H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.


Mellékhatás bejelentő
NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

7. How should updates to risk minimisation tools or programs be managed?

MAHs are requested to update risk minimisation tools or programs if and only if there is a change in the key elements or the medicine becomes available for new target groups (e.g. new indication). In these cases, the procedure detailed above applies. If product information is updated without any impact on the key elements, please refrain from updating the risk minimisation tool or program.

Please note that all updates should be indicated in the materials by track changes; otherwise, the application will not be assessed. When tracking changes, the last approved documents should be taken as reference, and only the latest updates should be indicated for which the approval is requested.

Please inform the target group briefly (e.g. in a paragraph) at the beginning of the risk minimisation tool on updates introduced in the material and their justification.

Despite of the explicit request of OGYÉI, there still may be MAHs introducing merely administrative updates in the risk minimisation tools or programs, not affecting the key elements. If a MAH wishes to distribute such copies in Hungary, please submit it to OGYÉI (farmakovigilancia@nngyk.gov.hu), marked with the appropriate version number (please refer to Q9), indicating that updates are only of administrative nature, with no impact on key elements, and listing them, if relevant. OGYÉI checks whether key elements are really not involved and issues an acknowledgment of the updated tool. Updated risk minimisation materials can be disseminated following the receipt of the acknowledgment. If OGYÉI establishes that updates introduced in the material are not only administrative in nature, the normal approval procedure will be initiated.

Last updated: 2021.06.07 15:07