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Reminder – update RD pregabalin/gabapentin
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. The correction was necessary because the last line of the table included in the new Annex IVC...
Updated deontological code animal health pharma.be
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. The revised Code strengthens the sector’s...
Cover letter variation submission
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. To reflect this update, several guidance documents have been revised, including: Requirements on...
IML Updates Code of Ethics and Hospitality Thresholds
Luxembourg On 10 June 2026, the General Assembly of Innovative Medicines for Luxembourg (IML) approved a revised version of the IML Code of Ethics. The updated code introduces several targeted changes, including new provisions on complaints, a dedicated patient...
Guidance FAMHP on premiums and benefits
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. This document aims to further clarify the legal framework governing the granting...
The mandatory use of EUDAMED
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 following modules are now in scope: Actors (economic operator registration)UDI/Devices (device...
New Law on Food Contact Materials
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...
Update Stock Monitoring Tool
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...
Update Notification Form “Meldpunt”
The Netherlands A change has been made to the notification form of the Medicine Shortages and Defects Notification Centre in response to a new policy rule. The new policy rule and notification form have been implemented as of 01 April 2026. In the Netherlands,...
Planned legislative updates NL
The Netherlands The CGR communicated on three planned topics where updates to Dutch legislation are being proposed: Transparency register: Currently, transparency is based on self-regulation. A proposal to introduce a legal base for transparency in the...
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