[co-author: Linden Thomson]

• MHRA updates post-transition guidance
  Since 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) has been updating various aspects of the regulatory regime for medicines and medical devices following the end of the Brexit transition period such as:

  • MHRA’s 150-day objective for assessing applications for marketing authorisations (MAs);
  • The rolling review process for MA applications (rather than a consolidated full dossier submission);
  • The process by which, for a two-year period from 1 January 2021, MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure when determining an application for a Great Britain (GB) MA.
  • MHRA’s decentralised or mutual recognition procedures which would enable MAs approved in EU member states (or Iceland, Liechtenstein, Norway) to be granted in the UK or GB;
  • The ‘Unfettered Access Procedure’ which would enable MA holders in Northern Ireland to seek recognition in GB.

In addition, the MHRA has updated its post-transition guidance on, among other matters: (i) importing medicines into GB, (ii) pharmacovigilance procedures (in particular on the use of country codes and worldwide case IDs when submitting Individual Case Safety Reports (ICSRs)) and (iii) its intended approach for medicinal products approved or pending in the decentralised procedure (DCP) or mutual recognition procedure (MRP).

• UK-Canada interim agreement on Good Manufacturing Practice (GMP)
  On 5 January 2021, the MHRA and Veterinary Medicines Directorate (VMD) announced that they had entered into an interim agreement with the Regulatory Operations and Enforcement Branch of Health Canada. The Interim Agreement will permit ongoing mutual recognition of GMP certification and acceptance of batch testing certificates.