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UK Marketing Authorisation Procedures from 1 January 2021

UK Marketing Authorisation Procedures from 1 January 2021
Published on: 23 February 2021
Published by: LexisPSL
  • UK Marketing Authorisation Procedures from 1 January 2021
  • What types of MAs are available for placing a medicinal products on the UK market from 1 January 2021?
  • The Medicines and Healthcare products Regulatory Agency (MHRA) offers new assessment routes—what are they and what are their main features?
  • 150-day assessment for national MAs
  • Rolling Review of MAAs
  • Innovative Licensing and Access Pathway (ILAP)
  • Authorisations in response to pandemics
  • The MHRA may grant MAs which rely on the EU MA procedures—how do these reliance procedures work?
  • What are the routes available to place a medicinal product on the NI market? What is the MHRA’s role and what guidance is provided?
  • What are the rules for placing a medicinal product authorised in NI on the GB market?

Article summary

Life Sciences analysis: Grant Castle, partner and Ellie Handy, associate, at Covington & Burling summarise the new procedures the UK has provided to obtain marketing authorisations (MAs) for medicinal products in the UK. These procedures will most likely change as the UK develops and refines its regulatory frameworks. or take a trial to read the full analysis.

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