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

Information for marketing authorisation holders on change of requirements concerning DHPC submissions

From now on, MAHs should submit Hungarian translation of DHPCs for regulatory approval even if the medicinal product is not marketed in Hungary. For further information, please consult Information on DHPCs, Question 2. The new procedure is effective from its publication on the OGYÉI’s website.

Last updated: 2019.01.14 17:52