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

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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

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

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TABLE OF CONTENTS












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”


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

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