Progress with amendments to the EU variations regulation and guideline

Last updated: 26 November 2024 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 guideline. Timeline of events leading to the publishing of…

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

Last updated: 23 November 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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Licensing routes to obtain a marketing authorisation for a medicine in the UK, GB or NI post Brexit

Last updated: 21 November 2024 To see updates, click on the ‘+’ sign below. Post Brexit, there are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) (GB) or Northern Ireland…

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