Category New legislation

Progress with amendments to the EU variations regulation and guideline

This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guideline. Timeline of events leading to the publishing of the commission delegated regulation Date Event Call for evidenceFeedback period29 August 2023 – 26…

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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: 18 April 2024 See updates below 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…

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 April 2024 See updates at the end of the post 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 adapted…

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