The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on Oct. 6 told medical device manufacturers that beginning next month they must send post-market vigilance reports via the MHRA’s “new” Manufacturer's On-line Reporting Environment (MORE) portal.
But beginning on Nov. 21, “reports relating to adverse incidents for devices to the MHRA must be submitted via the new MORE portal or via our custom Application Programming Interface (API) for direct submission from your internal systems,” the agency tells firms.
The MHRA has not provided many details about its new portal.
And here’s a catch: even if they already have a MORE account, manufacturers must nevertheless create a new account to use the “new” MORE portal and/or the API. Firms can start making new accounts beginning on Oct. 13. The MHRA says it will provide a link and instructions on creating an account soon, to be posted on this page.
The agency stresses that on Nov. 21, companies “will no longer be able to submit reports via the old MORE portal.” Further, firms “will have read-only access and will be able to download existing reports” only through April 30.
And the MHRA warns: “If you currently hold an account on MORE, we are not migrating any of your data to your new MORE account. We recommend that you download any historical reports from your old MORE account, as these will not be available in your account after 30 April 2023. Any draft reports in your old account will need to be recreated in your new MORE account for submission.”
The agency also points out that reports sent to the AICxml@mhra.gov.uk address will not be visible on new MORE accounts.
“The AICxml@mhra.gov.uk mailbox will still be available for submissions until 30 April 2023 to allow you to transition your processes to the new submission routes,” the MHRA says. “We recommend you register to use the new routes of submission as soon as possible. After 30 April 2023, any reports received via this mailbox will not be accepted.”
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