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EMA Guidance: XEVPRM – Electronic Submission of Medicinal Product Information
Accurate and structured medicinal product information is an important part of the regulatory and pharmacovigilance framework. Chapter 3.II: XEVPRM Detailed User Guidance provides detailed instructions for marketing authorisation holders (MAHs) on the electronic submission of information on medicinal products for human use to the European Medicines Agency through the XEVMPD. What is XEVPRM? XEVPRM stands for eXtended EudraVigilance Medicinal Product Report Message. It is the m
Sharan Murugan
3 hours ago3 min read