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ICH ICSR Implementation Guide 12 April 2013
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G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)
User Guidance Based on G.k.2.2 and the ICH M5 IG, this data element captures the most
specific identifier, being either the MPID or the PhPID. If an MPID or a
PhPID for the reported medicinal product is not available, these data
elements should be left blank.
Conformance Optional, not allowed if G.k.2.1.1 is provided.
Data Type Refer to M5 IG.
OID Refer to M5 IG.
Value Allowed Refer to M5 IG.
Business Rule(s)
Any given drug entry may have either MPID or PhPID, but NOT both.
When a MPID (G.k.2.1.1) is not available but a PhPID (G.k.2.1.2) is provided,
G.k.2.3.r (G.k.2.3.r.1 through G.k.2.3.r.3) should be blank.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source
User Guidance This data element captures the name of the medicinal product as used by
the reporter. It is recognized that a single product can have different
proprietary names in different countries, even when it is produced by a
single manufacturer.
Conformance Required
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.2.3.r Substance /Specified Substance Identifier and Strength (repeat as necessary)
If either of MPID or PhPID is not available, each active ingredient should be specified
individually by repeating this section. For each active ingredient, the ICH M5 substance /
specified substance TermID should be provided, if available. If the substance /specified
substance TermID is not available, the INN or the active ingredient name or the drug
identification code should be provided.
ICH ICSR Implementation Guide 12 April 2013
-119-
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)
User Guidance Based on G.k.2.2 and the ICH M5 IG, this data element captures the most
specific identifier, being either the MPID or the PhPID. If an MPID or a
PhPID for the reported medicinal product is not available, these data
elements should be left blank.
Conformance Optional, not allowed if G.k.2.1.1 is provided.
Data Type Refer to M5 IG.
OID Refer to M5 IG.
Value Allowed Refer to M5 IG.
Business Rule(s)
Any given drug entry may have either MPID or PhPID, but NOT both.
When a MPID (G.k.2.1.1) is not available but a PhPID (G.k.2.1.2) is provided,
G.k.2.3.r (G.k.2.3.r.1 through G.k.2.3.r.3) should be blank.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source
User Guidance This data element captures the name of the medicinal product as used by
the reporter. It is recognized that a single product can have different
proprietary names in different countries, even when it is produced by a
single manufacturer.
Conformance Required
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.2.3.r Substance /Specified Substance Identifier and Strength (repeat as necessary)
If either of MPID or PhPID is not available, each active ingredient should be specified
individually by repeating this section. For each active ingredient, the ICH M5 substance /
specified substance TermID should be provided, if available. If the substance /specified
substance TermID is not available, the INN or the active ingredient name or the drug
identification code should be provided.