The marketing authorisation holders (hereinafter referred to as the “MAH”) or their representatives authorised by Powers of Attorney, may submit applications for transfer of the marketing authorisations of their medicinal products only after the Marketing Authorisation Decisions come into force (rather than in the national phase of the MRP/DCP or immediately after the issuance of the Marketing Authorisation Decisions that have not come into force yet). Furthermore, the application for the MA transfer should not be submitted in the course of a procedure concerning the MA renewal for the medicinal product in question.
The following documents are to be submitted for a medicinal product MA transfer:
- Cover letter specifying the type of an application;
- Application for the MA transfer, which is to be submitted for one marketing authorisation of a medicinal product (for each MA number separately) on a completely filled-in effective version of form REG-69, incl. Annexes 1 and 2, which are available from here;
- The MA transfer application form shall always contain the following information:
- The current MAH, the proposed MAH, and, if applicable, their representatives authorised by respective Powers of Attorney (information on Powers of Attorney and their specimens are available from here);
- Justification for the proposed MA transfer;
- The date when the MA transfer should become effective, i.e., the date as of which the proposed MAH assumes responsibility for any activities concerning the medicinal product in question:
a) As of the date when the MA transfer decision comes into force:
- implementation: prior to the MA transfer decision comes into force, the medicinal product has to be released pursuant to the dossier valid prior to the approval of the MA transfer; once this decision comes into force, the manufacture, incl. release, has to be performed only in compliance with the approved MA transfer;
- final sale: the 180 days for the placement on the market of the medicinal product complying with the data and dossier prior to the implementation of the MA transfer, shall begin to run upon the date when the MA transfer decision comes into force;
- it is possible to apply for the issuance of merged product information along with another text procedure (i.e., for the completion of the MA transfer application and another text procedure), but only if the anticipated approval date for both procedures is approx. within the same statutory timeline and the implementation of both procedures is to be carried out in parallel, due to the fact that once the MA transfer decision comes into force, it is not possible to release the product in the previous version anymore;
b) As of a future date (in the day/month/year format, approx. 2–6 months of the submission of the MA transfer application):
- a future date should not be used if occurring within approx. 2 months of the planned submission of the MA transfer application (the proposed future date would probably come prior to the issued decision coming into force, which is legally unacceptable, or immediately after the issued decision coming into force);
- ideally, the future date should not be more than 6 months of the submission of the MA transfer application, either;
- implementation: prior to the specified future MA transfer date, the medicinal product has to be released pursuant to the dossier valid prior to the approval of the MA transfer; after the future MA transfer date, the manufacture, incl. release, has to be performed only in compliance with the approved MA transfer;
- final sale: the 180 days for the placement on the market of the medicinal product complying with the data and dossier prior to the implementation of the MA transfer, shall begin to run upon the specified future date when the MA transfer becomes effective;
- it is not possible to issue merged product information along with another text procedure (i.e., it is not possible to apply for the joint completion of the MA transfer application and another text procedure), because with another procedure, such as a MA variation, the final sale timeline would run from the approval of this MA variation, while for the MA transfer only as of the future date (when the MA transfer becomes effective); for this reason, these procedures must be handled separately, or subsequently, with a view to their approval;
- the product information issued for the transfer shall mention both MAHs at the same time, incl. the date until which the current MAH is the holder, and the date as of which the new MAH becomes the holder, yet; in the future text procedure, it is shall be necessary for the MAH to amend the product information so as to contain the new MAH only;
- the printed materials (labelling and PIL), however, shall mention only one specific MAH, depending on whether the batch of the medicinal product was manufactured (i.e., also released) prior to the selected future date (when the MA transfer becomes effective), or afterwards.
