The Q&As provide an overview of the EMA's position on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.
From January 2025, marketing authorisation holders should use the IRIS platform when managing transfers of marketing authorisation after the original submission.
Further guidance on the use of the IRIS platform and how to prepare submissions is available on the dedicated IRIS website:
IRIS does not replace the current submission gateway; they coexist serving different functions.
Applicants should use the eSubmission Gateway / Web Client for the initial application to transfer a market authorisation. For more information, including links to guidance on registration with the system see the Veterinary eSubmission website.
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, e.g. in the event of a merger / acquisition, or be needed in anticipation of the MAH ceasing to exist as a separate legal entity and the MA being taken over by another legal entity.
In case the same transfer is sought for several veterinary medicinal products, a common data package may be prepared but an application must be submitted for each marketing authorisation (i.e. one application per main EU authorisation number).
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 would be notified through a variation not requiring assessment (VNRA), classification A.1.a of Commission Regulation (EU) 2021/17).
A transfer of MA can only be initiated once a MA has been granted. Where 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 via Service Now (see below Q&A 14 for more details).
From this point forward within these Q&As on transfers:
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Transfer applications consist of a cover letter accompanied by three attachments and other documents mentioned. The attachments (electronic documents) should be prepared following to a letter format bearing the name and contact details of the Transferor or Transferee, as appropriate.
A template is provided for the cover letter and for each attachment to give guidance on the information expected to be included in each document.
The summary of product characteristics and package leaflet bearing the name of the MAH to whom the transfer is to be granted must be provided electronically in Word format (highlighted using track changes) and in PDF format (clean), in all EU languages, Icelandic and Norwegian.
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.
Notes:
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Applicants should closely follow any separate dedicated advice on the format/route of e-Submissions as this may change over time.
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 Agency via Service Now (for more details, see Q&A 14 below), 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 within 10 calendar days from the date of the EMA notification. The EMA will not be able to issue a favorable opinion on the transfer if the documentation is incomplete.
The Agency will finalize the procedure within 30 days from the receipt of a valid transfer application (or within 30 days upon receipt of the applicant’s response if corrections or additional documentation were requested by the Agency to validate the application), provided fees were paid.
The transfer opinion will be sent to the Transferor, Transferee, the European Commission and national competent authorities. Subsequently, the European Commission will amend the initial marketing authorisation decision and notify both the transferor and the transferee. The transfer of the MA is authorised from the date of the notification of the Commission decision on the transfer.
Note: For products migrated to IRIS, the Opinion will be available to the Transferor through the IRIS Industry Portal. Please refer to the IRIS guidance page.
However, the Agency by mutual agreement with the Transferor and the Transferee can set an implementation date for the transfer (see also Q&A 5 below).
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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 Agency. The implementation date will be stated in the opinion adopted by the Agency and also in the European Commission decision, and will be legally binding.
For the transfer of a marketing authorisation covering medicinal products already marketed by the Transferor, the proposed date should be set taking into account the following timelines (see also Q&A 4 above):
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 released as well. Nevertheless, it should be noted that as of Day B, the responsibility for all released batches falls 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.
The obligation to report annually on the product sales will fall under the responsibility of the new MAH as of Day B. The Transferor would have to provide to the Transferee the sales data concerning the batches they released, until the shelf-life of those batches expires or until they are no longer being marketed for whatever other reason.
For the transfer of a marketing authorisation covering medicinal products not yet marketed by the Transferor, the proposed date should refer to the day on which the Commission decision on the transfer will be issued.
Find a visual representation of the timelines to consider when proposing an implementation date in the following document:
Transfer of Marketing Authorisation - questions and answersFor information on the fee applicable for transfer applications, please refer to the fees payable to the European Medicines Agency.
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MAHs should avoid submitting variation procedures in parallel to a transfer of MA application.
MAHs are strongly advised to contact the Agency in advance of the submission of the transfer of marketing authorisation application, in order to discuss how to handle any planned/ongoing procedures (especially when the product information is affected) or when there are variations linked to the transfer procedure (other than the variations not requiring assessment mentioned in the answer to question 12). Log any request related to the future Transfer via Service Now (see Q&A 14 below).
