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Updates to the Dutch Medicines Act
The Netherlands Recent updates to the Dutch Medicines Act (Geneesmiddelenwet) of 8 February 2007 have been published. This Act defines the composition and responsibilities of the Medicines Evaluation Board (MEB) and regulates the licensing of manufacturers,...
Update LCPV notification form
Luxembourg As part of the pharmacovigilance system, the marketing authorization holder has at its disposal, on a permanent and continuous basis, an appropriately qualified person responsible for pharmacovigilance. The person responsible for pharmacovigilance resides...
EC Regulation impacting pharmacovigilance
Europe The European Commission (EC) has adopted Implementing Regulation (EU) 2025/1466, introducing important amendments to the EU pharmacovigilance framework.The regulation will enter into force 20 days after publication and will apply from 12 February 2026....
Recent Updates to GVP Guidance Documents
Europe The European Medicines Agency (EMA) has recently published several important updates to Good Pharmacovigilance Practices (GVP) guidance: GVP Module VI – Addendum II introduces new guidance on the masking of personal data in Individual Case Safety Reports...
New hourly fees for the Netherlands for 2026
The Netherlands GMH (Gedragscode Medische Hulpmiddelen) has published the maximum hourly fees for service contracts for 2026. These hourly fees are indexed every year and are subcategorized by the education level of the health care professional. You can find the...
Publication updated Variations Guidelines
Europe Following the revision of the Variation Regulation effective as of 1 January 2025, the European Commission (EC) has adopted and published the final version of the guidelines concerning the classification of variations and the operation of the relevant...
End-of-Year Withdrawals for Human Medicines in the Netherlands
The Netherlands Requests for the withdrawal of marketing authorizations and parallel import licenses for human medicines effective 31 December 2025 — the so-called “end-of-year withdrawals” — must be received by the Medicines Evaluation Board (CBG) no later than 1...
Update fee document Luxembourg
Luxembourg A new version (V5 – September 2025) of the document ‘Fees in relation to marketing authorizations Luxembourg’ has been published. This updated version clarifies that for applications for variation type IA/IB, no fees are required for notifications (e.g.,...
End of public reference price communication by APB
Belgium As of September 1st, 2025, the Algemene Pharmaceutische Bond (APB - General Pharmaceutical Association in Belgium) has ceased the publication of recommended retail prices (RRP) for products that do not fall under regulated pricing schemes. This decision is...
Expansion Opium Act with List IA
The Netherlands On July 1st, 2025, the NPS (New Psychoactive Substances) legislative amendment came into force, adding list IA to the Opium Act. The amendment is aimed at combating New Psychoactive Substances and to take more effective actions against designer drugs...
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