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EU Veterinary Medicinal Products Regulation becomes applicable on 28 January 2022

28.1.2022

EU Veterinary Medicinal Products Regulation (2019/6) becomes applicable today, 28 January 2022. The EU Veterinary Medicines Regulation is directly applicable and, as such, binding on all operators in the Member States starting from 28 January 2022.

In particular, the reform aims to improve the availability of veterinary medicines and reduce the administrative burden for pharmaceutical companies, as well as to stimulate the development of innovative veterinary medicines. The efforts to strengthen the actions to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals and by collecting data on the use of antibiotics on a per-species basis.

In practice, the reform is reflected in measures such as the introduction of new EU-wide databases. The Union Product Database intend for everyone serves as a single source of information on all authorised veterinary medicines and their availability in the EU, regardless of their marketing authorisation process, and on the availability of veterinary medicinal products in different Member States.

Amendments to national legislation currently in progress

National legislation supplementing the Regulation can be adopted on certain matters where the Regulation allows this for the Member States. National legislation shall not conflict with EU legislation. The Commission will also draw up implementing and delegated acts relating to the Veterinary Medicinal Products Regulation. These acts will also be binding regulations in EU Member States.

The Ministry of Social Affairs and Health is preparing a government proposal to amend the Medicines Act. Updates to Fimea’s administrative regulations will be finalised once the amendments to Medicines Act have entered into force, and they will be circulated for comments after finalisation. A proposal to update the Decree on fees chargeable by the Finnish Medicines Agency is being prepared at Fimea.

If you have questions before the amendments to national legislation have entered into force, please contact the persons listed for additional information below. Fimea is preparing a Frequently Asked Questions section on its website with a collection of questions and answers. We will send out an update when the FAQ section is published.

EMA press release 28 January 2022: New EU rules for safe and high-quality medicines for animals become effective

Fimea online news article 17 December 2022: EU Veterinary Medicines Regulation becomes effective on 28 January 2022 – national regulations currently under preparation