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.
The Veterinary Medicinal Products Regulation (EU) 2019/6 : http://data.europa.eu/eli/reg/2019/6/oj.
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 most frequently asked questions can be found in the following articles:
