Regulation on veterinary medicinal products (VMPs)
As from 28 January, a revamped legislation on veterinary medicinal products is applicable in the EU.
Adopted three years ago, Regulation (EU) 2019/6 is a cornerstone to support the achievement of the objectives set in the European One Health Action Plan and in the Farm to Fork Strategy against antimicrobial resistance (AMR). The legislation also consolidates the EU’s leading role on the global stage to act against AMR.
The Regulation is central to achieve the Farm to Fork Strategy target to reduce overall EU sales of antimicrobials by 50% for farmed animals and in aquaculture by 2030, through very concrete measures such as banning the preventive use of antibiotics in groups of animals.
20 June 2022: Event organised by the Commission to welcome legislation’s achievements
The Commission organised a half-day event, which took place on 20 June 2022, to celebrate the achievements of the veterinary medicines legislation and its key role in the EU’s fight against antimicrobial resistance as a tool to achieve the Farm to Fork Strategy objectives, in particular cutting EU sales of antimicrobials for animal farming 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 webstream at any one time during the meeting.
- See recording of the event
- See the event programme
- The presentations given at the meeting are available below:
- Breaking New Ground with the VMP Regulation - Achievements and Challenges Ahead - E Zamora
- Delivering EU Regulation 2019 6 - Climbing the mountain together - I Claassen
- How implementation of the VMP regulation strengthens the European Medicine Regulatory Network - JP Orand
- New Veterinary Legislation – Medicines Availability – The journey, the ambition and measuring the outcome - R Feller
- Generic and added value veterinary medicines entering a new era - D Cainzos
- The Veterinary Medicines Regulation - A New Toolbox For Veterinarians In The Fight Against AMR - N De Briyne
EU logo for online sale of veterinary medicines
The EU has introduced a common logo for the sale of veterinary medicinal products by online pharmacies/retailers in EU countries. The logo vouches for the authenticity of the websites and guarantees the safety of the products.
Questions and answers
To view questions and answers related to the regulation, please click here
DG SANTE statement on Article 152(2) of Regulation 2019/6
To view the statement released by DG SANTE, please click here
Marketing authorisations expiring on or after 28 January 2022
- Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6
Safe and effective veterinary medicinal products
Veterinary medicines, also known as medicinal products for veterinary use, veterinary drugs or veterinary medicinal products (VMPs), are substances or combinations of substances to treat, prevent or diagnose disease in animals. The EU works to support the development and authorisation of safe, effective and quality veterinary medicinal products for food producing and companion animals, ensuring their availability and guaranteeing the highest level of public health, animal health and environmental protection.
The law governing veterinary medicinal products in the EU sets standards to ensure adequate health protection. Based on the principle of marketing authorisation by the EU or by the national competent authorities, it also promotes the functioning of the internal market, with measures to encourage innovation. These also include harmonised provisions for the manufacture, wholesale and advertising of veterinary medicinal products.
EU-wide authorisation procedures are in place since the mid-90s and the system is supported by the European Medicines Agency (EMA).
Medicated feed – Safe and controlled oral treatment
Medicated feed is a mixture of animal food and veterinary medicinal product produced under controlled conditions and has the purpose of treating or controlling disease in farmed animals, aquaculture species and pets. It requires a veterinary prescription and is one of the oral routes to administer veterinary medicines to animals. Depending on specific situation, this can be the most effective way to administer veterinary medicines to animals.
The EU regulates the manufacture, placing on the market and use of medicated feed, which is a specific type of feed.
Consumer protection through Maximum Residue Limits
Veterinary medicinal products may leave residues in the foodstuffs obtained from treated or diagnosed animals. These residues comprise pharmacologically active substances, excipients or degradation products, and their metabolites. Some of these substances could be harmful to humans.
To protect human health, the European Parliament and Council laid down uniform rules to ensure consumer protection against potentially harmful effects of residues in foodstuffs of animal origin. These rules provide for a science-based establishment of maximum residue limits for veterinary medicinal products. A maximum residue limit is the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin.
Implementation of Regulation (EU) 2019/6 on veterinary medicinal products and Regulation (EU) 2019/4 on medicated feed
The current legal framework for veterinary medicinal products and medicated feed Directive 2001/82/EC, Regulation (EC) No 726/2004 and Directive 90/167/EEC have been replaced by Regulation (EU) 2019/6 on veterinary medicinal products and Regulation (EU) 2019/4 on medicated feed; the new regulations will apply from 28 January 2022. As part of their implementation, the two Regulations require the European Commission to adopt delegated and implementing acts.
Delegated acts empower the Commission to supplement or amend the non‑essential elements of the basic act. Implementing acts may have individual or general application. They are often of an administrative or technical nature.
Unit E5 at DG Health and Food Safety: Animal nutrition, veterinary medicines
- Directive 2001/82/EC
- Regulation (EC) No 726/2004
- Regulation (EU) 2019/6
- Directive (90/167/EEC)
- Regulation (EU) 2019/4
- Questions and Answers on regulatory expectations for veterinary medicinal products during the COVID-19 pandemic - Updated
- Notice to stakeholders - Withdrawal of the United Kingdom and EU Rules for Medicinal Products for Human Use and Veterinary Medicinal Products