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 about Appendix V of the product information

In view of the fact that, pursuant to Paragraph 19(1)–(2) of Government Regulation 333/2023 (VII. 20.) the National Institute of Pharmacy and Nutrition ceased to exist on 1 August 2023, by way of merger, and its general successor is the National Center for Public Health and Pharmacy (hereinafter referred to as the NNGYK), we hereby inform the MAHs regarding Appendix V of the product information for medicinal products.

The new organisation will continue to communicate with and manage public affairs through unchanged channels and methods until further notice.

Adverse reaction reporting can continue directly to the Authority via the contact details in Appendix V of the product information, via the online reporting interface on the website: https://mellekhatas.ogyei.gov.hu/ and via email: adr.box@nngyk.gov.hu. We have requested that Appendix V be amended accordingly.

If sent by post, please send the adverse reaction reports using the new name of the organisation (addressed to the NNGYK), to the same address as in Appendix V (H-1372 Budapest P.O. Box 450).

As for the printed version of PIs, the new name of the National Authority should be introduced at the next packaging production, and no new variation needs to be submitted for this purpose.

Last updated: 2023.09.15 14:05