On 1 November 2024, the new Article 105/1 came into force. 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. The notification forms are now available.
As of 1 November 2024, wholesalers are 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 the latter does not oppose it. More information on the procedure for such notification is available on our website.
The following must be communicated immediately by the wholesaler to the minister or their delegate.
- Any change to:
- the requested data from the initial notification form;
- an increase in the initial quantity not opposed by the minister or their delegate;
- an extension of the initial period not opposed by the minister or their delegate.
- The (premature) stock exhaustion of the imported or acquired medicinal product.
In addition, the FAMHP asks that the start of distribution to Belgian pharmacies be notified to the FAMHP. This enables an optimal communication via PharmaStatus about the availability of the medicinal product.
This new provision is intended to better manage the unavailability of medicinal products in Belgium, which is or threatens to become critical, in particular when no or insufficient suitable alternatives are available on the Belgian market.
Forms
- Initial notification for the import of medicinal products in case of unavailability
- Modification of the initial notification for the import of medicinal products in case of unavailability
- Start of distribution of imported medicinal products by the wholesaler in case of unavailability
- Stock exhaustion of imported medicinal products by the wholesaler in case of unavailability
More information
Article 105/1 of the Royal Decree of 14 December 2006 on medicinal products for human use: import for special needs