Regulatory

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Final(ly) Rules of Procedure of the UPC
Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations, directives and laws governing the operation of the Unified Patent Court (UPC), another important piece of legislation consists of the UPC’s Rules of Procedure (RoP). The RoP presents a detailed and elaborate set of rules establishing the framework within which all the UPC divisions and panels will operate. It is a must read for any party considering proceedings before the UPC. The...
July 18, 2022
1 min read
New Draft Implementing Regulations propose key changes...
On 9 May 2022, the National Medical Products Administration (the...
May 19, 2022
5 min read
The Return of Biosimilar Substitution in France
Every year the Social Security Financing Law for 2022 (LFSS 2022)...
March 28, 2022
3 min read
International Comparative Legal Guide to Digital Health 2022
Our Life Sciences IP, Regulatory and Data Protection experts...
March 17, 2022
1 min read
Renewal of early access and compassionate use frameworks in France
On 1 July 2021, the early access and compassionate use reform entered into force. A medical treatment...
November 10, 2021
6 min read
UK medical devices regime set for an upgrade
Just 7 months after the expiry of the Brexit transition period, the Medicines and Healthcare products...
October 7, 2021
4 min read
Dutch competition authority ACM imposes EUR 20 million fine on orphan drug manufacturer Leadiant for excessive pricing
The Netherlands Authority for the Consumer and Markets’ ("ACM") announced focus on drug...
July 21, 2021
6 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns and arrests
Operation Pangea is a yearly recurring operation in which Interpol aims to remove the online sale of...
June 24, 2021
2 min read
EU merger control – new guidance brings uncertainty – particularly for tech and pharma acquisitions
Illumina’s acquisition of cancer testing startup, Grail, looks set to be the testing ground for the Commission’s...
April 20, 2021
7 min read
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