Saturday, 30 March 2019

WHO guidance on testing of “suspect” falsified medicines


This new World Health Organization document provides technical guidance on laboratory testing of samples of suspect deliberately falsified medical products detected on the markets of WHO Member States and related aspects of sampling and reporting. This guidance should be read in conjunction with the guidelines on sampling and market surveillance.

“Suspect” medicines can be divided into three main categories of products as follows:

(a) substandard medicines - Also called “out of specification”, these are authorized medicines that fail to meet either their quality standards or their specifications, or both.

(b) unregistered/unlicensed medicines - Medicines that have not undergone evaluation and/or approval by the national regulatory authority (NRA) for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation. These medicines may or may not have obtained the relevant authorization from the NRA of their geographical origin.

(c) falsified medicines - Medicines that deliberately/fraudulently misrepresent their identity, composition or source. Any consideration related to intellectual property rights does not fall within this definition. Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, reproduction of an authorized medicine or the manufacture of a medicine that is not an authorized product.

Within the document it defines falsified medicines as medicines that deliberately/fraudulently misrepresent their identity, composition or source. Any consideration related to intellectual property rights does not fall within this definition. Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, reproduction of an authorized medicine or the manufacture of a medicine that is not an authorized product.

This document provides technical guidance on laboratory testing of samples of suspect deliberately falsified medical products detected on the markets of WHO Member States and related aspects of sampling and reporting. This guidance should be read in conjunction with the guidelines on sampling and market surveillance. Within the document it defines falsified medicines as medicines that deliberately/fraudulently misrepresent their identity, composition or source. Any consideration related to intellectual property rights does not fall within this definition. Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, reproduction of an authorized medicine or the manufacture of a medicine that is not an authorized product.



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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