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ICH ICSR Implementation Guide 12 April 2013
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G.k.2.1 Medicinal Product Unique Identifier /Pharmaceutical Product Unique Identifier
G.k.2.1.1a MPID Version Date /Number
User Guidance This data element provides the version date for G.k.2.1.1b.
Conformance Optional, but required if G.k.2.1.1b is provided.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
G.k.2.1.1b Medicinal Product Identifier (MPID)
User Guidance Based on G.k.2.2 and the ICH M5 IDMP guideline, 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
Data Type Refer to M5 IG.
OID Refer to M5 IG.
Value Allowed Refer to M5 IG.
Business Rule(s)
When a MPID (G.k.2.1.1) is provided, the remainder of Section G.k.2.1 and
G.k.2.3.r (G.k.2.3.r.1 through G.k.2.3.r.3) should be blank.
G.k.2.1.2a PhPID Version Date/Number
User Guidance This data element providesthe version date for G.k.2.1.2b.
Conformance Optional, but required if G.k.2.1.2b is provided.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)