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

Subject

Livestock, Fisheries

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

Geographical area

European Union Countries

Abstract

This Regulation lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products. Its scope includes veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market. Active substances used as starting materials in veterinary medicinal products are subject to these provisions too.

Full text

English

Website

eur-lex.europa.eu

References - Legislation

Repeals

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

Legislation | European Union | 2001

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

Source: FAO, FAOLEX

Implemented by

European Union (Veterinary Medicinal Products and Medicated Feed) Regulations 2022 (S.I. No. 36/2022).

Legislation | Ireland | 2022

Keyword: Animal feed/feedstuffs, Animal health, Enforcement/compliance, International relations/cooperation, Offences/penalties, Drugs

Source: FAO, FAOLEX

Act No. 14 on veterinary medicinal products.

Legislation | Iceland | 2022

Keyword: Institution, Biosafety, Vending, Authorization/permit, Procedural matters, Packaging/labelling, Data collection/reporting, Food quality control/food safety, Residues, Meat, Animal welfare, Animal health, Animal production, Drugs, Pests/diseases, Monitoring, Royalties/fees, Inspection, Waste disposal, Waste management

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2022/209 establishing the format of the data to be collected and reported in order to determine the volume of sales and the use of antimicrobial medicinal products in animals in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

Legislation | European Union | 2022

Keyword: Drugs, Animal health, Data collection/reporting, Internal trade, International trade

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

Legislation | European Union | 2021

Keyword: Animal health, Procedural matters, Protection of environment, Public health, Drugs, Fish disease

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2021/16 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database).

Legislation | European Union | 2021

Keyword: Access-to-information, Data collection/reporting, Drugs, Fish disease, Animal health

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2021/1280 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

Legislation | European Union | 2021

Keyword: Animal health, Business/industry/corporations, Internal trade, International trade, Drugs, Fish disease

Source: FAO, FAOLEX

Commission Delegated Regulation (EU) 2021/578 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals.

Legislation | European Union | 2021

Keyword: Animal health, Data collection/reporting, Fish disease, Fish products, Internal trade, Marine fishes, Drugs, Cattle, Sheep/goats, Poultry, Swine

Source: FAO, FAOLEX

Commission Delegated Regulation (EU) 2021/1760 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans.

Legislation | European Union | 2021

Keyword: Public health, Animal health, Fish disease, Drugs, Pests/diseases

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2021/1904 adopting the design of a common logo for the retail of veterinary medicinal products at a distance.

Legislation | European Union | 2021

Keyword: Animal health, Fish disease, Internal trade, International trade, Standards, Drugs, Pests/diseases

Source: FAO, FAOLEX

Regulation No. 1573 on veterinary drugs.

Legislation | Norway | 2022 (2022)

Keyword: Animal health, Drugs, Processing/handling, Internal trade, Authorization/permit, Data collection/reporting, Offences/penalties, Royalties/fees

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2021/1281 laying down rules for the application of Regulation (EU) 2019/6 as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products.

Legislation | European Union | 2021

Keyword: Authorization/permit, Business/industry/corporations, Capacity building, Certification, Data collection/reporting, Inspection, Risk assessment/management, Drugs, Fish disease, Animal health

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2022/1255 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

Legislation | European Union | 2022

Keyword: Public health, Animal feed/feedstuffs, Animal health, Drugs, Fish disease

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2021/1248 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council.

Legislation | European Union | 2021

Keyword: Authorization/permit, Business/industry/corporations, International trade, Packaging/labelling, Transport/storage, Traceability/product tracing, Drugs, Animal health

Source: FAO, FAOLEX

Act on the Enactment of a Veterinary Medicinal Products Act and on the Adaptation of Pharmaceutical and Other Regulations.

Legislation | Germany | 2021

Keyword: Drugs, Fish disease, Animal health, Animal production, Packaging/labelling, Public health, Basic legislation, Internal trade, International trade, Authorization/permit, Registration, Animal feed/feedstuffs, Animal welfare, Monitoring

Source: FAO, FAOLEX

Ordonnance no 2022-414 du 23 mars 2022 portant adaptation des dispositions du code de la santé publique et du code rural et de la pêche maritime au droit de l’Union européenne dans le domaine des médicaments vétérinaires et aliments médicamenteux.

Legislation | France | 2022

Keyword: Food quality control/food safety, Animal feed/feedstuffs, Animal health, Animal production, Animal welfare, Authorization/permit, Classification/declassification, Data collection/reporting, Education, Hygiene/sanitary procedures, Inspection, Internal trade, International trade, Packaging/labelling, Offences/penalties, Pests/diseases, Procedural matters, Public health, Registration, Residues, Transport/storage, Vaccination, Drugs

Source: FAO, FAOLEX

Commission Delegated Regulation (EU) 2023/905 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union.

Legislation | European Union | 2023

Keyword: Cattle, Sheep/goats, International trade, Meat, Milk/dairy products, Poultry products, Public health, Swine, Drugs, Food quality control/food safety, Animal health, Pests/diseases

Source: FAO, FAOLEX

Animals Act.

Legislation | Netherlands | 2011 (2021)

Keyword: Food quality control/food safety, Meat, Framework law, Animal welfare, Animal health, Pests/diseases, Institution, Animal production, Animal reproduction, Slaughtering, Animal by-products, Biotechnology, Transport/storage, Authorization/permit, Biosafety, Biosecurity, Animal feed/feedstuffs, Drugs, Game, Wildlife products, Ranching/captive breeding, Keeping of live animals, Wild fauna

Source: FAO, FAOLEX

Act on the Marketing of Veterinary Medicinal Products and on the Implementation of Regulations under EU Law concerning Veterinary Medicinal Products.

Legislation | Germany | 2021 (2022)

Keyword: Drugs, Animal health, Internal trade, International trade, Authorization/permit, Access-to-information, Inspection, Offences/penalties, Business/industry/corporations, Animal production, Packaging/labelling, Public health, Registration, Animal feed/feedstuffs, Animal welfare, Monitoring, Residues

Source: FAO, FAOLEX

Amended by

Commission Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council.

Legislation | European Union | 2021

Keyword: Animal health, Classification/declassification, Drugs, Fish disease

Source: FAO, FAOLEX