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Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for drug regulatory authorities

http://whqlibdoc.who.int/hq/1998/WHO_DMP_RGS_98.5.pdf

It provides guidance to countries which do not already have a fully functioning system of premarket evaluation and market authorization, and have a particular interest in the assessment and authorization of multisource (generic) pharmaceutical products.

Originator(s): World Health Organization. Essential Drugs and Medicines Policy - WHO / EDM
Resource added in: 09/01/2002
Available languages: English
Legislation, Drug, Drugs, Generic, Pharmaceutical Preparations
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