This is an archived version. Please see the current version here: M. PMF/VAMF
D.1 Change in the name and/or address of the VAMF certificate holder
D.2 Change in the name and/or address of the PMF certificate holder
D.7 Addition of a new blood establishment for the collection of blood/plasma not included in the PMF
D.11 Deletion of a blood establishment or centre(s) in which storage of plasma is carried out
D.12 Replacement or addition of an organisation involved in the transport of plasma.
D.13 Deletion of an organisation involved in the transport of plasma
D.16 Change of kit/method used to test pools (antibody or antigen or NAT test).
D.17 Introduction or extension of inventory hold procedure.
D.18 Removal of inventory hold period or reduction in its length.
D.19 Replacement or addition of blood containers (e.g. bags, bottles)
#d1
| D.1 Change in the name and/or address of the VAMF certificate holder | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1 | IAIN | |
| Conditions | |||
| 1. The VAMF 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. | |||
#d2
| D.2 Change in the name and/or address of the PMF certificate holder | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1 | IAIN | |
| Conditions | |||
| 1. The PMF 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. | |||
#d3
| D.3 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 | IAIN | ||
| 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. | |||
#d4
| D.4 Change in the name and/or address of a blood establishment including 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 (e.g. merger, take over); change in the name of the blood establishment/ collection centre provided the blood establishment must remain the same. | |||
| 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. | |||
#d5
| D.5 Replacement or addition 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 |
| 1, 2, 3 | IB | ||
| Documentation | |||
| 1. Epidemiological data for viral markers related to the blood/plasma collection centre covering the last 3 years. For newly opened centre(s) or in case no data are yet available, a declaration that epidemiological data will be provided at the time of the next annual update(s). | |||
| 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. | |||
#d6
| D.6 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, 2 | 1 | IA | |
| Conditions | |||
| 1. The reason for deletion or change of status should not be related to a GMP issue. | |||
| 2. The establishments(s)/centre(s) should comply with the legislation in terms of inspections in case of change of status from non-operational to operational. | |||
| Documentation | |||
| 1. Updated relevant sections and annexes of the PMF dossier. | |||
#d7
| D.7 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 |
#d8
| D.8 Replacement or addition of a blood centre 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 |
| 1, 2 | IB | ||
| Documentation | |||
| 1. Statement that the testing is performed following the same SOPs and/or test methods as already accepted. | |||
| 2. Updated relevant sections and annexes of the PMF dossier. | |||
#d9
| D.9 Addition of a new blood establishment for testing of donations and/or plasma pool not included in the PMF | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| II |
#d10
| D.10 Replacement or addition of a new blood establishment or centre(s) in which storage of plasma is carried out | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1, 2 | IB | ||
| 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. | |||
#d11
| D.11 Deletion of a blood establishment or centre(s) in which storage of plasma is carried out | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1 | IA | |
| Conditions | |||
| 1. The reason for deletion should not be related to a GMP issues. | |||
| Documentation | |||
| 1. Updated relevant sections and annexes of the PMF dossier. | |||
#d12
| D.12 Replacement or addition of an organisation involved in the transport of plasma. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | IB | ||
| Documentation | |||
| 1. Updated relevant sections and annexes of the PMF dossier, including a list of all the blood establishments using this transport organisation, a summary of the system in place to ensure that the transport is performed under appropriate conditions (time, temperature and GMP compliance) and confirmation that transport conditions are validated. | |||
#d13
| D.13 Deletion of an organisation involved in the transport of plasma | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1 | IA | |
| Conditions | |||
| 1. The reason for deletion should not be related to GMP issues. | |||
| Documentation | |||
| 1. Updated relevant sections and annexes of the PMF dossier. | |||
#d14
| D.14 Addition of a CE-marked test kit to test individual donations as a new test kit or as a replacement of an existing test kit | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1, 2 | IA | |
| Conditions | |||
| 1. The new test kit is CE-marked. | |||
| Documentation | |||
| 1. List of testing site(s) where the kit is 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”. | |||
#d15
| D.15 Addition of a non-CE marked test kit to test individual donations as a new test kit or as a replacement of an existing test kit | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| a) The new test kit has not previously been approved in the PMF for any blood centre for testing of donations | II | ||
| b) The new test kit has been approved in the PMF for other blood centre(s) for testing of donations | 1, 2 | IA | |
| Documentation | |||
| 1. List of testing centre(s) where the kit 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”. | |||
#d16
| D.16 Change of kit/method used to test pools (antibody or antigen or NAT test). | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| II |
#d17
| D.17 Introduction or extension of inventory hold procedure. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1 | IA | |
| Conditions | |||
| 1. The inventory hold procedure is a more stringent procedure (e.g. release only after retesting of donors). | |||
| Documentation | |||
| 1. Updated relevant sections of the PMF dossier, including the rationale for introduction or extension of inventory hold period, the sites where the inventory hold takes place and for changes to procedure, a decision tree including new conditions. | |||
#d18
| D.18 Removal of inventory hold period or reduction in its length. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | IB | ||
| Documentation | |||
| 1. Updated relevant sections of the PMF dossier | |||
#d19
| D.19 Replacement or addition 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, 2 | 1 | IA |
| b) The new blood containers are not CE-marked | II | ||
| Conditions | |||
| 1. The container is CE-marked. | |||
| 2. 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. | |||
#d20
| D.20 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). | |||
#d21
| D.21 Introduction of test for viral markers when this introduction will have significant impact on the viral risk assessment. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| II |
#d22
| D.22 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. | |||
#d23
| D.23 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 |