Belgian Pharma Law Summer Blog Series (Part 1): the Act of 30 May 2026 containing various provisions on medicinal and health products

In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 1 focuses on the Act of 30 May 2026 containing various provisions on medicinal and health products (the “Act of 30 May 2026”), which amended several acts falling within the competence of the Federal Agency for Medicines and Health Products (FAMHP). We discuss in particular some key changes relating to medicine shortages, the FAMHP’s functioning, and clinical trials.

Medicine shortages

Medicine shortages remain one of the most pressing public health challenges. To address this, Belgium is placing greater emphasis on preventive measures to reduce the risk of shortages occurring. In particular, the Act of 30 May 2026 introduces changes concerning export authorisations and stock allocation.

Export authorisations

Under the Royal Decree of 19 January 2023, the export of medicinal products intended for the Belgian market may be subject to authorisation where:

• a shortage has been notified or established;
• the shortage is likely or certain to last at least one month;
• the medicinal product is urgently required due to a risk of serious health deterioration; and
• the shortage cannot – or not sufficiently – be addressed by an alternative medicinal product.

Through a new amendment to the Medicines Act of 25 March 1964, an export authorisation may now also be required where the FAMHP determines that the stock of a medicinal product available on the Belgian market is insufficient to meet patients’ needs, or that such a shortage is imminent or likely to occur.

Stock allocation

In case of a shortage or if the FAMHP determines that the stock of a medicinal product available on the Belgian market is insufficient to meet patients’ needs, or that this is imminent or likely, the following measures may now also be taken:

1. The redistribution of remaining stocks;
2. The making available of stocks as a priority to hospitals or specific healthcare practitioners, or their priority use for specific patients categories or profiles, and, where necessary, allowing hospital pharmacies to supply ambulant patients;
3. Ordering wholesalers-distributors and/or persons authorised to supply medicinal products to the public to be supplied only up to a certain quantity, or that only a certain percentage of available stocks may be supplied to these operators, or otherwise require a proportional distribution among them.

The above measures, the procedure for which can be further specified in a Royal Decree, may only be taken where necessary to protect public health. Should these measures result in an operator being unable to fulfil its contractual obligations, no compensation may be claimed from that operator, nor may any penalty clause be enforced.

Functioning of the FAMHP

The FAMHP was established by the Act of 20 July 2006, which lays down its powers and responsibilities. The Act of 30 May 2026 introduces several targeted amendments to that framework. We focus below on two of those changes: the subcontracting of certain regulatory tasks and the FAMHP’s collection of fees and other payments.

Subcontracting of certain regulatory tasks

The Act of 20 July 2006 already allows the FAMHP to seek assistance from third parties and to assist other public authorities in performing their tasks. This mechanism is used, for instance, to allocate responsibilities between the FAMHP and the Federal Agency for the Safety of the Food Chain (FASFC) where their competences overlap, thereby avoiding dual inspections. The law now expressly provides that, where such delegation involves supervisory and control powers, the FAMHP may exercise the full range of powers of the delegating authority. Conversely, the FAMHP may also sub-contract its own supervisory and control functions to the FASFC or another authority by means of a cooperation agreement, empowering the competent staff of that authority to exercise the same powers as FAMHP inspectors.

Fees and payments collection

Certain financial (enforcement) provisions in the Act of 20 July 2006 have also been amended:

• The fifteen-day payment deadline (running from receipt of the payment notice) is replaced by a thirty-day period running from dispatch — or, where the notice is not sent via the PEPPOL electronic transmission network, from the third working day after dispatch, unless the debtor proves later receipt through no fault of its own. The same deadline now applies to mandatory contributions to finance clinical trials ethics committees.
• The introduction of a single late-payment interest of 0,8 % per month.
• The obligation to publish indexed levy amounts in the Official Gazette is replaced by a requirement to publish them on the FAMHP’s website.
• The FAMHP’s power to suspend services to non-paying operators is extended to ‘connected persons’ within the meaning of Article 1:20 of the Companies and Associations Code.
• The rules on limitation periods are clarified to confirm that the dispatch of a payment reminder resets the limitation period, rather than merely suspending it.

Clinical trials

Despite the harmonisation brought about by the EU Clinical Trials Regulation, certain ancillary matters remain within the competence of EU Member States. In that context, the Act of 30 May 2026 introduces rules on the remote delivery of investigational and auxiliary medicinal products and slightly amends the voluntary administrative appeal procedure.

Remote delivery of investigational and auxiliary medicinal products

The Clinical Trials Act of 7 May 2017 now enables the delivery of investigational and auxiliary medicinal products outside the clinical trial site – both in person (including at the participant’s home address) and via courier. This reflects the broader trend towards decentralised clinical trials, accelerated by the COVID-19 pandemic, and aims to make Belgium more attractive for clinical research while improving participant access to innovative medicines.

Delivery to a participant’s address in Belgium is also permitted where the participant is enrolled in a trial authorised in another Member State, even if that trial has not been authorised in Belgium. More detailed requirements can still be introduced, including minimum standards for courier services and safeguards to prevent undue access to participants’ personal data.

Voluntary administrative appeal procedure

Under the Clinical Trials Act, a trial sponsor may lodge a voluntary administrative appeal with the Minister of Health against decisions relating to clinical trial authorisation requests. The Act of 30 May 2026 amends this procedure in two respects:

• The requirement for the Minister to hold an oral hearing with the appellant is removed, on the basis that the appellant’s arguments are already set out in the written notice of appeal and that the Minister is legally required to follow the opinions of the Commission for Medicinal Products for Human Use and the relevant Ethics Committee.
• The sponsor is now also expressly granted the right to submit observations in response to any unfavourable or conditional opinion issued by the aforementioned bodies. The Commission and/or Ethics Committee then have a short period to confirm or revise their opinion in light of those observations.

Conclusion

The Act of 30 May 2026 introduced a wide range of amendments spanning several key areas of Belgian pharmaceutical law. Given that the amendments discussed in this post entered into force on 14 June 2026, pharmaceutical companies are encouraged to assess their implications for both day-to-day operations and longer-term strategic planning. In the next instalment of our Belgian Pharma Law Summer Blog Series, we will cover the FAMHP’s new guidelines on the application of Article 10 of the Medicines Act in the context of the promotion of medicinal products.

Written by

• Christophe Ronse

  Partner

• Kirian Claeyé

  Partner

• Bart Junior Bollen

  Associate