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Read our story ↗XEVMPD (Article 57)
XEVMPD is a European Medicines Agency software that collects structured information on authorised and development medicinal products, all to assist pharmacovigilance signal detection. Submissions have been mandatory since 2 July 2012, by which date all marketing authorisation holders were required to submit information on every product for which they hold marketing authorisations in the European Economic Area. Our members have been certified EudraVigilance XEVMPD trainers for the European Medicines Agency since 2011.
Meet your ongoing submission deadlines
Since 2 July 2012, marketing authorisation holders must submit information on any newly authorised medicinal product within 15 calendar days, and information on modifications to the terms of the marketing authorisation within 30 calendar days. We help you keep these submissions accurate and on time. In 2014, XEVMPD was extended to capture two further fields: the legal status of the marketing authorisation and the medicinal product type.
Verify the transfer of your data to PMS
XEVMPD is now preparing its data to be transferred to its successor, Product Management Services (PMS). Once information is extracted into PMS, marketing authorisation holders need to check that the synchronisation is correct - and, where it is not, raise service desk tickets. We help you verify the transfer and resolve any discrepancies.
Obtain the right roles and training
We assist you in obtaining the proper roles for both XEVMPD and PMS, and provide training for XEVMPD submissions drawing on our EMA-certified experience.
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