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.
Pharmaceutics
Information for marketing authorisation holders on change of requirements concerning DHPC submissions
Appeared: 2019.01.14 17:52, Last modified: 2019.01.14 17:52
