Are you ready for the new veterinary Regulation?
Implementation of the new veterinary medicines regulation in the EU (Regulation 2019/6, or the new VMP-Reg) is imminent: the Regulation will come into force on January 28th, 2022.
For two decades, the EU legislation around veterinary medicines has remained largely the same; clarifications have been made of certain scientific and legal aspects of Directive 2001/82 EC as amended, and the associated legislation and guidelines – but essential principles have not changed during this time. The new VMP-Reg represents a significant departure from the ‘old’ legislation for all of us - from Marketing Authorisation Holders to manufacturers, from regulatory affairs strategists to clinical study monitors.
The Animal Health Team at knoell have prepared this series of e-learnings, providing expert insights into the content of the new VMP-Reg from different perspectives and within different contexts.
In this presentation, the new approach to Limited Market products (formerly referred to as Minor Use, Minor Species or MUMS) is outlined, with particular focus on immunological VMPs:
- Limited Markets vs. MUMS
- Limited Market classification (Art. 4.29)
- Limited Market Applications (Art. 23)
- Eligible and non-eligible products
- Data requirements for LM dossiers
Interested in latest news on Animal Health Regulations? Click here!