Authorisation, import and manufacture of veterinary medicines

 

SUMMARY OF:

Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC

WHAT IS THE AIM OF THE REGULATION?

It sets out rules for the sale, manufacture, import, export, supply, distribution, control and use of veterinary medicinal products (VMPs), aiming to:

KEY POINTS

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 intended for animals, which is used:

A modern innovative legal framework

Promoting availability of VMPs by stimulating innovation and competition

Fighting antimicrobial resistance

The regulation continues and strengthens the EU’s fight against 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 antimicrobials for promoting growth and increasing yield, as well as the restrictions on antimicrobials designated as reserved for human use in the EU. This improves the protection of consumers in the EU against the risk of antimicrobial resistance spread through imports of animals or products of animal origin.

Repeal

The regulation repeals Directive 2001/82/EC (see summary on EU rules on the authorisation, import and production of veterinary medicines) with effect from 27 January 2022.

FROM WHEN DOES THE REGULATION APPLY?

It applies from 28 January 2022.

BACKGROUND

For more information, see:

KEY TERMS

Antimicrobial resistance: the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it. Resistance means that standard treatments become ineffective, infections persist and could spread to others.
Pharmacovigilance: the science and activities relating to the detection, assessment, understanding and prevention of suspected adverse events or any other problem related to a medicinal product.

MAIN DOCUMENT

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)

RELATED DOCUMENTS

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)

last update 27.02.2019