H-1051 Budapest, Zrínyi u. 3.

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

Mail: 1372 P.O. Box: 450.

MAGYAR

8. What should be done if the product information or the risk minimisation tool of the medicine are updated during an ongoing approval procedure?

Please note once again, that OGYÉI assesses obligations only that originate from completed and closed regulatory procedures. Consequently, we will not deal with draft updates of product information, only approved and effective ones.

If update of the product information has no impact on the key elements, it is enough to send a notification to OGYÉI, and the approval procedure continues as normal.

If update of the product information has impact on the key elements, i.e. the risk minimisation tool is updated, the ongoing approval procedure is closed without a conclusion (i.e. no approval issued) and a new procedure will start.

Last updated: 2017.02.10 10:49