M. PMF/VAMF

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

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

M. PMF/VAMF

M.1 Change in the name and/or address of the certificate holder

M.2 Change or transfer of the current PMF certificate holder to a new PMF certificate holder, i.e. different legal entity

M.3 Change in the name and/or address of a blood establishment and/or blood/plasma collection centres

M.4 Addition or relocation of a blood/plasma collection centre within a blood establishment already included in the PMF

M.5 Deletion or change of status (operational/non-operational) of establishment(s)/centre(s) used for blood/plasma collection or in the testing of donations and plasma pools

M.6 Addition of a new blood establishment for the collection of blood/plasma not included in the PMF

M.7 Addition or relocation of a centre/laboratory for testing of donations and/or plasma pools within an establishment already included in the PMF

M.8 Addition of a new laboratory for testing of donations and/or plasma pool not included in the PMF

M.9 Changes of an establishment or centre(s) in which storage of plasma is carried out or organisation(s) involved in the transport of plasma

M.10 Addition or replacement of blood and plasma tests

M.11 Change of inventory hold procedure

M.12 Addition or replacement of blood containers (e.g. bags, bottles)

M.13 Change in storage/transport

M.14 Introduction of test for a new viral marker when this will have significant impact on the viral risk assessment

M.15 Change in the plasma pool preparation (e.g. manufacturing method, pool size, storage of plasma pool samples)

M.16 Change in the steps that would be taken if it is found retrospectively that donation(s) should have been excluded from processing (‘look-back’ procedure)

#m1

M.1 Change in the name and/or address of the certificate holder	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) PMF certificate holder	1	1	IA_IN
(b) VAMF certificate holder	1	1	IA_IN
Conditions
1. The certificate holder must remain the same legal entity.
Documentation
1. A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name or new address is mentioned.

#m2

M.2 Change or transfer of the current PMF certificate holder to a new PMF certificate holder, i.e. different legal entity	Conditions to be fulfilled	Documentation to be supplied	Procedure type
		1, 2, 3, 4, 5, 6	IA_IN
Documentation
1. A document including the identification (name and address) of the current PMF holder (transferor) and the identification (name and address) of the person to whom the transfer is to be granted (transferee) together with the proposed implementation date – signed by both companies.
2. Copy of the latest PMF Certificate page ‘EMA Plasma Master File (PMF) certificate of compliance with Community legislation’.
3. Proof of establishment of the new holder (Excerpt of the commercial register and the English translation of it) – signed by both companies.
4. Confirmation of the transfer of the complete PMF documentation since the initial PMF certification to the transferee – signed by both companies.
5. Letter of Authorisation including contact details of the person responsible for communication between the competent authority and the PMF holder – signed by the transferee.
6. Letter of Undertaking to fulfil all open and remaining commitments (if any) – signed by the transferee.

#m3

M.3 Change in the name and/or address of a blood establishment and/or blood/plasma collection centres	Conditions to be fulfilled	Documentation to be supplied	Procedure type
	1, 2	1, 2, 3	IA
Conditions
1. The blood establishment must remain the same legal entity.
2. The change must be administrative.
Documentation
1. Signed declaration that the change does not involve a change of the quality system within the blood establishment.
2. Signed declaration that there is no change in the list of the collection centres.
3. Updated relevant sections and annexes of the PMF dossier.

#m4

M.4 Addition or relocation of a blood/plasma collection centre within a blood establishment already included in the PMF	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) Relocation	1, 2, 3	2, 3	IA
(b) Addition		1, 2, 3	IB
Conditions
1. It remains the same legal entity.
2. Inspection authorities have issued new inspection approval status.
3. The blood/plasma collection centre should retain the same quality system.
Documentation
1. Epidemiological data for viral markers related to the blood/plasma collection centre to be provided as requested in the Guideline on epidemiological data on blood transmissible infections.
2. Statement that the centre is working under the same conditions as the other centres belonging to the blood establishment, as specified in the standard contract between blood establishment and PMF holder.
3. Updated relevant sections and annexes of the PMF dossier including also inspections and audit information.

#m5

M.5 Deletion or change of status (operational/non-operational) of establishment(s)/centre(s) used for blood/plasma collection or in the testing of donations and plasma pools	Conditions to be fulfilled	Documentation to be supplied	Procedure type
1. Deletion.	1	1	IA
2. Change of status.
(a) from operational to non-operational	1	1	IA
(b) from non-operational to operational	2, 3, 4	1, 2, 3, 6	IA
(c) from non-operational to operational when epidemiological data has not been annually submitted or there have been other than administrative changes in blood establishment or centres since there were moved to non-operational (e.g. blood bags, testing kits)		1, 4, 5, 6	IB
Conditions
1. The deletion or change of status should not relate to a GMP issue or other safety reasons.
2. The establishments(s)/centre(s) should comply with the legislation in terms of inspections.
3. There have been no other than administrative (Type IA) changes in blood establishment or centres since they were moved to non-operational (e.g. blood bags, testing kits) and standard contract between blood establishment and PMF holder is in place.
4. For collection centres epidemiological data have been annually submitted and evaluated in the PMF annual update.
Documentation
1. Updated relevant sections and annexes of the PMF dossier including inspections and audit information, as needed.
2. Confirmation no changes other than administrative (Type IA) have been implemented.
3. Declaration that, while the establishment(s)/centre(s) has remained in non-operational, the epidemiology data have been submitted annually.
4. Updated epidemiological data for viral markers related to the blood/plasma collection centre.
5. Declaration of changes introduced, and variation applications submitted.
6. Confirmation that standard contract between blood establishment/centre and PMF holder is in place.

