Animal Health - Session 1: Distribution arrangements for APIs (Article 95)

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!

Interested in latest news on Animal Health Regulations? Click here!

Marketing Authorisation Holders, Manufacturers, Importers, Distributors and Regulatory Affairs professionals all in the field of veterinary medicines, specifically vet pharmaceuticals.