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WHOPAR Guidance for Applicants
(2004; 140 pages)
Table of Contents
View the documentGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
View the documentAppendix 1 - Characteristics of WHOPAR Parts
View the documentAppendix 2 - Documentation to submit together with the initial submission
Open this folder and view contentsAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
View the documentAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

Appendix 1 - Characteristics of WHOPAR Parts

Part

Title

Responsibility for

Purpose

   

Drafting

Submission

Acceptance

To provide:

1

Abstract

WHO

 

WHO

Overview of key information

2

All Accepted Presentations

WHO

 

WHO

Tabulated product summary

3

All Package Leaflets in English

Applicant

Applicant

WHO

Practical, easily understandable information for the user on the FPP such that, if necessary, he is able to directly act on it

4

All Summaries of Product

Applicant

Applicant

WHO

All practical and essential medical (back

 

Characteristics in English

     

ground) information on FPP for health care

         

providers

5

All Labelling in English

Applicant

Applicant

WHO

All text for packaging

6

Discussion

WHO, based on

 

WHO

Outcome of quality and bio equivalence

   

• assessor reports on Quality and Bioequivalence and
• Summary of Product

Applicant1

 

evaluation and, if required, the overview of current product safety and efficacy

   

Safety and Efficacy

     

7

Steps taken for

WHO

 

WHO

Chronological description of main steps

 

Prequalification

     

undertaken for assessment of the product

         

and by whom

8

Steps taken following Prequalification

WHO

 

WHO

Chronological description of main steps undertaken following assessment of the product and by whom

 

1 As appropriate, see 'Requirements for Submission' and Appendix 2

 

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