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Current status: Obsolete, superseded by version Variations Guidelines C/2025/5045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.II FINISHED PRODUCT – B.II.h) Adventitious Agents Safety (obsolete version)

This is an archived version. Please see the current version here: Q. QUALITY CHANGES – Q.II. FINISHED PRODUCT – Q.II.h) Adventitious Agents Safety

B.II.h.1 Update to the “Adventitious Agents Safety Evaluation” information (section 3.2.A.2)

#biih1

B.II.h.1 Update to the “Adventitious Agents Safety Evaluation” information (section 3.2.A.2)Conditions to be fulfilledDocumentation to be suppliedProcedure type
a) Studies related to manufacturing steps investigated for the first time for one or more adventitious agents  II
b) Replacement of obsolete studies related to manufacturing steps and adventitious agents already reported in the dossier   
1) with modification of risk assessment  II
2) without modification of risk assessment 1, 2, 3IB
Documentation
1. Amendment of the relevant section(s) of the dossiers including the introduction of the new studies to investigate the capability of manufacturing steps to inactivate/reduce adventitious agents.
2. Justification that the studies do not modify the risk assessment.
3. Amendment of product information (where applicable).