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Change to MHRA eSUSAR Reporting process

Date: 28 July 2022

Please be advised that the eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September 2022 and only SUSARS via the Individual Case Safety Reports (ICSR) Submissions portal route will be accepted from 01 October 2022. Attempts to submit SUSARs via the eSUSAR website after this date will not be received by the MHRA and your reporting obligations as required by UK SI 2004/1031 (as amended) will not be met.

With ICSR Submissions you will receive acknowledgement that the MHRA has received your report. You will have access to live submissions status giving you visibility of your reports. You will also benefit from the data validation checks within ICSR Submissions portal, which will help you with submitting ICH E2B compliant data.

To avoid being in breach of regulatory requirements please see guidance below to assist you with preparing for this change.

If as an organisation you use both eSUSAR and ICSR Submissions for reporting SUSARs to the MHRA then you should only use ICSR Submissions going forward. Please ensure that all of your eSUSAR users are informed of this requirement and your internal processes updated accordingly.

If you only use the eSUSAR website to submit reports you are required to register and begin submitting SUSARs via ICSR Submissions which allows time for any issues to be addressed, internal processes to be developed and training to be completed within your organisation ahead of the deadline of the end of September. Please see the guidance here for further information on the sign-up process. Please note that we are no longer processing new request for eSUSAR accounts; new users are required to register with ICSR submissions instead.

Please contact us via ICSRtesting@mhra.gov.uk if you require further assistance.

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