How to submit information on authorised and investigational medicines

Marketing-authorisation holders and sponsors of clinical trials are required to submit information on authorised and investigational medicines to the European Medicines Agency (EMA).

The information is submitted to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) using the Extended EudraVigilance Product Report Message (XEVPRM) schema.

The information can be submitted using the EudraVigilance Gateway or via EMA's EVWEB data-entry tool.

Submitting data

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:

• Registration
• Training and best practice

In-house tools

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:

• Extended EudraVigilance product report message (XEVPRM) schema (opens in html)

EudraVigilance eXtended medicinal product dictionary acknowledgement codes

Reference Number: EMA/792575/2014

The gateway allows for:

• confidentiality;
• verification of integrity;
• non-repudiation of origin and receipt.

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.

EVWEB (Article 57 user interface)

Marketing authorisation holders and sponsors of clinical trials may also use the XEVMPD data-entry tool known as EVWEB (or the Article 57 user interface) to submit information. This tool was developed by EMA for small and medium-sized enterprises, but it can be used by any company.

EVWEB is the interface to the EudraVigilance database management system (EDBMS). It allows registered users to create, send and view XEVPRMs and acknowledgement messages. EVWEB also enables users to perform queries on medicinal product information.

Registered users can access EVWEB by logging into the production or XCOMP (i.e. test) environment via the EudraVigilance web page. 

Further technical information on accessing EVWEB is available for registered users on the EudraVigilance restricted area. See XEVMPD Support in the User Support section.

EMA strongly recommends using the latest version of Windows and supported web browsers to access the latest security updates, in line with best practice. EMA will provide further guidance on supported browsers in early 2022.

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.

Article 57 user interface (UI) installation guide: Installation of Article 57 UI components and initial set up

Reference Number: EMA/550318/2021 Rev.1 Summary:

This document provides detailed steps to follow to install Article 57 components on users' computers to support the use of the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) data-entry tool user interface known as EVWEB.

Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

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:

• create a list of all medicines authorised in the European Union (EU);
• create a list of investigational medicinal products studied in clinical trials in the EEA;
• accurately identify medicines, especially medicines included in reports of suspected adverse reactions;
• coordinate the regulation and safety monitoring of medicines across the EU.

Extended EudraVigilance Product Report Message (XEVPRM) schema

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:

• the details of the legal basis of the marketing authorisation;
• a description of the medicinal product based on selected criteria;
• information on the authorised pharmaceutical form and, where applicable, before reconstitution into the administered pharmaceutical form;
• a description of the size of the organisation.

Full details on the data-submission requirements are available in the legal notice, detailed guidance and other documents available on Guidance documents.

Training

EMA provides online and face-to-face training on the submission of medicinal product data. For more information, see:

• Training and best practice