Send and receive information on adverse drug reactions (ADRs)

How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.

Marketing authorisation holders (MAHs) must send all UK individual case safety reports (ICSRs) and serious non-UK ICSRs directly to MHRA via either ICSR Submissions or Gateway.

For cases in respect to Northern Ireland, use the country code XI to send ICSRs to MHRA.

MHRA accepts E2B R2 and R3 format XMLs and will convert E2B R3 cases to E2B R2 for processing into the database. MHRA will transmit Adverse Drug Reaction (ADR) reports received directly to the relevant MAH. This will be decided using the suspect drug in the report.

Those wishing to report to MHRA need to register with MHRA. Follow the guidance on registering to make submissions to MHRA.

We are replacing our legacy IT systems, including a new adverse incident database. The new system will be deployed over the weekend of 25 and 26 May 2024 and will be live from Tuesday 28 May 2024. Any files received after 6am on Friday 24 May 2024 will be queued and loaded into our new database and will receive acknowledgements in the E2B R3 format.

R3 standard compliant systems: what’s changing for vigilance reporting for MAHs?

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

While the database will be based on the R3 standard, our new system will be able to convert R2 standard XMLs into the R3 standard for ingestion. After go-live of our new systems we will continue to accept ICSRs in both R2 and R3 standards.

All XML files sent from MHRA will be in the R3 standard format. This includes both ASPRs and acknowledgements. It is important that your systems and/or procedures can receive and manage files in the R3 standard effectively as our new systems will not be able to send R2 files. ​

No updates are necessary to the sender or receiver ID in XMLs. The MHRA receiver ID will continue to be MHRAUK.​