Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
- In force
- CELEX number: 32019R0006
- Official Journal: JOL_2019_004_R_0003
- Form: Regulation
- Procedure number: 2014/0257(COD), 2014/0257/COD
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- ga
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - December 11, 2018
- January 7, 2019
- January 27, 2019
- Entry into force - Date pub. +20 See Art 160
- January 28, 2022
- Application - See Art 160
- January 27, 2019
- See Art 153.5
- January 27, 2021
- At the latest See Art 153.3
- September 27, 2021
- At the latest See Art 153.2
- January 28, 2022
- At the earliest See Art 153.4
- At the latest See Art 154 And 155
- See Art 153.1 And 153.2 And 153.3 And 153.5 And 156
- January 29, 2025
- At the latest See Art 153.4 And 158
- January 29, 2027
- See Art 157
Modified by
Modified by:
- Commission Delegated Regulation (EU) 2023/183 of 23 November 2022 amending Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the requirements on compliance with good laboratory practice for veterinary medicinal products set out in Annex II to that Regulation (Text with EEA relevance) - detail
- Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance) - detail
Completed by:
- Commission Delegated Regulation (EU) 2024/1159 of 7 February 2024 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by laying down rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed and administered by the animal keeper to food-producing animals
- Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 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 (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 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 (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 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 (Text with EEA relevance)
All documents based on this document:
- Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database)
- Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 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 (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2021/963 of 10 June 2021 laying down rules for the application of Regulations (EU) 2016/429, (EU) 2016/1012 and (EU) 2019/6 of the European Parliament and of the Council with regard to the identification and registration of equine animals and establishing model identification documents for those animals (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 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 (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 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 (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 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 (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2022/209 of 16 February 2022 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 (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2022/524 of 27 January 2022 correcting Delegated Regulation (EU) 2021/577 as regards certain references to veterinary medicinal products (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 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 (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/183 of 23 November 2022 amending Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the requirements on compliance with good laboratory practice for veterinary medicinal products set out in Annex II to that Regulation (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 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 (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2023/997 of 23 May 2023 amending 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 (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2024/875 of 21 March 2024 adopting a list of abbreviations and pictograms common throughout the Union to be used on the packaging of veterinary medicinal products for the purposes of Article 10(2) and Article 11(3) of Regulation (EU) 2019/6 of the European Parliament and of the Council
- Commission Implementing Regulation (EU) 2024/878 of 21 March 2024 adopting uniform rules on the size of small immediate packaging units of veterinary medicinal products as referred to in Article 12 of Regulation (EU) 2019/6 of the European Parliament and of the Council
- Commission Implementing Regulation (EU) 2024/916 of 26 March 2024 amending 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
- Commission Delegated Regulation (EU) 2024/1159 of 7 February 2024 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by laying down rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed and administered by the animal keeper to food-producing animals
- Commission Implementing Regulation (EU) 2024/1973 of 18 July 2024 establishing a list of antimicrobials which shall not be used in accordance with Articles 112 and 113 of Regulation (EU) 2019/6 of the European Parliament and of the Council or which shall only be used in accordance with those Articles subject to certain conditions
Modifies
Implicit repeal:
- Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance)
- Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Text with EEA relevance)
Affected by case
- Judgment of the Court (First Chamber) of 17 March 2021. UH v An tAire Talmhaíochta Bia agus Mara and Others. Request for a preliminary ruling from An Ard-Chúirt. Reference for a preliminary ruling – Article 288 TFEU – Directive 2001/82/EC – Community code relating to veterinary medicinal products – Articles 58, 59 and 61 – Information to be provided on outer packaging, immediate packaging and the package leaflet for veterinary medicinal products – Obligation to provide information in all the official languages of the Member State in which the product is marketed – National legislation providing that the information may be provided in one or other of the official languages of the Member State – National court hearing an action for a declaration that the Member State had failed correctly to transpose Directive 2001/82/EC and that the competent national authorities must amend the national legislation. Case C-64/20.
- Case C-64/20: Reference for a preliminary ruling from the High Court (Ireland) made on 6 February 2020 — UH v Minister for Agriculture, Food and the Marine, Ireland and Attorney General
- article 7
Legal basis
- Consolidated version of the Treaty on the Functioning of the European Union PART THREE - UNION POLICIES AND INTERNAL ACTIONS TITLE XIV - PUBLIC HEALTH Article 168 (ex Article 152 TEC)
- Consolidated version of the Treaty on the Functioning of the European Union PART THREE - UNION POLICIES AND INTERNAL ACTIONS TITLE VII - COMMON RULES ON COMPETITION, TAXATION AND APPROXIMATION OF LAWS CHAPTER 3 - APPROXIMATION OF LAWS Article 114 (ex Article 95 TEC)
EuroVoc Vocabulary
- Labelling
- Market approval
- Veterinary medicinal product
- Pharmacology
- Animal health and zootechnics
- Proprietary medicinal products
- Medicinal products
- Pharmaceutical legislation
- Health control
- Marketing standard
- Veterinary legislation
- Import (EU)
- Veterinary inspection
- Export (EU)