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

  1. The Windsor Framework and its Effect on Medicines

General Regulatory – EU

  1. Extension of the MDR and IVDR Transitional Periods
  2. Commission Q&A guidance on extended MDR and IVDR transitional periods
  3. Amendment of MDR and IVDR reassessment period
  4. Scientific advice for high-risk medical devices launched by EMA
  5. Inquiry into reclassification of brain stimulation devices under MDR
  6. Use of CTIS now mandatory for new clinical trial applications
  7. EMA mid-point report on regulatory science in the EU published
  8. HERA, ECD and EMA sign agreements to cooperate on health emergency preparedness and response
  9. EESC opinion on proposed revision of Product Liability Directive

Competition Law

  1. Novartis fined for abuse of collective dominant position held

Data Protection

  1. Guidance published by the EMA on application of transparency principles to pilot evaluating raw data


  1. CJEU judgment on the advertising of medicinal products
  2. CJEU judgment on medicinal products by presentation
  3. CJEU judgment on national measures controlling prices of individual medicines
  4. CJEU judgment regarding EU legislation on medicinal product safety features
  5. 2022 Human Medicine highlights published by EMA
  6. Review of pseudoephedrine-containing medicines
  7. Updated guidance on unforeseen variations to marketing authorisations released by EMA
  8. 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.​