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ICH ICSR Implementation Guide 12 April 2013
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3.2.1 Terminologies and Vocabularies Employed by the ICSR Message
3.2.1.1 ISO Identification of Medicinal Products (IDMP)
In collaboration with the ICH M5 EWG, ISO developed a set of standards to enhance exchange
of information for medicinal products. These include identifiers to allow mapping of
international terminologies for routes of administration, dosage forms and units of measurement,
as well as controlled identifiers to enable cross-border identification of pharmaceutical products
and mapping to their core components, e.g. substances.
The ICH M5 Implementation Guide for the IDentification of Medicinal Products (IDMP) will
be available after this IG is published. The ISO IDMP standards, the basis for this ICH M5 IG,
include:
ISO 11238 Health informatics － Identification of medicinal products－Data elements and
structures for the unique identification and exchange of regulated information on
substances
ISO 11239 Health Informatics － Identification of medicinal products －Data elements and
structures for the unique identification and exchange of regulated information on
pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO 11240 Health informatics － Identification of medicinal products －Data elements and
structures for the unique identification and exchange of units of measurement
ISO 11615 Health Informatics －Identification of medicinal products – Data elements and
structures for the unique identification and exchange of regulated medicinal product
information
ISO 11616 Health informatics － Identification of medicinal products－Data elements and
structures for the unique identification and exchange of regulated pharmaceutical product
information
The data elements that use the ICH M5 IDMP vocabularies are described in Section 3.4 of this
document. However, where ICH M5 IDMP terms and/or identifiers (e.g. codes) are not
available, the IG provides instructions for alternate meanings to code the information until the
availability of the ICH M5 IG.
Until the M5 controlled vocabularies for the IDMP are available, temporary rules
are applied to the data elements. Terms and identifiers (codes) may be provided by
each region until the standard M5 IDMP controlled vocabularies are implemented.
ICH ICSR Implementation Guide 12 April 2013
-24-
3.2.1 Terminologies and Vocabularies Employed by the ICSR Message
3.2.1.1 ISO Identification of Medicinal Products (IDMP)
In collaboration with the ICH M5 EWG, ISO developed a set of standards to enhance exchange
of information for medicinal products. These include identifiers to allow mapping of
international terminologies for routes of administration, dosage forms and units of measurement,
as well as controlled identifiers to enable cross-border identification of pharmaceutical products
and mapping to their core components, e.g. substances.
The ICH M5 Implementation Guide for the IDentification of Medicinal Products (IDMP) will
be available after this IG is published. The ISO IDMP standards, the basis for this ICH M5 IG,
include:
ISO 11238 Health informatics － Identification of medicinal products－Data elements and
structures for the unique identification and exchange of regulated information on
substances
ISO 11239 Health Informatics － Identification of medicinal products －Data elements and
structures for the unique identification and exchange of regulated information on
pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO 11240 Health informatics － Identification of medicinal products －Data elements and
structures for the unique identification and exchange of units of measurement
ISO 11615 Health Informatics －Identification of medicinal products – Data elements and
structures for the unique identification and exchange of regulated medicinal product
information
ISO 11616 Health informatics － Identification of medicinal products－Data elements and
structures for the unique identification and exchange of regulated pharmaceutical product
information
The data elements that use the ICH M5 IDMP vocabularies are described in Section 3.4 of this
document. However, where ICH M5 IDMP terms and/or identifiers (e.g. codes) are not
available, the IG provides instructions for alternate meanings to code the information until the
availability of the ICH M5 IG.
Until the M5 controlled vocabularies for the IDMP are available, temporary rules
are applied to the data elements. Terms and identifiers (codes) may be provided by
each region until the standard M5 IDMP controlled vocabularies are implemented.