Category European Commission

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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The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms

Last updated: 30 May 2024 See history of updates below. The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project will have a wide ranging and positive impact on industry stakeholders…

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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…

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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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European Commission initiative on compulsory licensing of patented inventions and Supplementary Protection Certificates

Last updated: 18 March 2024 See updates at the end of the post. On 27 April 2023, the Commission proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies…

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European Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply

Last updated: 23 February 2024 See updated at the end of the post. On 23 January 2024, the European Commission published a proposal to extend transition periods for certain in vitro diagnostic medical devices (IVDs), gradual roll-out of Eudamed and an…

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