- Contact details of the qualified person responsible for pharmacovigilance (QPPV) of the proposed MAH shall only be reported to the Article 57 database; if the proposed MAH has a different pharmacovigilance system, he is obliged to submit an application for type IAIN variation to MA, classification C.I.8 (see below);
- Contact details for the publicly available scientific information service for medicinal products (VPOIS) of the proposed MAH shall only be reported via e-mail to vpois@suklcz;
- Powers of Attorney for the authorised representatives of the current and proposed MAHs;
- A valid proof of establishment in the EEA for the proposed MAH in the Czech or English language;
- Prior to the submission of the MA transfer application, it is mandatory to pay an administrative fee in the amount of 2,000 CZK (code S-002) and covering expenditures in the amount of 20,000 CZK (code R-011); the documents to be submitted are the payment orders of the administrative fee and covering expenditures specifying the variable symbols necessary for the payments thereof, which should be generated from here for the administrative fee and here for covering expenditures;
- Proposed product information (Summary of Product Characteristics, Package Leaflet, and labelling) in the Czech language in the MS word format in track version;
- Annexes 1 and 2 to form REG-69, i.e., declaration of the current and proposed MAHs, including their signatures or the signatures of their representatives authorised by submitted Powers of Attorney;
- Mock-ups of outer and inner packaging including graphical design in which the product is to be placed on the market:
a) where the mock-ups change and are available: mock-ups shall be submitted in the form in which the product is to be placed on the market after the MA transfer implementation;
b) where the mock-ups do not change or are currently unavailable: nothing shall be submitted, it is only necessary to tick the following option in the application form: “Proposed MAH declares that mock-ups have not been changed as of the MA transfer approval date or are not available yet” (implying that the proposed MAH wishes to keep the existing approved mock-ups or that the mock-ups for the Czech market are currently unavailable; thereafter, the new MAH shall be obliged to submit the mock-ups for assessment no later than 3 months prior to the placement of the medicinal product on the market in compliance with the effective version of guideline REG-96);
- It is strongly recommended to submit the application in the eCTD format, nevertheless, the NeeS format complied with the effective validation criteria is also acceptable; for more information on the format of dossier for MA transfers of medicinal products authorised via MRP/DCP, please refer to sections 4.6 and 4.8 of document CMDh Best Practice Guide on the use of eCTD in the MRP/DCP;
- The application must be sent officially, i.e., via CESP, data mailbox (in these cases, scans of required signatures shall be sufficient on the cover letter, the application form, and Annexes 1 and 2 thereto) or via e-mail with a certified electronic signature of the current MAH or his authorised representative sent to posta@suklcz.
Following validation of the MA transfer application, SÚKL shall send an e-mail confirmation of the payments made; no notification of application completeness shall be issued.
In the course of the MA transfer procedure, the necessary applications for MA variations shall be submitted, such as application for change in the name of the medicinal product (in case of a common name of the medicinal product, it is necessary to submit an application for change in the name if the proposed MAH has a different identifier; information on the joint completion of the MA transfer application and application for change in the name is provided below) or if the proposed MAH has a different pharmacovigilance system (the PSMF summary shall be submitted as an application for type IAIN variation to MA, classification C.I.8). For medicinal products authorised via MRP/DCP, these variations are to be submitted as MRP variations to MA. Variations associated with the MA transfer may be grouped in one application.
The decision on the MA transfer shall be issued within 30 days of the submission of the application, if all of the conditions for MA transfers have been met and the application is complete. The decision shall be sent both to the current and proposed MAH, or, if applicable, to their representatives authorised by Powers of Attorney. The date of revision specified in the issued Summary of Product Characteristics and Package Leaflet shall correspond to the date as of which the decision on the MA transfer is issued. Upon issuance of this decision, the existing SÚKL codes of the medicinal product shall be changed to “B” status (i.e., in final sale) and, at the same time, new SÚKL codes with “R” status will be generated for all authorised product presentations. The list of all valid SÚKL codes shall be sent together with the MA transfer decision in the form of an identification list. Also, upon the issuance of the decision on the change in the name of the medicinal product, new SÚKL codes with “R” status will be allocated and the existing SÚKL codes will be changed to “B” status. For this reason (unless the MAH chooses a future MA transfer implementation date and meets also the other requirements mentioned above), it is advisable to apply for the joint completion of the MA transfer application and application for change in the name of the medicinal product. More information about SÚKL codes is available from SÚKL's website.
In case of a company merger, when all rights and obligations of the absorbed company (i.e., the current MAH) are transferred to the acquiring company (i.e., the new MAH), no MA transfer applications for the concerned medicinal products shall be submitted, but it is always necessary to submit some applications for MA variations, consisting, in particular, of the entry of the change of the person and address of the MAH into the MA dossier, incl. product information, by means of applications for type IAIN variations to MA, classification A.1 (for medicinal products authorised via MRP/DCP in the form of MRP variations to MA). As concerns the fact of the merger implementation proper, it is necessary to inform SÚKL about the merger and the date of its effect, so that this fact may be entered in SÚKL's database.
For detailed information on the implementation of MA variations, renewals, and transfers, please refer to SÚKL's website.
For detailed information on the final sale of medicinal products following approval of a MA variation, renewal, and transfer, please refer to SÚKL's website.
Marketing Authorisation Section
19 August 2022