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, wholesalers, and importers of medicinal products, marketing authorisation requirements, distribution channels, pharmacovigilance, and the advertising and promotion of medicines.
The Act has been revised (effective 5 July 2025) to include the following amendments:
- Minor adjustments to the definitions of investigational medicinal product, investigator’s file, and test subject in Article 1 to align with EU Regulation 536/2014.
- Introduction of a new point (fff.2) in Article 1.
- Deletion of point (e) from Article 9.
- Amendments to Articles 18(7) and 34(2).
In addition, a further update was published on 9 September 2025.
Following this change, the Health and Youth Care Inspectorate (IGJ) is now authorised to grant exemptions to manufacturers, wholesalers, and pharmacists, allowing them to import a comparable alternative medicinal product from abroad in the event of a temporary supply shortage in the Netherlands.
This exemption applies to medicines that are not registered in the Netherlands, provided that they hold a valid marketing authorisation in another EU Member State, the United Kingdom, or a third country with a mutual recognition agreement.
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