicines.

Legislation | Slovenia | 2009

Keyword: Animal health, Drugs, Authorization/permit, Inspection

Source: FAO, FAOLEX

Veterinary Compliance Criteria Act.

Legislation | Slovenia | 2005 (2018)

Keyword: Aquaculture, Fish disease, Animal health, Animal feed/feedstuffs, Hygiene/sanitary procedures, Internal trade, Animal by-products, Pests/diseases, Drugs

Source: FAO, FAOLEX

Order No. 533 on veterinary use, administration and prescription of drugs for animals.

Legislation | Denmark | 2014

Keyword: Animal feed/feedstuffs, Animal health, Animal production, Authorization/permit, Drugs, Hormones/steroids, Inspection, Residues, Equine-animals, Pests/diseases

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

Regulation on the preliminary control of immunological veterinary medicinal products.

Legislation | Poland | 2009

Keyword: Animal health, Drugs, Authorization/permit, Inspection, Institution

Source: FAO, FAOLEX

Regulation No. 543 on veterinary use, administration and prescription of drugs for animals.

Legislation | Denmark | 2013

Keyword: Animal feed/feedstuffs, Animal health, Animal production, Authorization/permit, Drugs, Hormones/steroids, Inspection

Source: FAO, FAOLEX

Order No. 1432 on use of medicines for animals, official controls and food companies self-monitoring of residues.

Legislation | Denmark | 2014

Keyword: Inspection, Residues, Consumer protection, Food quality control/food safety, Drugs, Internal trade, Animal health

Source: FAO, FAOLEX

Order No. 1226 on veterinary use, administration and prescription of drugs for animals.

Legislation | Denmark | 2015

Keyword: Consumer protection, Food quality control/food safety, Hormones/steroids, Animal health, Authorization/permit, Drugs, Pests/diseases, Animal production

Source: FAO, FAOLEX

Order No. 1362 on veterinary use, administration and prescription of drugs for animals.

Legislation | Denmark

Keyword: Animal health, Authorization/permit, Drugs, Pests/diseases, Animal production, Hormones/steroids

Source: FAO, FAOLEX

Order No. 1361 on the use of medicines for animals, official controls and food companies self-monitoring of residues.

Legislation | Denmark | 2015

Keyword: Inspection, Residues, Consumer protection, Food quality control/food safety, Drugs, Internal trade, Animal health

Source: FAO, FAOLEX

Décret n° 2016-317 du 16 mars 2016 relatif à la prescription et à la délivrance des médicaments utilisés en médecine vétérinaire contenant une ou plusieurs substances antibiotiques d'importance critique.

Legislation | France | 2016

Keyword: Drugs, Fish disease, Authorization/permit, Research, Use restrictions, Public health, Classification/declassification, Animal feed/feedstuffs, Animal health

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

Commission Implementing Regulation (EU) 2018/470 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC.

Legislation | European Union | 2018

Keyword: Crustaceans, Molluscs, Drugs, Fish disease, Animal health, Aquatic animals, Food quality control/food safety, MRL-maximum residue limit, Fish products

Source: FAO, FAOLEX

Law no. 10 of 2006 concerning Veterinary Medicinal Products (Quality Control, Registration, Circulation, Manufacture, Administration and Use).

Legislation | Cyprus | 2006 (2011)

Keyword: Animal feed/feedstuffs, Animal health, Animal production, Authorization/permit, Basic legislation, Biotechnology, Business/industry/corporations, Classification/declassification, Pests/diseases, Hormones/steroids, Inspection, Institution, Intellectual property rights/patents, Internal trade, International trade, Packaging/labelling, Legal proceedings/administrative proceedings, Toxicity/poisoning, Protection of environment, Public health, Research, Risk assessment/management, Rodents, Standards, Drugs

Source: FAO, FAOLEX

Decree of the Minister of Economic Affairs no. WJZ/12375497, appointing supervisors under the Animals Act.

Legislation | Netherlands | 2012

Keyword: Animal health, Drugs, Animal feed/feedstuffs, Animal production, Enforcement/compliance, Monitoring

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

Cabinet Regulation No. 401 of 2004 on Procedures for Monitoring of Adverse Reactions Caused by Veterinary Medicinal Products

Legislation | Latvia | 2007 (2008)

Keyword: Animal health, Drugs, Procedural matters, Animal feed/feedstuffs, Packaging/labelling, Environmental standards, Protection of environment, Standards

Source: FAO, FAOLEX

Decree-Law No. 148/2008 transposing Directives 2001/82/EC of the EU Parliament and the Council of 6 November on the Community Code relating to veterinary medicinal products into national law.

Legislation | Portugal | 2008

Keyword: Animal health, Hygiene/sanitary procedures, Drugs, Packaging/labelling, Internal trade, International trade

Source: FAO, FAOLEX

Cabinet Regulation No. 600 of 2006 on Procedures for the Authorisation of Veterinary Medicinal Products

Legislation | Latvia | 2006 (2010)

Keyword: Drugs, Animal health, Registration, Authorization/permit, Internal trade, Liability/compensation, Procedural matters, Animal feed/feedstuffs

Source: FAO, FAOLEX

Arrêté du 6 mai 2008 fixant la présentation et le contenu du résumé des caractéristiques du produit mentionné à l'article R. 5141-15 du code de la santé publique

Legislation | France | 2008 (2020)

Keyword: Drugs, Internal trade, Authorization/permit, Intellectual property rights/patents, Fish disease, Animal health, Packaging/labelling

