The Federal Agency for Medicines and Health Products (FAMHP) has published its first version of the Belgian list of essential medicinal products for human use. The list includes medicinal products whose unavailability could have a critical impact on patients' health.
Methodology
The FAMHP, together with other European medicines authorities, actively collaborated in establishing the European list of critical medicinal products (Union list of critical medicines) of the European Medicines Agency (EMA), a first version of which was published in December 2023.
Starting from this European list, the FAMHP now compiled a first version of the list of medicinal products for human use (version of 4 November 2024) that are currently available on the Belgian market. This list was completed with:
- medicinal products for which task forces were previously organised;
- antimicrobials considered essential in Belgium.
The list is formatted into ATC (Anatomical Therapeutic Chemical) codes and routes of administration.
The list is sorted alphabetically by ATC code and therefore not by priority.
Although the most up-to-date version is always available, the list on the website is not complete. It is a dynamic list that will be updated when necessary.
Legislation
In the interest of public health, pharmaceutical companies have an obligation to deliver medicinal products to wholesaler-distributors and pharmacies within three working days. When a wholesaler cannot meet this requirement and cannot deliver the products at all, not on time or not all the products, the authorisation holder must report the unavailability of these medicinal products through PharmaStatus.
For those medicinal products included on the Belgian list of essential medicinal products, the additional monitoring of the delivery and reporting requirements is crucial to better manage and anticipate the risks of critical unavailability.