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EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD

XEVMPD stands for Extended EudraVigilance Medicinal Product Dictionary. It is a database developed by the European Medicines Agency (EMA) to facilitate the exchange of information on medicinal products for human use within the European Economic Area (EEA).

The database contains detailed information on medicinal products authorized in the EEA, including their composition, packaging, indications, and marketing authorization status.

This guidance aims to offer comprehensive business guidance to users from sponsor organizations registered with the European Medicines Agency (EMA) regarding the submission of medicinal product information in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).

This guidance outlines the inclusion requirements for each XEVPRM data element associated with an unauthorised medicinal product, known in the XEVMD as a 'development medicinal product' (DMP). In Short, this guidance  aims to improve the efficiency and accuracy of data collection and reporting for investigational medicinal products.

Investigational Medicinal Product information (IMP) is defined as "a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form."

Type of data that can be submitted by sponsors to the XEVMPD

Sponsors can use an XEVPRM to submit the following types of data to the XEVMPD:

  • Development product entities

  • Sponsor organisation entities

  • ATC Codes (development)

  • Pharmaceutical form entities (development )

  • Routes of administration entities (development )

  • Attachments

  • Pharmacovigilance Master File Locations (PSMFLs), however, these are not applicable for development product submissions.

You can find more additional details reslated to the Pre-submission requirements, Initial submissions, Maintenance of medicinal product information, and many more by clicking this LINK.


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