Post-authorisation safety study

A Post-Authorisation Safety Study (PASS) of a medicinal product may be initiated, monitored, or sponsored by the market authorization holder voluntarily or under an obligation imposed on it by an authorized body as a condition of issuing a market authorization or after issuing market authorization, if there is an assumption of risks associated with a registered medicinal product that require further investigation through clinical study.

The objectives of the post-authorisation safety study are:

• quantification of potential or identified risks, as well as the study of risk factors and factors modifying the effect of the drug product;
• assessment of the risks of a drug used for an approved indication in groups of patients who have not been studied or have been insufficiently studied at the pre-registration stage;
• assessment of the risks associated with long-term use of the drug;
• confirmation that there are no risks associated with the use of the drug;
• evaluation of standard clinical practice for prescribing medications;
• assessment of the effectiveness of risk minimization measures.