News FAMHP

The FAMHP is participating in a webinar organised by the European Medicines Agency specifically for Belgium to support non-commercial sponsors involved in the new Clinical Trials Regulation 536/2014.

During the end-of-year period, the FAMHP will be closed from Thursday 25 December 2025 to Thursday 1 January 2026. Deadlines have been set for the submission of different types of dossiers.

The ‘Commission Santé et Égalité des Chances/Commissie voor Gezondheid en Gelijke Kansen’ once again addressed donor matters at its meeting on 4 November 2025, including a presentation and explanation of the Federal Internal Audit report and the reading guide for the FAMHP inspection reports.

By reporting suspected side effects, you help to make medicines safer for everyone. That is the core message of the #MedSafetyWeek campaign, which is celebrating its 10th anniversary this year. To mark this anniversary, the FAMHP is publishing statistics on side effect reporting in Belgium over the last ten years.

Several respiratory syncytial virus immunisation agents are available in Belgium. It is essential not to confuse them: each one is intended for a different target group.

Following the award of a new public contract, BNP Paribas Fortis will take over the federal government’s public bank accounts from bpost during the weekend of 13 and14 December 2025.

During its September 2025 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started a review of medicines containing levamisole, authorised in four countries of the European Union to treat infections caused by parasitic worms in adults and children. This medicinal product is not marketed in Belgium, but it is included in the World Health Organization’s list of essential medicines. Additionally, the PRAC adopted DHPCs for medicines containing caspofungin, as well as for the medicines Crysvita (burosumab), Remsima (infliximab) and Tegretol (carbamazepine).

From January 1, 2026 onwards all Belgian VAT-liable companies are required to send electronic invoices via the Peppol network. For correct processing of your data, please send your Peppol ID to the FAMHP now.

There are more and more adverts on social media and online platforms for so-called 'non-invasive' glucose meters. These are devices such as smartwatches, rings or finger meters that claim to measure blood glucose levels without a finger prick and without using needles or other invasive techniques. Although this technology sounds alluring, there is no product on the European market that can do this safely and reliably.

As of 1 January 2026, there are a number of important changes to the registration of antibiotic use in animals that are necessary to comply with European regulations, namely Regulation 2019/6 on veterinary medicinal products and Delegated Regulation 2021/578, and the pending amendments to the Royal Decree of 21 July 2016.