Public data from Article 57 database

As of July 2018, the European Medicines Agency (EMA) publishes data from the Article 57 database on all medicines authorised in the European Economic Area (EEA). Marketing authorisation holders must submit and maintain this information in accordance with European Union (EU) legislation.

Access the data

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

Article 57 product data

Reference Number: EMA/518502/2018 Rev.66

The document contains the following data fields:

• product name (product short name: brand name or the concatenation 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.

EMA updates this document periodically to reflect changes in the Article 57 database.

Only products that have a valid marketing authorisation are included in the document.

For further details, including package leaflets, on:

• centrally authorised medicines, search Medicines.
• nationally authorised medicines, visit the websites of the national competent authorities.

Objectives

The primary objective of making this information public is to provide a complete list of all medicines authorised in the EEA with marketing authorisation holders' dedicated contact details for pharmacovigilance enquiries.

It also aims to enable marketing authorisation applicants to better assess their potential invented names and facilitate the activities of the (Invented) Name Review Group which assesses whether a proposed invented name could create a public health concern or potential safety risk.

Legal background

Marketing authorisation holders 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 publication of this dataset complies with Article 26 (1) of the same regulation as amended by Regulation (EU) No 1235/2010, which made it a legal requirement for the EMA to publish contact details for pharmacovigilance enquiries and of the location of the pharmacovigilance system master file in the EU.