Application of the Veterinary Medicines Regulation to begin
The Veterinary Medicines Regulation (2019/6) will be applied as-is in all EU Member States from 28 January 2022. The Regulation will lead to changes in the pharmacovigilance, distribution and marketing of veterinary medicinal products, as well as applying for marketing authorisation and maintaining it.
In January 2022, the Union Product Database (UPD) for veterinary medicinal products and the EudraVigilance Veterinary (EVVET) pharmacovigilance database will be opened. Marketing authorisation holders must register a super user and a controlled user in the UPD.
The Finnish government is currently working on a project that involves examining what changes need to be made to the national legislation and drafting a government proposal to amend the Medicines Act. The proposal is expected to be presented in week 13/2022. Fimea will set up a section for frequently asked questions on its website. Fimea will hold events concerning the national application of the Regulation once the amendments to the Medicines Act and Fimea’s administrative regulations are in force.
The Danish and Norwegian medicines agencies NoMA and DKMA have collected information about the changes resulting from the Veterinary Medicines Regulation on their websites.
The Swedish Medical Products Agency (MPA) has held webinars for holders of marketing authorisations about topics such as the new databases.