Regulatory

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Dialogue at EU level on the legalisation of recreational cannabis – the German Federal Government’s White Paper will not suffice
The Federal Government submits its White Paper on the legalisation of recreational cannabis to the EU Commission for an informal review. There will only be a draft act if the Commission shares the Federal Government’s liberal interpretation of EU and international law on cannabis. The White Paper, however, lacks solid arguments. There is a need for improvement here. At the same time, the Federal Minister of Health is putting all his eggs in one basket: full legalisation and no Plan B. As an alternative,...
December 1, 2022
11 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 com...
Approximately twenty years ago, the regulation of Substances...
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
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
New Draft Implementing Regulations propose key changes for pharmaceuticals in China
On 9 May 2022, the National Medical Products Administration (the “NMPA”) published the Implementing Regulations...
May 19, 2022
5 min read
The Return of Biosimilar Substitution in France
Every year the Social Security Financing Law for 2022 (LFSS 2022) introduces several measures resulting...
March 28, 2022
3 min read
International Comparative Legal Guide to Digital Health 2022
Our Life Sciences IP, Regulatory and Data Protection experts Sally Shorthose, Toby Bond, Emma Drake and...
March 17, 2022
1 min read
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