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EU: Preparation for the implementation of the Veterinary Medicinal Products Regulation

The EMA Management Board acknowledged the preparations for the implementation of the Veterinary Medicinal Products Regulation.

21 December 2021
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Delivery of the Union Product Database, the Union Pharmacovigilance Database and the Union Manufacturers and Wholesale Distributors Database is on track for go-live on 28 January 2022, when the new veterinary regulation for the authorisation, use and monitoring of veterinary medicinal products becomes applicable in the EU. An extensive training programme is ongoing and provisions are being made for enhanced support functions after the go live.

The EMA Management Board acknowledged the preparations for the implementation of the regulation and endorsed the extension of the expiry date of the “Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS/limited market)” to 27 January 2022. This policy was introduced in September 2009 to stimulate development of veterinary medicines in Europe and the extension provides for coverage until the limited market provisions of the new regulation come into force.

The Board adopted the mandate of the future VMP-Reg Systems Improvement Advisory Group (VSIAG). The group will include representatives from the network, industry and veterinary healthcare professionals and will be in charge of proposing new functionalities and improvements to be prioritised for VMP-Reg related IT systems.

Finally, revised rules of procedure for the Committee for Veterinary Medicinal Products (CVMP) were approved and will enter into force on 28 January 2022. The updated rules are required to implement the changes brought about by the new veterinary regulation and cover topics such as the delegation of tasks between Member States or scientific opinions for international organisations for animal health.

December 17, 2021/ EMA/ European Union.
https://www.ema.europa.eu

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