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

10. Can the MAH publish the risk minimisation tool or program on its website?

Risk minimisation tools or programs may take very diverse formats, and OGYÉI is not willing to limit this diversity unless well-justified. Nevertheless, please note that all content related to risk minimisation tools or programs and all the updates should be checked and approved by the national competent authority. This is valid for the content of websites as well. The approval procedure is the same as detailed above. When submitting such requests, please make sure that the assessor of the Pharmacovigilance Division is also granted access to such sites.

It should also be noted that the website where the risk minimisation material is published should not contain any promotional items (for allowed graphical and visual entities, please refer to Q3). Consequently, it is recommended to keep and manage risk minimisation content completely separated from other type of content or information. The website should not display any links referring to other sites, e.g. for more information. (An exception may be links referring to approved product information; however, these links are also subject for regulatory approval).

Last updated: 2017.02.10 10:51