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:

• • Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
  • Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
  • Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)  from 1 January 2021
  • Registering new packaging information for medicines from 1 January 2021
  • Reference Medicinal Products (RMPs) from 1 January 2021
  • Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
  • Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes
  • How Marketing Authorisation Applications referred under Article 29 will be  handled from 1 January 2021
  • Applying for a Certificate of Pharmaceutical Product from 1 January 2021
  • Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
  • Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
  • Renewing Marketing Authorisations for medicines from 1 January 2021
  • Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January  2021

• Importing and exporting:

• • Acting as a Responsible Person (import) from 1 January 2021
  • Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021
  • Importing investigational medicinal products into Great Britain from approved countries  from 1 January 2021
  • Importing medicines on an approved country for import list from 1 January 2021
  • List of approved countries for authorised human medicines from 1 January 2021

• IT systems:

• • Registering to make submissions to the MHRA from 1 January 2021
  • Webinars: preparing to make submissions to the MHRA from 1 January 2021

• Pharmacovigilance:

• • Guidance on pharmacovigilance procedures in the event from 1 January 2021

• Paediatrics:

• • Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021
  • Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021
  • Completed Paediatric Studies – submission, processing and assessment from 1 January 2021

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:

• • GOV.UK—Transition guidance and regulation
  • European Commission: Getting ready for the end of the transition period

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

Source: MHRA post-transition period information