Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “post-authorisation procedures”.
The guidance published under ‘Post-authorisation procedural Q&A’ provides an overview for different types of post-authorisation procedures that occur frequently and, in each case, addresses a number of questions which marketing authorisation holders (MAHs) may have.
Applicants should use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. 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 existing marketing authorisation holder (MAH) to a new MAH. Such a transfer may be needed e.g. in the event of a merger/acquisition where the MAH is taken over by another company and ceases to exist as a separate legal entity, or in the event that one company sells products and product rights to another.
A change of name and/or address of the MAH is not a transfer if the holder remains the same person/legal entity. Such change would be notified through a Type IAIN variation application.
Where there is a need to change the proposed MAH during the initial evaluation procedure (e.g. in the event of a merger/acquisition, asset purchase), please refer to the separate Q&A ‘How can I change the applicant for an ongoing marketing authorisation application’.
From this point forward within these Q&As on transfers:
- the MAH of the MA to be transferred is termed the Transferor,
- the person/company to whom the transfer is to be granted is termed the Transferee.
- Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for centralised medicinal product falling within the scope of Council Regulation (EC) No 2309/93
- Commission Regulation (EC) No 1234/2008
- Commission Regulation (EU) No 712/2012 amending Regulation (EC) No 1234/2008
Transfer applications should be accompanied by a cover letter and be presented as follows:
- The name of the medicinal product concerned by the authorisation transfer, the authorisation number(s) and the date(s) on which the authorisation(s) was (were) granted.
- The identifications (name, address and email) of the Transferor and the Transferee.
- A document certifying that the complete and up-to-date file concerning the medicinal product or a copy of this file has been made available to or has been transferred to the Transferee.
- A document stating the date on which the Transferor and the Transferee finalise the transitional organisational arrangements. 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 “How to choose the implementation date?”)
- Proof of establishment of the Transferee within the European Economic Area (EEA), issued in accordance with national provisions and dated within the last six months.
- Documents showing the capacity of the Transferee to perform all the responsibilities required of a MAH under Union pharmaceutical legislation:
- A document identifying the Qualified Person responsible for Pharmacovigilance (QPPV) within the meaning of Article 48 of Regulation (EC) No 726/2004, together with his/her Curriculum Vitae, address, email address and telephone number. The QPPV must be permanently and continuously at the disposal of the Transferee and must be established within the EEA.
- Where a Detailed Description of the Pharmacovigilance System (DDPS is authorised as part of the MA, and the transfer has resulted in a change of the QPPV, a signed statement from the Transferee and new QPPV must be included, confirming that the Transferee has the services of the new QPPV and has the necessary means for the collection and notification of any adverse reaction occurring either in the Union or in a third country.
However, changes to the DDPS resulting from the transfer (other than the above mentioned) require the submission of a separate variation by the new MAH once the transfer has been finalised. The authorised DDPS would remain in force until the DDPS variation is finalised. Where there is no authorised DDPS, the QPPV change (which is the only official change in this case) can be covered during the transfer procedure.
- A document identifying the person/company authorised for communication between the Transferee and the Agency after authorisation of the transfer of MA.
- A document identifying the contact details of the person responsible for quality defects and batch recall including the name, address, telephone, and e-mail address.
- 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.
- If applicable, a document titled “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.
- If appropriate, a signed statement that none of the presentations of the medicinal product concerned have yet been marketed in the EU.
- A letter of undertaking signed by the Transferee listing any remaining post-authorisation measures. Where no post-authorisation measures remain a letter stating this must be submitted.
- The Summary of Product Characteristics, the Annex II, the labelling, and the package leaflet bearing the name of the person to whom the transfer is to be granted in all languages (EU languages, Iceland and Norway) - complete set of annexes (clean & highlighted).
- Documents 1, 2, 3, 4, 7 and 8 must be signed by both the Transferor and the Transferee.
- Document 9 must be signed by the Transferor.
- Documents 5, 6 and 10 must be signed by the Transferee.
- Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the Transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93.
- Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
The application should be sent electronically to the Agency.
Applicants should use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see the Veterinary eSubmission website.
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 email@example.com at least 1 month before submission of the application. 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 the eSubmission Gateway/Web Client 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’s 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, the 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 MA 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 “How to choose the implementation date?”).
