Variations Guidelines

Guidelines on the details of the various categories of variations

ANNEX

A. Administrative changes

B. Quality changes

B.I ACTIVE SUBSTANCE

B.I.a) Manufacture

B.I.b) Control of active substance

B.I.c) Container closure system

B.I.d) Stability

B.I.e) Design Space and post-approval change management protocols

B.II FINISHED PRODUCT

B.II.a) Description and composition

B.II.b) Manufacture

B.II.c) Control of excipients

B.II.d) Control of finished product

B.II.e) Container closure system

B.II.f) Stability

B.II.g) Design Space and post approval change management protocol

B.II.h) Adventitious Agents Safety

B.III CEP/TSE/Monographs

B.IV Medical Devices

B.V. Changes to a marketing authorisation resulting from other regulatory procedures

B.V.a) PMF/VAMF

B.V.b) Referral

C. Safety, efficacy, pharmacovigilance changes

C.I Human and veterinary medicinal products

C.II Veterinary medicinal product – specific changes

D. PMF / VAMF

Links

Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use

Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures | European Medicines Agency (EMA)

Consolidated text: Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)Text with EEA relevance