How marketing authorisation holders should inform the MHRA of a signal or an ADR to a medicine.
Marketing authorisation holders (MAHs) must send all UK ICSRs and serious non-UK ICSRs directly to the 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 the MHRA.
The 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 the MHRA are required to register with the MHRA and should do so by following the guidance.
E2B R2 Validation rules
Follow these rules when sending ICSRs to MHRA as well as those on the ICH website.
|A1.1||primarysourcecountry||Mandatory field for each case|
|A.2.1.4||qualification||At least one required for each case|
|B1.2.2a||patientonsetage||Age cannot be greater than 120 years|
|B.1.3||patientweight||Not to be greater than 500kg|
|B.1.4||patientheight||Not to be greater than 300 cm|
|B.1.7.1c||patientmedicalstartdate||Date is not greater than the transmission date|
|B.1.7.1f||patientmedicalstartdate||Date is not greater than the transmission date|
|B.1.8c||patientdrugstartdate||Date is not greater than the transmission date|
|B.1.8e||patientdrugstartdate||Date is not greater than the transmission date|
|B.2.i.8||reactionoutcome||All outcomes should be populated. If the outcome is unknown this field should be populated with ‘unknown’ and not left blank|
|B.3.1b||testdate||Date is not greater than the transmission date|
|N/A||all dates||All dates must be less than today’s date – future dates will be rejected|
|B.2.i.4b||reactionstartdate||The reaction start date must be greater than the suspect drug start dates|
|B.4.k.7||drugdosageform||The pharmaceutical form can be reported using both the text and code format*|
|B.4.k.18.1b||drugreactionassess||the MeDRA code used should match the ‘reactionmeddrallt’ field|
|All numerical fields||-||The unit field must be completed for every numerical field. For eg both dosage fields must be completed.|
*The terms / codes will need to be selected from the
The MHRA will not publish a literature monitoring list, instead MAHs will be responsible for conducting relevant literature searches and sending these to the MHRA. These should include reports received from the EMA Medical Literature Monitoring (MLM) service. Email email@example.com if you have any queries on reporting new literature for ADRs.
A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. The 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 the MHRA (firstname.lastname@example.org).
When a MAH becomes aware of an emerging safety issue, they should notify it in writing to the MHRA (email@example.com). For guidance on emerging safety issues, see GVP IX.
Email E2B.firstname.lastname@example.org 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 email@example.com.
Or, if you’re unhappy with how your query is dealt with, contact the pharmacovigilance service coordinator, Faiza Farooq, 0203 080 6312.