Page contentsPage contents Post-authorisation measure (PAM) assessment report templates Signal assessment report templates Risk-management-plan assessment report templates PRAC advice template Variation assessment report templates Extension of market/data protection assessment report templates Topics Post-authorisation measure (PAM) assessment report templates Assessment report for post-authorisation measures (PAMs) English (EN) (120.74 KB - DOCX)First published: 28/05/2014 Last updated: 05/03/2024 View CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46 English (EN) (112.83 KB - DOCX)First published: 28/05/2014 Last updated: 05/03/2024 View PRAC rapporteurs' assessment report for non-imposed non-interventional PASS protocol English (EN) (235.5 KB - DOC)First published: 27/09/2021 View Signal assessment report templates Signal assessment report - template English (EN) (125 KB - DOCX)First published: 29/10/2014 Last updated: 21/10/2022 View Risk-management-plan assessment report templates Risk management plan (RMP) assessment report sub-template for type II variations and periodic safety update reports (PSURs) English (EN) (112.32 KB - DOCX)First published: 04/08/2017 Last updated: 18/09/2018 View Generics - Hybrids - PRAC D94 Rapporteur RMP assessment report template rev. 01.23Reference Number: Rev. 01.23 Legal effective date: 16/08/2018 English (EN) (76.78 KB - DOCX)First published: 21/05/2015 Last updated: 20/01/2023 View PRAC advice template PRAC advice template English (EN) (301 KB - DOC)First published: 04/08/2017 Last updated: 13/12/2024 View Variation assessment report templates Post-authorisation efficacy studies (PAES) assessment report sub-template for type II variations English (EN) (143.5 KB - DOCX)First published: 04/08/2017 Last updated: 18/09/2018 View Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations English (EN) (110.19 KB - DOCX)First published: 04/08/2017 Last updated: 18/09/2018 View Extension of market/data protection assessment report templates One year of additional market protection for new indication assessment report template English (EN) (177.92 KB - DOCX)First published: 04/08/2017 Last updated: 18/09/2018 View One year extension of data protection for legal status switch assessment report template English (EN) (105.17 KB - DOCX)First published: 04/08/2017 Last updated: 18/09/2018 View One year extension of data protection for new indication of well-established use product assessment report template English (EN) (105.55 KB - DOCX)First published: 04/08/2017 Last updated: 18/09/2018 View Topics Regulatory and procedural guidance Share this page