Templates for assessors

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Post-authorisation measure (PAM) assessment report templates

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Document(s) Language Status First published Last updated Effective Date
CHMP rapporteurs' assessment report for post-authorisation measures (PAMs) (English only)   2014-05-28 2015-03-23  
CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46 (English only)   2014-05-28 2015-03-23  

Signal assessment report templates

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Document(s) Language Status First published Last updated Effective Date
Signal assessment report - template (English only)   2014-10-29 2018-02-19  

Risk-management-plan assessment report templates

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Document(s) Language Status First published Last updated Effective Date
PRAC rapporteur risk-management-plan assessment report - report template (English only)   2013-05-13 2013-07-03  
Risk management plan (RMP) assessment report sub-template for type II variations and periodic safety update reports (PSURs) (English only)   2017-08-04    

PRAC advice template

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Document(s) Language Status First published Last updated Effective Date
PRAC advice template (English only)   2017-08-04    

Imposed PASS assessment report templates

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Document(s) Language Status First published Last updated Effective Date
PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template (English only)   2012-12-11 2017-11-30  

PSUR/PSUSA assessment report templates

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Document(s) Language Status First published Last updated Effective Date
PRAC periodic-safety-update-report assessment report template CAP and NAP (English only)   2013-03-05 2016-12-19 2013-02-21
PRAC periodic-safety-update-report assessment report template CAP only (English only)   2016-01-11 2016-12-19  
PRAC periodic-safety-update-report assessment report template NAP only (English only)   2016-01-11 2016-12-19  

Variation assessment report templates

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Document(s) Language Status First published Last updated Effective Date
Post-authorisation efficacy studies (PAES) assessment report sub-template for type II variations (English only)   2017-08-04    
Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations (English only)   2017-08-04    

Annual re-assessment and Renewal assessment report templates

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Document(s) Language Status First published Last updated Effective Date
Annual re-assessment assessment report template (English only)   2017-08-04    
Annual renewal assessment report template (English only)   2017-08-04    
Renewal assessment report template (English only)   2017-08-04    

Extension of market/data protection assessment report templates

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Document(s) Language Status First published Last updated Effective Date
One year of additional market protection for new indication assessment report template (English only)   2017-08-04    
One year extension of data protection for legal status switch assessment report template (English only)   2017-08-04    
One year extension of data protection for new indication of well-established use product assessment report template (English only)   2017-08-04