A post-authorisation safety study is any study of an authorised medicinal product that is conducted to identify, characterise or quantify a safety risk, to confirm a medicinal product’s safety profile or to measure the effectiveness of risk management measures. § 4 Abs. 34 AMG

Post-authorisation safety study (PASS) Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures [DIR 2001/83/EC Art 1(15)]. A post-authorisation safety study may be an interventional clinical trial or may follow an observational, noninterventional study design. See also Clinical trial, Non-interventional study. GVP Annex I - Definitions (Rev 5)