Post-authorisation safety study
A post-authorisation safety study means any study relating to an authorised medicinal product conducted with the aim of identifying, characterising, and assessing safety risk, confirming the safety profile of the medicinal product or measuring the effectiveness of risks minimisation measures. Such a study may i.e. confirm that there is no safety risk related to a specific adverse reaction, or can further investigate the safety concern or study the use of a medicinal product in specific populations which were not included in clinical trials or about which there is insufficient information.
The study is performed on a voluntary basis by the marketing authorisation holder holder or at the request of the competent authority.
Information about non-intervention safety studies is published in the European Union electronic register of Post-authorisation Studies (EU PAS Register within the ENCePP network).