The PSUR Repository is the central EU infrastructure for periodic safety update report submissions for human medicines.
Core official resources
- PSUR Repository — EMA eSubmission entry point, guidance and access information.
- PSUR Repository mandatory-use Q&A — explains the regulatory transition to direct repository submission.
Practical use
For EU human medicines, the repository is the operational destination for PSUR submissions rather than separate submission to individual national competent authorities. Users should distinguish the repository itself from the EURD list, which determines whether and when many active substances require PSUR submission and whether the assessment follows a PSUSA procedure.