17/18 March 2021
The European Medicines Agency, EMA, published information on all authorized medicines contained in the Article 57 database in the form of an Excel® document entitled Article 57 product data. Marketing authorization holders are required to submit information on their medicines to the Article 57 database in accordance with Regulation (EC) No. 726/2004.
Post-authorization data on medicines (ISO IDMP standards):
All holders of marketing authorizations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the EMA on authorized medicines via the extended EudraVigilance medicinal product dictionary (xEVMPD), also known as Article 57 database, and keep this information up-to-date. EMA says "this is aimed at ensuring the quality of data in the xEVMPD on authorized or investigational medicinal products" (IMPs).
As of July 2018 EMA publishes extracted data from the Article 57 database on all medicines authorized in the EEA. Marketing authorization holders (MAHs) must submit and maintain this information in accordance with EU legislation. According to the agency, "the primary objective of making this information public is to provide a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries". It also aims to enable marketing authorization 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. In addition, it is a legal requirement for the EMA to publish contact details for pharmacovigilance enquiries and of the location of the pharmacovigilance system master file (PSMF).
The file currently contains the following data (only products that have a valid marketing authorization are included in the document):
The EMA will update this Excel file periodically to reflect changes in the Article 57 database.
Register for the new Drug Safety/Pharmacovigilance Newsletter and find out what the latest trends are.
Excel is a registered trademark of Microsoft Corp.