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NIS2 Directive and the CER Directive General
Deirdre Kilroy
Deirdre Kilroy
 Georgina Parkinson
Georgina Parkinson
The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector
The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased...
February 17, 2023
9 min read
General
Sally Shorthose
Sally Shorthose
Guide to EU and UK Pharmaceutical Regulatory Law 2023
Eighth Edition, Edited by Sally Shorthose The Guide to EU and UK Pharmaceutical Regulatory...
January 31, 2023
3 min read
standards on health data General
Nour Saab
Nour Saab
 Alexandre Vuchot
Alexandre Vuchot
 Johanna Harelimana
Johanna Harelimana
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...
January 16, 2023
2 min read
medicinal products General
Heidi Hurdle
Heidi Hurdle
Rebranding generics as branded medicines – CJEU issues new guidance
The CJEU has provided welcome new guidance on when parallel importers can rebrand generic medicines with...
December 9, 2022
5 min read
parallel traders General
Guillaume de Villegas
Guillaume de Villegas
 Silke Fiers
Silke Fiers
To repackage or not? Latest CJEU rulings provide guidance for parallel traders of medicines
Repackaging of medicine is a hotly debated issue between pharmaceutical companies and parallel traders....
November 22, 2022
8 min read
General
Pieter Erasmus
Pieter Erasmus
 Hadrien Espiard
Hadrien Espiard
Update on the UK’s future medical device regulations: Extended timelines
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction...
October 31, 2022
2 min read
Biotech
Phillipus Putter
Phillipus Putter
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
General
Johanna Harelimana
Johanna Harelimana
 Alexandre Vuchot
Alexandre Vuchot
 Nour Saab
Nour Saab
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
General
Morten Nissen
Morten Nissen
 Frederik Haugsted
Frederik Haugsted
Badmouthing your competitor’s products: Commission investigation indicates that so-called disparagement claims in the market could be considered stand-alone abuses of dominance
On June 20 2022, the European Commission (“Commission”) published the opening of an...
August 22, 2022
3 min read
General
Federico Marini Balestra
Federico Marini Balestra
 Lucia Antonazzi
Lucia Antonazzi
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
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