Publication of Article 105/1: import of medicinal products by wholesalers in case of special needs

date: 29/10/2024

Wholesalers will be allowed to distribute medicinal products that are not authorised in Belgium in our country if they meet a special need in Belgium due to a critical unavailability, as determined by the Federal Agency for Medicines and Health Products (FAMHP).

On 1 November 2024, the new Article 105/1 of the Royal Decree of 14 December 2006 inserted by the Royal Decree of 12 September 2024 came into force. This new provision will allow the import of medicinal products that are not authorised in Belgium for which there is a critical unavailability or a critical unavailability threat. The medicinal products can be imported from another member state within the European Economic Area (EEA), where the medicinal products are authorised, for a period limited to the period of unavailability.

Wholesalers will be able to distribute medicinal products in the event of critical unavailability under certain conditions after notifying the minister of Health or their delegate, and if they do not oppose it. More information on the procedure for such notification will soon be published on our website.

The FAMHP determines whether an unavailability is critical or not, based on its determination on the conditions contained in Article 105/1 (§ 2, ninth paragraph) of the Royal Decree of 14 December 2006.

List of unavailable critical medicines
When Article 105/1 comes into force, a list of critical unavailable medicinal products for which imports are considered a possible solution will be published. The list is published on PharmaStatus and is continuously updated.

For packages included in this list, the unavailable medicinal product is of such importance that its absence from the Belgian market poses significant (vital) risks and there are no solutions at the national level other than importing from abroad. In other words, there are no equivalent or alternative medicinal products available on the Belgian market, nor is magistral preparation a valid option.

Cost
The price of the imported medicinal product may differ from the unavailable medicinal product. The Royal Decree of 26 April 2024 on the compensation of the patient's additional expenses by the National Institute for Health and Disability Insurance (NIHDI) will come into force on 1 January 2025. Reimbursement will then be possible, provided that the conditions of this Royal Decree are met.

Import based on medical prescription and doctor's declaration
Currently, it is already possible for pharmacists to import a medicinal product from abroad via Article 105 of the Royal Decree of 14 December 2006 as a solution to unavailability in Belgium (when the conditions are met). This will remain possible. The FAMHP publishes relevant information on the Availability of Medicinal Products webpage and on PharmaStatus.
 

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