The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance for all pharmaceutical companies involved in the submission of Individual Case Safety Reports (ICSRs) or Suspected Unexpected Serious Adverse Reactions (SUSARs) in the event of a no-deal Brexit.
The MHRA recommends that companies watch two short video demonstrations which cover the MHRA Gateway registration process and the ICSR Submissions registration process. The videos aim to help organisations register to send and receive ICSRs/SUSARs via the MHRA Gateway or ICSR Submissions. The MHRA have also released two user reference guides, which contain step by step guidance on registering for ICSR Submissions and the MHRA Gateway.
Once registration for the MHRA Gateway has been completed, the MHRA Submissions company administrators can register to send both ICSRs or SUSARs via the MHRA Gateway by selecting the ‘Gateway Management’ title. The MHRA aims to complete the registration within 5 working days of receipt of the registration request. The MHRA encourages companies to perform a connectivity test in UAT once registration has been completed. When sending ICSRs and SUSARs via the MHRA Gateway, the sender will receive an acknowledgement within 48 hours. If you submit ICSRs or SUSARs to the MHRA via the MHRA Gateway, you will also receive serious and non-serious United Kingdom (UK) reports from the MHRA via the MHRA Gateway.
If your company does not have the capability to send or receive via the MHRA Gateway, then ICSRs or SUSARs can be sent to the MHRA via ICSR Submissions. The MHRA has stated that in order to register for ICSR Submissions, companies should visit the ICSR Submissions, select the ‘Request company account’ option, and follow the process which is detailed in the user reference guide. If a company submits ICSRs or SUSARs to the MHRA via ICSR Submissions, they will also receive serious and non-serious UK reports from the MHRA via ICSR Submissions.
If you have any queries regarding the ICSR/SUSR process, then MHRA have requested you email E2B.email@example.com.
If you have any queries about setting up the gateway company administrator on MHRA Submissions, the MHRA have suggested you email firstname.lastname@example.org.
To read more on registering to use the vigilance systems: MHRA Gateway and ICSR Submissions, please click here.