Transfer of marketing authorisation: questions and answers

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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:

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.

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1. What is a transfer of marketing authorisation? Rev. July 2014

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 ceasings 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, 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 “10. 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, the applicant who initially applied for the MA is advised to contact the Agency.

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

2. How shall I present my application for the transfer of marketing authorisation? Rev. July 2014

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:

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. The name of the medicinal product concerned, the authorisation number(s) and the date on which the authorisation was granted. (Attachment 1) – see 'Authorisation details' tab of the product-specific webpage on the European Medicines Agency website.
  2. The identification (name, address, contact person at MAH address, telephone number and email address) of the Transferor and the Transferee. (Attachment 2)
  3. A document certifying 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 has been transferred to the Transferee. (Attachment 3)
  4. 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. (See also “5. How to choose the implementation date?”) (Attachment 4)

    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.
  1. Proof of establishment of the Transferee within the EEA issued in accordance with national provisions. The Proof of Establishment is commonly issued by appropriate Chamber of Commerce. (Attachment 5)
  2. Documents showing the capacity of Transferee to perform all the responsibilities required of a MAH under Community Pharmaceutical legislation:
    • 6.1 A document identifying the qualified person responsible for Pharmacovigilance (QPPV), the Member State(s) in which he/she resides and carries out his/her tasks, email address, telephone and fax numbers . It must be stated that the Transferee has permanently and continuously at its disposal the services of a QPPV, that it has the necessary means to fulfill the tasks and responsibilities listed in Title IX of Directive 2001/83/EC and that the QPPV resides and operates within the European Economic Area. In case a summary of the pharmacovigilance system was introduced as part of the MA prior to the transfer, please also mention the location where the pharmacovigilance master file is kept together with its reference number. A switch from a DDPS to a Summary of the Pharmacovigilance System or the first introduction of a Summary of the Pharmacovigilance System cannot be included as part of the transfer application. (Attachment 6.1)
    • 6.2 A document identifying the scientific service in charge of information about the medicinal product within the meaning of Article 98 of Directive 2001/83/EC, including the address, email address, telephone and fax number. (Attachment 6.2)
    • 6.3 A document identifying the person/company authorised for communication between the Transferee and the Agency after authorisation on the Transfer of MA. (Attachment 6.3)
    • 6.4 A document identifying the contact details of the person responsible for quality defects and batch recall within the meaning of Article 79 of Directive 2001/83/EC, including the Name, address, telephone, fax and email address. (Attachment 6.4)
  1. If the medicinal product concerned has not yet been marketed in the EEA in any of its presentations, this should be specified in a signed statement. (Attachment 7)
  2. If appropriate, a letter of recommendation or a letter of undertaking signed by the Transferee listing any remaining recommendations or follow-up measures. (Attachment 8)
  3. A signed statement 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. (Attachment 9)
  4. Confirmation from the NRG on the acceptability of the proposed name, if applicable. When the name of a product is composed of INN + company name see (See also “13. Can I change the name of a medicinal product as part of a transfer application?).

Documents 1, 2, 3, 4, and 9 must be signed by both the Transferor and the Transferee.

Document 7 must be signed by the Transferor.

Documents 6and 8 must be signed by the Transferee.

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)

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 “9. Do I have to submit mock-ups and specimens?”).

Reference

3. How and to whom shall I submit my transfer of marketing-authorisation application? Rev. March 2013

The Agency strongly recommends using the eSubmission Gateway or the eSubmission web client as the preferred submission method for all electronic common-technical-document (eCTD) submissions. Detailed information on the required naming conventions and file formats can be found in European Medicines Agency eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation and eSubmission Gateway web client: Guidance for applicants. Applicants must not send duplicate submissions electronically or via CD-ROM or DVD as this might lead to delays in the handling of applications.

Applications that are sent using the eSubmission Gateway and eSubmission web client receive an automated ‘acknowledgement’, confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool. There is no need to send any separate paper cover letters for these submissions, as the cover letter will be in the relevant part of eCTD module 1 in PDF format.

MAHs not yet using the eSubmission Gateway or the web client solution should send their transfer applications as CD-ROM or DVD to:

Product and Application Business Support (PA-BUS)
European Medicines Agency
Loading Dock
Ontario Way
Canary Wharf
London
E14 4HB
UNITED KINGDOM

Only one CD-ROM or DVD (in eCTD format) of the transfer should be submitted to the Agency, together with one original, signed paper cover letter when using this format of submission. The PTL should be indicated in copy (cc) on the cover letter (no additional copy needed).

Revised annexes in all languages should be included in electronic (Word and PDF) format in the same eSubmission Gateway and eSubmission web-client package or CD-ROM or DVD within a folder called ‘working documents’. Changes in Word documents should be indicated with tracked changes. Clean PDF versions should have all changes accepted.

One electronic copy should also be sent to the Committee for Medicinal Products for Human Use (CHMP) (co-)rapporteur and other CHMP committee members, to maintain their eCTD life cycle of the dossier.

