4. EudraVigilance: The EudraVigilance database containing “Article 57 database”

1. EudraVigilance

1.4. The EudraVigilance database containing “Article 57 database”

The submission of data on medicines by MAHs is a legal requirement from the 2010 pharmacovigilance legislation. Data in EudraVigilance is submitted electronically by NCAs and by pharmaceutical companies that hold the marketing authorisation for medicines. The aim is to establish a complete inventory of all medicines authorised for use in the EU and EEA, including both, centrally authorised medicines via the EMA and those authorised at national level. MAHs are required to submit information on their medicines to the Article 57 database in accordance with Article 57(2) of Regulation (EC) No. 726/2004.

The EMA uses this information for:

analysis of data in EudraVigilance and signal management;
reporting and coding of individual case safety reports;
facilitating medicines regulation and fulfilling regulatory actions and legal obligations;
and strengthening communication with stakeholders.

EMA publishes information on all authorised medicines contained in the Article 57 database in the form of an excel document.

The document contains the following data fields:

product name (product short name: brand name or the combination of the generic name and the company name);
active substance;
route of administration;
country of authorisation;
name of the marketing authorisation holder (company);
country of location of the pharmacovigilance system master file;
marketing authorisation holder's contact email address and telephone number for pharmacovigilance enquiries.

Only products that have a valid marketing authorisation are included in the document and
EMA updates this document periodically to reflect changes in the Article 57 database.

Below the link to an example for this information:

Article 57 product data (XLSX/7.31 MB) (updated)

First published: 30/07/2018
Last updated: 02/06/2021
EMA/518502/2018 Rev. 35

The EudraVigilance database holds over 16 million Individual Case Safety Reports (ICSRs) referring to over 9 million cases and is one of the largest pharmacovigilance databases in the world. Enhanced functionalities, following significant recent development, allow for a better support of pharmacovigilance activities and the protection of public health. In other jurisdictions similar approaches exist.