6 WHO codes for Products and Ingredients in Post-marketed Foreign Cases
For post-marketed foreign cases, it is mandatory to transmit the WHO Medicinal Product ID for every Company and Non-company Product, and WHO CAS Number for every Ingredient of the Product in the KR specific regional data elements (outlined in the table below) in E2B(R3) report as per the Business rules.
Note:
Based on discussion with MFDS, only WHO Global C3 coding is accepted while submitting foreign ICSRs. ICSRs using other formats (e.g. B3 format) will be rejected.| Element ID | Element Description | Data Original |
|---|---|---|
| D.8.r.1.KR.1a | WHO-DD version | WHO-DD version |
| D.8.r.1.KR.1b | Medicinal Product ID
(Patient Past drug Therapy) |
WHO Medicinal Product ID |
| D.10.8.r.1.KR.1a | WHO-DD version | WHO-DD version |
| D.10.8.r.1.KR.1b | Medicinal Product ID
(Parent Past drug Therapy) |
WHO Medicinal Product ID |
| G.k.2.1.KR.1a | WHO-DD version | WHO-DD version |
| G.k.2.1.KR.1b | Medicinal Product ID
(Suspect/Concomitant/Interacting Products) |
WHO Medicinal Product ID |
| G.k.2.3.r.1.KR.1a | WHO-DD version | WHO-DD version |
| G.k.2.3.r.1.KR.1b | Substance ID
(Ingredients of Suspect/Concomitant/Interacting Products) |
WHO CAS Number |
For more information, see: