Guidelines on submission of documentation for a finished product

Guidelines on submission of documentation for a multisource (generic) finished product: General format: preparation of product dossiers in common technical document format

Annex 15

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TABLE OF CONTENTS

1. Introduction

1.1 Background

1.2 Objectives

1.3 Scope

1.4 General principles

2. Glossary

3. Organization of a product dossier for a multisource pharmaceutical product in common technical document format

4. Modules (including Module 1) of a product dossier for a multisource pharmaceutical product

5. Module 3 — quality

6. Module 5 of a product dossier for a multisource pharmaceutical product

7. Guidance on format and presentation of a product dossier in common technical document format

7.1 Guidance on format

7.2 Guidance on presentation

8. Variations

References

1. Introduction

1.1 Background

In its forty-fifth report, the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations published the Procedure for prequalification of pharmaceutical products (1) which outlines the procedure and considerations for the process undertaken by WHO in providing United Nations agencies with advice on the acceptability in principle of pharmaceutical products for procurement by such agencies. The above-mentioned report states:

“This activity of WHO aims to facilitate access to priority essential medicines that meet WHO-recommended norms and standards of acceptable quality”

Guidelines on submission of documentation for a finished product - Annex 15