Source: FAO, FAOLEX

Arrêté du 6 mai 2008 portant application de l'article R. 5141-35 du code de la santé publique et relatif aux modifications des autorisations de mise sur le marché des médicaments vétérinaires

Legislation | France | 2008

Keyword: Drugs, Authorization/permit, Internal trade, Fish disease, Animal health

Source: FAO, FAOLEX

Cabinet Regulation No. 327 of 2016 on Procedures for Importing and Exporting Veterinary Medicinal Products

Legislation | Latvia | 2016

Keyword: Drugs, Animal health, International trade, Standards

Source: FAO, FAOLEX

Regulation No. 21 of 2005 of Minister of Agriculture of Estonia on Requirements and Procedure for the Use of Medicinal Products and Medicated Feed for the Prevention and Treatment of Animal Diseases

Legislation | Estonia | 2005 (2011)

Keyword: Drugs, Animal feed/feedstuffs, Animal health, Transport/storage, Internal trade, Public health, Hygiene/sanitary procedures

Source: FAO, FAOLEX

Regulation No. 26 of 2012 of Minister of Social Affairs of Estonia on Procedure for providing safety information about medicinal products, for calculating the fees charged for the safety and quality monitoring of medicinal products and for the payment of such fees

Legislation | Estonia | 2012 (2013)

Keyword: Drugs, Public health, Royalties/fees, Monitoring, Packaging/labelling, Procedural matters, Animal health, Animal feed/feedstuffs

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

Cabinet Regulation No. 337 of 2016 on Labelling Regulations of Veterinary Medicinal Products

Legislation | Latvia | 2016

Keyword: Drugs, Packaging/labelling, Animal health

Source: FAO, FAOLEX

Décision du 5 mars 2014 relative aux bonnes pratiques de pharmacovigilance vétérinaire

Legislation | France | 2014

Keyword: Drugs, Internal trade, International trade, Vaccination, Registration, Early warning system, Enforcement/compliance, Inspection, Access and benefit-sharing, Public health, Research, Fish disease, Animal health, Food quality control/food safety, Slaughtering, Milk/dairy products, MRL-maximum residue limit

Source: FAO, FAOLEX

Arrêté du 4 mai 2010 relatif à la fixation par le vétérinaire du temps d'attente applicable lors de l'administration d'un médicament en application de l'article L. 5143-4 du code de la santé publique

Legislation | France | 2010

Keyword: Fish products, Drugs, Fish disease, Public health, Residues, Standards, Animal health, Food quality control/food safety, Poultry products, Milk/dairy products, Meat, MRL-maximum residue limit, Classification/declassification, Slaughtering, Animal feed/feedstuffs, Equine-animals

Source: FAO, FAOLEX

Décret n° 2003-263 du 20 mars 2003 relatif aux établissements pharmaceutiques vétérinaires, aux aliments médicamenteux et aux prescriptions de médicaments vétérinaires, modifiant le code de la santé publique (deuxième partie : Décrets en Conseil d'Etat)

Legislation | France | 2003

Keyword: Drugs, Animal health, Animal feed/feedstuffs

Source: FAO, FAOLEX

Ministerial Decision no. 282371 of 2006. Harmonisation of Greek legislation to the corresponding Community legislation in the field of production and circulation of veterinary medicinal products, in compliance with Directives 2001/82/EC and 2004/28/EC of the European Parliament and of the Council on the Community code for veterinary medicinal products.

Legislation | Greece | 2006

Keyword: Food quality control/food safety, Animal health, Drugs, Animal feed/feedstuffs, Authorization/permit, Internal trade, Packaging/labelling, Pests/diseases, Public health, Risk assessment/management, Vaccination, Offences/penalties

Source: FAO, FAOLEX

Joint Ministerial Decision no. 282371 of 2006 on veterinary medicinal products.

Legislation | Greece | 2006

Keyword: Animal health, Milk/dairy products, Fish products, Food quality control/food safety, Meat, Poultry products, Animal feed/feedstuffs, Apiculture/sericulture, Animal production, Biotechnology, Hygiene/sanitary procedures, Inspection, Packaging/labelling, MRL-maximum residue limit, Offences/penalties, Pests/diseases, Protection of environment, Public health, Residues, Risk assessment/management, Slaughtering, Standards, Toxicity/poisoning, Transport/storage, Use restrictions, Vaccination, Drugs, Waste management, Waste non-domestic sources

Source: FAO, FAOLEX

Amended by

Regulation (EC) No. 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No. 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No. 726/2004 of the European Parliament and of the Council.

Legislation | European Union | 2009

Keyword: Food quality control/food safety, MRL-maximum residue limit, Drugs, Animal health

Source: FAO, FAOLEX

Commission Regulation (EC) No. 1950/2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae.

Legislation | European Union | 2006

Keyword: Animal health, Drugs, Equine-animals

Source: FAO, FAOLEX

Directive 2004/28/EC of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

Legislation | European Union | 2004

Keyword: Animal health, Drugs, Authorization/permit, Internal trade, International trade

Source: FAO, FAOLEX

Commission Directive 2009/9/EC amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use.

Legislation | European Union | 2009

Keyword: Animal health, Drugs, Authorization/permit, Internal trade, International trade, Animal feed/feedstuffs

Source: FAO, FAOLEX

Repealed by

Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC.

Legislation | European Union | 2018 (2022)

Keyword: Aquaculture, Aquatic animals, Fish disease, Drugs, Animal health, Basic legislation, Internal trade, International trade, Authorization/permit, Access-to-information, Inspection, Offences/penalties, Business/industry/corporations

Source: FAO, FAOLEX