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The UK leaves the EU on Friday 31 January 2020. The UK will then enter a transition period from 1 February to 31 December 2020, while the UK and EU negotiate additional arrangements.
The UK will continue to stay aligned to EU law during the transition period.
The current rules on trade and business for the UK and EU will continue to apply during the transition period. This means you can operate as now throughout the transition period.
Therefore, our European Systems Contingency (ESC) plans will not be activated from 23:00 on Friday 31 January 2020.
Regulatory submissions and adverse events for the UK should continue to be submitted through the European systems until further notice.
Submission of Individual Case Safety Reports (ICSRs) should continue to follow existing reporting modalities outlined in EU legislation. You should not attempt to send ICSRs to the MHRA Gateway, or ICSR submissions portal during this period as they will not be processed. The MHRA will continue to receive relevant ICSRs via EU systems.
We will keep your registration details in the event these systems might be needed again in future. You will still be able to log into MHRA Submissions to manage administrators and users.
The submissions@mhra.gov.uk inbox will be closed from Monday 3 February 2020.
If you have any queries, please contact info@mhra.gov.uk.
We would like to take this opportunity to thank all our stakeholders for your engagement and co-operation in our preparations for no-deal.
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