Key Contacts: Ronan Dunne – Partner | Marie Kinsella – Partner
Welcome to the latest update from the Philip Lee Healthcare, Pharmaceutical and Life Science group in respect of the first quarter of 2023.
This update covers a range of topics:
General Regulatory – Ireland
- The Windsor Framework and its Effect on Medicines
General Regulatory – EU
- Extension of the MDR and IVDR Transitional Periods
- Commission Q&A guidance on extended MDR and IVDR transitional periods
- Amendment of MDR and IVDR reassessment period
- Scientific advice for high-risk medical devices launched by EMA
- Inquiry into reclassification of brain stimulation devices under MDR
- Use of CTIS now mandatory for new clinical trial applications
- EMA mid-point report on regulatory science in the EU published
- HERA, ECD and EMA sign agreements to cooperate on health emergency preparedness and response
- EESC opinion on proposed revision of Product Liability Directive
Competition Law
- Novartis fined for abuse of collective dominant position held
Data Protection
- Guidance published by the EMA on application of transparency principles to pilot evaluating raw data
Healthcare
- CJEU judgment on the advertising of medicinal products
- CJEU judgment on medicinal products by presentation
- CJEU judgment on national measures controlling prices of individual medicines
- CJEU judgment regarding EU legislation on medicinal product safety features
- 2022 Human Medicine highlights published by EMA
- Review of pseudoephedrine-containing medicines
- Updated guidance on unforeseen variations to marketing authorisations released by EMA
- CJEU judgment on global marketing authorisations
To read the full update see: Philip Lee – Healthcare Newsletter Q1 2023
For further information in relation to this article please contact Ronan Dunne or Marie Kinsella.
