Regulatory information – New tool for companies to facilitate maintenance of information on authorised medicines

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10/11/2014

Regulatory information – New tool for companies to facilitate maintenance of information on authorised medicines

Information on medicines must be updated by end of December 2014

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

Companies are reminded that they need to complete this process by 31 December 2014.

For user convenience, a direct link to full details on the data-submission requirements is now available on the homepage of this website (see ‘Data submission for medicines’).

In line with Article 57(2) of the 2010 pharmacovigilance legislation, holders of marketing authorisations must submit information to EMA on all medicines authorised for use in the European Economic Area (EEA) and keep this information up-to-date.

This database reinforces the supervision of medicines in the European Union, as it supports pharmacovigilance data analysis, facilitates follow-up of regulatory actions and monitoring of legal obligations, and strengthens communication with EMA's stakeholders and partners. By streamlining the identification of products relevant to pharmacovigilance procedures, this database is expected to simplify adverse reaction reporting for marketing-authorisation holders and ensure that fees are calculated accurately.

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