Setterwalls Life Sciences Report December 2023
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We have the pleasure of presenting the latest issue of Setterwalls’ Life Sciences report. The report presents our view on selected current issues with respect to life sciences.
In this edition, the following subjects are included:
- EU Artificial Intelligence act: potential implications for healthcare AI
- Preparing for the NIS 2 Directive: Impacts on the health sector
- Pharmaceutical companies fined €13.4 million by the European Commission for price fixing
- Proposal for new Directive and Regulation on medicinal products for human use
- Pharmaceutical marketing compliance
- National exceptions for relabelling with new safety features – increased legal certainty and patient safety?
- First administrative fine based on the UTP Directive now imposed in Sweden
- Switch of biological medicinal products
- New timeline for EUDAMED
We hope you will find the report of interest and welcome to get in touch should you have any questions!