H-1051 Budapest, Zrínyi u. 3.

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

Mail: 1372 P.O. Box: 450.


National procedure

The assessment of the medicinal product’s documentation is done by the National Insitute of Pharmacy. The authorisation issued with the procedure is valid only in Hungary.

National Marketing Authorisation – New Application flow chart

Flowchart of the national procedure in case of new application.

Validation criteria for new application

The requirements concerning the submission of application.
Last updated: 2008.08.18 20:25