Guidance on submission of single assessment PSURs published

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Guidance on submission of single assessment PSURs published

The European Medicines Agency has given guidance to marketing-authorisation holders on how to submit periodic safety update reports (PSURs) for medicines subject to European Union single assessment via its eSubmission Gateway and web client.

The guidance document has been published on the eSubmission website.

The Agency started carrying out single assessments of PSURs of active substances contained in both centrally and nationally authorised medicines in April 2013.

The single assessment of PSURs is a deliverable of the 2010 pharmacovigilance legislation, which has given the Agency the responsibility to analyse all reports for medicines containing a particular active substance, for all types of marketing authorisation and for medicines authorised in more than one Member State.

Until April 2013, the Agency had only been assessing PSURs for centrally authorised medicines.

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