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!

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