Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
- No longer in force
- CELEX number: 32001L0082
- Official Journal: JOL_2001_311_R_0001_01
- Form: Directive
- Procedure number: 1999/0180(COD), 1999/0180/COD
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - November 6, 2001
- November 28, 2001
- December 18, 2001
- Entry into force - Date pub. + 20 See Art 97
- January 27, 2022
- Repealed by 32019R0006
Modified by
Modified by:
- 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) - detail
- 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) - detail
- Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 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 (Text with EEA relevance ) - detail
- Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four - detail
- Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (Text with EEA relevance) - detail
All documents based on this document:
- Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (Text with EEA relevance)
- Commission Directive 2006/130/EC of 11 December 2006 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 (Text with EEA relevance)
- Commission Regulation (EC) No 1950/2006 of 13 December 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 (Text with EEA relevance)
- Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)
- 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)
- Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products Text with EEA relevance
- Commission Regulation (EU) No 122/2013 of 12 February 2013 amending 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 Text with EEA relevance
Derogated in:
- undefined
Modifies
Repeal:
- Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products
- Council Directive 81/852/EEC of 28 September 1981 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
- Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products
- Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products
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.
- Judgment of the Court (Fourth Chamber) of 27 October 2016. Criminal proceedings against Association des utilisateurs et distributeurs de l’agrochimie européenne (Audace) and Others. Request for a preliminary ruling from the Cour d'appel de Pau. Reference for a preliminary ruling — Free movement of goods — Articles 34 and 36 TFEU — Quantitative restrictions — Parallel imports of veterinary medicinal products — Directive 2001/82/EC — Article 65 — National system of prior authorisation — Livestock farmers excluded from simplified marketing authorisation procedure — Obligation to hold a wholesale trading authorisation — Obligation to have an establishment within the Member State of import — Pharmacovigilance obligations. Case C-114/15.
- A77
- A76
- A73
- A79
- A74
- A75
- A72
- A78
- A65
- Case C-114/15: Request for a preliminary ruling from the Cour d’appel de Pau (France) lodged on 6 March 2015 — Association des Utilisateurs et Distributeurs de l’Agro Chimie Européenne (Audace), Phyteron 2000 SAS, Association des éleveurs solidaires, Cruzalebes EARL, Des deux rivières EARL, Mounacq EARL v GAEC Reconnu La Vinardière, Ministère public
- article 65
- 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 58 paragraph 4
- article 59 paragraph 3
- article 61 paragraph 1
Legal basis
- Treaty establishing the European Community (Amsterdam consolidated version) Part Five: Institutions of the Community Title I: Provisions governing the institutions Chapter 2: Provisions common to several institutions Article 251 Article 189b - EC Treaty (Maastricht consolidated version)
- Treaty establishing the European Community (Amsterdam consolidated version) Part Three: Community policies Title VI: Common rules on competition, taxation and approximation of laws Chapter 3: Approximation of laws Article 95 Article 100a - EC Treaty (Maastricht consolidated version)
EuroVoc Vocabulary
- Pharmaceutical legislation
- Veterinary drug
- Public health
- Approximation of laws
- Approximation of laws
- Legal code
- Single market
- Medicinal products
- Proprietary medicinal products
- Veterinary legislation