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

Version dated 02.08.2013, includung Addendum to the Variations Guidelines (2021/C 215 I/01).
Current status: Obsolete, superseded by version Variations Guidelines C/2025/5045

B. QUALITY CHANGES – B.V. Changes to a marketing authorisation resulting from other regulatory procedures – B.V.b) Referral (obsolete version)

This is an archived version. Please see the current version here: Q.V Changes to a marketing authorisation resulting from other regulatory procedures – Q.V.b) Referral

B.V.b.1 Update of the quality dossier intended to implement the outcome of a Union referral procedure

#bvb1

B.V.b.1 Update of the quality dossier intended to implement the outcome of a Union referral procedureConditions to be fulfilledDocumentation to be suppliedProcedure type
a) The change implements the outcome of the referral11, 2IAIN
b) The harmonisation of the quality dossier was not part of the referral and the update is intended to harmonise it  II
Conditions
1. The outcome does not require further assessment.
Documentation
1. Attached to the cover letter of the variation application: A reference to the Commission Decision concerned.
2. The changes introduced during the referral procedure should be clearly highlighted in the submission.