Brexit-related changes (Enhancement 32359983)

ICSR Reporting to MHRA -Post Brexit

Regulation updates published by EMA and MHRA effective from January 2021 for the implementation of the Protocol on Ireland/Northern Ireland have the following information regarding the ICSR submission:

1. Serious and Non-serious adverse reactions occurring in Great Britain, and Serious adverse reactions occurring from other countries must be submitted to MHRA.
2. For UK ICSRs that have not been previously submitted directly to the MHRA, the system schedules a downgrade or nullification report to the MHRA, and also to Eudra Vigilance.
3. Serious and Non-serious ICSRs for Northern Ireland must continue to be submitted to EudraVigilance and MHRA. A new ISO Country code is introduced specifically for Northern Ireland.
4. Non-serious adverse reactions occurring in the Great Britain [GB (England, Scotland and Wales)] are no longer submitted to EudraVigilance after the withdrawal date.
5. Follow-up reports (including nullifications) received for GB non-serious ADRs received prior to the withdrawal date, should continue to be submitted to EudraVigilance using country code GB.

Code List Updates

A new country, NORTHERN IRELAND, is included in the country code list and EEA flexible code list attribute is updated to include NORTHERN IRELAND as part of EEA.

EEA flexible code list attribute is updated to remove "United Kingdom" from the EEA Countries.

Interchange Updates

1. Import and Export Mapping Logic are updated for EMA R2 and R3 Profile for country code "XI".

   Profile	Elements for Export	Elements for Import
   ICH-ICSR V2.1 MESSAGE TEMPLATE –EMA	REPORTERCOUNTRY [A.2.1.3] PRIMARYSOURCECOUNTRY [A.1.1] OCCURCOUNTRY [A.1.2] SENDERCOUNTRYCODE [A.3.1.4e] RECEIVERCOUNTRYCODE [A.3.2.3e] OBTAINDRUGCOUNTRY [B.4.k.2.3] DRUGAUTHORIZATIONCOUNTRY [B.4.k.4.2]	REPORTERCOUNTRY [A.2.1.3 ] OCCURCOUNTRY [A.1.2] OBTAINDRUGCOUNTRY [B.4.k.2.3] DRUGAUTHORIZATIONCOUNTRY [B.4.k.4.2]
   ICH-ICSR V3.0 MESSAGE TEMPLATE –EMA	REPORTERCOUNTRYR3 [C.2.r.3] DRUGAUTHORIZATIONCOUNTRY [G.k.3.2] OBTAINDRUGCOUNTRY [G.k.2.4] REACTIONOCCURCOUNTRY [E.i.9]	REPORTERCOUNTRYR3 [C.2.r.3] SENDERCOUNTRYCODE [C.3.4.5] STUDYREGCOUNTRY [C.5.1.r.2] REACTIONOCCURCOUNTRY [E.i.9] OBTAINDRUGCOUNTRY [G.k.2.4 ] DRUGAUTHORIZATIONCOUNTRY [G.k.3.2]

2. Allowed value are updated for EMA R2 and R3 Profile with new country code "XI" for the following elements:

   Profile	Elements
   ICH-ICSR V2.1 MESSAGE TEMPLATE - EMA	DRUGAUTHORIZATIONCOUNTRY [B.4.k.4.2] OBTAINDRUGCOUNTRY [B.4.k.2.3] OCCURCOUNTRY [A.1.2] PRIMARYSOURCECOUNTRY [A.1.1] RECEIVERCOUNTRYCODE [A.3.2.3e] REPORTERCOUNTRY [A.2.1.3] SENDERCOUNTRYCODE [A.3.1.4e]
   ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA	DRUGAUTHORIZATIONCOUNTRY [G.k.3.2] OBTAINDRUGCOUNTRY [G.k.2.4] REACTIONOCCURCOUNTRY [E.i.9] REPORTERCOUNTRYR3 [C.2.r.3] SENDERCOUNTRYCODE [C.3.4.5] STUDYREGCOUNTRY [C.5.1.r.2]

For more information on mappings refer to the following mapping documents:

E2B R2	E2B R3
Import : ArgusInterchange823_E2B (R2) Import Mappings.xlsx Export: ArgusInterchange823_E2B (R2) 2.1 Export Mappings.xlsx	Import: ArgusInterchange823_E2B (R3) Import Mappings.xlsx Export: ArgusInterchange823_E2B (R3) Export Mappings.xlsx