Medicines – Brexit transition guidance from MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on medicines, to help stakeholders prepare for the end of the transition period and beyond. 

Further new and updated guidance may be issued as the transition period progresses, so stakeholders are advised to monitor these pages for updates.  The MHRA has published the following guidance to help stakeholders prepare for the end of the transition period:

  • Authorisations of medicinal products:
  • Importing and exporting:
  • IT systems:
  • Pharmacovigilance:
  • Paediatrics:

Both the UK and EU are keeping their Brexit-related guidance under review and re-issuing stakeholder notices where necessary or appropriate to aid preparation for the end of transition.  Not all changes or updates are substantive.  For instance, in some cases, the detail of the guidance may not have changed, but the context, timescales or status of the arrangements outlined may have been updated.  In other cases, guidance may contain placeholders for more detail (pending implementation of relevant legislation, regulatory changes, fees or systems).

The guidance will be updated as those arrangements are finalised during transition.  As revised Brexit notices and guidance documents are being issued it is a good idea to bookmark the relevant guidance pages and check for updates, in particular:

The bulk of the government’s Brexit guidance has been gathered in its revised webpage: GOV.UK—Transition

Source: MHRA post-transition period information