WHO TRS (Technical Report Series) 961, 2011 Annex 15


WHO TRS (Technical Report Series) 961, 2011 Annex 15

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

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”.

As mentioned in this report, when submitting an Expression of Interest (EOI) for product evaluation, the applicant should send to the WHO focal point (together with the other data requirements) a product dossier (PD), in the format specified in the WHO guidance documents on submitting product data and information.

Through the International Conference on Harmonisation (ICH) process, considerable harmonization has been achieved in the organization of the registration documents with the issuance of the common technical document (CTD) guideline (2-5). This recommended format in the CTD guideline for registration applications has become widely accepted by regulatory authorities both within and beyond the ICH Regions.

This document provides recommendations on the format and presentation for these types of PDs.

See pdf file for complete details:

WHO TRS (Technical Report Series) 961, 2011 Annex 15:


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