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Contingency legislation covering regulation of medicines, medical devices and clinical trials in a no deal scenario—Human Medicines (Amendment etc) (EU Exit) Regulations 2019

Contingency legislation covering regulation of medicines, medical devices and clinical trials in a no deal scenario—Human Medicines (Amendment etc) (EU Exit) Regulations 2019
Published on: 06 March 2019
Published by: LexisPSL
  • Contingency legislation covering regulation of medicines, medical devices and clinical trials in a no deal scenario—Human Medicines (Amendment etc) (EU Exit) Regulations 2019
  • Original news
  • What is the purpose of the Human Medicines (Amendment etc) (EU Exit) Regulations 2019? What is the scope of the Regulations?
  • HMRs, among other things, implement EU directives relevant to the regulation of medicinal products into UK law. There are however a number of EU regulations that are currently directly applicable. How do the draft 2019 Human Medicines Regulations deal with those regulations?
  • Marketing authorisations
  • Paediatric investigation plans and studies
  • Orphan medicinal products
  • Advanced therapy medicinal products (ATMPs)
  • Manufacturing and batch testing
  • Parallel import licences and parallel distribution notices
  • More...

Article summary

Life Sciences analysis: As part of our series on contingency legislation covering regulation of medicines, medical devices and clinical trials in a no deal scenario, Julia Gillert and Els Janssens, associates at Baker McKenzie’s healthcare team, look at the Human Medicines (Amendment etc) (EU Exit) Regulations 2019. or take a trial to read the full analysis.

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