MHRA Gateway configuration

Dear Colleagues

Our company is in the process of testing the MHRA Gateway configuration and require the MHRA to respond to us in order to ensure that in the non production environment that the Gateway will be able to function with our system at the beginning of January. Despite various emails having been sent to the MHRA, we have not received a response and without their support, it is difficult to know as to whether we will be able to submit the cases through the Gateway from 01 Jan 2021. Have any other members had the same experience where the MHRA is not responding to requests regarding configuration?

If configuration has not been completed by 01 Jan 2021, is there an alternative way of submitting the reports to the MHRA?

Thank you for your enquiry. It seems other companies may be facing the same issue which may be due to the high demands at this time. If you had not previously registered to send ICSRs/SUSARs directly to the MHRA prior to November 2017 and have followed the MHRA registration process to register your company Routing ID and configuration set up, the MHRA should email back once they have performed their manual review. We suggest you contact the MHRA via the phone line if contacting them via email has been unsuccessful. The guidance page at the link below provides contact details and useful information for companies.

https://www.gov.uk/guidance/registering-to-make-submissions-to-the-mhra-from-1-january-2021

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