Application of the EU Veterinary Medicines Regulation will begin on 28 January 2022 – national regulations currently under preparation
The EU Veterinary Medicines Regulation (2019/6) is directly applicable and, as such, binding on all operators in the Member States starting from 28 January 2022.
The Veterinary Medicines Regulation is binding on all operators
The essential changes for operators resulting from the Veterinary Medicines Regulation were presented at a virtual discussion event arranged by the Ministry of Social Affairs and Health and Fimea on 9 June 2021. The presentations given at the event and links to relevant EU information resources were published in an online news article on 11 June 2021.
In particular, the reform aims to improve the availability of veterinary medicines and reduce the administrative burden imposed on operators, as well as to increase pharmaceutical innovation. The efforts to combat antimicrobial resistance will be intensified by making the regulation of antimicrobials more stringent and by collecting data on the use of antibiotics on a per-species basis.
In practice, the reform will also be reflected in the opening of the Union Product Database (UPD) maintained by the European Medicines Agency (EMA) in January. The online service, which is open to all, provides information on all authorised veterinary medicinal products and their availability in the EU. The online service will be available in all official languages of the European Economic Area (EEA). Further information about the UPD is available on the EMA website.
National preparations currently in progress
The Ministry of Social Affairs and Health is currently preparing the national regulatory amendments required by the Veterinary Medicines Regulation in collaboration with Fimea.
A new estimated presentation week for the act amending the Medicines Act concerning the regulatory amendments necessitated by the Veterinary Medicines Regulation has been published by the Ministry of Social Affairs and Health in the Gateway to Information on Government Projects. The estimated presentation week for Parliament is week 13/2022. Fimea’s administrative regulations are dependent on the Medicines Act, so their updates will be finalised once the Medicines Act has entered into force. The administrative regulations will be circulated for comments as soon as possible.
Frequently Asked Questions section will be set up on the Fimea website. Questions can be sent to the contact persons listed below. Events will be arranged on the national application of the regulation when the Medicines Act and Fimea’s administrative regulations have entered into force.
Fimea online news article 11 June 2021:
The presentations given at the discussion event related to the national implementation of the Veterinary Medicines Regulation held on 9 June 2021 are available (in Finnish)
Ministry of Social Affairs and Health: National implementation of the Veterinary Medicines Regulation (Gateway to Information on Government Projects)
For further information, please contact:
Irmeli Happonen, Head of Unit, tel. +358 29 522 3330
Heidi Mustalammi (marketing authorisations and UPD),
Procedure Manager, tel. +358 29 522 3329
Anne Junttonen (supervision of operators),
Head of Unit, tel. +358 29 522 3219
E-mail address format: firstname.lastname@example.org