Belgium
A Stock Monitoring Tool (SMT) will be implemented by the government. The goal of this tool is to anticipate and manage (un)availabilities of medicinal products for human use.
A Royal Decree is being drafted and includes mandatory reporting:
- By MAHs, parallel traders, wholesale distributors, hospital pharmacies and public pharmacies. Please note that the local distributor may report on behalf of the MAH and that not both need to report.
- On a daily basis
- For medicinal products for human use that are or have been marketed in the last two years and are subject to prescription and/or reimbursable, supplemented by medicinal products available over the counter with the same ATC code as a prescription or reimbursable medicinal product.
- Of the available stock at the end of the day, the quantity sold during that day, the average monthly sales volume (only for marketing authorization holders, parallel traders, and wholesale distributors), the date and expected volumes of the next two deliveries (only for marketing authorization holders and parallel traders).
- By uploading a completed CSV template (manually) or API (Machine-to-Machine).
The SMT, integrated in FarmaStatus, will be operational as of January 1st, 2026. There is an implementation period of 6 months, with a deadline of July 1st, 2026.
More information about how the tool works can also be found in the FarmaStatus user manual from page 82 onwards. You can download this from the ‘Frequently Asked Questions’ page on FarmaStatus under the question ‘How do I use FarmaStatus?’ in the section for pharmaceutical companies. This user manual will be updated in early January.
Source: FAMHP