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”.
This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.
- More information on this post-authorisation procedural advice Q&A.
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), the applicant who initially applied for the MA is advised to contact the Agency to discuss the consequences of the change on the procedure and the required documentation.
From this point forward,
- 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
Transfer applications should be accompanied by a cover letter and be presented as follows, preferably in a tab-separated dossier:
- 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 Transfer of Marketing Authorisation - “How to choose the implementation date?”)
- Proof of establishment of the Transferee within the EEA.
- Documents showing the capacity of the Transferee to perform all the responsibilities required of a MAH under Community 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, telephone and fax number. The QPPV must be permanently and continuously at the disposal of the Transferee and must be established within the European Economic Area.
- Where a Detailed Description of the Pharmacovigilance System (DDPS – Module 1.8.1) is authorised as part of the Marketing Authorisation, 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 Community 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 on 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, fax and E-mail address.
- A signed statement that no other changes have been made to the product information literature other than those to the details of the MAH and, if appropriate, the details of the local representatives.
8. If applicable, a document entitled “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 being the period between the date of notification of the Commission Decision on the Transfer and the implementation date.
9. If appropriate, a signed statement that none of the presentations of the medicinal product concerned have yet been marketed in the EU.
10. A letter of undertaking signed by the Transferee listing any remaining Follow-up Measures or Specific Obligations. Where no Follow-up Measures or Specific Obligations remain a letter stating this must be submitted.
11. 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):
- English language version: complete set of annexes (clean & highlighted)
- All other language versions: 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.
The Agency has published a new formatted table template to be inserted in cover letters, found here.
- 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.
- Formatted table template to be inserted in application submission cover letters for veterinary procedures
The application should be sent electronically to the Agency.
From 1 January 2017 it will be mandatory for applicants to 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.
MAHs should notify the Agency of their intention to transfer a Marketing Authorisation prior to the planned submission date. The Agency will provide instructions on the required documentation for the submission of the application and clarify the timetable for the procedure if needed.
The Agency will check whether the transfer application is correct and complete (“validation”) before start of the procedure.
Within 30 days receipt of a valid 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 Marketing Authorisation following consultation of the standing Committee.
The implementation date is the date on which the transfer of Marketing Authorisation 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 of 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 taken 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 C the transferor is responsible for released batches. Only batches with the name of transferor should be on the market between day B and C. The transferee can produce but not release batches on the market before day C. After day C (the implementation day) the transferee can 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.
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.
If the application is considered 'invalid', an administrative fee will be retained by the Agency as described in the Explanatory note on fees payable to the European Medicines Agency.
For information on the fee applicable for transfer applications, please refer to the Explanatory note on fees payable to the European Medicines Agency.
The Agency will issue an invoice following the notification of the administrative validation to the applicant and fees will be payable within 30 calendar days of the date of the invoice. The invoice will be sent to the billing address indicated by the MAH and will contain clear details of the product and procedures involved, the type of fee, the amount of the fee, the bank account to where the fee should be paid and the due date for payment.
To facilitate this operation, applicants/MAHs who are requesting a Purchase Order Number on the Agency invoice should quote this Number clearly on the cover letter of a given application. The Agency will no longer accept separate notifications of Purchase Order Numbers not associated with the dossier.
If the applicants/MAHs do not require a Purchase Order Number on the Agency invoice, this must also be clearly stated in the cover letter.
For more information about fees and fee payment in the Centralised Procedure, please consult the dedicated part of the European Medicines Agency website.
- Council Regulation (EC) 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended
- “Explanatory note on fees payable to the European Medicines Agency"
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 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 preferable 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 changes must be used in the product information of the transfer opinion. The MAH will be asked to submit updated annexes electronically.
Post-authorisation commitments such as FUMs or SOs, may have been agreed at the time the CVMP opinion was granted for the medicinal product to be transferred. When FUMs/SOs are still remaining for the medicinal product concerned, it is the responsibility of the transferee to fulfil those FUMs/SOs 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 FUMs or SOs 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 FUMs or SOs 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 FUMs/SOs fulfilment as well as the letter of undertaking template can be found in the Agency post-authorisation guidance on FUMs/SOs.
Please consult the Mock-ups section of this Q&A
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 the Agency in order to discuss the appropriate timeframe of this variation.
In addition, when the need for GMP inspections is anticipated by the MAH, it is advisable to contact the Agency in advance of variation submission.
In the case where 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.
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.
The acceptance of the new name, following the EMA procedure for checking proposed (invented) names (see Pre-submission Q&A on 'How shall I compose the complete name of my veterinary medicinal product), 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.