Transmitting R2 ICSR Reports to MHRA and Importing R3 Acknowledgments in Argus Safety (Doc ID 2986383.1)

Last updated on JUNE 07, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.3.1 and later
Information in this document applies to any platform.

Goal

The Medicines and Healthcare Products Regulatory Agency (MHRA) is replacing their legacy IT systems, including a new adverse incident database. The new system will be live from Tuesday 28th May, 2024. Please refer to the 'New MHRA systems' sections in this link for details.

The new MHRA database is compliant with the ICH ICSR R3 standard and conforms with EU implementation guidance.

After go-live of their new systems, the MHRA will continue to accept ICSRs in both R2 and R3 formats. Any files received after 6 AM GMT on Friday 24th May, 2024 will receive acknowledgements in the R3 format.

Customers making E2B submissions to the MHRA in R2 format will receive Acknowledgements in R3 format.

Are any changes required in Argus Safety to facilitate the transmission of R2 ICSR reports and importing R3 Acknowledgements from the MHRA?

Solution

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In this Document

Goal

Solution

References

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Transmitting R2 ICSR Reports to MHRA and Importing R3 Acknowledgments in Argus Safety (Doc ID 2986383.1)

Applies to:

Goal

Solution

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!