This document is an excerpt from the EUR-Lex website
Document 32019R0006
Authorisation, import and manufacture of veterinary medicines
Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC
It sets out rules for the sale, manufacture, import, export, supply, distribution, control and use of veterinary medicinal products (VMPs), aiming to:
The regulation is part of a package of laws on improving animal and human health, which also includes:
Veterinary medicinal products
A VMP is any substance or combination of substances intended for animals which is used:
A modern innovative legal framework
Promoting increased availability of VMPs by stimulating innovation and competition
Fighting antimicrobial resistance
The regulation continues and strengthens the EU’s fight against antimicrobial resistance by introducing:
In addition, for their exports into the EU, non-EU countries will have to respect the ban on using antimicrobials for promoting growth and increasing yield and the restrictions on antimicrobials designated as reserved for human use in the EU. This will improve the protection of consumers in the EU against the risk of antimicrobial resistance spread through imports of animals or of products of animal origin.
Transitional rules
Amending Regulation (EU) 2022/839 lays down transitional rules allowing marketing authorisation and registration holders to place VMPs complying with the packaging and labelling requirements of Directive 2001/82/EC or Regulation (EC) No 726/2004 (see summary) on the market until 29 January 2027, even if these products do not comply with the relevant requirements of Regulation (EU) 2019/6. The regulation addresses concerns about the practical application of Article 152(2) of Regulation (EU) 2019/6 and the need to ensure the continued supply of VMPs and to establish legal certainty*.
Repeal
The regulation repeals Directive 2001/82/EC on EU rules on the authorisation, import and production of veterinary medicines with effect from 27 January 2022.
It has applied since 28 January 2022.
For more information, see:
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 (OJ L 4, 7.1.2019, pp. 43–167).
Successive amendments to Regulation (EU) 2019/6 have been incorporated in the original text. This consolidated version is of documentary value only.
Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 4, 7.1.2019, pp. 24–42).
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, pp. 1–23).
Communication from the Commission to the Council and the European Parliament – A European One Health Action Plan against Antimicrobial Resistance (COM(2017) 339 final, 29.6.2017)
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, pp. 33–79).
See consolidated version.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33).
See consolidated version.
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 (OJ L 311, 28.11.2001, pp. 1–66).
See consolidated version.
last update 02.08.2022