1. In what circumstances should an additional risk minimisation tool or program be implemented in Hungary, and how to schedule the submission of the application for national approval?

Additional risk minimisation tools or programs should be implemented in Hungary if the medicine is marketed or if the marketing authorisation holder (MAH) is aware that at least one patient may use the medicine that is authorised but not marketed in Hungary. Examples of the latter case may be gifts, special reimbursement or individual import, about which the MAH may be informed by the health insurance fund or directly by the prescribing physician.

 

In a number of cases, the need to implement a centrally agreed risk minimisation tool or program is in the remit of the national competent authority. In such cases, it is recommended to obtain the position of the Hungarian Agency (OGYÉI) prior to the submission of the application, whether it is necessary to implement the tool or program in Hungary. The decision is usually made on a case-by-case basis.

Please also apply for a prior consultation with OGYÉI, if implementation of the program could be troublesome due to the specialities of the Hungarian healthcare system. In such cases, prior agreement of the applicant and the authority may enhance the effective introduction of the tool or program in Hungary, and shorten the approval procedure. Some examples may include controlled access or controlled distribution programs. Please submit your request for a prior consultation in line with OGYÉI’s rules for scientific advice.

In case of newly authorised medicines, introduction of the first version of a risk minimisation tool or program should be scheduled so that it immediately precedes the start of product launch, and should be completed by that time. Applicants are requested to submit the planned date of product launch in the application documentation.

For medicines already authorised, if there is an agreed schedule for implementation defined by the authorities, this should be highlighted in the application and this should be followed. Otherwise, the tool or program should be introduced within the shortest possible time, which is monitored by OGYÉI. If the medicine is already authorised/marketed, it should be considered whether other MAHs are concerned or not. If more MAHs are concerned, cooperation and joint distribution of one unified, common material is the explicit request of OGYÉI.

If the MAH is not aware of any patient using the medicine in Hungary, and is not willing to launch the product within a reasonable timeframe, the risk minimisation tool or program should not be implemented in Hungary. Please, notify the OGYÉI on reasons for non-implementation.

To observe the planned time schedule, it is recommended to submit the valid (complete) documentation to OGYÉI at least 4, but at most 6 months prior to the planned introduction of the risk minimisation tool or program.