Templates for assessors

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PRAC 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 2017-04-04  
PRAC rapporteur advice on the renewal of the conditional marketing authorisation - Template (English only)   2013-06-26    
PRAC rapporteur advice on the annual re-assessment of the marketing authorisation under exceptional circumstances - Template (English only)   2013-06-26    
PRAC rapporteur generic risk-management-plan assessment report - report template (English only)   2013-05-13 2013-07-03  
PRAC rapporteur risk-management-plan assessment report - report template (English only)   2013-05-13 2013-07-03  
PRAC rapporteur risk-management-plan update assessment report - report template (English only)   2013-05-13 2013-07-03  
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  
PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template (English only)   2012-12-11 2015-07-02  

Variation assessment report templates

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Document(s) Language Status First published Last updated Effective Date
CHMP rapporteur assessment report - Extension of indication clinical guidance (English only)   2013-03-05 2014-05-28  
CHMP rapporteur assessement report - Extension of indication clinical template (English only)   2013-03-05   2013-02-21
CHMP rapporteur assessment report - Extension of indication overview template (English only)   2013-03-05 2014-05-28 2014-05-28
Rapporteur variation assessment report - Template (English only)   2011-11-03 2013-03-05  

Post-authorisation 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