The obligations of Marketing Authorisation Holders (MAH) and pharmaceutical companies to submit regularly updated reports on the safety of medicinal products (Periodic Safety Update Report, called "PSUR" in the following) are laid down in Section § 63d AMG and in Directive 2010/84/EU.

For further information regarding PSUR submission please see EMA websites:

Periodic safety update reports: questions and answers
Implementation of pharmacovigilance legislation
Good pharmacovigilance practices (GVP) – Modul VII / PSUR
EU reference dates and submission of periodic safety update reports