Setterwalls Life Sciences Report May 2024

Setterwalls has 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. 

Content overview Life Sciences Report May 2024:

• New regulation introduces stricter accessibility requirements – do your products and services meet the new requirements?
• Overview of recent developments regarding the distinction between marketing and non-commercial information in relation to medicinal products
• The new Product Liability Directive and AI Liability Directive – implications for medical devices with AI functionalities
• Key takeaways for the environmental risk assessment (ERA) in the proposal for new EU pharmaceutical legislation
• EMA’s new recommendations to strengthen supply chains of critical medicines – a short recap of what and why
• Recent developments and an update on Geographical Indications (GIs)
• Switch and substitution of biological medicinal products in pharmacies
• The Swedish Supreme Administrative Court seeks guidance from the CJEU on the interpretation of the provisions of EU law on the labelling of food for special medical purposes
• Labelling sausages “riktig korv” (eng. real sausage) was misleading

The report is available here.

We hope you will find the report of interest and welcome to contact us should you have any questions.