MHRA post-transition period information

Published: 24/9/2020

More Information and guidance concerning MHRA post-transition period for industries and organisations.

Stakeholders need to get ready for new rules from 1 January 2021, as the transition period from the EU allows UK to offer fully independent regulatory decisions for medicines and medical devices.

The guidelines cover all the aspects of Clinical Trials, Devices, Licensing, Importing and exporting, IT systems, Pharmacovigilance and Paediatrics which were published on 1 September 2020 and thereafter updated on 4 September.

These documents cover the proper information regarding the Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master Files (PSMF) which will be effective from 1 January 2021 in the pharmacovigilance section, including:

  • UK and non-UK Individual Case Safety Reports (ICSRs)
  • Periodic Safety Update Reports (PSURs)
  • Risk Management Plans (RMPs)
  • Post-Authorization Safety Studies (PASS) protocols and final study reports

Click on the link below for further guidance and information: MHRA post-transition period information » News » MHRA post-transition period information