Give your opinion on a genetically modified medicine against Retinoschisis
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine ATSN-201 for the treatment of Retinoschisis. The public consultation will take place from 8 June to 8 July 2026.
EUDAMED: clarifications regarding obligations from 28 May 2026
From 28 May 2026, the use of the first modules of EUDAMED, the European database on medical devices, has become mandatory.
Public consultation on updated guidelines for paracetamol
The FAMHP has updated the guidelines related to paracetamol for marketing authorisation applicants and holders. Stakeholders are invited to comment on these changes.
Jyseleca®
| Active substance | Filgotinib |
| Holder | Impatients N.V.
Flash VIG-news - Paracetamol: good practices for use against pain and fever in childrenThe FAMHP would like to remind caregivers of the main recommendations to prevent dosing errors when administering paracetamol to children, particularly with oral solutions.
Submission of an application for a general activity authorisationThere is no predefined form for applying for a general authorisation for the manufacturing, import or distribution of raw materials. Additional information EUDAMED webinars: training for modules for Actors, UDI/Devices and Notified Bodies/CertificatesAs part of the gradual implementation and mandatory use of EUDAMED, the European Commission is organising a series of webinars in April and May 2026 to support economic operators in using the system.
Flash VIG-news - Ixchiq vaccine against chikungunya: reminder of recommendationsThe FAMHP has been notified of a case of a serious side effect following the administration of Ixchiq vaccine in Belgium.
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