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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Pharmaceutical Microbiology