The new EU veterinary medicinal products (VMP) regulation
The Veterinary Medicinal Products Regulation (EU) 2019/6 is valid from 28 Jan. 2022.
It replaces Directive 2001/82/EC and Regulation (EC) 1234/2008 (as far as Tierarzneimittel (TAMs) are concerned) and complements Regulation (EC) 726/2004 (as far as TAMs are concerned).
The Veterinary Medicinal Products Regulation (EU) 2019/6 aims to harmonise and promote the internal market for veterinary medicinal products, reduce administrative burdens, support innovation, increase the availability of TAMs 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.
Therefore three new online databases must be established:
• the Union Product Database (UPD),
• the pharmacovigilance database and
• the manufacturing and wholesale distribution database.
European Guidelines, some important consequences for applicants in Austria and the most frequently asked questions can be found in the following articles:
-Application for marketing authorization and variations
-Implementation of the new QRD templates
-Implementation status in Austria