The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the 2010 pharmacovigilance legislation.
Pharmaceutical companies can use in-house tools to initiate the electronic submission of information on medicinal products in full compliance with the agreed and mandatory format.. Electronic submissions of eXtended EudraVigilance Medicinal Product Report Messages (XEVPRMs) should be performed via the EudraVigilance Gateway to the Agency.
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Pharmaceutical companies can use the XEVMPD data entry tool (EVWEB) provided by the Agency; this was specifically developed for Small and Medium Sized Enterprises (SMEs) but can be made available to any pharmaceutical company for the purpose of electronic submission of information on medicinal products to the Agency.
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