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Term Definition
Medicinal Product Any substance or combination of substances presented as having
properties for treating or preventing disease in human beings
Any substance or combination of substances which might be
used in or administered to human beings either with a view to
restoring, correcting or modifying physiological functions by
exerting a pharmacological, immunological or metabolic action,
or to making a medical diagnosis.[ISO 11615]
Any substance or combination of substances which might be
administered to human beings or animals for treating or
preventing disease, with the view to making medical diagnosis or
to restore, correct or modify physiological functions [ENV
13607] [Directive 65/65/EEC, modified]
Non-proprietary Drug
(generic) Name
Drug name that is not protected by a trademark, usually
descriptive of its chemical structure sometimes called a public
name. International Non-proprietary Names (INN) allocated by
WHO, identify pharmaceutical substances or active
pharmaceutical ingredients. Each INN is a unique name that is
globally recognised and is public property. A non-proprietary
name is also known as a generic name. In the US, most generic
drug names are assigned by the US Adopted Name Council
(USAN).
Pharmacovigilance The science of activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
drug-related problem.[(2) WHO 2002 ]
Product A thing or things produced by labour or effort for a specific use
and marketed to satisfy a need or want. [HL7 Patient Safety]
Regional
Pharmacovigilance Centre
A governmentally recognised centre (or integrated system)
within a country with the clinical and scientific expertise to
collect, collate, analyze and give advice on all information
related to drug safety.
Regulatory Agency or
Regulatory Authorities
Geopolitical entities have established agencies/authorities
responsible for regulating products used in health care. The
agencies are collectively referred to as regulatory agencies.
Reference Information
Model (RIM)
The HL7 information model from which all other information
models, e.g. RMIMS, and messages are derived.
Refined Message
Information Model
(RMIM)
An information structure that represents the requirements for a
set of messages.
Reporter The primary source of the information, e.g. a person who
initially reports the facts provided in the ICSR. This should be
distinguished from the sender of the message, though the
reporter could also be a sender.[ICH E2B(R2)]
Safety Message A safety message is an EDI message including the information
provided for one/more Individual Case Safety Reports contained
in one safety file exchanged between one sender and one
receiver in one message transaction.[EMA]
ICH ICSR Implementation Guide 12 April 2013
-164-
Term Definition
Medicinal Product Any substance or combination of substances presented as having
properties for treating or preventing disease in human beings
Any substance or combination of substances which might be
used in or administered to human beings either with a view to
restoring, correcting or modifying physiological functions by
exerting a pharmacological, immunological or metabolic action,
or to making a medical diagnosis.[ISO 11615]
Any substance or combination of substances which might be
administered to human beings or animals for treating or
preventing disease, with the view to making medical diagnosis or
to restore, correct or modify physiological functions [ENV
13607] [Directive 65/65/EEC, modified]
Non-proprietary Drug
(generic) Name
Drug name that is not protected by a trademark, usually
descriptive of its chemical structure sometimes called a public
name. International Non-proprietary Names (INN) allocated by
WHO, identify pharmaceutical substances or active
pharmaceutical ingredients. Each INN is a unique name that is
globally recognised and is public property. A non-proprietary
name is also known as a generic name. In the US, most generic
drug names are assigned by the US Adopted Name Council
(USAN).
Pharmacovigilance The science of activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
drug-related problem.[(2) WHO 2002 ]
Product A thing or things produced by labour or effort for a specific use
and marketed to satisfy a need or want. [HL7 Patient Safety]
Regional
Pharmacovigilance Centre
A governmentally recognised centre (or integrated system)
within a country with the clinical and scientific expertise to
collect, collate, analyze and give advice on all information
related to drug safety.
Regulatory Agency or
Regulatory Authorities
Geopolitical entities have established agencies/authorities
responsible for regulating products used in health care. The
agencies are collectively referred to as regulatory agencies.
Reference Information
Model (RIM)
The HL7 information model from which all other information
models, e.g. RMIMS, and messages are derived.
Refined Message
Information Model
(RMIM)
An information structure that represents the requirements for a
set of messages.
Reporter The primary source of the information, e.g. a person who
initially reports the facts provided in the ICSR. This should be
distinguished from the sender of the message, though the
reporter could also be a sender.[ICH E2B(R2)]
Safety Message A safety message is an EDI message including the information
provided for one/more Individual Case Safety Reports contained
in one safety file exchanged between one sender and one
receiver in one message transaction.[EMA]