This page lists questions that marketing-authorisation holders (MAHs) may have on transfers of marketing authorisations. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available:

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

Reference Number: EMEA-H-19984/03 Rev. 107

English (EN) (2.63 MB - PDF)

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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

Reference Number: EMEA-H-19984/03 Rev. 107

English (EN) (2.65 MB - PDF)

First published: Last updated:
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These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

Also on this topic

Questions and answers

A Transfer of Marketing Authorisation (MA) is the procedure by which the MA is transferred from the currently approved Marketing Authorisation Holder (MAH) to a new MAH which is a different person/legal entity.

Such a Transfer may result from the MAH's commercial decision to divest the MA or be needed in anticipation of the MAH ceasing to exist as a legal entity and MA being taken over by another legal entity.

In case a MA Transfer is sought for several medicinal products, a common data package may be prepared but an application must be submitted for each MA (i.e. 1 application per product).

A change of name and/or address of the MAH is not a MA Transfer if the holder remains the same person/legal entity. Such change should be notified through a Type IAIN, A.1 variation application.

A Transfer of MA does not include a Transfer of Orphan designation since this is subject to a different procedure (see also “Do I also have to transfer the Orphan designation when my medicinal product has been granted such a designation?”).

A Transfer of a MA can only be initiated once a MA has been granted. In case there is a need to change the proposed MAH during the initial Marketing Authorisation Application procedure, please see the question and answers in the EMA pre-authorisation guidance “How can I change the applicant for an ongoing marketing authorisation application?”

From this point onward:

  • The MAH of the MA to be transferred is termed the Transferor.
  • The person/legal entity to whom the Transfer is to be granted is termed the Transferee.

References

Transfer applications should be presented as follows, in accordance with the appropriate headings and numbering of the EU-CTD format.

Module 1:    
1.0    Cover letter (signed by the Transferor) with the following documents attached (Cover letter):

All documents to be submitted from the Transferee and/or the Transferor, as appropriate, must be legible and preferably shall be printed on a headed paper. A template for each document is attached to provide guidance on the information that should be included in each document. 

 1)   A document is required that contains information about the Transferor, Transferee (name, address, contact person at MAH address, telephone number, and email address) and concerned product(s), including the authorisation number(s) and date(s) of initial marketing authorisation(s) – see 'Authorisation details' tab of the product-specific website on the European Medicines Agency website or respective information in the Union product database.

The document should also include declarations stating that all necessary information has been made available to the Transferee. This includes confirmation that the complete and up-to-date file concerning the medicinal product or a copy of this file, including any data/documents related to the paediatric obligations, has been made available to or transferred to the Transferee. 

Additionally, if appropriate, a declaration of undertaking signed by the Transferee listing any remaining recommendations or post-authorisation measures should be provided with the referred attachment 1. See also “Transfer of Marketing Authorisation – How to handle remaining follow-up measures and specific obligations when transferring a marketing authorisation?”

Furthermore, a signed statement should confirm that no other changes have been made to the product information other than those to the details of the MAH and, if appropriate, the details of the local representatives.

Please refer to (Attachment 1).

2)   A document stating the date on which the Transferor and the Transferee finalise the transitional organisational arrangements and the Transferee takes over all responsibilities. This is referred to as the implementation date. The transitional period between the notification of the Commission decision on the transfer of a marketing authorisation and the implementation date should be proportionate to the organisational activities that need to be performed by the Transferor and Transferee and this date should not exceed 6 months (see also Transfer of Marketing Authorisation “How to choose the implementation date?”).

If applicable, this document should include a “Statement of activities performed by the Transferor during the transitional period”. This statement should briefly provide the Agency with an overview of the organisational activities which will be performed by the Transferor - as agreed with the Transferee - during the transitional period. The transitional period is the period between the date of notification of the Commission Decision on the Transfer and the implementation date.
Moreover, a statement should confirm the status of the product in the market. If the medicinal product concerned has not yet been marketed in the EU/EEA in any of its presentations or has been marketed in the EU/EEA in any of its presentations this should be specified in a signed statement. 

Please refer to (Attachment 2).

3)   An updated list of contacts allowing the Transferee to communicate with the Agency and showing the Transferee’s capacity to perform all the responsibilities required of a MAH.

Please refer to (Attachment 3).

4)   A proof of establishment of the Transferee within the European Economic Area (EEA), issued in accordance with national provisions (e.g. Chamber of Commerce). This document should be no older than 6 months.

