From 1 October 2021, the FAMHP uses a new invoicing method for applications for national scientific-technical advice of types I, II and III that are treated by the National Innovation Office and Scientific-Technical Advice Unit.
The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021.
Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP
A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.
The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN). The public consultation will run from 28 July 2021 to 27 August 2021.
Discontinuation of the telephone contact point of the Marketing Authorisation Division (variations and renewals)
The telephone contact point of the Marketing Authorisation Division (variations and renewals) will be discontinued as of Friday 16 July 2021. The division can still be contacted by email.
The FAMHP is organising two information sessions on 23 September 2021 and 25 November 2021 for sponsors and applicants of clinical trials about the new Clinical Trial Regulation (CTR). The first information session will take place virtually on 23 September 2021 from 9 a.m. to 12:30 p.m.
FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 25 November 2021 on the new Clinical Trial Regulation (CTR).
Close monitoring of medicine stocks proved particularly useful during the COVID-19 pandemic. The FAMHP managed to act proactively and find solutions in time. The monitoring was done manually, but is now automated using a new Stock Monitoring Tool.
Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally
Manufacturing authorisations and/or distribution authorisations of medicines and registrations of active pharmaceutical ingredients are no longer automatically sent in paper format by post to the marketing authorisation holder. The FAMHP is now sending these documents in digital format by e-mail. Marketing authorisation holders can still request paper versions.
The FAMHP invites establishments of human body material to apply for regularisation as stool banks. The term "stool" is no longer excluded from the scope of the law of 30 October 2018 on human body material. Establishments carrying out activities on faecal material as described in this law are subject to the implementing Royal Decrees and should apply for regularisation as stool bank.materiaal zoals beschreven in deze wet zijn onderhevig aan de uitvoeringsbesluiten en moeten zich regulariseren als stoelgangbank.