Variation applications should preferably be finalised prior to the submission of a transfer application. Where a procedure affecting the product information is not yet finalised at the time of the submission of the transfer application, the last product information accepted/adopted should be used at the submission of the transfer application by the MAH.
If a variation procedure is finalised during the finalisation of the transfer procedure, the accepted/adopted variation changes must be used in the product information of the transfer opinion. The MAH will be asked to submit the updated product information electronically in all languages.
Post-authorisation measures (PAMs), including recommendations, conditions or specific obligations (specific obligations are only applicable to MAs granted in exceptional circumstances - Article 26 of Regulation (EU) 2019/6)) may have been agreed at the time the CVMP opinion was granted for the medicinal product to be transferred.
When PAMs are still pending for the veterinary medicinal product concerned, it is the responsibility of the Transferee to complete them within the agreed timeframe (as specified in the CVMP opinion and/or assessment report). PAMs will be listed in Attachment 2.
Detailed information on fulfilment of PAMs, as well as the letter of undertaking template can be found in the Agency’s post-authorisation guidance on PAMs.
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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. However, in line with the current EMA guidance on veterinary mock-up requirements, it is recommended (not mandatory) that applicants 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) 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 without any impact on the overall artwork design, a declaration stating that only the details of the MAH have been modified should be provided and there would be no need for the recommended submission of mock-ups.
Please consult the Q&A on mock-ups.
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Changes to manufacturers resulting from the transfer of the MA are not considered part of the transfer procedure. Therefore, the appropriate variation(s) should be submitted and handled separately. In such case, the MAH is advised to contact the Agency via Service Now (see Q&A 14 below) prior to submitting a transfer application in order to discuss the appropriate timeframe of such variation(s).
In addition, when the need for GMP inspections is anticipated by the MAH, it is advisable to contact the Agency well in advance of the variation and transfer submission.
A change to the Qualified Person for Pharmacovigilance (QPPV) can be notified as part of the transfer application without the need for a separate variation (see also Q&A 2 above, Attachment 3). The EMA will update the necessary databases.
If a summary of pharmacovigilance system master file (Summary of PSMF), or information regarding the PSMF location and reference number was previously submitted to the EMA by the Transferor for the concerned product, the new MAH (i.e. the Transferee) will have to vary the PSMF information contained in UPD via the submission of separate VNRAs C.5 (PSMF location) and C.6 (PSMF number/other information contained in the Summary PSMF which are not covered by other VNRA), once the Notification of the EC is received (see “How shall my transfer of marketing authorisation application be handled?”). The variations can be grouped.
In case no information on PSMF was previously submitted by the transferor, the transferee is invited to file a VNRA C.6 to introduce a Summary of PSMF for the product.
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The name of a medicinal product can be changed as part of the transfer of marketing authorisation procedure. In case the name of the product to be transferred bears the name of the Transferor, it must be changed as the result of the transfer application and all batches manufactured after Day B (see Q&A 5 above) will need to carry the name of the new MAH or the new invented name.
Whatever the chosen new name structure (invented name or International non-proprietary name (INN) / common name + name of the Transferee), the proposed names will have to undergo the EMA (invented) name check procedure to verify their acceptability.
Ideally, the new name should be agreed before the submission of the transfer application. The Transferee is therefore advised to plan the submission of the proposed name(s) so that the (invented) name-check procedure is completed by this time, especially if the name of the transferred product refers to the Transferor (see above), and/or when the submission of mock-ups is intended (see Q&A 9 above).
For more information on the procedure to change the name of a veterinary medicinal product, please refer to the Q&A on changing the (invented) name of a centrally authorised veterinary medicine. See also the Pre-submission Q&A.
After the transfer is agreed (e.g. Day B, Notification of the EC Decision), the new marketing authorisation holder will have to submit a VNRA type A.2 in UPD to change the product name in the database. The new name can be used as soon as the VNRA is approved by the Agency.
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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 Service Now. Select post -authorisation queries followed by the sub-option “MAH transfer”.
If you do not have an EMA Account, you may create one via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance "Create an EMA Account". If you have any questions about registrations, please send an e-mail to Reset.Password@ema.europa.eu. Failure to register may cause delay in communication.
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.