Periodic Safety Update Reports (PSURs)

Under responsibility of our QPPVs, we

• prepare Periodic Safety Update Reports (PSURs) in accordance with current guidelines and
• monitor frequently changing PSURs requirements on your behalf, including the List of European Union Reference Dates (EURD list).

Periodic Safety Update Reports (PSURs)

represent a written evaluation of the benefits and risks of a medicinal product and shall be submitted by the marketing authorisation holder at certain time points during the post-authorisation phase. The frequency with which PSURs shall be submitted for a particular product is defined by European and national regulations, taking into account the product type and the amount of clinical evidence and experience available for the concerned active substance.