XEVMPD Pharmaceutical Data Submission Obligation
EU Regulation No 1235/2010 amended the data submission obligations of the marketing authorization holder (MAH) regarding medicinal products. The MAH is required to electronically upload the requested data to the European Medicines Agency's (EMA) EUDRAVIGILANCE portal. This data forms the basis of the XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) maintained by the EMA, which is closely linked to the EU's pharmacovigilance and adverse reaction reporting systems.
Registration and Training
To perform the upload, the MAH must register with EUDRAVIGILANCE. Access for uploading data is granted only to users who have completed EMA training and passed the associated exam. Details on training dates and venues are available on the EUDRAVIGILANCE website. Training sessions are organized by the Drug Information Association; the registration fee is EUR 1,550.
Data Submission
Data must be uploaded in structured XML format together with mandatory attachments, for each strength of the product. Most of the information must be coded in accordance with EMA and MedDRA databases (e.g., indications for use, active substances and their quantities, excipients, pharmaceutical forms, chemical therapy). The MAH is responsible for keeping the data updated and current.
The MedDRA license required for uploading XEVMPD data can be obtained via MSSO.
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