{"id":5589,"date":"2022-10-11T15:57:24","date_gmt":"2022-10-11T20:57:24","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=5589"},"modified":"2023-04-28T16:07:26","modified_gmt":"2023-04-28T21:07:26","slug":"uk-mhra-new-vigilance-process","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/uk-mhra-new-vigilance-process\/","title":{"rendered":"UK MHRA Updates Vigilance Reporting Process"},"content":{"rendered":"
[vc_row][vc_column width=”1\/6″][\/vc_column][vc_column width=”2\/3″][vc_empty_space height=”22″][vc_message message_box_style=”outline” message_box_color=”black” icon_fontawesome=”fas fa-exclamation”]On 24 April 2023 the MHRA stated it would continue to accept vigilance submitted by email until 31 August 2023. This is an update from the below statement from the MHRA, which stated they would no longer accept vigilance submitted by email after 30 April 2023. So companies have a little more time to create their new account in the MORE vigilance reporting platform.\u00a0<\/span>[\/vc_message][vc_column_text] <\/p>\n The MHRA announced \u201cChanges to the Incident reporting system\u201d, available:<\/span> HERE<\/a><\/strong><\/p>\n Incident reports can be submitted:<\/span><\/p>\n 1) Through the MHRA\u2019s Manufacturer’s On-line Reporting Environment (MORE) portal; or<\/span><\/p>\n 2) by emailing an XML output of th<\/span>e Manufacturer Incident Report (MIR) form<\/a> to the MHRA.<\/span><\/p>\n Starting 21 November 2022, incidents must be submitted:<\/span><\/p>\n 1) Through the new version of the MHRA\u2019s MORE portal, which allows upload of an xml report or submission via the portal’s webform; or<\/span><\/p>\n 2) via the MHRA\u2019s new Application Programming Interface (API) for direct submission from the submitter’s internal system.<\/span><\/p>\n Anyone interested in option two (API connector) should contact the MHRA directly to establish this process.<\/span><\/p>\n The old version of the MORE portal will not accept new incident report submissions after the above date.<\/span><\/p>\n Previous reports remain available in the old MORE system only until 30 April 2023. i.e., manufacturers should ensure to download those records by April 2023, if needed.<\/span><\/p>\n The MHRA has advised that they will not migrate any data from the old system. This means that any draft reports saved in the old system, must be re-created in the new system.<\/span><\/p>\n To help with a smoother transition process, the MHRA will allow incident reports to be emailed until 30 April 2023. After that time, the mailbox will no longer accept submissions. Instead, industry must follow the new practice. Note that any emailed incident reports will not appear in your new MORE account.<\/span><\/p>\n The MHRA published a webinar on the new process if of interest, located:<\/span> HERE<\/a><\/strong><\/p>\nCurrent Process<\/strong><\/span><\/h5>\n
New Process <\/strong><\/span><\/h5>\n
Important Notes<\/strong><\/span><\/h5>\n
Next Steps<\/strong><\/span><\/h5>\n