PSURs: EMA revises Post-Authorization Procedural Advice

The European Medicines Agency (EMA) revised its post-authorization procedural advice for users of the centralized procedure. The new and revised Questions and Answers (Q&A´s) have been published on December 11, 2017.

The following Q&A´s regarding Periodic Safety Update Reports have been revised or newly introduced:

17. Periodic Safety Update Reports (PSURs)

  • 17.16. Will I have to submit PSUR after withdrawal/non-renewal/revocation of the marketing authorisation of my product?
    Answer: "Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization in case of non-renewal, marketing authorization holders may still be required to submit a PSUR".


  • 17.22. What happens if I missed the submission deadline? (New)
    Answer: "If you have missed the submission deadline due to technical issues with the PSUR Repository, please contact EMA as soon as possible via the Service Desk portal in order to request a late submission ID. Please note that late submissions can no longer be accepted once the procedure has started". Furthermore EMA states that "It is the responsibility of MAHs to ensure that they submit the necessary PSUR by the submission deadline as stated in the EURD list and that they are not in breach of their legal obligations with respect to the submission of PSURs".

Further information can be found on the EMA Post-marketing authorization: Regulatory and procedural guidance website.

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