Q.V Changes to a marketing authorisation resulting from other regulatory procedures – Q.V.b) Referral

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Valid Version — C/2025/5045 (effective 16.01.2026)

Previous version is available here: Variations Guidelines 2013/C 223/01

Q.V Changes to a marketing authorisation resulting from other regulatory procedures – Q.V.b) Referral

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

#qvb1

Q.V.b.1 Update of the quality dossier intended to implement the outcome of a Union referral procedure	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) The change implements the outcome of the referral	1	1, 2	IA_IN
(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.

Q.V Changes to a marketing authorisation resulting from other regulatory procedures – Q.V.b) Referral

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