For the time being, the “step 1” of the re-launch has been implemented considering MA applications for new active substances (NAS), that received a CHMP opinion or were withdrawn from September 2023 onwards. “Step 2” is expected to be activated for other applications apart from new actives active substances and Covid-19 treatments during 2024. Clinical data in scope of the policy are defined as clinical reports and individual patient data (IPD). Clinical reports shall mean the clinical overviews and clinical summaries and the clinical study reports (CSR). These documents correspond respectively to modules 2.5, 2.7 and 5.3 of the common technical document (CTD).” oAñadir a continuación: “Clinical reports must be anonymised to prevent patients and professionals who participated in clinical trials from being identified. The approach followed must be described in the Anonymisation report, compiling the risk assessment technique, the anonymisation methods used and their impact on data utility.