In an update to their guidance on pharmacovigilance procedures post-Brexit transition, the Medicines and Healthcare products Regulatory Agency (MHRA) has added content covering country codes for Individual Case Safety Report (ICSR) submissions.
From 01 January 2021, the MHRA will require submission of all UK, including Northern Ireland (NI), ICSRs (serious and non-serious) and serious ICSRs from other countries via the new MHRA Gateway or ICSR Submissions portal. Registration for the Gateway or Portal should be made as early as possible to enable system configuration in preparation for the cutover (11pm 31 December 2020).
For products placed on the market in NI, marketing authorisation holders (MAHs) will need to submit ICSRs according to the EudraVigilance database, including all serious reports from the UK and other countries and non-serious reports that occur in the EEA or NI. These cases should be identified by using the country code “XI” in the field primary source country for regulatory purposes. Organisations will have the option to use the either the country code “XI” or “GB” as the first two characters of the worldwide case ID and the safety report ID.
The EMA is due to provide further information on the technical changes required when reporting to EudraVigilance shortly.
For UK cases that relate to NI which were initially submitted before 01 January 2021, the worldwide case ID should not be changed, however, in line with GVP module VI, organisations can change the safety report case ID if needed for follow-up reports.
The country code “GB” should be used for all reportable suspected unexpected serious adverse reactions (SUSARs) occurring in the UK. It will not be a requirement for organisations to use “XI” for SUSAR reporting, as reporting requirements between NI and the rest of the UK for clinical trial cases will not differ.
The added content can be found in section 2.2 of the updated guidance, accessible here.