Templates for assessors
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Assessment report for post-authorisation measures (PAMs) (DOC/210 KB)
First published: 28/05/2014
Last updated: 30/09/2021
Rev. 4 -
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CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46 (DOC/105 KB)
First published: 28/05/2014
Last updated: 30/09/2021
Rev. 4 -
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PRAC rapporteurs' assessment report for non-imposed non-interventional PASS protocol (DOC/235.5 KB)
First published: 27/09/2021
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Risk management plan (RMP) assessment report sub-template for type II variations and periodic safety update reports (PSURs) (DOCX/112.32 KB)
First published: 04/08/2017
Last updated: 18/09/2018 -
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PRAC D94 Rapporteur RMP assessment report template rev. 01.23 (DOCX/76.78 KB)
First published: 21/05/2015
Last updated: 20/01/2023
Legal effective date: 16/08/2018
Rev. 01.23
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Post-authorisation efficacy studies (PAES) assessment report sub-template for type II variations (DOCX/143.5 KB)
First published: 04/08/2017
Last updated: 18/09/2018 -
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Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations (DOCX/110.19 KB)
First published: 04/08/2017
Last updated: 18/09/2018
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One year of additional market protection for new indication assessment report template (DOCX/177.92 KB)
First published: 04/08/2017
Last updated: 18/09/2018 -
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One year extension of data protection for legal status switch assessment report template (DOCX/105.17 KB)
First published: 04/08/2017
Last updated: 18/09/2018 -
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One year extension of data protection for new indication of well-established use product assessment report template (DOCX/105.55 KB)
First published: 04/08/2017
Last updated: 18/09/2018