Changes to product information following the outcome of PSUSA procedures (PSUR single assessment) can be found on:
- for centrally authorised products (CAPs) - a Decision will be published per product for the CAPs and the Decisions are identified by the word PSUSA in the procedure number. The European Commission’s website.
- for mix of centrally authorised products and nationally authorised products (NAPs, including MRP/DCP products) - PSUSAs are listed under both “Procedures for centrally authorised medicinal products” and “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 PSUSA in the procedure number.
- for NAPs only (including MRP/DCP products) for which there is no CMDh consensus - PSUSA are listed under “Procedures for nationally authorised medicinal products”.
- for NAPs only (including MRP/DCP products) for which there is consensus within the CMDh - EMA website. Published results from PSUSA NAP (MRP + NP) can be searched by substance name and category or procedure number on the EMA’s website as follows: Categories – Human Medicine – Periodic safety update report single assessments. EMA publishes the lists of nationally authorised medicines involved in PSUR single assessments for active substances contained only in nationally authorised medicines, together with the outcomes of assessments that lead to a variation of marketing authorisations EMA Website.
Other considerations (e.g. extrapolation) resulting from PSUSA procedures are published in CMDh Press Release or CMDh minutes