5)   A document showing the capacity of Transferee to perform all the responsibilities required of a MAH under Union Pharmaceutical legislation.

Please provide an updated summary of the Pharmacovigilance System Master File (PSMF) under the Transferee’s name in Module 1.8.1 of the application, and ensure to include the following elements:
•    proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance,
•    the Member States in which the qualified person resides and carries out his/her tasks,
the contact details of the qualified person,
•    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,
•    a reference to the location where the pharmacovigilance system master file (PSMF) for the medicinal product is kept.

6)    Confirmation from the Name Review Group (NRG) on the acceptability of the proposed name, if applicable. When the name of a product is composed of INN + company name (see also Transfer of Marketing Authorisation - “Can I change the name of a medicinal product as part of a transfer application?”.

1.3 Product Information 1.3.1     SmPC, Annex II, Labelling and Package Leaflet

The revised product information (SmPC, Annex II, labelling, and package leaflet) in all EU languages including Iceland and Norway must be provided electronically in Word format (highlighted using track changes) and in PDF format (clean).

Please be reminded that in accordance with Union data protection requirements, no personal data should be included in the annotated PIs. This applies to the English version and all the translations. Please submit annotated PIs in an anonymised format (i.e. names of the reviewers removed from the track-changes). If you do not wish to do so, please ensure that the individuals whose data is included consented to its sharing with EMA and its further sharing by EMA with third parties such as other applicants, marketing authorisation holders (MAH) and National Competent Authorities, as relevant. EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated PI submitted by the MAH.

1.3.2 Mock-up

English and multi-lingual (‘worst-case’) colour mock-up of outer and immediate packaging for each pharmaceutical form in each container type (e.g. blister and bottle, vial and pen) in the smallest pack-size (see also “Transfer of Marketing Authorisation – Do I have to submit mock-ups and specimens?”).

Reference

 

Information is available on ‘Submitting a post-authorisation application’.

A Transfer application follows a 30-day procedure following receipt of the application. There are no set submission dates. In order to choose the best submission date, especially in case of any other ongoing/expected procedures, the transferor should contact the EMA at least 1 month prior to the submission of the application (see also “Transfer of Marketing Authorisation - Who should I contact if I have a question when preparing my application or during the procedure?”)

Within 7 days upon receipt of the Transfer application, the EMA will check whether the Transfer application is correct and complete. In case the application is correct and complete the Agency aims to finalise the procedure by Day 10. In case of an incorrect or incomplete application the applicant will be notified and required to provide the amended and/or additional documentation via eCTD submission within 10 calendar days from the date of the EMA notification. The EMA will not be able to issue a favourable opinion on the Transfer in case the documentation is incomplete. Upon receipt of the applicant responses the Agency aims to finalise the procedure by Day 20.

In any case finalisation of the opinion should be within 30 days upon receipt of the Transfer application.

The Transfer opinion will be sent to the Transferor, Transferee, European Commission and the competent authorities of Iceland and Norway. Subsequently, the European Commission will issue a decision on the Transfer of the MA. The transfer of the marketing authorisation is authorised from the date of the notification of the Commission decision on the Transfer.

However, the Agency by mutual agreement with the Transferor and the Transferee can set an implementation date for the Transfer (see also“How to choose the implementation date?”).

Reference

The implementation date is the date on which the Transferee takes over ALL responsibilities as the Holder of the MA. This date is proposed by the Transferor and Transferee in the Transfer application, attachment 2, and will be subject to agreement by the EMA. This date is stated on the opinion adopted by the Agency and also on the European Commission decision.

