Last updated on November 2, 2025
Yes, but only under strict conditions. Belgium’s law permits the temporary import of unauthorized medicines during critical shortages, provided that no alternatives exist and the Federal Agency for Medicines and Health Products (FAMHP) authorizes the process under Article 105/1 of the Royal Decree of 14 December 2006.
Why Belgium Made Room for Exceptions
Belgium is known for its rigorous pharmaceutical regulations, but even the most robust systems face challenges when essential medicines run out. In recent years, shortages have become a pressing issue, affecting everything from antibiotics to oncology drugs. To tackle this, Belgium introduced a legal mechanism that allows the import of medicines not authorized for use in the country—under very specific circumstances.
This exception is not a loophole; it’s a controlled response to protect public health. The rule is embedded in the Royal Decree of 14 December 2006, which governs medicinal products for human use. In September 2024, the decree was amended to include Article 105/1, creating a framework for importing unauthorized medicines when shortages pose serious risks to patients.
What Counts as a Critical Shortage?
Not every shortage qualifies. The FAMHP determines whether a situation meets the threshold of “critical unavailability.” This means the absence of a medicine on the Belgian market must pose significant health risks, such as interrupting treatment for acute or chronic conditions, endangering vulnerable groups like children, or undermining national health programs. There must also be no suitable alternative available—no equivalent medicine, no magistral preparation, nothing.
Once a medicine is flagged as critically unavailable, it appears on the PharmaStatus list, which is continuously updated. Only products on this list can be considered for import under the special regime.
How the Process Works
The procedure is tightly regulated. A wholesaler wishing to import an unauthorized medicine must notify the Minister of Health or their delegate using an official form. The FAMHP reviews the request and can oppose it within ten working days. If no objection is raised, the wholesaler may proceed—but only for the duration of the shortage.
The imported medicine must come from another European Economic Area (EEA) country where it is authorized. This ensures that the product meets EU-level safety and quality standards. The Minister can also impose conditions on distribution, supply, and administration, including additional safety measures.
Why Such Strict Oversight?
Belgium’s approach balances urgency with caution. Allowing unauthorized medicines without safeguards could compromise patient safety. By requiring formal notification, regulatory review, and adherence to strict criteria, the system ensures that imports are a last resort—not a shortcut.
This mechanism also reflects Belgium’s commitment to EU principles. While national law provides flexibility in emergencies, it aligns with broader European rules on named patient use and public health protection.
What About Costs and Liability?
The price of imported medicines may differ from the original product. Starting January 2025, a compensation mechanism will allow reimbursement of additional costs under conditions set by the Royal Decree of 26 April 2024. Importantly, liability for unlicensed use is waived for the manufacturer, the marketing authorization holder in the exporting state, and the prescribing physician—provided all legal conditions are met.
Looking Ahead
Medicine shortages are unlikely to disappear overnight. Belgium’s legal framework for emergency imports is a pragmatic solution, but it underscores a deeper challenge: the fragility of global supply chains. For now, Article 105/1 offers a lifeline for patients when no other options exist—under the watchful eye of regulators.
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Sources
Article 105/1 – Import for Special Needs | FAMHP
Article 105/1 of the royal decree of 14 December 2006 on medicinal products for human use: import for special needs | FAMHP
Ongoing
FPS Public Health – Medicines and Shortages
https://www.health.belgium.be/en
Ongoing