[Ip-health] WHO official definition of counterfeit

Alexandra HEUMBER Alexandra.HEUMBER@brussels.msf.org
Fri May 2 10:10:08 2008


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There has been discussions in the IGWG on the official WHO definition of
counterfeit reproduced below.

"a counterfeit medicine is one which is deliberately and fraudulently
mislabelled with respect to identity and/or source. Counterfeiting can
apply to both branded and generic products and counterfeit products and
may include products with the correct ingredients or with the wrong
ingredients, without active ingredients, with insufficient active
ingredients or with fake packaging."

The original source is "Guidelines for the development of measure to
combat counterfeit drugs" (WHO/EDM/QSM/99.1, page 8). The document is
available at http://whqlibdoc.who.int/hq/1999/WHO_EDM_QSM_99.1.pdf).

The definition has been included in further related guidelines published
in the respective technical report series.

The definition is included in tthe WHO Quality Assurance of Medicines
Terminology Database, available at
http://www.who.int/medicines/services/expertcommittees/pharmprep/TermListca=
tegory.pdf

Alexandra Heumber
EU Advocacy Liaison Officer
M=E9decins Sans Fronti=E8res
Access to Essential Medicines Campaign
Rue Dupr=E9, 94. 1090 Brussels
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