For the Transfer of a Marketing Authorisation covering medicinal products already marketed in the EU/EEA by the Transferor, the proposed date should be set taking into account the following timelines (see also “Transfer of Marketing Authorisation – How shall my Transfer of Marketing Authorisation application be handled (timetable)?”):
•    The EMA timeframe for finalisation of the opinion is 30 days from the receipt of an application (Day A).
•    The Commission will subsequently issue a Commission Decision on the Transfer of the marketing authorisation. As of the date of notification of the Commission Decision on the Transfer of the marketing authorisation (Day B), the Transfer is effective and the Transferee becomes the new MAH of the medicinal product.
•    Between Day B and Day C (implementation day) there is a transitional period during which the previous MAH and the new MAH have to finalise their organisational arrangements, as defined in the Transfer application (e.g. contractual agreements as regards to batch release). The Transfer application should include information as to the date on which the Transferor will release the last produced batch in the distribution chain, duly justifying why that particular date has been chosen. The transitional period between the notification of the Commission decision on the transfer of a marketing authorisation (Day B) and the implementation date (Day C) should be proportionate to the organisational activities that need to be performed by the Transferor and Transferee. Nevertheless, it should be noted that as of Day B, the Transferee becomes the new MAH of the medicinal product and the EMA will only deal with the new MAH for any further regulatory activity (e.g. variations applications).
•    Before Day B the Transferor is responsible for released batches. As of Day B, the new MAH can start releasing batches. The batches released by the new MAH should be in accordance with the Annexes of the Commission Decision on the Transfer and therefore, these batches should have the name of the new MAH in the Product Information. During this transitional period and on the basis of the arrangements agreed between Transferor and Transferee, batches bearing the name of the previous MAH can be placed on the market as well. Nevertheless, it should be noted that as of Day B, the responsibility on all released batches rely on the new MAH.
•    After day C only the new MAH (Transferee) can release batches and place them on the market. The batches that have been placed on the market before Day C and that bear the name of the previous MAH can remain on the market.

For the Transfer of a Marketing Authorisation covering medicinal products not yet marketed in the EU/EEA by the Transferor, the proposed date should always refer to the day on which the Commission Decision on the Transfer will be issued.
 

For information on the fee applicable for Transfer applications, please refer to the explanatory note on fees payable to the European Medicines Agency. Such fee covers all authorised presentations of a given medicinal product.

The fee will become due on the date of receipt of Transfer application notification and fees will be payable within 45 calendar days of the date of the said notification. After approximately 15 days an invoice will be sent to the applicants billing address held on the Agency’s file.

The invoice will contain details of the product and type of procedure involved, the fee amount, financial information and the customer purchase order number associated with the procedures invoiced (if provided in the eSubmission delivery file). The Agency does not accept stand-alone notifications of purchase order numbers that are not associated with a dossier.

The Agency will charge the fee for Transfer application notification at the start of the procedure, irrespective of its outcome (positive, negative or partial/full withdrawal).

Guidance is available on How to pay an invoice.

References:

MAHs should avoid submitting variation procedures in parallel to a Transfer of MA application.

MAHs are strongly advised to contact the EMA in advance of the submission of the Transfer of application, in order to discuss how to handle any planned/ongoing procedures (especially in case the product information is affected) or in case there are variations linked to the Transfer procedure (see also “Transfer of Marketing Authorisation – Who should I contact if I have a question when preparing my application or during the procedure?”).

Enforceable Post-Authorisation Measures (PAMs) may have been agreed for the medicinal product at the time of the granting of the marketing authorisation or subsequent modifications. If such PAMs are still remaining for the medicinal product concerned, it is the responsibility of the Transferee to fulfil them within the timeframe previously agreed. 

In case of remaining PAMs, a declaration of undertaking signed by the Transferee listing them should be provided with the referred attachment 1.

Reference

Mock-ups

According to point 6 in the Annex to Regulation (EC) No 2141/96 on transfers of centrally authorised medicinal products, mock-ups are to be included in the transfer application. Ideally, applicants must provide at submission an English and multi-lingual ('worst-case') colour mock-up of outer and immediate packaging for each pharmaceutical form in each container type (e.g. blister and bottle, vial and pen) in the smallest pack-size. If not available, relevant example mock-ups of the marketed presentation may be submitted instead.

If the transfer only affects the MAH details on the packaging and package leaflet without any impact on the overall design, in addition to the submission of the mock-ups, a declaration stating that only the details of the MAH have been modified and that such changes will be introduced in all product presentations should be included in module 1.3.2 of the application dossier.

In case of comments on the mock-ups, the MAH should submit responses and/or updated mock-ups, as applicable, to the EMA (muspecimens@ema.europa.eu) prior to the specimen printing. EMA will discuss the best and feasible corrective action with the MAH, taking into account the nature and amount of issues identified. EMA will endeavour to provide such feedback as soon as possible and taking into consideration the production plan of the medicinal product, as applicable.

Specimens

Only in case the transfer has an impact on the overall design, relevant revised example specimens should be provided to the EMA by the new MAH, in line with the requirements for new applications and extensions

If the transfer only affects the MAH details on the packaging and package leaflet without any impact on overall design, specimens are not required.

The EMA will perform a general check within 15 working days, and will check if any previous comments on specimens have been duly implemented. The applicant will be informed about the outcome of the check.

