The new Veterinary Medicine legislation (on veterinary medicine and medicated feed) will come into force on 28 January 2022. The main Regulations will be supplemented with several delegating and implementing acts.
FVE is consulted by the European Medicines Agency and the European Commission on many of these supplementary acts.
Here you can see an overview of the responses given by FVE:
- In respect to criteria for reserving antibiotics to the human field, FVE underlines that animals need treatment too and that antibiotics should only be reserved as a last option. FVE also provided feedback on the draft delegated act early January 2021 and the public consultation in April 2021, to underline the need for a science-based decision making in reserving antibiotics for humans only.
- In respect to the common logo for online sales of veterinary medicines, FVE welcomes that the logo is similar to the human logo but has another colour and the letters for ‘vet’. FVE also welcomes the insertion of a hyperlink to the Member State competent authority list of authorised retailers.
- In respect to the Union Product Database, FVE greatly welcomes the development of this database which has the potential to be a great tool to increase availability of veterinary medicines. We urge that the database is as user-friendly as possible.
- In respect to the future surveillance system of veterinary antibiotics (ESVAC), FVE welcomes the ambitious goal to start measuring use data of antimicrobials. Automated systems need to be developed without additional bureaucracy and cost for the veterinarian.
- In respect to pharmacovigilance, the new Regulation will move to a new system using signal detection. FVE underlines that we need to stimulate reporting and improve the feedback giving to veterinarians.
- FVE also provided feedback on the draft CVMP strategy on antimicrobials 2020-2025 – seen hereunder.
An overview of all implementing and delegating acts including the mandates given, the European Medicines Agency advice and stakeholder comments can be found here.