PSURs

Periodic Safety Update Reports (PSURs) are pharmacovigilance documents intended to provide a risk-benefit profile report for a medicinal product, that Marketing Authorisation (MA) Holders are bound to submit during post-authorisation.

In this framework, the European Union Reference Dates list (EURD list) is particularly relevant: this is a list of active substances and active substance combinations, published by EMA, for which the PSUR preparation is required, along with the relevant timetable for their submission.

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, and can therefore assist companies in PSUR preparation and submission.