H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.


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