For a full overview of dossier requirements for national competent authorities of (co-)rapporteurs and Committee members, including delivery addresses, please refer to dossier requirements for centrally authorised products.

Please note that the Agency only accepts submissions made in the mandatory eCTD format.

References:

4. How shall my transfer-of-marketing-authorisation application be handled (timetable)? Rev. July 2014

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 Pre-submission Queries Service (matransferquery@ema.europa.eu) at least 1 month before submission of the application.

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. This implementation date should be understood as the date on which the Transferee takes over all responsibilities. This date is stated on the opinion adopted by the Agency and also on the European Commission decision. (See also “5. How to choose the implementation date?”).

Reference

5. How to choose the implementation date? Rev. July 2014

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 will be be subject to agreement by the EMA.

For the transfer-of-marketing-authorisation covering medicinal products already marketed by the Transferor, the proposed date should be set taking into account the following timelines (See also “4. 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 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 released 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 on the market. The batches that have been released before Day C and that bear the name of the previous MAH can remain on the market.

For the transfer-of-marketing-authorisation covering medicinal products not yet marketed in the EEA by the Transferor, the proposed date should always refer to the day on which the Commission Decision on the Transfer will be issued.

6. What fee do I have to pay for my transfer-of-marketing-authorisation application? Rev. June 2013

For information on the fee applicable for transfer applications, please refer to fees payable to the European Medicines Agency. Such fees cover 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 this notification. After approximately 15 days, an invoice will be sent to the applicant's billing address held on the Agency’s files.

The invoice will contain details of the product and type of procedure involved, the fee amount, the customer purchase-order number associated with the procedures invoiced and financial information.

Applicants requiring a purchase-order number or similar references on the invoice are requested to clearly indicate this on the cover letter or application form accompanying the dossier. The Agency does not accept stand-alone notifications of purchase-order numbers that are not associated with a dossier. Applicants not requiring a purchase-order number on the invoice should also clearly state this in the cover letter. Applicants are requested to provide this information in the cover letter template.

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

Guidance is avaialble on how to pay an invoice.

References:

7. How to handle planned or ongoing variations procedures during the transfer-of-marketing-authorisation? Rev. July 2014

MAHs should avoid submitting variation procedures in parallel to a transfer-of-marketing-authorisation application.

MAHs are strongly advised to contact the pre-submission queries service 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.

8. How to handle remaining follow-up measures and specific obligations when transferring a marketing authorisation? Rev. December 2013

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 recommendations or follow-up measures, a letter of recommendation or a letter of undertaking signed by the Transferee listing them must be submitted (attachment 8 to the cover letter).

Reference

9. Do I have to submit mock-ups and specimens? Rev. December 2013

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, 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.imca.is/imca/news/nr/1263.

No mock-ups and specimens are required for Norway.

References

10. Do I also have to transfer the orphan designation when my medicinal product has been granted such a designation? Rev. December 2007

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:

11. Can I include changes to manufacturing sites in my transfer-of-marketing-authorisation application? Rev. July 2014

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 pre-submission queries service 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.

12. Can I change the qualified-person-for-pharmacovigilance information as part of my transfer-of-marketing-authorisation application? Rev. July 2014

A change to the Qualified Person for Pharmacovigilance (QPPV) resulting from the transfer of the marketing authorisation can be notified as part of the transfer application without the need for a separate variation (see also “2 .How shall I present my application for the transfer of marketing authorisation”).

This applies to all MAs that have introduced the summary of the pharmacovigilance system master file (PSMF) in their MA dossier and to MAs with or without a Detailed Description of the Pharmacovigilance System (DDPS).

Other changes to the DDPS, a switch from a DDPS to a summary of the pharmacovigilance system or the first introduction of a summary of the pharmacovigilance system cannot be included as part of the transfer application. The appropriate variation application for changes to the DDPS or introduction of a summary of the pharmacovigilance system should be submitted separately from the transfer application.

References:

13. Can I change the name of a medicinal product as part of a transfer application? New June 2013

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

In the case the transfer procedure concerns a medicinal product whose name is constructed as [international non-proprietary name (INN) / common name + name of the MAH], the name of the medicinal product needs to be changed to reflect the name of the transferee.

As a result, the variation to change the name of the medicinal product constructed as [INN / common name + name of the transferee] should be submitted in parallel of the transfer procedure.

For more information on the procedure to change the name of a medicinal product, please refer to changing the (invented) name of a centrally authorised medicine: questions and answers and 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.

14. Will there be any publication on the transfer of marketing authorisation?

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

References:

 

15. Who should I contact if I have a question when preparing my application? New April 2014

If you cannot find the answer to your question in the Q&A when preparing your application, please contact us using the following email address: matransferquery@ema.europa.eu

The Agency aims to respond to your query within 5 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.

The above email address is only applicable when you have a pre-submission query. A dedicated Procedure Manager (PM) will be assigned to the procedure once your application has been validated. You will be able to contact this PM throughout the procedure.