May 19, 2015
The European Union (EU) has proposed a regulation for veterinary medicinal products. The proposal is released through Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014) 558 final).
The proposal intends to include provisions focused on veterinary medicines, including all authorization procedures, in one legal act, designed to deal effectively with the specificities of the veterinary sector.
The proposal features the following:
- Possibility of granting a centralized (EU-level) marketing authorization for all types of veterinary medicinal products
- Simplified rules on post-authorization procedures; incentives for innovation: longer protection period for the data submitted for authorization of a veterinary medicine in particular for minor species (e.g. bees, fish)
- Specific measures to address the threat of the development of anti-microbial resistance, – streamlining the procedures to authorize veterinary medicines, including centralized, mutual recognition and decentralized procedures
- The public consultation is open for this proposal until July 1, 2015.