01. Does the submission of the PSUR via common repository within 70/90 days fulfil IMA’s requirements?

Yes. On 13th of June 2016 the PSUR Repository became mandatory. This means that marketing authorisation holders must use the PSUR repository as a single point for all submissions and should no longer submit PSURs to NCAs (national competent authorities) directly.


Last updated: December 17, 2021
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