Introduzione
The European regulatory framework for veterinary medicinal products requires strict compliance with pre- and post-market procedures to ensure product safety, quality, and efficacy.
The process of obtaining a Veterinary Marketing Authorisation (MAA) involves compiling a detailed dossier covering clinical and safety documentation. Additionally, any changes to authorised veterinary medicinal products must adhere to specific variation procedures under EU regulations.
This interactive training course provides a structured approach to understanding the MAA dossier requirements, focusing on clinical and safety documentation, and offers insights into key MAV processes, including Variations Not Requiring Assessment (VNRA) and Variations Requiring Assessment (VRA).
Participants will gain hands-on experience in preparing critical regulatory documents and best practices for managing variations efficiently.
This course is beneficial for regulatory professionals seeking a deeper understanding of EU veterinary medicinal product authorisation and variation management.