New Veterinary Medicinal Products Regulation and Medicated Feed Regulation have come into force

Three years after the publication of the new Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and the Medicated Feed Regulation (Regulation (EU) 2019/4), both have now definitively come into force. The previous regulations, 2001/82/EC and 90/167/EEC, therefore no longer apply.

Newsupdate

The European Medicines Agency (EMA) has published a news report on the Veterinary Medicinal Products Regulation and the Medicated Feed Regulation. Among other things, the news report states that the European public database of veterinary medicinal products can be found on the website Medicinesinfo.eu.

As of today, information on the Veterinary Medicinal Products Regulation and the Medicated Feed Regulation can also be found on the website of the Dutch government (Rijksoverheid.nl).

Aim

The new European legislation aims to:

  • reduce the administrative burden for businesses;
  • encourage innovation;
  • enhance the functioning of the European market;
  • combat the development of antimicrobial resistance.┬áStrict rules have therefore been introduced for the use of antimicrobial veterinary medicinal products.

This should all contribute to the better availability and better use of veterinary medicinal products.

UPD

The European Medicines Agency (EMA) published the Union Product Database (UPD) on 28 January 2022. The UPD contains information on all veterinary medicinal products authorised for use in the European Union. Marketing authorisation holders can submit administrative changes to veterinary medicinal products directly in the UPD. The UPD also forms the basis for the database of reported suspected adverse effects of veterinary medicinal products.

National legislation

The provisions of the regulations are directly applicable throughout the European Union. Only a number of the items referred to in the regulations offer limited scope for national interpretation. The Animals Act (Wet dieren), the Veterinary Medicinal Products Decree (Besluit diergeneesmiddelen) and the Veterinary Medicines Regulations (Regeling diergeneesmiddelen) have been amended accordingly. All matters that are set out directly in the Regulation has been removed from the national legislation. Only those areas where the Regulation allows national competences continue to be included in the national legislation.

Current situation

The amended Animals Act and the Veterinary Medicines Regulations 2022 have now been published. The new Veterinary Medicinal Products Decree 2022 is still pending before the Council of State. For this reason, a number of items from the new Veterinary Medicinal Products Decree 2022 have been added to the new Veterinary Medicines Regulations 2022. We will inform you on our website as soon as the Veterinary Medicinal Products Decree 2022 has been published.

More information

We try to keep our website as up to date as possible and to incorporate new information as soon as it becomes available. So please regularly check our our website.

Any further questions? Contact the Veterinary Medicinal Products Unit.