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

You can now use the comment section at the end of each page to discuss the topic and ask questions.

Note: For quick navigation, use the browser search function (e.g. Ctrl+F) and enter the variation category without the full stop (e.g. Q.II.b.3 -> qiib3).

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

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

Q.V.a) PMF/VAMF

Q.V.b) Referral

Q.V.a) PMF/VAMF

Q.V.a.1 Inclusion of a new, updated or amended Plasma Master File in the marketing authorisation dossier of a medicinal product. (PMF 2nd step procedure)

Q.V.a.2 Inclusion of a new, updated or amended Vaccine Antigen Master File in the marketing authorisation dossier of a medicinal product. (VAMF 2nd step procedure)

#qva1

Q.V.a.1 Inclusion of a new, updated or amended Plasma Master File in the marketing authorisation dossier of a medicinal product. (PMF 2nd step procedure)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) First-time inclusion of a new Plasma Master File affecting the properties of the finished product			II
(b) First-time inclusion of a new Plasma Master File not affecting the properties of the finished product		1, 2, 3, 4, 5	IB
(c) Inclusion of an updated/amended Plasma Master File when changes affect the properties of the finished product		1, 2, 3, 4, 5, 6	IB
(d) Inclusion of an updated/amended Plasma Master File when changes do not affect the properties of the finished product	1	1, 2, 3, 4, 5	IA
Conditions
1. The updated or amended Plasma Master File has been granted a certificate of compliance with legislation of the Union in accordance with Annex I of Directive 2001/83/EC.
Documentation
1. Declaration that the PMF Certificate and Evaluation Report are fully applicable for the authorised product, PMF holder has provided the PMF Certificate, Evaluation report and PMF dossier to the holder (where the marketing authorisation holder is different to the PMF holder), the PMF Certificate and Evaluation Report replace the previous PMF documentation for this marketing authorisation.
2. PMF Certificate and Evaluation Report.
3. An expert statement outlining all the changes introduced with the certified PMF and evaluating their potential impact on the finished products including product specific risk assessments.
4. The variation application form should clearly outline the ‘present’ and ‘proposed’ PMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other PMFs to which the medicinal product refers even if they are not the subject of the application.
5. Updated product information whenever this is required by the relevant national legislation.
6. Updated affected sections of the dossier for the medicinal product.

#qva2

Q.V.a.2 Inclusion of a new, updated or amended Vaccine Antigen Master File in the marketing authorisation dossier of a medicinal product. (VAMF 2nd step procedure)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) First-time inclusion of a new Vaccine Antigen Master File			II
(b) Inclusion of an updated/amended Vaccine Antigen Master File, when changes affect the properties of the finished product		1, 2, 3, 4	IB
(c) Inclusion of an updated/amended Vaccine Antigen Master File, when changes do not affect the properties of the finished product	1	1, 2, 3, 4	IA_IN
Conditions
1. The updated or amended Vaccine Antigen Master File has been granted a certificate of compliance with legislation of the Union in accordance with Annex I to Directive 2001/83/EC.
Documentation
1. Declaration that the VAMF Certificate and Evaluation Report are fully applicable for the authorised product, VAMF holder has submitted the VAMF Certificate, Evaluation report and VAMF dossier to the holder (where the marketing authorisation holder is different to the VAMF holder), the VAMF Certificate and Evaluation Report replace the previous VAMF documentation for this marketing authorisation.
2. VAMF Certificate and Evaluation Report.
3. An expert statement outlining all the changes introduced with the certified VAMF and evaluating their potential impact on the finished products including product specific risk assessments.
4. The variation application form should clearly outline the ‘present’ and ‘proposed’ VAMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other VAMFs to which the medicinal product refers even if they are not the subject of the application.

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.a) PMF/VAMF

Q.V.b) Referral

Leave a Reply Cancel reply