In case of comments on the specimens, the MAH should submit responses and/or updated mock-ups, as applicable, to the EMA (muspecimens@ema.europa.eu) prior to the launch of the medicinal product. EMA will discuss the best and feasible corrective action with the MAH, taking into account the nature and amount of issues identified. EMA will endeavour to provide such feedback as soon as possible and taking into consideration the launch plan of the medicinal product, as applicable.

The above principles also apply to mock-ups for Iceland. The mock-ups should be sent by e-mail to mockups@ima.is. See also http://www.ima.is.

No mock-ups and specimens are required for Norway.

References

When transferring the MA of a designated orphan medicinal product, the MAH must also transfer the orphan designation of the product concerned in accordance with Article 5(11) of Regulation (EC) No 141/2000 in order to maintain the orphan status.

Transfers of orphan designation and transfers of MA are different procedures and must be handled as such. The applications for transfer of the orphan designation and transfer of the MA should preferably be submitted to the Agency at the same time. The cover letter accompanying each of the applications should make reference to the two applications, as the two procedures will be handled in parallel by the Agency.

Fee waivers can only apply to the transferred medicinal product once the transfer of the orphan designation is completed.

In preparing an application to transfer an orphan designation, sponsors should follow the guidance given in the European Commission’s “Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designation from one sponsor to another” and in the “Checklist for sponsors applying for the transfer of orphan medicinal product designation”.

References:

Changes to a manufacturer(s) resulting from the transfer of the MA are not considered part of the transfer procedure. Therefore, the appropriate variations should be submitted separately. These variations will be handled separately from the transfer procedure. In such case, the MAH is advised to contact the EMA prior to submitting a transfer application in order to discuss the appropriate timeframe of such variations.

In addition, when the need for Good Manufacturing Practice inspections is anticipated by the MAH, it is advisable to contact the Agency in advance of the variation and transfer submission (see also “Transfer of Marketing Authorisation – Who should I contact if I have a question when preparing my application or during the procedure?”).

A change to element(s) to the summary of the pharmacovigilance system master file (PSMF), e.g. the Qualified Person for Pharmacovigilance (QPPV) or of the PSMF location resulting from the transfer of the marketing authorisation (MA) can be notified as part of the transfer application without the need for a separate variation (see also, 'How shall I present my application for the transfer of marketing authorisation').

The summary of the transferor's pharmacovigilance system in the MA dossier needs to be replaced in the transfer application with an updated summary of the transferee's pharmacovigilance system including:

  • a proof that the transferee has at his disposal a QPPV, the Member State(s) in which the QPPV resides and carries out his/her tasks and its contact details,
  • a statement signed by the transferee 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,
  • a reference to the location where the PSMF for the medicinal product is kept.

It is nevertheless required to update accordingly the information in the Article 57 database after the conclusion of the procedure for the MA transfer.

References

In order to change the name of a medicinal product, a variation is required and should be submitted separately and concurrently with the transfer procedure. 

In the case the transfer procedure concerns a medicinal product whose name is constructed as [INN / common name + name of the MAH], the name of the medicinal product needs to be changed to reflect the name of the new MAH (transferee) through a Type IAIN variation (No. A.2) (see also “Changing the (invented) name of a centrally authorised medicine: questions and answers” and “Generic and hybrid applications  - How will I know if the proposed (invented) name of my generic/hybrid medicinal product is acceptable from a public health point of view?”)

The acceptance by the Name Review Group (NRG) of the new name has to be finalised prior to the submission of the variation for changing the name of the medicinal product, including where the transferee wishes to use the common or scientific name, together with a trademark or the name of the MAH.

Reference

The Commission decision on the transfer of Marketing Authorization is published in the Union register of medicinal products for human use on the European Commission website.

The European public assessment report (EPAR) will also be revised to implement the change in the MAH.

Reference

•    Union register of medicinal products (centrally-authorised products for human use)
•    EPARs

If you cannot find the answer to your question in the Q&A when preparing your application, please contact us by raising a ticket via EMA ServiceNow, selecting the sub-option: “MAH transfer queries”.

If you do not have an EMA Account, you may create one via the EMA Account Management portal. For further information or guidance on creating an EMA Account, please refer to the guidance “Create an EMA Account” guidance. 

The Agency aims to respond to your query within 10 working days. To help us deal with your enquiry, please provide as much information as possible including the name of the product in your correspondence.

Transfers will be handled by a dedicated team of Procedure Managers (PM). A PM will be nominated upon receipt of the application. This allocated PM will be the contact point for this procedure.

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