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.
The first of these presentations focuses on Chemistry, Manufacturing and Controls (CMC) for veterinary pharmaceuticals, and will look at:
- Registration of API manufacturers, importers and distributors
- Union Database
- ManA holders’ audit of manufacturers, importers and distributors of API, GMP certification
- Manufacturing Authorisations
- Implementing Act for GDP for active substances
Don’t forget to check back later in the spring of 2022, when we will publish the next e-learnings in this series!
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