Europe – Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Submission of substance information

As previously communicated, in the context of improvement of the XEVMPD Substance Controlled Vocabulary data quality, the XEVMPD business rules have been revised to reject any operation type related to submission of approved and development substances.

This implies that any XEVPRM messages containing operation type ‘Insert (1)’, ‘Update (2)’ or ‘Nullification (4)’ of an approved or development substance will be rejected, and will generate a negative XEVPRM acknowledgement.

Providing that an approved substance is not listed in the XEVMPD substance controlled vocabulary list (sheets 1_Substance CV and 4b_ Invalid substance names) available in the ‘Controlled Vocabularies’ section of the Data submission on authorised medicines – Guidance documents webpage, or in the XEVMPD substance look-up table MAHs should submit their substance requests or any substance related enquiries to the EMA Service Desk (https://servicedesk.ema.europa.eu/).

Guidance on how to handle approved substance names is included in the ‘EMA Substance names best practice’ document published in section « Data Quality-control methodology » on the Agency’s website.