EMA Issues Tool to Facilitate Data Submission

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 11-11-2014 13:35


The European Medicines Agency (EMA) has made available a new tool to facilitate editing of key data fields by marketing-authorization holders as part of the maintenance of information on authorized medicines that they have submitted to the EMA.

This tool is available to users of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB). A user manual explaining how to use this tool has been published.

As announced in January and June 2014, marketing-authorization holders are required to complete previously submitted information on medicines with additional data elements that are included in the new data-submission format by the end of 2014. Companies are also required to bring medicine information up to date and to check that the quality of the information is in line with the updated reporting requirements. This process has to be completed by December 31, 2014.

In line with Article 57(2) of the 2010 pharmacovigilance legislation, holders of marketing authorizations must submit information to he EMA on all medicines authorized for use in the European Economic Area (EEA) and keep this information up to date. The EMA says the database will support pharmacovigilance data analysis, facilitate follow-up of regulatory actions and monitoring of legal obligations, and strengthen communication with the EMA's stakeholders and partners. By streamlining the identification of products relevant to pharmacovigilance procedures, the database is expected to simplify adverse-reaction reporting for marketing-authorization holders and ensure that fees are calculated accurately.

Source: European Medicines Agency


Thank you for reading DCAT Value Chain Insights (VCI), an information resource from the
Drug, Chemical & Associated Technologies Association (DCAT). 

Learn more and sign up to receive a complimentary subscription