Belgium
An update has been shared about the implementation timeline and scope of the Stock Monitoring Tool (SMT).
Based on the latest information, the implementation of the SMT will be postponed to a later date, which is yet to be determined.
In addition, several updates have been made to the Royal Decree (RD) proposal. According to the current draft, the SMT will apply to the following categories of medicinal products:
- Prescription-only medicines for human use;
- Reimbursable medicines for human use;
- Non-prescription medicines that share the same ATC code as medicines in the above categories.
The draft RD also provides for specific exemptions, including:
- Medicinal products with a pharmaceutical form classified as ‘medical gas’;
- Custom-made Advanced Therapy Medicinal Products intended to meet the specific needs of an individual patient and not designed for mass production;
- Radionuclide generators, kits, and radionuclide precursors for radiopharmaceuticals, as well as industrially manufactured radiopharmaceuticals.
Please note that the reporting template currently available in Farmastatus has already been updated to fully align with the scope outlined above. As such, the templates include only those medicinal products subject to mandatory reporting and no additional filtering / selection is required.
Source: FAMHP