Post-authorisation safety studies (PASS) are studies carried out after a medicine has been authorised in order to obtain further information on the medicine's safety, or to measure the effectiveness of risk-management measures. The PRAC assesses both the protocols and the final study results of all imposed non-interventional PASS.

All procedures to assess final results of imposed non-interventional PASS result in a change to the marketing authorisation (i.e. a variation).

The assessment of results from imposed non-interventional PASS for active substances found only in centrally authorised medicines will result in an update of relevant EPAR documents, as described in Section 3.2. A document called Scientific conclusions, amendments to product information and implementation timetable is also published on the medicine’s page in the section ‘Assessment history’.

The outcomes of assessments of imposed non-interventional PASS results for active substances found only in nationally authorised medicines are published on the page Outcomes of imposed noninterventional post-authorisation safety studies within 2 months of the conclusion of the procedure. EMA publishes on this page the List of medicines that were assessed in the PASS together with the Scientific conclusions, amendments to product information and implementation timetable. This latter document is available in all official EU languages. An Assessment report is only published when changes are considered to be of significant clinical relevance.