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Streamlining Incident Reporting: Transitioning to a New System for Vigilance Submissions MORE MHRA

As of 24th April 2023, the MHRA has provided an update regarding the submission of vigilance reports. They have extended the acceptance of vigilance reports submitted by email until 31st August 2023. This update supersedes the previous statement from the MHRA, which indicated that email submissions would no longer be accepted after 30th April 2023. This additional timeframe allows companies some extra time to create their new account in the MORE vigilance reporting platform.

The MHRA announced “Changes to the Incident reporting system”.

Current Process

Incident reports can be submitted:

  1. Through the MHRA’s Manufacturer’s On-line Reporting Environment (MORE) portal; or

  2. by emailing an XML output of the Manufacturer Incident Report (MIR) form to the MHRA.

New Process

Starting 21 November 2022, incidents must be submitted:

  1. Through the new version of the MHRA’s MORE portal, which allows upload of an xml report or submission via the portal’s webform; or

  2. via the MHRA’s new Application Programming Interface (API) for direct submission from the submitter’s internal system.

Anyone interested in option two (API connector) should contact the MHRA directly to establish this process.

Due date:

Improved version:

Effective from the specified date mentioned above, the older version of the MORE portal will no longer support the submission of new incident reports.

Please note that the old MORE system will retain access to previous reports only until 30th April 2023. Manufacturers are advised to download any necessary records from the old system before April 2023.

It is important to be aware that the MHRA will not transfer any data from the old system to the new system. Therefore, any draft reports that have been saved in the old system must be recreated in the new system.

To facilitate a seamless transition process, the MHRA has implemented a temporary measure allowing incident reports to be submitted via email until 30th April 2023. However, it is crucial to note that after this date, the designated mailbox will no longer accept any submissions. Instead, industry professionals are required to adhere to the new practice outlined for incident reporting. It's important to be aware that any incident reports submitted via email during this interim period will not be visible in your new MORE account.

Contact us as UKRP to help you with nte new MORE registration!

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