News FAMHP

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.

From 28 May 2026, the use of the first modules of EUDAMED, the European database on medical devices, has become mandatory.

The FAMHP has updated the guidelines related to paracetamol for marketing authorisation applicants and holders. Stakeholders are invited to comment on these changes.

The FAMHP would like to remind caregivers of the main recommendations to prevent dosing errors when administering paracetamol to children, particularly with oral solutions.

Many liquid medicines, food supplements, medical devices … come in liquid form, bottled in vials of different sizes. Such vials can easily be confused, which can be dangerous. Always check the product you intend to use.

As 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.

When must an ending or interruption in the marketing of medical and in vitro diagnostic devices be notified? The European Commission recently published a decision tree to support the economic operators concerned.

The FAMHP has been notified of a case of a serious side effect following the administration of Ixchiq vaccine in Belgium.

The medicinal product Fibclot 1.5 g is temporarily unavailable from 9 October 2025 until 31 January 2027. The task force Unavailability of the FAMHP makes recommendations to physician specialists and hospital pharmacists.

During its March 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended an update to the vaccine’s product information to reflect that serious side effects, such as aseptic meningitis, have also been observed in healthy young adults.