Belgium Loi du 29 février 2024: mandatory authorisation and GMP regime for pharmaceutical raw materials used by pharmacists

Mechanism

The Loi du 29 février 2024 creates a mandatory federal authorisation architecture under AFMPS covering three tiers of the pharmaceutical raw-materials supply chain:

Tier 1 — Manufacturers / importers: Must hold a fabrication authorisation and demonstrate compliance with Good Manufacturing Practice (GMP) for active substances. They are the only actors permitted to import raw materials into Belgium.

Tier 2 — Distributors: Must hold a distribution authorisation and comply with Good Distribution Practice (GDP) principles. They may only source from authorised manufacturers or other authorised distributors.

Tier 3 — Pharmacists: May only procure raw materials from Tier 1 or Tier 2 authorised actors. Limited exceptions exist for materials with "limited use" status as defined by ministerial decree.

Quality standards hierarchy: Raw materials require authorisation based on reference standards in priority order — (1) European Pharmacopoeia, (2) Belgian Pharmacopoeia or recognised official standards, (3) Deutscher Arzneimittel-Codex, (4) Minister-approved monographs. AFMPS evaluates applications; the minister grants final authorisation.

Enforcement: Violations carry imprisonment of one month to two years and fines of €25 to €250,000. Enhanced penalties apply for offences causing serious health harm, abuse of professional trust, large-scale distribution methods, or organised crime involvement.

Context: EU Critical Medicines Alliance

The statute was prepared and promulgated during Belgium's EU Council Presidency (1 January – 30 June 2024). Belgium hosted the founding conference of the EU Critical Medicines Alliance (CMA) on 24 April 2024 in Leuven — an EU-wide initiative to address critical medicines shortages driven partly by concentration of API and raw-material production outside the EU (predominantly India and China). The Belgian law provides the national supply-chain security layer that complements the CMA's EU-level voluntary coordination mechanism and anticipates mandatory EU-wide requirements under the proposed EU Critical Medicines Act (filed as 2025-03-11-eu-critical-medicines-act-proposal).

Downstream implications

• The 1 June 2026 enforcement trigger is an immediate near-term compliance deadline: any Belgian manufacturer, importer, or distributor of pharmaceutical raw materials lacking AFMPS authorisation after that date faces criminal exposure.
• Belgium's federal first-mover statute may template implementation legislation in other EU member states ahead of the EU Critical Medicines Act entering into force — the statutory architecture (tiered authorisation + pharmacopoeia hierarchy + ministerial monograph power) is directly portable.
• Umicore (cobalt/nickel refining, also a supplier of catalyst and chemical intermediates), Solvay (specialty chemical manufacturers operating in Antwerp), and Belgian pharma incumbents (UCB, Janssen, Galapagos) may face upstream supply-chain reconfiguration costs if existing raw-material suppliers are non-EU and lack AFMPS authorisation.
• The Port of Antwerp-Bruges (EU's largest chemical hub) handles significant pharmaceutical raw-material import flows; the import-authorisation requirement under Tier 1 will add regulatory friction to flows from Chinese/Indian API manufacturers not already operating under EU GMP certificates.

Open questions

• How many AFMPS authorisations have been granted or applied for ahead of the 1 June 2026 enforcement date? AFMPS has not published a public register as of May 2026.
• Will the implementing Royal Decrees (Arrêtés Royaux / Koninklijke Besluiten) delegated under the statute expand coverage beyond pharmacist-facing compounding inputs to broader pharmaceutical manufacturing intermediates?
• How will the statute interact with ICH Q7 GMP guidelines for active pharmaceutical ingredients, which are already referenced by EU GMP Annex 15 — will mutual recognition apply?