Skip to main content
European Commission logo
en
Food, Farming, Fisheries
Food Safety

Veterinary medicines

Veterinary medicines, in legislation referred to as veterinary medicinal products, are used to treat, prevent or diagnose disease or restore, correct or modify physiological functions in animals. These medicines are crucial for protecting, maintaining or restoring the health of both food-producing and companion animals. Products authorised for euthanasia of animals are also considered veterinary medicines.

EU objectives

The EU is committed to supporting the development and authorisation of veterinary medicines that are safe, efficacious and of high quality. This commitment aims to stimulate innovation, ensure these medicines are readily available, and protect public health, animal health and welfare, and the environment.

To do so, EU law:

  • encourages innovation in the development of new medicines (e.g. by granting extra regulatory data protection under certain circumstances).
  • sets standards for issuing the authorisations to place veterinary medicines on the market in the EU (marketing authorisations).
  • sets uniform rules for manufacturing, wholesale, retail, advertising, prescription and use of veterinary medicines.

Veterinary medicines can be authorised nationally by Member States, or EU-wide by the European Commission. Since the mid-1990s, EU-wide marketing authorisation procedures have been in place, supported by the European Medicines Agency (EMA). National authorisations can be the result of different types of procedures, which are either limited to one Member State or involve more than one Member State.

More information is available on the dedicated webpage on types of marketing authorisation procedures for veterinary medicines.

EU regulation on veterinary medicines

The EU regulation on veterinary medicines – Regulation (EU) 2019/6 – is the main EU legislation on veterinary medicinal products. It sets harmonised rules for these products as regards:

  • authorisation
  • manufacturing
  • importing/exporting
  • supplying/distributing
  • post-marketing monitoring (‘pharmacovigilance’), prescription and use
  • controls on relevant business operators, such as manufacturers, marketing authorisation holders, etc…

This regulation, taking a 'One Health' approach, is also a key part of EU action on antimicrobial resistance (AMR). It includes specific measures to reduce the risk posed by AMR to public and animal health, such as reserving some antimicrobials for the treatment of infections in humans or restricting the preventive use of antimicrobials, especially in groups of animals. The requirement that Member States monitor sales and use of veterinary antimicrobial medicines in animals supports the aim of halving EU sales of antimicrobials for farmed animals and aquaculture by 2030. The aims for reducing use of antimicrobials in animals were complemented by the 2023 Council recommendations on stepping up EU actions to combat antimicrobial resistance in a One Health approach.

More information on the EU regulation on veterinary medicines is available as Frequently asked questions (FAQs) and corresponding answers.

Implementing the EU regulation on veterinary medicines

The EU regulation on veterinary medicines became applicable on 28 January 2022. Transitional rules for packaging and labelling of veterinary medicines authorised under the previous framework were clarified, and guidance for persons or companies wishing to apply for marketing authorisation of veterinary medicines was developed. The Commission provided clarification to holders of marketing authorisations expiring on or after 28 January 2022 on regulatory options for their products. Lastly, the EU regulation on veterinary medicines mandated the Commission to adopt further supplementary rules.

These rules are available on the dedicated webpage on Implementing the EU regulation on veterinary medicines.

Consumer protection through Maximum Residue Limits

Veterinary medicines , or rather the substances contained in veterinary medicines, may leave residues in food from animals treated with them. In some cases, above certain levels such residues could be harmful to consumers.

To protect human health, the EU has rules to limit residues to levels that are safe to consumers, by setting maximum residue limits (MRLs) for pharmacologically active substances contained in veterinary medicines.

More information is available on the dedicated webpage on maximum residue limits.

Contact

Unit D4 – Veterinary medicines – DG Health and Food Safety

  • sante-veterinary-medicinesatec [dot] europa [dot] eu (sante-veterinary-medicines[at]ec[dot]europa[dot]eu)

Brexit

Further information

Questions and Answers on regulatory expectations for veterinary medicinal products during the COVID-19 pandemic – Last updated in June 2022

Marking the entry into application of the EU regulation on veterinary medicines – event on 20 June 2022 organised by the Commission

The Commission organised a half-day event, which took place on 20 June 2022, to celebrate the achievements made in the implementation of the veterinary medicines legislation and to acknowledge its key role in the EU’s fight against antimicrobial resistance as a tool for achieving the Union objectives, in particular the reduction of EU sales of antimicrobials for farm animals and aquaculture by 50% by 2030.

Commissioner Kyriakides and the French Presidency of the Council of the European Union addressed the participants.

More than 50 people attended the meeting in person. Between 80 and 104 people followed the event’s webstream.

Implementing the EU Regulation on veterinary medicines
The EU regulation on veterinary medicines requires the European Commission to adopt delegated and implementing regulations on some well-defined topics to further specify technical requirements on the topics concerned.
Consumer Protection through Maximum Residue Limits
Veterinary medicines contain substances which may have pharmacological effects. The use of these medicines in food-producing animals may leave residues of the substances in foodstuffs of animal origin.