Detailed Guidance on the Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorization Holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004

On 14 September 2021 the EMA updated the extended EudraVigilance Medicinal Product Report Message (XEVPRM) user guidance.

This document provides user guidance on:

  • the data elements to be completed for the electronic submission of information on medicinal products for human use authorized in the European Economic Area (EEA) using the XEVPRM;
  • the maintenance of medicinal product data previously submitted.
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