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

Last updated: 10 July 2025 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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Patents, Supplementary Protection Certificates (SPCs) and SPC manufacturing waivers

Last updated: 4 July 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to provide basic information about patents, Supplementary Protections Certificates (SPCs) and Supplementary Protection Certificate (SPC) manufacturing waivers. The information provided is…

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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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