The implementation date is the date on which the transfer of MA actually takes place.
Such a date will be proposed by the Transferor and Transferee in the transfer application and will subsequently be agreed with the Agency. The implementation date will be stated in the opinion on the transfer.
For the transfer of a marketing authorisation covering medicinal products already marketed by the Transferor, the proposed date should be the date on which the Transferee will start to release batches on the market with the name of the new MAH and the Transferee takes full responsibility for the old and new batches of the medicinal product concerned.
The proposed date should be set taking into account the accumulation of the following timeframes (see also “How shall my transfer of marketing authorisation application be handled (timetable)?”):
- The Agency timeframe for finalisation of the Opinion is 30 days from the receipt of a valid application (Day A)
- The Commission will subsequently issue a Commission decision (Day B)
- Between Day B and the date on which the transfer “actually” takes place (implementation day = Day C), there will be a transitional period during which the transfer has to be completely implemented on the market. In some cases the Transferor and Transferee choose to have Day C as the day of the Commission decision, in which case there is no transitional period. The transfer application should, in addition as part of the information on such date, also include information on the shelf life of the medicinal product concerned and a commitment 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.
- 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.
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.
For information on the fee applicable for transfer applications, please refer to the 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 procedure 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, as well as in the “Customer reference” box of the delivery file to be generated for submission via the EMA Gateway. The Agency does not accept standalone 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 or full withdrawal).
Guidance is available on how to pay an invoice.
MAHs are strongly advised to contact firstname.lastname@example.org in advance of the submission of the transfer of marketing authorisation application, in order to discuss how to handle any ongoing procedures (especially when the product information is affected) or when there are variations or extensions linked to the transfer procedure.
Variations / extension 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/extension procedure is finalised during the finalisation of the transfer procedure, the accepted/adopted variation/extension 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 (SOBs) (NB SOBs are only applicable for MAs issued under exceptional circumstances) may have been agreed at the time the CVMP opinion was granted for the medicinal product to be transferred. When PAMs are still remaining for the medicinal product concerned, it is the responsibility of the Transferee to fulfil those PAMs within the timeframe initially agreed at the time of CVMP opinion. Therefore, a letter of undertaking signed by the Transferee must be submitted including those PAMs still remaining to be addressed as per the undertaking letter signed by the Transferor on the day of the adoption of the CVMP opinion.
When no PAMs remain, a letter stating this must be submitted. See also “How shall I present my application for the transfer of my marketing authorisation?”
Detailed information on PAMs fulfilment can be found in the Agency’s post-authorisation guidance on PAMs.
- Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93.
- Q&A: Post-authorisation measures (recommendations, conditions and specific obligations)
Changes to manufacturers resulting from the transfer of the MA are considered as separate procedure, usually requiring a variation. Therefore, the appropriate variation(s) should be submitted separately. These variation(s) will be handled separately from the transfer procedure. In such case, the MAH is advised to contact email@example.com in order to discuss the appropriate timeframe of the 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 variation submission.
Yes, the EPAR (published on the Agency’s website) will be revised to implement the change in MAH.
- Search 'Medicines' (EPARs)
In 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 may need to be changed to reflect the name of the Transferee. A Type IA variation will be required and should be submitted in advance of the transfer application to allow the new product name to be reflected in the Commission decision on the transfer. Confirmation that the change of name has been requested should be reflected in the cover letter for the marketing authorisation transfer. The invented name check procedure must be completed, prior to the submission of the variation for changing the name of the medicinal product. Alternatively, in case the product name is constructed as [international non-proprietary name (INN) / common name + name of the MAH] but where the Transferee and Transferor have an agreement for the Transferee to continue using the MAH name of the Transferor as a trademark ( i.e. name of product will be regarded as [international non-proprietary name (INN) / common name + Trademark]), only a proof of trademark authorisation is to be provided to the Agency (firstname.lastname@example.org), but no formal invented name check will be required.
For more information on the procedure to change the name of a medicinal product, please refer to the Q&A on changing the (invented) name of a centrally authorised medicine.
For more information on composition of invented names, please refer to Pre-submission Q&A on ‘How shall I compose the complete name of my veterinary medicinal product.