Category New legislation

Progress with amendments to the EU variations regulation and guidelines

Last updated: 3 July 2025 To view updates, click on the ‘+’ sign below. This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. The commission delegated regulation Timeline of events leading…

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A closer look at some aspects of the proposed revision of the EU pharmaceutical legislation

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Last updated: 16 June 2025 On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to taker a closer…

Read MoreA closer look at some aspects of the proposed revision of the EU pharmaceutical legislation

European Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines

Last updated: 12 June 2025 To view updates, click on the ‘+’ sign below. The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and…

Read MoreEuropean Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines