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MHRA to change method of reporting adverse events

By August 19, 2022No Comments

On 18 August, MHRA held a webinar to explain what changes are coming in how adverse events vigilance reports should be submitted.

The current MORE reporting system is being updated to a new MORE system. This means that adverse event reports must be submitted using this new system from November 2022 or via MHRA’s custom API for direct submission through your internal organisation system.

You can submit reports by:

  • Uploading xml reports
  • Manual input and submission by the web form
  • Application programming interface set up between your IT system and MHRA’s IT system

To access the new MORE system, individuals must register. A lead person will need to be appointed to submit the first registration for an organisation, with future individuals linking into that account. The organisation information is linked to what is inputted during device registration.

The aicxml@gov.uk email mailbox will still be available until April 2023, but organisations are encouraged to switch to the new MORE system as soon as it goes live.

Importantly, existing information will not be migrated to the new MORE system. If you would like to keep historical reports, you are encouraged to access the current system and extract it.

Natalie Creaney

About Natalie Creaney