A 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 measuring the effectiveness of risk management measures (Decree-Law No. 128/2013 of September 5).

A post-authorisation safety study (PASS) can be performed by a marketing authorization holder (MAH) voluntarily or by imposition of the competent authority.

INFARMED, I.P. taking into account the European Commission's guidelines, may force the MAH to conduct a PASS study in the following cases:
1) If there are doubts to the authorized medicinal product risks;
2) If the knowledge about the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly (D.L.128/ 2013 of September 5, article 26-A).