Belgium is a central and strategically important EU market, offering strong opportunities for pharmaceutical, medical device, and biotech manufacturers with its multilingual healthcare system and full access to the European single market.
The Federal Agency for Medicines and Health Products (FAMHP – Agence fédérale des médicaments et des produits de santé / Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten) is the national competent authority in Belgium responsible for regulating medicines, medical devices, in vitro diagnostics, clinical trials, pharmacovigilance, and vigilance. As an EU Member State, Belgium fully applies centralized procedures via EMA for medicines and MDR/IVDR for devices, with FAMHP managing national procedures, decentralized/mutual recognition procedures, bilingual (Dutch/French) requirements, and local compliance oversight. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Belgium’s EU-harmonized framework efficiently, prepare compliant submissions in multiple languages, secure timely approvals, and ensure long-term compliance in this key Benelux and EU market.
Get Belgium Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Belgium-specific adaptation (Dutch/French/English), scientific/technical review, and quality assurance for FAMHP/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via FAMHP and EMA, including multilingual validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to FAMHP, ethics committee coordination (multilingual), and regulatory support for clinical trials in Belgium.
Belgian QPPV/local contact person services, PSUR/PBRER submissions to FAMHP/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and FAMHP registration/oversight compliance in Belgium.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per FAMHP and EU requirements.
Dutch/French labelling review (Belgium trilingual requirements), Blue Box/EEA specifics, mock-ups, readability testing, and FAMHP approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with FAMHP and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), FAMHP scientific advice preparation, and up-to-date Belgian/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Belgium — from FAMHP/EMA submissions and MDR/IVDR compliance to pharmacovigilance, multilingual labelling, and sustained EU market success.
Contact Our Belgium Regulatory Experts