About this document
EU Guidelines on Marketing Authorisation Variations by pires35 is a document available to read on EtoBox.
This document provides guidelines on classifying variations to the terms of marketing authorizations for medicinal products. It defines minor and major variations and provides details for each category. The guidelines classify variations into four chapters: A) Administrative changes; B) Quality changes; C) Safety and efficacy changes; and D) Specific changes to plasma and vaccine master files. For each chapter, the guidelines list which variations should be minor Type IA or major Type II, and examples of mi
- Author
- pires35
- Language
- EN