#m6

M.6 Addition of a new blood establishment for the collection of blood/plasma not included in the PMF	Conditions to be fulfilled	Documentation to be supplied	Procedure type
			II

#m7

M.7 Addition or relocation of a centre/laboratory for testing of donations and/or plasma pools within an establishment already included in the PMF	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) Relocation	1, 2, 3	1, 2	IA
(b) Addition		1, 2	IB
(c) Link existing collection centres to another existing or new blood/plasma testing centres in PMF		2	IA
Conditions
1. It remains the same legal entity.
2. Inspection authorities have issued new inspection approval status.
3. The centre/laboratory should retain the same staff, equipment and quality system.
Documentation
1. Statement that the testing is performed following the same SOPs and/or analytical procedures as already accepted.
2. Updated relevant sections and annexes of the PMF dossier including inspections and audit information.

#m8

M.8 Addition of a new laboratory for testing of donations and/or plasma pool not included in the PMF	Conditions to be fulfilled	Documentation to be supplied	Procedure type
			II

#m9

M.9 Changes of an establishment or centre(s) in which storage of plasma is carried out or organisation(s) involved in the transport of plasma	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) Relocation of storage establishment or centre	1, 2	1, 2	IA
(b) Addition of storage establishment/centre or transport organisation		2	IB
(c) Deletion of storage establishment/centre or transport organisation	3	2	IA
Conditions
1. It remains the same legal entity.
2. Inspection authorities have issued new inspection approval status.
3. The reason for deletion should not be related to GMP issues.
Documentation
1. Statement that the storage centre is working following the same SOPs as the already accepted establishment.
2. Updated relevant sections and annexes of the PMF dossier including inspections and audit information, as needed.

#m10

M.10 Addition or replacement of blood and plasma tests	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) Test kit for individual donations (serology markers and NAT)
1. CE-marked	1	1, 2	IA
2. Non-CE-marked, not previously been approved in the PMF for any blood centre for testing of donations			II
3. Non-CE-marked, previously approved in the PMF for other blood centre(s) for testing of donations		1, 2	IB
(b) Test for mini-pools NAT
1. CE-marked	1	1, 2	IA
2. Non-CE-marked			II
(c) Test for plasma pools (antibody, antigen or NAT test)			II
Conditions
1. The new test kit is CE-marked and used in line with instructions of use.
Documentation
1. List of testing site(s) where the test is currently used and a list of testing centre(s) where the kit will be used.
2. Updated relevant sections and annexes of the PMF dossier, including updated information on testing as requested in the ‘Guideline on the scientific data requirements for a PMF’.

#m11

M.11 Change of inventory hold procedure	Conditions to be fulfilled	Documentation to be supplied	Procedure type
		1	IA
Documentation
1. Updated relevant sections of the PMF dossier.

#m12

M.12 Addition or replacement of blood containers (e.g. bags, bottles)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) The new blood containers are CE-marked	1	1	IA
(b) The new blood containers are not CE-marked and there is no impact on the quality criteria of the blood in the container		1, 2, 3, 4	IB
(c) The new blood containers are not CE-marked and there is potentially an impact on the quality criteria of the blood in the container			II
Conditions
1. The quality criteria of the blood in the container remain unchanged.
Documentation
1. Updated relevant sections and annexes of the PMF dossier, including the name of container, manufacturer, anticoagulant solution specification, confirmation of CE-mark and the name of the blood establishments where the container is used.
2. Confirmation and data demonstrating compliance with equivalent quality standard as CE-mark as requested in the ‘Guideline on the scientific data requirements for a PMF’.
3. Confirmation that any anticoagulant solution complies with Ph. Eur. requirements.
4. Justification that there is no impact on the quality criteria of the blood in the container.

#m13

M.13 Change in storage/transport	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) storage and/or transport conditions	1	1	IA
(b) maximum storage time for the plasma	1, 2	1	IA
Conditions
1. The change should tighten the conditions and be in compliance with Ph. Eur. requirements for Human Plasma for Fractionation.
2. The maximum storage time is shorter than previously.
Documentation
1. Updated relevant sections and annexes of the PMF dossier, including detailed description of the new conditions, confirmation of validation of storage/transport conditions and the name of the blood establishment(s) where the change takes place (if relevant).

#m14

M.14 Introduction of test for a new viral marker when this will have significant impact on the viral risk assessment	Conditions to be fulfilled	Documentation to be supplied	Procedure type
			II

#m15

M.15 Change in the plasma pool preparation (e.g. manufacturing method, pool size, storage of plasma pool samples)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
		1	IB
Documentation
1. Updated relevant sections of the PMF dossier.

#m16

M.16 Change in the steps that would be taken if it is found retrospectively that donation(s) should have been excluded from processing (‘look-back’ procedure)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
			II

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