Changes to product information following the outcome of imposed non-interventional post-authorisation safety studies (PASS) can be found on: for centrally authorised products (CAPs) – the outcomes of imposed non-interventional PASS final study results assessments are published as part of each medicine’s European public assessment report (EPAR) and the Decision will be published per product for the CAPs at EC website The Decisions are identified by the word PSR in the procedure number. for mix of centrally authorised products and nationally authorised products (NAPs, including MRP/DCP products) – PASS are listed under “Procedures for centrally authorised medicinal products” as well as “Procedures for nationally authorised medicinal products” A Decision will be published per product for the CAPs; a single Commission Decision will be published per active substance for the NAPs. The Decisions are identified by the word PSR in the procedure number for NAPs only (including MRP/DCP products) for which there is no CMDh consensus – the outcomes of imposed non-interventional PASS final study results assessments are published at «Procedures for nationally authorised medicinal products» for NAPs only (including MRP/DCP products) for which there is consensus within CMDh – the outcomes of imposed non-interventional PASS final study results assessments are published at EMA website More information on PASS can be found at EMA website
