162
ICH ICSR Implementation Guide 12 April 2013
-163-
Term Definition
Counterfeit Medicine A medicine 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
can include products with the correct ingredients or with the
wrong ingredients, without active ingredients, with insufficient
active ingredients or with fake packaging.[WHO]13
Drug (See Medicinal Product)
Electronic Data Interchange
(EDI)
A technology for exchanging structured information for the
purpose of conducting business transactions.[ICH M2]
EDI Message An EDI Message consists of a set of segments, structured using
an agreed standard, prepared in a computer readable format and
capable of being automatically and unambiguously
processed.[EMA]
The International
Conference on
Harmonisation of Technical
Requirements for
Registration of
Pharmaceuticals for Human
Use (ICH)
The International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human
Use (ICH) is a project that brings together the regulatory
authorities of Europe, Japan and the United States and experts
from the pharmaceutical industry in the three regions to discuss
scientific and technical aspects of product registration. The
Observers are WHO, EFTA, and Canada (represented by Health
Canada).
Healthcare Professional Person entrusted with the direct or indirect provision of defined
healthcare services to a subject of care or a population of
subjects of care[ENV 1613:1995] [ISO 21574-7]
EXAMPLE Qualified medical practitioner, pharmacist, nurse,
social worker, radiographer, medical secretary or clerk
Individual Case Safety
Report
The complete information provided by a reporter at a certain
point in time to describe an event or incident of interest. The
report can include information about a case involving one subject
or a group of subjects. [27953 Human Pharmaceutical Reporting]
Marketing Authorisation
Holder
An organisation, usually a biopharmaceutical firm, that holds a
valid marketing authorisation for a medicinal product delivered
by the Health Authority of a country.
Medical Dictionary for
Regulatory Activities
Medical Dictionary for Regulatory Activities (MedDRA)
terminology for adverse event reporting used globally by the
biopharmaceutical industry and regulators to promote consistent
reporting and data analysis.
13World Health Organisation International Medical Products Anti-Counterfeiting Task Force
(IMPACT)http://www.who.int/impact/FinalBrochureWHA2008a.pdf
ICH ICSR Implementation Guide 12 April 2013
-163-
Term Definition
Counterfeit Medicine A medicine 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
can include products with the correct ingredients or with the
wrong ingredients, without active ingredients, with insufficient
active ingredients or with fake packaging.[WHO]13
Drug (See Medicinal Product)
Electronic Data Interchange
(EDI)
A technology for exchanging structured information for the
purpose of conducting business transactions.[ICH M2]
EDI Message An EDI Message consists of a set of segments, structured using
an agreed standard, prepared in a computer readable format and
capable of being automatically and unambiguously
processed.[EMA]
The International
Conference on
Harmonisation of Technical
Requirements for
Registration of
Pharmaceuticals for Human
Use (ICH)
The International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human
Use (ICH) is a project that brings together the regulatory
authorities of Europe, Japan and the United States and experts
from the pharmaceutical industry in the three regions to discuss
scientific and technical aspects of product registration. The
Observers are WHO, EFTA, and Canada (represented by Health
Canada).
Healthcare Professional Person entrusted with the direct or indirect provision of defined
healthcare services to a subject of care or a population of
subjects of care[ENV 1613:1995] [ISO 21574-7]
EXAMPLE Qualified medical practitioner, pharmacist, nurse,
social worker, radiographer, medical secretary or clerk
Individual Case Safety
Report
The complete information provided by a reporter at a certain
point in time to describe an event or incident of interest. The
report can include information about a case involving one subject
or a group of subjects. [27953 Human Pharmaceutical Reporting]
Marketing Authorisation
Holder
An organisation, usually a biopharmaceutical firm, that holds a
valid marketing authorisation for a medicinal product delivered
by the Health Authority of a country.
Medical Dictionary for
Regulatory Activities
Medical Dictionary for Regulatory Activities (MedDRA)
terminology for adverse event reporting used globally by the
biopharmaceutical industry and regulators to promote consistent
reporting and data analysis.
13World Health Organisation International Medical Products Anti-Counterfeiting Task Force
(IMPACT)http://www.who.int/impact/FinalBrochureWHA2008a.pdf