About this document
Accelerated Assessment for Veterinary Drugs by basikraj is a document available to read on EtoBox.
The document provides procedural advice for the accelerated assessment of marketing authorization applications for veterinary medicinal products under Article 44(3) of Regulation (EU) 2019/6, allowing for a reduced evaluation period from 210 to 150 days. It outlines the necessary steps, justifications required for an accelerated review, and the importance of early communication with the European Medicines Agency (EMA). The guidance is intended for applicants seeking to demonstrate that their product is of m
- Author
- basikraj
- Language
- EN