Public Data From Article 57 Database to Ease Assessment of Potential Invented Names for Medicinal Products

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). The database lists all medicinal products that have a valid marketing authorisation in one of the EEA states, including national, MRP, DCP and Centralised licences.

Although the main aim of making the database 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 will also help marketing authorisation applicants, regulatory affairs professionals and pharmaceutical marketing teams to better assess their potential invented names during the marketing authorization applications as they will be able to see all product names available EEA wide. Not to mention all other potential advantageous uses of this comprehensive dataset.

As of today, the database lists more than 90 000 invented medicinal product names of more than 10 000 active pharmaceutical ingredients and more than 4 000 different marketing authorization holders.

The Article 57 database has become an invaluable tool enabling centralized access to all medicinal product licences across EEA through a single routinely updated dataset, whichever the purpose or information you are looking for:

  • product name;
  • active substance;
  • route of administration;
  • country of authorisation;
  • name of the marketing authorisation holder (MAH);
  • country of location of the pharmacovigilance system master file;
  • MAH’s contact email address and telephone number for pharmacovigilance enquiries.

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