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Introduction
This document provides user guidance on:
• The data elements to be completed for the electronic submission of information on medicinal
products for human use authorised in the European Union using the eXtended EudraVigilance
Medicinal Product Report Message (XEVPRM);
• The maintenance of medicinal product data previously submitted.
The data elements for medicinal products are based on the following reference information:
• Summary of Product Characteristics (SmPC), which serves the purpose of validation of the
information provided in the structured data elements
− Section 1. Name of the medicinal product
− Section 2. Qualitative and quantitative composition
− Section 3. Pharmaceutical Form
− Section 4.1 Therapeutic indications
− Section 4.2 Posology and method of administration
− Section 5.1 Pharmacodynamic properties
− Section 6.1 List of excipients
− Section 6.5 Nature and contents of container
− Section 7. Marketing Authorisation Holder
− Section 8. Marketing Authorisation Number
− Section 9. Date of first authorisation/renewal of the authorisation
− Section 10. Date of revision of the text
• Medicinal product authorisation information (as referred to in the Legal Notice on the
Implementation of Article 57(2) of Regulation (EC) No. 726/2004 published by the Agency)
• Pharmacovigilance information (as referred to in the Legal Notice on the Implementation of Article
57(2) of Regulation (EC) No. 726/2004 published by the Agency)
All medicinal product names/Marketing Authorisation Holder names used in this document
are fictitious and were created for the purposes of being used as examples in this User
Guidance.
Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 10/163