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.
Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally
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.
Pilot project on Clinical Trial Regulation (CTR): webinar on the new temporary procedure for submission of initial dossiers
From mid-February 2021, a reservation system with time slots will be used for the submission of initial dossiers for the Clinical Trial Regulation (CTR) pilot project. This procedure will be explained during a webinar on 4 February 2021 at 2 PM.
The European Medicines Agency (EMA) issued a positive opinion for “COVID-19 Vaccine Moderna”, making it the second COVID-19 vaccine to be authorised for marketing in the European Union. This recommendation still has to be confirmed by the European Commission. Belgium has purchased the vaccine and will use it in its vaccination campaign.
The European Medicines Agency (EMA) will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.
Coronavirus: European Commission gives conditional market authorisation for vaccine against COVID-19
The European Commission granted a conditional marketing authorisation for Comirnaty, the Pfizer/BioNTech vaccine. The Commission is following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The European Medicines Agency (EMA) issued a positive opinion for Comirnaty, the Pfizer/BioNTech vaccine, making it the first COVID-19 vaccine that could be authorised for marketing in the European Union. This opinion still has to be confirmed by the European Commission. Belgium purchased the vaccine and will use it immediately in its vaccination campaign.
Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP
Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.
Circular No. 635 of 4 May 2018 details the approval procedure for risk minimisation activities (RMA). Certain paragraphs of this circular could be misinterpreted and specific situations were not considered. Therefore, the FAMHP would like to provide details on the RMA material included in the medicine package and on the addition / modification of RMA material for a medicine that is already available on the market.
The FPS Public Health and the FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers. The public consultation will run from 10 November 2020 to 10 December 2020.