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G.k.3.2 Country of Authorisation /Application
User Guidance If MPID (G.k.2.1.1)is unavailable, this data element captures the country
where the drug was authorised when the case report is sent to that country
if known.
Conformance Optional, but required if G.k.3.1 is provided.
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
BusinessRule(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.
G.k.3.3 Name of Holder /Applicant
User Guidance This data element captures the name of the licence holder as indicated on
the package.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.4.r Dosage and Relevant Information (repeat as necessary)
Data elements G.k.4.r.1 through G.k.4.r.3 should be used to provide dosage information. For
example, 5mg (in one dose) every other day, subsections G.k.4.r.1 through G.k.4.r.3 would be 5,
mg, 2, day, respectively. In the same way, 50mg daily would be 50, mg, 1, day, respectively.
For multiple dosages within a given interval, a fraction of that interval is given. For example,
5mg four times in one day (QID), subsections G.k.4.r.1 through G.k.4.r.3 would be 5, mg, 0.25,
day, respectively.
For fixed dose combination drugs dose unit (G.k.4.r.1b) should be provided as arbitrary unit
{DF} instead of mg.
In the case of a parent-child/foetus report, the dosage section applies to the known parental dose.
For example, if the mother took the drug(s) suspected of causing adverse reaction(s) in a nursing
infant, then the dosage information (G.k.4.r.1 to G.k.4.r.11.2) relates to how the mother took the
medication(s). If the mother is the source of the suspect drug(s) then the dosage information
reflects how the mother ingested or was administered the drug(s). If a father is the source of the
suspect drug(s) then the additional information on drug (G.k.10) is provided. The case narrative
(H.1) should describe the entire case, including the father’s information.
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G.k.3.2 Country of Authorisation /Application
User Guidance If MPID (G.k.2.1.1)is unavailable, this data element captures the country
where the drug was authorised when the case report is sent to that country
if known.
Conformance Optional, but required if G.k.3.1 is provided.
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
BusinessRule(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.
G.k.3.3 Name of Holder /Applicant
User Guidance This data element captures the name of the licence holder as indicated on
the package.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.4.r Dosage and Relevant Information (repeat as necessary)
Data elements G.k.4.r.1 through G.k.4.r.3 should be used to provide dosage information. For
example, 5mg (in one dose) every other day, subsections G.k.4.r.1 through G.k.4.r.3 would be 5,
mg, 2, day, respectively. In the same way, 50mg daily would be 50, mg, 1, day, respectively.
For multiple dosages within a given interval, a fraction of that interval is given. For example,
5mg four times in one day (QID), subsections G.k.4.r.1 through G.k.4.r.3 would be 5, mg, 0.25,
day, respectively.
For fixed dose combination drugs dose unit (G.k.4.r.1b) should be provided as arbitrary unit
{DF} instead of mg.
In the case of a parent-child/foetus report, the dosage section applies to the known parental dose.
For example, if the mother took the drug(s) suspected of causing adverse reaction(s) in a nursing
infant, then the dosage information (G.k.4.r.1 to G.k.4.r.11.2) relates to how the mother took the
medication(s). If the mother is the source of the suspect drug(s) then the dosage information
reflects how the mother ingested or was administered the drug(s). If a father is the source of the
suspect drug(s) then the additional information on drug (G.k.10) is provided. The case narrative
(H.1) should describe the entire case, including the father’s information.