Legal News

Life Sciences weekly highlights—19 September 2019

Published on: 19 September 2019
Published by: LexisPSL
  • Life Sciences weekly highlights—19 September 2019
  • In this issue:
  • Brexit
  • Updated MHRA no-deal guidance on medical devices—UK Responsible Person
  • Disputes and regulatory enforcement
  • Crucial development on the presumption of confidentiality in the access to document saga (PTC Therapeutics v EMA and MSD Animal Health Innovation, Intervet v EMA)
  • Manufacture, marketing and sale
  • Medicines agency continues to make progress with public quality standards
  • The assessing science authority and proportionality in judicial review (R (on the application of Actegy Ltd) v Advertising Standards Authority)
  • Enforcement action taken on online pharmacies supplying high-risk medicine
  • More...

Article summary

This week's edition of Life Sciences weekly highlights includes news of the updated MHRA no-deal Brexit guidance on medical devices, analysis of the Advocate General’s opinions in PTC Therapeutics v EMA and MSD Animal Health Innovation, Intervet v EMA on the presumption of confidentiality in access to document cases. It also includes commentary of the judgment in R (on the application of Actegy Ltd) v Advertising Standards Authority Ltd in which the court confirmed the ASA rightly did and should look beyond the manufacturer’s document submission of a CE report and/or the Notified Body’s assessment report when it determines whether the evidence substantiates advertised claim, updates on the MHRA strategy for pharmacopoeial public quality standards and the consultation launched by the European Network of Paediatric Research at the EMA on paediatric clinical trial preparedness. or take a trial to read the full analysis.

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