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February 3, 2021 at 11:40 pm #email@example.comParticipant
Having set up ICSR submission configuration for an MAH, I would like some guidance regarding downloading ASPRs from ICSR submission portal. ICSR submission had been configured for over a week, yet the appointed PV person has not yet received any ASPR/ICSR for the MP.
Has anybody had this issue? For those who have had ASPRs sent to you, could you please provide guidance to how it was achieved?
Please see below for reference:
ASPRs will only be sent to one endpoint per organisation. If you are submitting solely via ICSR Submissions, you will receive ASPRs via ICSR Submissions. If you are normally submitting via the Gateway but then submit via ICSR Submissions, for example, because of business continuity during systems failure, you will receive ASPRs via the Gateway’.
Thank you.February 4, 2021 at 5:45 pm #42278Emma BoultonParticipant
Thank you for your query.
Please note that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.
There were delays at the beginning of January, but it has been noted that companies have started to regularly receive ASPRs either via the gateway or portal now.
At the last webinar from the MHRA (13 Jan 2021) it was stated that where companies had registered for both portal and gateway ASPRs would only be sent via one route a dual registration may cause some issues, but this was being worked on by the MHRA and is now resolved.
There is a question in the FAQ section on the MHRA portal on downloading of ASPRs. Additionally, there is a planned update of the MHRA SSL certificates which may have an impact on transmission of cases between parties. You can find the announcement and relevant links in the announcement section of the MHRA portal.
Similar to the EMA, the MHRA has committed to posting downtimes and business continuity plans on the portal. These would be in the announcements; you can subscribe to these announcements in you profile settings.
If you continue to have concerns or issues we suggest that you raise a support ticket in the help and support section of the MHRA portal front page.
We do hope that the above answers your query.
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