In April 2023, the European Commission published legislative proposals for the revision of the European Union (EU) General Pharmaceutical Legislation. The revision would merge various pieces of legislation into one Directive and one Regulation, simplifying and replacing existing legislation. Negotiations between Member States on these proposals have started in the first half of 2024. The Dutch Ministry of Health, Welfare and Sports (VWS) has requested a QuickScan of the proposals to assess whether the draft EU General Pharmaceutical Legislation is fit for purpose to assess innovative medicines for marketing authorisation, and whether there are possibilities to further revise the system for a positive impact on innovation and access to medicine in Europe and the Netherlands.
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