Information for healthcare professionals and consumers on the reporting of adverse drug reactions to the National Institute of Pharmacy
Healthcare professionals (HCPs) are legally obliged to report all suspected adverse drug reactions that they become aware of to the National Competent Authorities, i.e. to the National Institute of Pharmacy (NIP) in Hungary.
Furthermore, patients/consumers and all laymen are offered the opportunity and are encouraged to notify the Authority, if they obtain knowledge of any unwanted reactions presumably related to the use of a medicinal product.
Reporting of suspected adverse drug reactions (ADRs) by HCPs and consumers remains a primary means for the health authorities to obtain important information on the possible risks of a medicinal product so that appropriate and timely regulatory actions may be initiated, if required, to maintain the safe use of medicines and ensure that benefits of treatment continuously outweigh the potential risks for the individual patient.
The more information is available concerning a medicinal product, the easier to ensure its safe use. Therefore, NIP kindly asks you to report all suspected adverse drug reactions that you have experienced or have become aware of by downloading and filling in the Adverse Drug Reaction Reporting Form below. You may fill in the ADR Reporting Form either electronically or by hand, but please be sure to provide as accurate and detailed information on the observed reaction as possible. The completed ADR Reporting Form may be submitted to NIP via e-mail, fax or the post to either of the contact possibilities below:
E-mail: adr.box@ogyi.hu
Fax: +36-1-886-9472
Postal address: 1372 Budapest, Pf. 450.
