GovWire

Reporting arrangements

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 the country code XI should be used 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 relevant MAH. This will be decided using the suspect drug in the report.

Those wishing to report to MHRA need to register with MHRA and should do so by following the guidance on registering to make submissions to MHRA.

A list of reports received via the EMA from 28 December to 31 December (MS Excel Spreadsheet, 105 KB)

New MHRA systems

We are replacing our legacy IT systems, including a new adverse incident database. Our new system will be deployed over the weekend of 11 and 12 May 2024 and will be live from Monday 13 May 2024. Any files received after Thursday 11.59pm on 9 May 2024 will be queued and loaded into our new database and will receive acknowledgements in the E2B R3 format.

R3 standard compliant systems: whats 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.?

There will not be a transition period between databases. Any ICSRs sent before 23.59pm on Thursday 9 May 2024 will be acknowledged in R2. Any sent after will be acknowledged in R3.

MHRA gateway users

The gateway will continue to accept R2 and R3 XMLs both for ICSRs and acknowledgements.

You do not need to make any changes to your application programming interface (API) connection to our systems. You do not need to inform us that your organisation is R3 ready.

ASPRs will be sent as individual files rather than in batches.

No testing is required. However, if you wish to test the system it is now available to do so.

As with production, no changes are necessary for using the test environment to either the API or to the sender/receiver ID.The test receiver ID continues to be MHRAUKTEST.

If you would like to receive an R3 ASPR via the gateway, contact david.sullivan@mhra.gov.uk.

ICSR submissions portal users

The portal will continue to accept R2 and R3 XMLs via Post XML.

Portal users will be able to create new reports using either the R2 or R3 form.

Acknowledgements and ASPRs sent from MHRA will be in the R3 format.

Portal users will continue to be able to download ASPRs as a PDF file, but these will now be in the R3 standard.

Literature monitoring

We will not publish a literature monitoring list. Instead, MAHs will be responsible for conducting relevant literature searches and sending these to MHRA. These should include reports received from the EMA Medical Literature Monitoring (MLM) service. Email vigilanceservice@mhra.gov.uk if you have any queries on reporting new literature for ADRs.

Signals

A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. MHRA is responsible for detecting and managing safety signals in regards to UK products.

In line with GVP IX requirements, standalone notifications of signals should be sent to signalmanagement@mhra.gov.uk.

Standalone signal notification form (MS Word Document, 132 KB)

When an MAH becomes aware of an emerging safety issue, they should notify it in writing to MHRA (signalmanagement@mhra.gov.uk). For guidance on emerging safety issues, see GVP IX.

Contact

Email E2B.support@mhra.gov.uk with technical queries or to escalate an E2B issue you can speak to a member of the E2B team:

• David Sullivan, David.Sullivan@mhra.gov.uk

If your query specifically relates to ASPRs email vigilanceservice@mhra.gov.uk.

Or, if youre unhappy with how your query is dealt with, contact the pharmacovigilance service coordinator, Faiza Farooq, 0203 080 6312.