Article 105/1 of the royal decree of 14 December 2006 on medicinal products for human use: import for special needs

On 1 November 2024 the new article 105/1 of the Royal Decree of 14 December 2006 on medicinal products for human use came into force. This new provision allows wholesalers to import medicinal products that are unauthorised for use in Belgium if they meet a special need due to critical unavailability. In this regard, solutions other than the import of a valid therapeutic equivalent or alternative are not allowed. The import and distribution of the medicinal products by wholesalers is limited to the period of unavailability.

The FAMHP determines whether the reported unavailability is critical and adds it to the list of critical unavailabilities (critical medicines list) for which imports from other European Union/European Economic Area (EEA) member states are considered a possible solution. 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 on 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.

Procedure
Before a medicinal product that is not authorised in Belgium can be distributed on the Belgian market for delivery and administration, the following procedure must be followed.

1. A wholesaler wishing to distribute an unauthorised medicinal product in Belgium based on the most current list of critical unavailabilities, must notify the minister or their delegate in advance using the initial notification form.

2. The FAMHP considers all applications in chronological order of time and may prioritise an application based on the following elements, ranked in order of importance:

when the proposed therapeutic equivalent more closely matches the unavailable medicinal product;
when the quantity offered better matches the anticipated period of temporary discontinuation;
when the proposed therapeutic equivalent or alternative is more beneficial to the patient, especially if the therapeutic equivalent or alternative has fewer adverse reactions;
other reasons of interest to the patient or other reasons of public interest.

3. The wholesaler may place a medicinal product that is not authorised in Belgium on the market if the minister or their delegate has not opposed the application within 10 working days after the initial notification.

The FAMHP assesses whether each of the following conditions is met during this 10-working-day period.

The medicinal product that the wholesaler wants to distribute to Belgian pharmacies is a therapeutic equivalent or a valid alternative to the unavailable medicinal product on the critical unavailability list.
A temporary discontinuation of marketing of the unavailable medicinal product was reported or noted.
The temporary discontinuation of the marketing of the above medicinal product leads to/may lead to critical unavailability.
The anticipated period of import or acquisition and distribution is shorter than or corresponds to the anticipated period of the temporary discontinuation of the unavailable medicinal product.
The anticipated quantity is not more than what is necessary to meet the needs of the patients during the period of unavailability.
The medicinal product that is not authorised in Belgium is authorised in another member state within the EEA and is imported from this state.

The FAMHP may request any additional data from the wholesaler in order to evaluate the quality, safety and efficacy of the medicinal product that is not authorised in Belgium. If the FAMHP requests additional data, the 10-working-day period is temporarily suspended until the date that the requested data are submitted. If the requested data are not submitted to the FAMHP within 5 working days, the notification will be considered inadmissible.

4. The following matters 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