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Publication of CNIL standards on health data processing implemented in the context of early access and compassionate use authorisations
The French data protection authority (Commission Nationale de l'Informatique et des Libertés – “CNIL”) has published two standards relating to the processing of personal data within the framework of "early access authorisations" (“AAP”)[1] and within the framework of "compassionate access authorisations" (“AAC”)[2]. These standards were adopted after a public consultation by two deliberations of 22 September 2022 and published in the French Official Journal of 10 November 2022. As a reminder,...
January 16, 2023
2 min read
Rebranding generics as branded medicines – CJEU issues...
The CJEU has provided welcome new guidance on when parallel importers...
December 9, 2022
5 min read
To repackage or not? Latest CJEU rulings provide guidance...
Repackaging of medicine is a hotly debated issue between pharmaceutical...
November 22, 2022
8 min read
Update on the UK’s future medical device regulations:...
The UK’s Medicines & Healthcare products Regulatory Agency...
October 31, 2022
2 min read
Blood, cells and tissues: regulatory change is coming
Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”)...
October 25, 2022
5 min read
Publication of the English version of the new French Clinical Trial Agreement templates
The French legislator recently updated the French clinical trial agreement template also called...
October 10, 2022
2 min read
Italy: Pharmaceutical company fined by the Italian Competition Authority for the sale of a lifesaving drug at excessive prices
Essetifin S.p.A., Leadiant Biosciences Ltd., Leadiant GmbH and Sigma – Tau Arzenmittel GmbH (“Leadiant”)...
July 18, 2022
6 min read
Final(ly) Rules of Procedure of the UPC
Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations,...
July 18, 2022
1 min read
To opt-out or not? The UPC will change the rules of the game in the European patent field possibly as soon as next fall
Early this year it became clear that the long-pending reform of the European patent system is finally...
June 1, 2022
7 min read
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