Single central submission now mandatory for all periodic safety update reports.

Single central submission now mandatory for all periodic safety update reports.

Starting from 13 June 2016 onwards the transitional rules for submission of PSURs to the National Competent Authorities are no longer applicable. MAHs are now required to submit PSURs directly to the PSUR repository using the eSubmission Gateway. Except PSURs for products under Article 58 of Regulation (EC) No 726/2004, all other PSURs are affected […]