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J Drug Code Does Not Display For Hidden Link License When It's Non-Primary Product (Doc ID 2890226.1)

Last updated on AUGUST 18, 2022

Applies to:

Oracle Argus Safety Japan - Version 8.2.2 and later
Information in this document applies to any platform.

Symptoms

There is a case with several products, let's say product(A) and product(B) and both products have the Japan MKT license.

For example, the Japan MKT license in product(B) is the hidden link license from product (C) and there is no other Japan MKT license in product (B).

Therefore, product(B) does not have the J-Drug Code in Argus Console > Business Configuration > Products and License.

PMDA E2B (R3) is scheduled to Japan MKT licese for product(A).

When viewing this report, J-Drug Code from product(A) which is the primary product displays properly in G.k.2.2 under first G.k. section.

However, in 2nd G.k section for non-primary product, English license name from product(B) displays in G.k.2.2 which is the issue.

It is supposed to populate J-drug Code from the product (C) since this is the hidden link license of the product (C).

Due to this, the user receives the error ACK with ACK code 71200300514.

 

Steps:

1. Argus Console > Business Configuration > Products and License
2. The product and license are configured as follows:

(For example)
Product (A) / J-Drug code : 12345689
    - US MKT license
    - JP MKT license
 
Product (B) / J-Drug code : <Blank>
    - US MKT license
    - JP MKT license is the hidden link from product (C)

Product (C) / J-Drug code : 987654321
    - JP MKT license

3. Create a new case with the license from product(A)
4. Go to the product tab
5. Confirm that J-Drug Code "12345689" is displayed

6. Go to product > (New) tab
7. Press the [Select] button
8. Select and add the license from Product(B)
9. Confirm that J-Drug Code is a blank field because product(B) does not have the J-Drug Code

10. Enter the mandatory information for PMDA E2B(R3)
11. Save the case
12. Schedule PMDA E2B(R3) to Japan MKT license for product(A)
13. Save the case
14. Click the draft link

1st G.K section
--------------
<drug>
  <druguniversallyuniqueid>xxxx</druguniversallyuniqueid>
  <drugcharacterization>1</drugcharacterization>
  <mhlwstatuscategoryofnewdrugs>5</mhlwstatuscategoryofnewdrugs>
  <medicinalproduct>12345689</medicinalproduct>
--------------
J-Drug code "12345689" for product(A) is displayed properly in G.k.2.2<medicinalproduct>

2nd G.k section
--------------
<drug>
  <druguniversallyuniqueid>xxxx</druguniversallyuniqueid>
  <drugcharacterization>1</drugcharacterization>
  <medicinalproduct>English license name</medicinalproduct>
--------------

English license name displays because the product(B) does not have the J-Drug Code.
The Japan license under product(B) is the hidden link license from product(C). Therefore, J-Drug code from product(C) should display.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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