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

24.11.2014.

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.

The Agency made available a Bulk Update Manager Tool to enable marketing-authorisation holders submitting medicinal product information using the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) to perform bulk data operations on their products held in the XEVMPD. The tool facilitates editing of key data fields and supports the re-submission of this data to the XEVMPD repository.

This tool is available to registered users in the restricted area of the EudraVigilance website in section “EV Services”, or via an IE browser at the following URL.
The corresponding user manual can also be found in in the restricted area of the EudraVigilance website in section “User Support” or at the following URL.

Marketing-authorisation holders submitting medicinal product information using EVWEB are encouraged to use this tool to update, complete and improve the quality of the submitted medicinal products.

Please allow us to remind you that by 31 December 2014, marketing-authorisation holders are required to update, complete and improve the quality of the submitted information. This involves completing the previously submitted XEVMPD entities with the additional data elements, and checking that the quality of all information is in line with the updated reporting requirements. The additional data elements include:

the details of the legal basis of the marketing authorisation;
a description of the medicinal-product type based on controlled vocabularies;
information on the authorised pharmaceutical form and before reconstitution into the ‘administered’ pharmaceutical form;
a description of the size of the marketing-authorisation-holder company.

Marketing-authorisation holders should also correct and maintain details of the available MAH organizations available in the XEVMPD, remove duplicates (where necessary) and re-link the affected medicinal products. For related information please see the processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance, sections 2.3.3. Bringing AMP entries up to date and amending the referenced information and 2.3.4. Nullification of duplicated/obsolete XEVMPD entities.

For full details on reporting requirements, see the legal notice and detailed guidance available on the Guidance documents webpage.