As of June 13, 2016, all periodic safety update reports ("PSURs") for human medicines authorized in the EU must be submitted to the PSUR repository, which has been developed by EMA in close collaboration with EU Member States and the industry. The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. It was introduced by the EU pharmacovigilance legislation to facilitate the exchange of information on the safety of authorized medicines between regulators and pharmaceutical companies. Marketing authorization holders must now use the repository as a single point for all submissions and should no longer submit their PSURs to national competent authorities. The eSubmission Gateway is available on the eSubmission website.
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