Category European Union

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. The Commission has today proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies and contribute…

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

Last updated: 28 February 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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Medical Device Coordination Group updates: October – December 2023

Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…

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Using the outcome of Case T-611/18 (Pharmaceutical Works Polpharma S.A vs the EMA) to better understand aspects of EU medicines legislation

Last updated: 21 December 2023 See updates at the end of the post. The parties involved in the case The parties involved in this case were Pharmaceutical Works Polpharma S.A versus the European Medicines Agency (Case T-611/18) supported by the…

Read MoreUsing the outcome of Case T-611/18 (Pharmaceutical Works Polpharma S.A vs the EMA) to better understand aspects of EU medicines legislation