Recent Updates: Variation to the terms of a marketing authorisation

Written By Layide Akin-Fadeni

Scope

Introduction

COMMISSION DELEGATED REGULATION (EU) 2021/756of 24 March 2021

Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024

Variation Categories – Refresh

Amendment to Guideline Document

The Regulations & Annex III

Supergrouping, Grouping, Worksharing

Presentation of Categories – the changes

Section E – Administrative Changes

Section Q – Quality Changes

Code Changes

New Categories

Design Space

Master Files

Vaccines

Digitalisation and the use of AI

Layide Akin-Fadeni
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