European requirements
The Veterinary Medicinal Products Regulation (EU) 2019/6 applies from 28 Jan. 2022.
It replaces Directive 2001/82/EC and Regulation (EC) 1234/2008 (as far as Veterinary Medicinal Products (VMPs) are concerned) and complements Regulation (EC) 726/2004 (as far as VMPs are concerned).
The Veterinary Medicinal Products Regulation (EU) 2019/6 aims to harmonise and promote the internal market for VMPs, reduce administrative burdens, support innovation, increase the availability of VMPs and strengthen the fight against antimicrobial resistance.
In addition, a large number of implementing acts and delegated acts were adopted. Accompanying information and FAQs: https://ec.europa.eu/food/animals/animal-health/vet-meds-med-feed_en.
For the application and implementation of the Regulation (EU) 2019/6, the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) provides numerous guidance documents and FAQ documents: Heads of Medicines Agencies: Role of CMDv.
The EMA also publishes further general information at www.ema.europa.eu/en/veterinary-regulatory/overview/veterinary-medicinal-products-regulation.
Some important topics for applicants in Austria and the frequently asked questions can be found in the following articles:
