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D.8.r.3b Pharmaceutical Product Identifier (PhPID)
User Guidance Based on D.8.r.1 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 D.8.r.2 is populated.
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.
D.8.r.4 Start Date
User Guidance This data element captures the start date of the medicinal product.
Imprecise dates can be used for both start and end dates.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.8.r.5 End Date
User Guidance This data element captures the start date of the medicinal product.
Imprecise dates can be used for both start and end dates.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
ICH ICSR Implementation Guide 12 April 2013
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D.8.r.3b Pharmaceutical Product Identifier (PhPID)
User Guidance Based on D.8.r.1 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 D.8.r.2 is populated.
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.
D.8.r.4 Start Date
User Guidance This data element captures the start date of the medicinal product.
Imprecise dates can be used for both start and end dates.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.8.r.5 End Date
User Guidance This data element captures the start date of the medicinal product.
Imprecise dates can be used for both start and end dates.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.