Vault supports the MFDS-compliant Korea Drug Dictionary for domestic Case and Localized Case processing for Korea, allowing you to add Korean Ministry of Food and Drug Safety (MFDS) codes for External Product types of Case Products submittable to the MFDS. Veeva updates Vault’s Korea Drug Dictionary twice per year, in line with the WHODrug Link Korea schedule. New versions are automatically available in your Vault. You cannot utilize a previous version.
Note: To understand how Vault maps data to E2B files submittable to the MFDS, see E2B Generation: MFDS E2B(R3) Mapping.
Prerequisites
Your Admin must enable the Korea Drug Dictionary in your Vault. To cross-reference Korea Drug Dictionary codes to WHODrug codes, your Admin must also enable WHODrug Link Korea.
Browse and Code MFDS Products
When processing domestic Cases or Localized Cases for Korea, you can search the Korea Drug Dictionary to code External Products in the Case Products and Drug History sections. When adding Substances to Case Products, Vault adds the related substance codes per MFDS submission requirements.
Add an External Product via the Korea Drug Dictionary
To add an External Product via the Korea Drug Dictionary:
- Expand the relevant section and select Create:
- Case Products
- Case Drug History
- Access the Korea Drug Browser:
- For Case Products:
- Next to the reported Product field, select the Advanced Search (
) icon to access the Product Browser. - In the top-right corner of the Product Coding Browser window, select Launch Korea Drug.
- Next to the reported Product field, select the Advanced Search (
- For Case Drug Histories: Under the Korea Drug field, select Search Korea Drug.
- For Case Products:
- In the Korea Drug Browser window, update or enter the search term in the search bar, then select the search (
) icon. You can sort and filter the search results using the following options:
- Filter by certain columns:
- In the column header, select the filter () icon.
- Select the applicable values.
- Select Apply.
- Select a column header to sort results by that column.
- Select the Previous Page (<) and Next Page (>) icons to navigate through the pages of results.
- Select Clear All Filters to remove all filters.
- Select Clear Filter on a column header to remove the filter for that column.
- Filter by certain columns:
- Select the row for the applicable drug to code.
- Select Confirm.
Results depend on whether you added a Case Product or a Case Drug History.
Result: Add a Case Product
When you save the changes to the Case Product after selecting a product code, Vault adds the selected product, Local MPID, and manufacturer to the Korea Drug field. For Localized Case Products, Vault also populates the Registration Holder/Applicant fields. To remove the code, edit the record and select Clear Selection.
Result: Add a Case Drug History
After you save a drug code, Vault populates the Korea Drug field with the Korean drug name and the MFDS Medicinal Product Identifier, when available. Vault uses the Korean data to perform a dictionary lookup for the related English drug data, then populates the English product name and corresponding MPID code in the WHODrug field, as well as your Vault’s active WHODrug dictionary version and a message describing the result of the cross-reference.
When you save a domestic Case Drug History, Vault maps the Korea Drug and WHODrug values to corresponding Korean Localized Case Drug Histories.
To remove the code, edit the record and select Clear Selection.
Code Substances Reportable to Korea
After coding an External Product on a domestic Case reportable to Korea, Vault generates Case Product Substances and attempts to populate Korean substance data on the related Localized Case Product Substances. Vault performs a dictionary lookup for the related Korean data using the data on the Case Product Substance, then populates the Korean substance name and MFDS Substance ID in the Korea Drug field on the Localized Case Product Substance.
On all populated records, Vault populates a message describing the result of the cross-reference in the Korea Drug field.
Korea Drug Browser Columns
When searching for products in the Korea Drug Browser, Vault displays the following columns:
- Product Name (제품명)
- English Product Name (제품영문명)
- Company Name (업체명)
- English Company Name (업체영문명)
- Local MPID (품목기준코드)
- Cancel (취소/취하)
- Cancellation Date (취소/취하일자)
- Permission Date (허가일)
- Item Classification (전문의약품)
- Finished Product (완제/원료구분)
- Additives (첨가제 )
- Main Ingredient / Main Raw Material (주성분/주원료)
- English name of main ingredient (주성분영문명)
- Standard Code (표준코드)
- ATC Code (ATC코드)
Korea Drug Dictionary to WHODrug Cross-Referencing
If configured by your Admin, when coding External Products for domestic Cases for Korea and foreign Localized Cases reportable to the MFDS, Vault may cross-reference the selected code with the Korea Drug Dictionary and populate the corresponding field using the WHODrugLink Korea. For more details about Korea Drug Dictionary to WhoDrug cross-referencing, see Code WHODrug Products.