News FAMHP

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.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine surabgene lomparvovec (ABBV-RGX-314) for the treatment of neovascular age-related macular degeneration. The public consultation will take place from 15 October to 14 November 2025.

From 1 January 2026, the FAMHP will introduce accelerated timelines for the assessment of initial clinical trial applications concerning medicinal products for human use. This measure ensures that clinical research can start faster, to the benefit of the patient, and strengthens Belgium's top position as a centre for clinical trials.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified vaccine MV-NiV for the prevention of Nipah virus infection. The public consultation will take place from 13 October to 12 November 2025.

Read the leaflet, follow the instructions, and use (over-the-counter) medicines wisely. That is the joint message from European medicines authorities involved in the campaign. The campaign aims to raise awareness among European citizens about the importance of proper use of over-the-counter (OTC) medicines.

A new formulation of Rybelsus (oral semaglutide) will be marketed in Belgium in early 2026. This formulation offers increased bioavailability compared with the initial formulation. As a result, the new formulation has a lower dosage in order to guarantee bioequivalence with the old formulation. The old and new formulations will temporarily coexist on the market, which may lead to confusion and a potential risk of overdose.

The number of temporarily unavailable medicines decreased in 2024: that is one of the main conclusions from the annual report of the Federal Agency for Medicines and Health Products. The year 2024 was also marked by the Belgian Presidency of the Council of the European Union. A unique opportunity for the FAMHP to strengthen its role at European level. At the same time, our other activities also continued. The FAMHP’s annual report provides an overview of that progress.

The use of the PLM Portal web-based electronic application form for human variations is now recommended and an eCTD validation report for Belgium as Reference Member State (RMS) is required.