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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