CAMBODIA CHECK LIST FOR NEW REGISTRATION

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CAMBODIA CHECK LIST FOR NEW REGISTRATION
CAMBODIA CHECK LIST FOR NEW REGISTRATION
CAMBODIA CHECK LIST FOR NEW REGISTRATION
5 (100%) 1 vote

CAMBODIA CHECK LIST FOR NEW REGISTRATION

CAMBODIA CHECK LIST-VERSION 00

I : ACTD SECTION ( drug-ethical , OTC) :

a): Brief recommendation on how to prepare the registration dossier as per ACTD format.

b): Introduction ( about the product )

c): Letter of Authorization

d): Table of contends

DOWNLOAD REQUIREEMENTS AND FORMS FOR REGISTRATION HERE

Other information from Cambodia here

TABLE OF CONTENTS

Product Name : …………………………………

No. Document Pages
Part I: Administrative and Product Information
1 Application Form For Market Authorization
2 GMP Certificate
3 Certificate of Pharmaceutical Product
4 Summary of Product Characteristics
Part II : Quality
6 Section A : Table of Contents
7 Section B: Quality Overall Summary (QOS)
             S- Drug Substance
             P- Drug Product
8 Section C: Body Data
             S- Drug Substance

–          General information

–          Manufacturer

–          Characterization

–          Control of drug substance

–          Reference standard or materials

–          Container closure system

–          Stability

             P- Drug Product

–          Description and composition

–          Pharmaceutical development

–          Manufacturer

–          Control of excipients

–          Control of finished product

–          Reference standard or materials

–          Container closure system

–          Stability

–          Product interchangeability

9 Section D: Key Literature Reference
Part III: Non-Clinical
10 Section A: Table of Contents
11 Section B: Non-clinical Overview
12 Section C: Non-clinical Written and Tabulated Summaries
13 Section D: Non-clinical Study Report
Part IV: Clinical Data
14 Section A: Table of contents
15 Section B: Clinical Overview
16 Section C: Clinical Summary
17 Section D: Tabular Listing of All Clinical Studies
18 Section E: Clinical Study Reports
19 Section F: List of Key Literature References

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