News FAMHP

Due to supply issues, Azactam 1 g and Azactam 2 g powder for solution for injection/infusion are currently only available in very limited quantities on the Belgian market. The available stock is not sufficient to meet patients’ needs during the expected period of shortage. Production is not expected to resume before July 2027. The FAMHP's task force on Unavailability issues recommendations.

European legislative initiatives such as the Biotech Act, the MDR/IVDR revision, the Critical Medicines Act, the new European pharmaceutical legislation and measures relating to online health information will have a significant impact on all stakeholders. The FAMHP provides an update on the current situation.

On 1 July 2026 VAMREG is officially launched. This new FAMHP application facilitates data collection on the volume of sales, and the use and the supply of antibiotics for animals used in animals in Belgium.

The FAMHP launches BioVigilance, a new online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin (SoHO) intended for human application.

During its June 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency completed its review of a safety signal for valproate and related substances and recommended New safety information for healthcare professionals regarding the chikungunya vaccine Ixchiq.

Since 2024, Zypadhera (powder and solvent for prolonged release suspension for injection) has been subject to limited availability. Availability has since improved. Therefore, distribution restrictions have been be gradually and carefully relaxed since 1 January 2026. The FAMHP Task Force Unavailability issues recommendations with a view to further easing.

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.

You risk developping (harsh) skin reactions when exposed to ultraviolet radiation (whether it’s from sun rays or from an artificial light source) while using certain medicinal products. The FAMHP provides an update on this issue.

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.