Stay up to date with the latest regulatory changes in Belgium, the Netherlands, Luxembourg and Europe.
Aug 20, 2026 · Belgium
The Federal Agency for Medicines and Health Products (FAMHP, Belgium) has published an updated version of its guidelines for Additional Risk Minimisation Activities (version 08/2026). The updated guidelines are available in Dutch and French.
Aug 5, 2026 · Narcotics/Psychotropics — Belgium
The Belgian Federal Agency for Medicines and Health Products (FAMHP) has issued a reminder regarding the correct and timely endorsement of import and export authorizations for narcotic drugs and psychotropic substances in NDS-web.
Jul 20, 2026 · Belgium
New measures concerning pregabalin and gabapentin entered into force on July 19, 2026. In the meantime, an erratum has been published in the Belgian Official Gazette, correcting the last line of the table included in the new Annex IVC.
Jul 16, 2026 · Belgium
The Animal Health Group of pharma.be has released an updated Code of Ethics, replacing the previous 2017 version to reflect the latest European veterinary medicines legislation and current industry practices.
Jul 13, 2026 · Europe
The CMDh has agreed to remove the requirement to submit a cover letter for Type IA and Type IAin variation applications. This change took effect on 1 July 2026, and several guidance documents have been revised.
Jul 13, 2026 · Luxembourg
On 10 June 2026, the General Assembly of Innovative Medicines for Luxembourg (IML) approved a revised version of the IML Code of Ethics, introducing new provisions on complaints and a dedicated patient chapter.
Jun 4, 2026 · Belgium
The Belgian Health Authorities (FAMHP) have recently published a guidance document on the interpretation of Article 10 of the Law of 25 March 1964 regarding premiums and benefits.
Jun 3, 2026 · Europe
As previously announced, as of 28 May 2026 the use of key modules of EUDAMED, the European database on medical devices, has become mandatory. The modules now in scope are Actors (economic operator registration) and UDI/Devices.
Jun 2, 2026 · Luxembourg
There is a new law in Luxembourg on materials and articles intended to come into contact with food, in line with Regulation (EU) 2017/625. This law also sets out the activities and controls carried out by the Luxembourg Veterinary and Food Administration.
Jun 2, 2026 · 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.
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