From 13 June 2016 all PSURs have to be submitted only to the PSUR Repository

From 13 June 2016 all PSURs have to be submitted only to the PSUR Repository

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that as of 13 June 2016, the European Medicines Agency (EMA) has adopted as a mandatory requirement to submit all PSURs only to the Repository. PSUR Repository supports both the PSUR Single Assessment Procedure as governed by the EURD list and the single, pure NAP procedures where the active substance is only authorised in one Member State. From that date PSURs can no longer be submitted to SAM.

If PSUR for the medicinal product authorised only in Latvia and will be evaluated at the national level is submitted to the Repository the marketing authorisation holders are recommended to use the EMA template table cover letter to accompany submission of purely national PSURs to the PSUR repository. For more details, please visit the EMA website.