EMA updates market authorization holder requirements

Pharmaceutical regulator the European Medicines Agency said yesterday that it has published an updated set of mandatory requirements for marketing authorization holders to comply with Article 57(2), one of the key measures of the new pharmacovigilance legislation.

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

The Agency will continue to support MA holders on the data submission process through on-line and face-to-face training and a dedicated helpdesk. An on-line data entry tool (EVWEB) hosted by the EMA to facilitate data submission by small and medium-sized enterprises was also released.