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Home / Activities / Registration / Post Authorisation Procedures / Transfer of marketing authorisation holder

Transfer of marketing authorisation holder

Introduction

 

The transfer procedure must be used where the legal entity of a marketing authorisation holder is changed and the product is transferred to a new company. This process is different from a change of name or address, which is considered as a type IA immediate notification (IAIN) variation as per "Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures", which can be found through this link.

A Marketing Authorisation Holder (MAH) transfer usually occurs as a result of a merger or acquisition and is always submitted as a national procedure including transfers for products authorised through European procedures (Mutual Recognition and Decentralised Procedures).

For products which are already authorised, the existing authorisation must have a remaining period of validity of more than three months. If the period is less than three months, the existing marketing authorisation must be renewed first, before the transfer application can be processed.

Transfer after authorisation

When requesting a transfer of marketing authorisation holder after granting of the marketing authorisation, both the current and proposed holders must notify the Medicines Authority immediately using Transfer Form A.

Transfer during the national phase

Where an authorisation is transferred during the national phase but before the granting of the marketing authorisation by the Medicines Authority, the new holder must notify the Medicines Authority using Transfer Form B. The earliest transfer date of the MAH is the date of receipt of the application by the Medicines Authority.

In order to use this procedure for transfer before authorisation, the following conditions must be met, where applicable:

  • Payment (as per current legal notice on Fees) must be effected per product (i.e. per MA number). Proof of payment must be submitted with documentation
  • Proof of establishment of the new MAH should be issued by an official body in the proposed MAH member state
  • All documents/declarations requested in the application form must be filled in and details must be correct in order for the application to be processed.
  • Once the application is considered valid, the transfer will be processed within approximately 60 days.
  • No change may be made, as part of the transfer application, to the authorisation schedule or approved SmPC. No change may be made to the technical data in Modules 3, 4 and 5.
  • No change may be made to the texts of the labels and leaflet, other than the MA number, the holder's name and address and the company logo, as applicable. Any change to the layout and design must not adversely affect the readability of their contents.
  • No stock bearing the existing MA number/MAH should be brought into Malta after the transfer effective date quoted on the marketing authorisation licence. Batches of the product bearing details of the previous MAH should be sold out within a period of six months after the transfer effective date. If this is not possible, please contact the Medicines Authority.
  • The new marketing authorisation document will be identical to the existing one, except for the name and address of the holder and the MA number. It is issued for the remaining period of validity of the existing authorisation, if applicable.
  • Any change (besides those mentioned in the previous bullet point) to the transferred authorisation, e.g., revised labelling/leaflet text or the introduction of a new manufacturer, must be applied for by a variation application or Article 61(3) notification, depending on the scope.
  • Variations affecting the information on the front page of the licence as a result of the transfer (e.g. change in name of the medicinal product; change, addition or removal of a batch release site etc.), should be submitted in parallel to the transfer through the appropriate variation applications.
  • Variations to change the PSMF (of new MAH) should be submitted in parallel to the transfer (or as otherwise requested from the RMS in the case of products authorised via MRP procedure)
  • Other variations (unless they concern urgent safety variations), can be submitted either pre- or post-transfer. These must be submitted by the current MAH at the time.
  • On expiry, the transferred authorisation is renewed in the usual way by the new holder of the authorisation. 

Pharmacovigilance Requirements - Submission of PSMF Declaration 

In support of the transfer application, the proposed MAH is requested to fill in the PSMF declaration. 

For transfers of nationally authorised products (including those authorised through MRP/DCP), kindly note the following:

Changes to the Qualified Person responsible for Pharmacovigilance (QPPV) or the location of the Pharmacovigilance System Master File (PSMF), no longer need to be submitted through variation applications. Instead the article 57 database should be updated with the new details.

If the actual content of the PSMF changes, this should be updated via the submission of a variation (C.1.8). In the case of a MRP/DCP approved product, this variation is to be submitted to the RMS and CMSs involved in the procedure and in the case of a national procedure this is to be submitted to the national competent authority (Medicines Authority).

