News FAMHP

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

Manufacturers and other stakeholders are invited to take part in the training on the European Medical Device Nomenclature organised by the SMEMDN consortium, which will take place on 4 June 2026.

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.

During its April 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency agreed on communication to healthcare professionals about cases of severe liver injury with the epilepsy medicine Ontozry.

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.