How marketing authorisation holders should inform MHRA of an ADR to a medicine, using the E2B messaging system.
Transition to new reporting arrangements
As announced by the European Medicines Agency (EMA), transitional reporting arrangements from MAHs to Member States will cease on the 22 November 2017.
From 23:59 on 21 November, you should no longer report ICSRs directly to MHRA, and should instead report ICSRs to the EMA. All serious UK reports will be rerouted to MHRA by the EMA.
As part of the EudraVigilance upgrade, EudraVigilance will be unavailable during a 10-day cutover period from 8 to 21 November 2017. MHRA will still be able to receive ICSRs during this cutover period, and requests that Marketing Authorisation Holders continue to submit ICSRs to us under the transitional reporting arrangements where systems allow.
During the downtime, if you report using a gateway solution then you should continue to report to MHRA, and we will continue to send acknowledgments for ICSRs received during this period. Any cases received during the downtime period will be transmitted to the EMA by MHRA following go live on the 22 November.
If you report ICSRs via EVWEB, then you will not be able to report to MHRA during the downtime. Reports that cannot be submitted electronically to the MHRA during the cutover period should be submitted electronically to the EMA during the designated ‘cutover legacy’ period from 22 November to 24 November 2017.
MHRA will stop sending ASPRs/ICSRs to Marketing Authorisation Holders from beginning of the downtime period on the 8 November 2017, since these will be made available to MAHs by the EMA when received post 22 November 2017.
After it goes live, MHRA will convert E2B R3 cases to E2B R2 for processing into the Sentinel database. MHRA will continue to transmit Adverse Drug Reaction (ADR) reports received directly from healthcare professionals and patients to the EMA. These reports will be made available for you to download in EudraVigilance.
Please note that separate guidance relating to SUSAR reporting during the cutover period has also been published.
Further details can be found in the EudraVigilance Go-Live Plan.
As you will no longer send ICSRs directly to MHRA, there is no longer the need to register to send ICSRs to MHRA. Additionally, as the EMA will be rerouting all UK ICSRs to MHRA, you are not required to test your gateway with MHRA.
Those wishing to report SUSARs to MHRA through eSUSAR are still required to register with the MHRA, and should do so by completing the E2B registration form and emailing this to ICSR.firstname.lastname@example.org.
The EU Medicines Directive 2001/83/EU applies to both the Channel Islands and the Isle of Man. In order to ensure that provisions under EU legislation are met, MHRA will request to receive ICSRs originating in the Crown Dependencies from the EMA. Likewise MHRA will request cases from EU based British Overseas Territories (Gibraltar), as EU legislation is generally considered to apply in this territory.
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
Literature report list
For a number of years, MHRA has published line listings of literature cases received online and encourages MAHs to check the list before submitting potentially duplicative articles. MHRA will cease to update this list after the 22 November 2017 as cases will have no longer received ICSRs directly from industry. Thewill remain published online for a limited time during the transitional period.
You can see MHRA’sfor help with searching through the list.
Email email@example.com if you have any queries on reporting new literature for ADRs.
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:
- Alex Smith, 020 3080 6769, email@example.com
If your query specifically relates to ASPRs email firstname.lastname@example.org
Or, if you’re unhappy with how your query is dealt with, contact the pharmacovigilance service coordinator, Christopher Penny, 0203 080 6511.