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.
- Data submission on authorised medicines (Article 57)
- Legal notice on the implementation of Article 57(2) of Regulation (EC) No. 726/2004
- Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004