A variation should also be submitted if the PSMF declaration (in module 1.8.1 of the dossier) changes, e.g.: 

  • If the PSMF referred to has changed from the previous one
  • If the PSMF is still the same but the details on the PSMF declaration have changed (e.g. the MAH or applicant signing the PSMF declaration has changed; in this case the new MAH or applicant must sign this) 

This variation should ideally be submitted in parallel with the transfer application. For MAH transfers of products authorised through the centralised procedure, kindly contact EMA.

Applications for transfers are to be submitted through the Common European Submission Portal (CESP).  For specific requirements on the electronic submission (e.g. on format, required templates, electronic signatures), refer to the Medicines Authority document, "Guideline for submission of applications and documents for medicinal products authorisation and post-authorisation activities procedures", which can be found through this link.

FAQs

1. Question: When does the transfer come into effect?

Answer: The transfer comes into effect on the transfer effective date quoted on the MA licence documents.

2. Question: Can the old MAH import/release the old product after the MAH transfer has been approved?

Answer: No stock bearing the existing MA number/MAH should be brought into Malta after the transfer effective date quoted on the marketing authorisation licence.
Batches of the product bearing details of the previous MAH should be sold out within a period of six months after the transfer effective date. If this is not possible, please contact the Medicines Authority.

3. Question: Is there a time frame given by the authorities where it is acceptable to release products in old artwork?

Answer: Batches of the product bearing details of the previous MAH should be sold out within a period of six months after the transfer effective date. If you have any issues about this please contact the Licensing directorate at the Medicines Authority.

4. Question: What should be the implementation date for the change of artwork?

Answer: The artwork should be produced/implemented from the transfer effective date and the old artwork should no longer be produced on/after the transfer effective date.

5. Question: Is new artwork required at submission, approval or when available?

Answer: The mock ups should be submitted to the Medicines Authority before product bearing the new details is placed on the market. The labelling in editable word format should be submitted together with the Product Information with the transfer application

6. Question: When applying for a transfer, should updated product information texts be submitted in clean version, annotated version or both clean and annotated versions?

Answer: Both clean and annotated versions should be submitted.

7. Question: Can a change in ownership/MA transfer application be submitted while a variation affecting the product information (Summary of product characteristics, package leaflet, and/or labelling) is under assessment/review?

Answer: In general, a transfer can be submitted while there are ongoing variations. However, if the variation has not yet been approved (i.e. if the transfer will be finalised before the variation is approved), the information pertaining to that variation should not be included in the product information (SmPC, PL and/or labelling) submitted with the transfer application. If, on the other hand, the variation affecting the product information will be processed with the transfer application and finalised/approved together with the transfer application, then the product information pertaining to that variation should be included in the product information submitted with the transfer application. 

8. Question: Is the dossier re-evaluated during the MAH transfer?

Answer: No, the dossier is not re-evaluated. Any changes to the dossier resulting from the MAH transfer must be submitted via a variation application and approved by the Medicines Authority. Please refer to the variations section of the website for more information on variations. For European procedures, the variations must be submitted to the RMS and CMSs simultaneously.

9. Question: Is it acceptable to fill in just one application form/PSMF declaration that covers a number of products?

Answer: Yes, it is acceptable to fill in one form for the products being transferred from one MAH to another MAH as long as the information in the application form is relevant and correct for all the products. The list appended to the form must include all the products included in the scope of the transfer application. The proof of payment for each product must be submitted.

10. Question: Does the MA transfer application/PSMF declaration have to be submitted by the current or the new MAH? 

Answer: The Transfer application has to be submitted by current MAH but there are sections within the form that need to be signed and filled in by both current and proposed MAH. The letter of authorization needs to be submitted for both current and proposed persons authorized for communication, where relevant. The PSMF declaration needs to be filled in by the proposed MAH.

11. Question: For European procedures, at what stage during the procedure can a transfer occur?

Answer: During a DCP, a transfer can occur at Day 106 (included in the day 106 responses) and Day 160 (included in the day 160 responses), whereby a new MAH different to the one proposed in the original application form is being proposed. The change in proposed MAH can only occur once during the procedure for the Reference Member State/Concerned Member State.

