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Given that up to now, the industry has been left with no clarity other than the withdrawn previous No-Deal guidance, this publication is largely to be welcomed. It provides more certainty on a number of areas and although it is largely similar to the previous guidance that was withdrawn earlier in 2020, it provides additional detail and in some cases deviates from that guidance, and so requires careful reading.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