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 NCPHP), we hereby inform the MAHs regarding Appendix V of the product information for medicinal products.
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 (https://mellekhatas.nngyk.gov.hu) available on the new HU NCA website (https://nngyk.gov.hu), and via email (adr.box@nngyk.gov.hu). Appendix V has been amended accordingly.
If sent by post, please send the adverse reaction reports using the new name of the organisation (addressed to the NCPHP), to the same address as in Appendix V (H-1372 Budapest P.O. Box 450).
With regards to the printed version of PI, the changes should be introduced at the next packaging production, and no new variation needs to be submitted for this purpose.
