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ICH ICSR Implementation Guide 12 April 2013
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G.k.2.3.r.3b Strength (unit)
User Guidance This data element captures the unit for G.k.2.3.r.3a.
Conformance Optional, but required if G.k.2.3.r.3a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.25
Value Allowed Constrained UCUM codes
Business Rule(s)
G.k.2.4 Identification of the Country Where the Drug Was Obtained
User Guidance This data element captures the country where the medicinal was obtained.
Conformance Optional
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
Business Rule(s)
A two character country code will be used in all instances.
The country code EU exists in the ISO 3166 country code list as an
exceptional reservation code to support any application that needs to
represent the name European Union.In this case, ‘EU’ will be accepted as
the country code.
Technically, data type of G.k.2.4 is defined as string instead of code by HL7. To
ensure data quality, this IG requires use of ISO country code instead of free text.
ICH ICSR Implementation Guide 12 April 2013
-121-
G.k.2.3.r.3b Strength (unit)
User Guidance This data element captures the unit for G.k.2.3.r.3a.
Conformance Optional, but required if G.k.2.3.r.3a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.25
Value Allowed Constrained UCUM codes
Business Rule(s)
G.k.2.4 Identification of the Country Where the Drug Was Obtained
User Guidance This data element captures the country where the medicinal was obtained.
Conformance Optional
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
Business Rule(s)
A two character country code will be used in all instances.
The country code EU exists in the ISO 3166 country code list as an
exceptional reservation code to support any application that needs to
represent the name European Union.In this case, ‘EU’ will be accepted as
the country code.
Technically, data type of G.k.2.4 is defined as string instead of code by HL7. To
ensure data quality, this IG requires use of ISO country code instead of free text.