Life Sciences: What will be the state-of-play post-Brexit?

Life Sciences: What will be the state-of-play post-Brexit?

 

Life Sciences analysis:

In this article, Marie Manley, partner and head of the UK Life Sciences team at Sidley Austin LLP and Bethany Wise, trainee solicitor, with the London Life Sciences team at Sidley Austin LLP outline two significant developments which provide insight into how the UK life sciences industry will be regulated following the end of the Brexit transition period, namely (i) the Medicines and Healthcare products Regulatory Agency (MHRA) post-transition period guidance; and (2) the government’s approach to the UK Supplementary Protection Certificates (SPC) waiver legislation.

More of Marie Manley's articles can be accessed here.

 

Topics covered include:

  • MHRA post-transition period guidance
  • Medicines
    • Authorisation
    • Pharmacovigilance
    • Paediatrics
  • Medical devices
    • Product marking
    • Registration
    • EU MDR and IVDR
  • Clinical trials
    • Registration and reporting
    • Sponsors and legal representatives
  • UK government amends SPC waiver legislation

 

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About the author:

Maria Isabel (‘Marie’) Manley leads Sidley Austin’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She represents development-stage and established global life sciences companies in a broad spectrum of matters, both contentious and non-contentious. Marie advises clients in the pharmaceutical, biotechnology, medical devices, chemicals, cosmetics and food sectors in proceedings before both national and European courts and the regulatory agencies in the UK and across Europe. She has particular experience on issues arising during the life cycle of medicinal products, including IP, advertising, product liability and competition.