The Royal Decree of 19 January 2023 (the Royal Decree) concerning the shortage of medicines (i) details the conditions under which a prior authorisation is required to export medicines aimed for the Belgian market to other EU countries and (ii) lists minimum criteria under which a request for a prior export authorisation may lead to an export ban or a limitation of exported quantities.
Drugs may be subject to such a prior export authorisation from the Minister of Health if four cumulative conditions are met:
- the drug's unavailability has been notified to or observed by the Federal Agency for Medicines and Health Products (FAHMP);
- the drug's unavailability will last for at least one month;
- the administration of the drug is urgent and necessary immediately as the lack of diagnostics or treatment may lead to acute or chronic health deterioration; and
- the drug's unavailability is not (sufficiently) compensated by other authorised drugs.
The Minister of Health determines the period during which wholesalers must request such authorisation. This period cannot exceed the planned or expected duration during which the drug is unavailable, but may be extended if the planned or expected duration of the drug's unavailability is extended.
Wholesalers will have to submit a request for authorisation via a form published on the FAHMP’s website, and the Minister of Health shall take a decision within five working days after having received such form.
In view of currently existing shortages, the FAHMP has adopted on 16 February 2023 six decisions subjecting one chemotherapy agent, two thrombolytic agents, one corticosteroid, one immunostimulant and one GLP-1 agonist to a prior authorisation.
