Belgium
The Royal Decree published on 30 September 2024, amending the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use, adds two elements concerning the search for substitutes, in the event of unavailability.
In the first place, a new regulation has been drawn up allowing wholesalers to obtain a certain quantity of medicines from another member state of the European Economic Area (EEA), even if the medicines are not authorised in Belgium. These medicines (not authorised in Belgium) can be used to replace an unavailable medicine during the period of unavailability. A ‘special need’ is thus met on the Belgian market. The new article 105/1 regulates the conditions and the procedure for the above-mentioned situation and specifies the types of critical unavailability for which this possibility can be used.
The second element concerns the addition of a second paragraph to article 110. This paragraph clarifies the conditions and responsibilities that have to be fulfilled when administering a non-authorised medicine to patients. Conditions are:
- The medicine is delivered at the hospital pharmacy and administered under the supervision of a doctor working at the hospital.
- The doctor must have obtained written consent from the patient before administering the medicine. This consent is added to the patients’ medical file.
- The doctor or pharmacist must report any serious or unexpected side effects to the Federal Agency for Medicines and Health Products (FAMHP).
- In emergencies, hospital pharmacies can supply the medicine to each other if the FAMHP has been notified.
This Royal Decree will come into effect on 01 November 2024.