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Latest Brexit guidance and updates from the MHRA

Latest Brexit guidance and updates from the MHRA

The MHRA is making preparations to ensure that Sponsors or their delegates can continue to submit regulatory and notification information to the UK after 1 January 2021. Submissions and applications will need to be submitted to the MHRA regulatory centre via the portal ‘MHRA Submissions’.

For applications to be submitted to both the EU and the UK, the information will need to be submitted separately through EU systems and the MHRA portals. These changes will impact:

  • all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
  • all medicines clinical trial sponsors wishing to make clinical trial submissions (Initial Applications, Substantial Amendments, End of Trial Notifications and Developmental Safety Update Reports (DSURs)) to the MHRA
  • brokers of medicinal products
  • e-cigarette producers

Gaining access to MHRA Submissions

The MHRA is encouraging companies to register and gain access to the MHRA Submissions portal as early as possible to ensure submissions are possible from day one.

The registration process is now open and User Reference Guides and training videos on how to register and gain access to the MHRA Submissions portal can be found on the MHRA Submissions page

Registering to use the vigilance systems: MHRA Gateway and ICSR Submissions

Pharmaceutical companies involved in the submission of individual case safety reports (ICSRs) or unexpected serious adverse reactions (SUSARS) will be required to submit these to the new MHRA Gateway, using the systems described above.

All current Eudravigilance Gateway users who wish to gain access to the new MHRA Gateway will need to first gain access to MHRA Submissions. Once registration for MHRA Submissions is complete, MHRA Submissions company administrators can register to send both ICSRs or SUSARs via the MHRA Gateway.

The MHRA Submissions page again provides access to related User Reference Guides and video demos.

Boyds’ regulatory team will contact clients with an update on implications on these new systems. To speak to a member of the team, click here.