Belgium introduces synchronised procedure guidance for combined clinical trials with medicinal products and device performance or clinical investigations.
FAMHP (Belgian Medicine Agency) · BelgiumFrom 1 September 2026, applicants must use new eAF version 1.28.0.0, aligned with ISO IDMP model and Veterinary Regulation 2019/6.
FAMHP (Belgian Medicine Agency) · BelgiumSince 1 July 2026, animal species must be specified on veterinary prescriptions under the new mandatory model.
FAMHP (Belgian Medicine Agency) · BelgiumDocument clarifies distinction between revision date and approval date in product information for human medicinal products.
FAMHP (Belgian Medicine Agency) · BelgiumImplementing Regulation (EU) 2026/1810 updates the list of essential substances for food-producing horses, entering into force 28 July 2026, with transition until 21 May 2027.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP and AMCRA offer e-learning to support veterinarians in recording antibiotic use in horses and aquaculture fish via VAMREG from 1 July 2026.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP reminds patients and healthcare professionals of rational use recommendations for benzodiazepines and related medicines following WOREL guideline publication.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP launches BioVigilance, an online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin intended for human application.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP publishes information on quota exceedances involving foreign gamete donors and emphasises its commitment to transparency and ongoing monitoring.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP updates on pending EU legislative initiatives including the Biotech Act, MDR/IVDR revision, Critical Medicines Act, pharmaceutical legislation and online health information measures.
FAMHP (Belgian Medicine Agency) · BelgiumPRAC completed review of valproate safety signal and recommended new safety information for Ixchiq chikungunya vaccine.
FAMHP (Belgian Medicine Agency) · BelgiumEMA PRAC recommended direct healthcare professional communication on meningioma risk with desogestrel and etonogestrel contraceptives and new safety measures for Litfulo.
FAMHP (Belgian Medicine Agency) · BelgiumNew version 1.28.0.0 of the Marketing Authorisation Application Form aligns product data with ISO IDMP model and reflects New Veterinary Regulation 2019/6 changes.
FAMHP (Belgian Medicine Agency) · BelgiumEMA Pharmacovigilance Risk Assessment Committee initiated review of injectable iron medicines for hypophosphataemia and bone-related adverse effects.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP launches VAMREG, a new application for mandatory collection of data on sales, use and supply of veterinary antibiotics in Belgium.
FAMHP (Belgian Medicine Agency) · BelgiumDistribution restrictions on Zypadhera have been gradually relaxed since 1 January 2026 as availability improves.
FAMHP (Belgian Medicine Agency) · BelgiumAzactam 1 g and 2 g powder are in very limited supply in Belgium; production not expected to resume before July 2027.
FAMHP (Belgian Medicine Agency) · Belgium