Holders of marketing authorizations must check their data in the EMA’s article 57 database

The Vigilance Division of the FAMHP has found encoding errors in the article 57 database of the EMA. The FAMHP is asking holders of a marketing authorization for a medicine to carefully check that their registered data are correct.

In its follow-up of the signal detection of pharmacovigilance, the Vigilance department of the FAMHP found errors in files created based on the information in the article 57 database sent through by the EMA. Medicines that have been authorized for the Belgian market, for instance, need to be encoded in the country’s three national languages.

Since 31 December 2014, MA holders have the legal responsibility of keeping the information about their products up-to-date and to improve the quality of the information in the article 57 database. MA holders are urged to carefully check the registered reports of their various medicines in the database and to correct them if necessary, in accordance with the instructions published on the EMA’s website.

Further information

Last updated on
15/04/2019