EMA Publishes Updated Set of Mandatory Article 57(2) Requirements for Marketing Authorisation Holders

Article 57(2) of the new pharmacovigilance legislation requires the Agency to establish lists of all human medicines authorised in the European Union (EU), based on structured data submitted by the marketing authorisation holders of these medicines.

The European Medicines Agency has published an updated set of mandatory requirements for marketing authorisation holders to comply with Article 57(2), one of the key measures of the new pharmacovigilance legislation.

The Agency has considerably reduced the number of data fields initially required in the format published on 2 July 2011, thus significantly reducing the administrative burden and helping marketing authorisation holders to meet their legal deadline of 2 July 2012.

Article 57(2) of the new pharmacovigilance legislation requires the Agency to establish lists of all human medicines authorised in the European Union (EU), based on structured data submitted by the marketing authorisation holders of these medicines. These lists will assist the Agency in the