GDP & Distribution

Stock Monitoring Tool: draft royal decree approved, mandatory reporting is coming

11 Aug 2026 Helena Roegiers 2 min read
Stock Monitoring Tool: draft royal decree approved on 18 July 2026

The planned go-live of the Stock Monitoring Tool on 1 July did not go ahead as scheduled, but the project remains very much alive. On 18 July 2026, the Belgian Council of Ministers approved a draft royal decree introducing the Stock Monitoring Tool, giving the system its formal legal basis. As we reported in June, the original go-live date was no longer achievable, but this decision confirms a postponement rather than a cancellation.

What was decided

The draft royal decree introduces a stock monitoring system that gives the FAMHP a global and detailed overview of the availability of a range of medicines authorised on the Belgian market. The goal: prevent shortages through greater stock transparency and better insight into demand, while safeguarding the continuity of care. The measure applies to specific categories of medicines of major therapeutic importance.

What happens next

The draft still needs to complete the legislative process before the reporting obligation takes effect, including advisory review by the Council of State and publication in the Belgian Official Gazette. No new mandatory start date has been communicated yet, so keep an eye on the FAMHP’s official channels for the definitive timing.

What to do now

If you hold marketing authorisations or distribute medicines in Belgium, use this window to prepare: determine which products in your portfolio are likely to be in scope, decide who will report and check whether your stock data can be extracted and submitted without manual work. Companies that set this up now will treat the eventual start date as a formality, not a scramble.

How MPCA can help

We help wholesalers and marketing authorisation holders prepare for the Stock Monitoring Tool: scoping your portfolio, setting up the reporting process and keeping you ahead of Belgian and EU supply-chain requirements. See our RP and GDP services and the official announcement by the Council of Ministers.

This article is for general information and reflects the situation at the time of writing. Always check the FAMHP’s official publications for binding requirements.

Helena Roegiers

M.P.C.A. International BV — Pharmaceutical Consultancy

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