12. Question: For a European procedure, should the transfer application be submitted to Malta and all Member states or just Malta? 

Answer: The transfer application form should be submitted to Malta if the transfer only affects Malta. If the transfer affects any other Member State, then it should also be submitted to that Member State/s in accordance with its/their specific requirements. The applicant should contact the Member State/s for information on the documentation that needs to be submitted.

13. Question: What documents will the new MAH receive from the Medicines Authority once the transfer is finalised?

Answer: An updated MA licence document bearing the transfer effective date will be sent to the new MAH on completion of processing of the transfer application.

14. Question: Does the applicant/MAH need to request a MA number before the transfer application is submitted to the Authority?

Answer: The MA number can be requested either before submission of the application (in this case the applicant /MAH must update the proposed product information with the new MAH details) or during the processing of the transfer application (in this case the MA number will be inserted in the editable word format texts by the Medicines Authority). When requesting the new MA number, the proof of establishment must be sent by email together with the request to licensing.medicinesauthority@gov.mt. The new MA numbers and MAH details must be included in the mock ups submitted to the Medicines Authority, before marketing the product in Malta.

15. Question: One of the requirements for submission of Transfer form A is to submit a variation to change the PSMF (reflecting new MAH) which is to be submitted in parallel to the transfer application (or as otherwise requested from the RMS in the case of products authorised via DCP or MRP). However, according to GL-PL 03.06: "All QPPV related information is to be entered into the Article 57 database for medicinal products for human use. MAHs no longer need to notify EMA (for centrally authorised products) or national competent authorities (for nationally authorised products) of changes to the QPPV or PSMF data, by submitting a type IAIN variation. All changes should be entered in the database in line with legal obligation". Is a variation required in view of the above? Is a PSMF declaration enough to fulfill this criterion?

Answer: Regarding transfers of nationally authorised products (including  MRP/DCP authorised products), kindly note the following: Changes to the Qualified Person responsible for PharmacoVigilance" (QPPV) or the location of the "Pharmacovigilance System Master File" (PSMF) no longer need to be submitted through variation applications. Instead, the article 57 database should be updated. 

If the content of the PSMF changes, this should be updated via the submission of a variation (C.I.8). In the case of a MRP/DCP approved product, this variation is to be submitted to the RMS and CMSs involved in the procedure and in the case of a national procedure this is to be submitted to the national competent authority (Medicines Authority).

A variation should also be submitted if the PSMF summary (in module 1.8.1 of the dossier) changes, e.g.:
• If the PSMF referred to has changed from the previous one
• If the PSMF is still the same but the details on the PSMF dsummary have changed (e.g. the MAH or applicant signing the PSMF summary has changed; in this case the new MAH or applicant must sign this)

This variation should ideally be submitted in parallel with the transfer application.

16. Question: In case the MAH or one or more member state(s) is changed, is a variation in all member states necessary to introduce the new summary of the pharmacovigilance system (human) of the new MAH or is a purely national variation in the member state(s) concerned sufficient? 

Answer: In case of the transfer of a MA in one or more member state(s) the new summary of the pharmacovigilance system (human) of the new MAH has to be submitted to all member states concerned via MRP variation (as a type IAIN notification, C.I.8.a, or under category C.II.7, as applicable). This is also applicable when using the Art. 57 database (human only) as the classification guideline (C.I.8) also requires a "proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance and a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC". Therefore, a variation for the introduction of a new summary PSMF of the pharmacovigilance system after a change of the MAH still has to be submitted, later changes of the contact details of the QPPV or location of the PSMF do not require variations anymore when they are introduced via the Art. 57 database. A variation to submit the summary of the pharmacovigilance system will not be necessary in cases where the MA is transferred within companies belonging to the same parent company and the same PSMF will continue to be used.

For MAH transfers of products authorised through the centralised procedure, kindly contact EMA.

 

Updated on: August 2018