EudraVigilance: Updated Electronic Reporting

On 15 February 2022 the EMA announced an update to electronic reporting in EudraVigilance.

As of February 2022, the test environment (XCOMP) will no longer accept the ICH E2B (R2) message format. Instead, users need to report ICSRs using the ISO ICSR/ICH E2B(R3) format and related ISO standard terminology for pharmaceutical form and route of administration.

This change supports the ISO ICSR/ICHE2B(R3) format and related terminology which will be mandatory on 30 June 2022.

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