On September 1, 2020, the UK’s medicines and medical devices regulator released the MHRA post-transition information, an extensive suite of guidance on the UK regulatory regime post the Transition Period expiring on December 31, 2020.

The new guidance spreads out across dozens of documents covering the following topics:

  • Clinical trials
  • Devices
  • Licensing
  • Importing and Exporting
  • IT systems
  • Pharmacovigilance
  • Paediatrics

Given that up to now, the industry has been left with no clarity other than the withdrawn previous No-Deal guidance, this publication is largely to be welcomed.  It provides more certainty on a number of areas and although it is largely similar to the previous guidance that was withdrawn earlier in 2020, it provides additional detail and in some cases deviates from that guidance, and so requires careful reading. 

Extensive though the new guidance is, certain gaps in detail provided still remain, and we continue to follow up with the MHRA in these important areas.

We have prepared a summary of the new guidance, which can be accessed here.

For further information please contact Julia Gillert or Magda Tovar of our London office.

Author

Julia Gillert is Of Counsel in the IP/Tech team at Baker McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Magda Tovar joined Baker McKenzie in September 2019 as a Knowledge Lawyer for the Global Healthcare and Life Sciences Industry Group, covering healthcare and life sciences legal issues for the EMEA region. She also supports the Industry Group at a global level on many knowledge management matters including thought leadership projects and global surveys. Before joining Baker McKenzie, Magda was a senior legal adviser at the European Medicines Agency (EMA) for 16 years where she advised on a broad spectrum of matters related to EU pharmaceutical law, covering medicines for human and veterinary use. She represented the EMA in cases before the General Court and the Court of Justice of the European Union.

Write A Comment