The information is submitted to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), also known as Article 57 database, using the Extended EudraVigilance Product Report Message (XEVPRM) schema.
The information can be submitted using the EudraVigilance Gateway or via EMA's user interface.
There are two ways to submit data on authorised and investigational medicines. For both methods, at least one member of staff of the organisation submitting the data must complete training and register before data submission can begin. For full details, see:
Companies can use in-house tools developed by pharmaceutical companies or software vendors. Information that complies with the updated guidance and XML schema definition (XSD) published by the Agency can be submitted via the EudraVigilance Gateway.
The EudraVigilance gateway supports the electronic data interchange (EDI) process, which is based on the secure electronic exchange of product messages between a sender and a receiver.
An acknowledgement message confirms the receipt and outcome of the validation of a product message and completes the EDI process.
For technical details, see:
The gateway allows for:
Companies are responsible for installing and operating software that is suitable for the successful transmission of encrypted and digitally-signed product report and acknowledgement messages. Alternatively, they can use service providers for this purpose.
Marketing authorisation holders and sponsors of clinical trials may also use the XEVMPD user interface to submit information.
This user interface was developed by EMA for small and medium-sized enterprises, but it can be used by any company. It allows registered users to create, send and view XEVPRMs and acknowledgement messages, browse medicinal products, and perform queries on medicinal product information.
EMA has developed an upgraded version of the current XEVMPD user interface (called 'XEVMPD/Art.57 EVWEB') and made this upgraded version (called 'XEVMPDweb') available to external users from 10 February 2026.
Registered users can access XEVMPD/Art.57 EVWEB and XEVMPDweb by logging into the production or XCOMP (i.e. test) environment via the EudraVigilance web page and selecting the required user interface in the 'EV Services' section.
Both user interfaces will be available for use during a transition period of three months.
It is foreseen that after 10 May 2026 the access to XEVMPD/Art.57 EVWEB will be restricted and external users will be required to use XEVMPDweb only.
To access XEVMPD via the XEVMPD/Art.57 EVWEB user interface, the latest version of Windows and supported web browsers must be used, together with additional Article 57 UI components (ActiveX and IE Tab).
Further technical information on accessing EVWEB is available for registered users on the EudraVigilance restricted area. See 'XEVMPD Support' in the 'User Support' section.
For guidance on compatibility issues, users should consult the XEVMPD Support section and the
detailed steps on enabling EVWEB in the Article 57 user interface installation guide below.
The user manual applicable for the XEVMPD/Art.57 EVWEB user interface is available here.
The final version of the user manual for the upgraded UI XEVMPDweb is available here.
XEVMPD is a database designed to support the collection, reporting, coding and evaluation of data on medicines in a standardised and structured way.
Its main objective is to assist pharmacovigilance activities in the European Economic Area (EEA), enabling EMA to:
XEVPRM is the schema that must be used to submit data on authorised and investigational medicines. It consists of a set of controlled vocabularies covering a set of codified data elements required by companies submitting information.
EMA first published the data format in July 2011 and the XML Schema Definition (XSD) for the individual data elements in September 2011. This was followed by updated requirements in March 2012, with fewer mandatory data fields, to reduce the administrative burden on marketing-authorisation holders.
The latest amendment to the XSD came into force on 16 June 2014. From this date, the following required fields were included in the data-submission format:
Full details on the data-submission requirements are available in the legal notice, detailed guidance and other documents available on Guidance documents.
EMA provides online and face-to-face training on the submission of medicinal product data. For more information, see:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in February 2026.
11 February 2026
Content on this webpage was updated to reflect the release of the upgraded XEVMPD user interface.