Module 6

03/10/2024

Scheduling of PSURs

Schedule of PSURs based on International Birth Date (IBD) & EURD list

For each authorized product, a PSUR will: – Be prepared immediately on request.

– For non-EU market authorizations: at least every 6 months after IBD until two full years of marketing experience in the EU has been gained and once a year for the following two years. Thereafter, reports shall be prepared at three-yearly interval. – For EU market authorizations, the EU reference dates (EURD) list will serve as the reference document. Periodicity may changed/amended due to the following:

– HA request; MAH request – And specifically for the EU,

o Reasons relating to public health o In order to avoid a duplication of the assessment o In order to achieve international harmonization Jullian, S., Lewis, D.J., et al. Aggregate analysis of regulatory authority assessors’

comments to improve the quality of periodic safety update reports. Pharmacoepidemiology & Drug Safety 2015 https://doi.org/10.1002/pds.3818 21

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EURD list

The EURD list contains: ● EU reference dates ● Frequencies of submission of PSURs ● Data lock points of the next submissions of PSURs ● Date of publication on the European Medicines web-portal The information on this list is specific for EU submissions. Any change to the dates of submission and frequency on PSURs specified in the MA take effect six months after the date of its publication. For EU submissions with periodicities which exceed three years (i.e. 5yr, 10yr, etc.), these PSURs will be scheduled separately and incorporated into the PSUR schedule.

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