Royal Decree “Pot-Pourri” 2026 Explained

Belgium continues to modernise its reimbursement procedures. Under the National Institute for Health and Disability Insurance (NIHDI) Roadmap on Access, the pricing and reimbursement process is being reformed step by step, with the aim of giving patients faster access to affordable and innovative medicines.

After the introduction of (EEFA) Early and Equitable Fast Access earlier this year, a new Royal Decree now brings a series of changes to the procedure of the Commission for Reimbursement of Medicines (CRM). Its nickname says it all: “Pot-Pourri” bundles administrative corrections, technical adjustments and several Roadmap reforms intended to make the CRM work more efficiently.

When does it apply?

The Royal Decree was published in the Belgian Official Gazette on 12 October 2026 and enters into force on 1 November 2026. CRM dossiers submitted before that date will continue to be processed will continue to be processed under the previous rules.”

Three changes that stand out

• Earlier submission, after a positive Committee for Medicinal Products for Human Use (CHMP) opinion (Roadmap reform 13). Companies can now submit a CRM application before the marketing authorisation is formally granted, as long as a positive CHMP opinion has been obtained. This applies to all medicines receiving a centralised European marketing authorisation, including biosimilars and generics. The expected time saving is around two months, so patients can access them soone.

• A new expert model (Roadmap reform 5). The clinical expert with experience in the medicinal product, previously designated by the company (the so-called “exclinex”), is removed. In exchange, external experts from clinical practice, scientific associations, universities and similar institutions, appointed by the CRM, get a stronger role. The expert appointed by the CRM Bureau is maintained, and the Bureau will collaborate with professional organisations. Clinical experts may still accompany the company during hearings, so the clinical perspective can still be brought in during the Q&A.

• One hearing moment less (Roadmap reform 22). Companies can no longer request a hearing after the provisional assessment report (D60). The possibility to request a hearing after the provisional proposal (D120) remains.

And more

The Royal Decree goes beyond these three reforms. Among other things, it:

• allows the CRM to initiate a modification of reimbursement conditions, or a group revision, on other duly justified grounds than new (inter)national recommendations, for example to simplify and harmonise conditions within a therapeutic class;

• introduces a review by the CRM Bureau six months before a scheduled individual revision, to check whether the procedure is still warranted;

• adds an admissibility check for requests to modify the price and/or reimbursement basis;

• lets the NIHDI administration make amendments and corrections without budgetary impact, without a CRM vote or Ministerial decision

See the full text in the Belgian Official Gazette

What it means for you

The new rules reward companies that prepare early and put their strongest case in writing.

• Start earlier. You can now submit your CRM dossier as soon as CHMP has given a positive opinion. To benefit from this, your Belgian dossier should be ready around that time, which means bringing your internal planning forward by about two months.

• Let the dossier speak for itself. Without a company-designated clinical expert, the clinical narrative must be fully convincing on paper. Engaging early with the scientific and professional associations in your therapeutic area becomes even more important.

• Make your written response count. With the hearing after the provisional assessment report (D60) gone, your written reaction to that report is now your main lever to steer the assessment. The hearing after the provisional proposal (D120) is your only remaining opportunity to present your case in person, so prepare it well in advance.

At Axes Health, we welcome every step that brings innovative medicines to patients faster, sustainably and meaningfully. Want to know what the Royal Decree “Pot-Pourri” means for your next CRM dossier? Get in touch at info@axeshealth.com.