Market Authorization Holder Populating With Incorrect Company (Doc ID 3037774.1)

Last updated on JULY 31, 2024

Applies to:

Goal

On the Products tab, the Market Authorization Holder (MAH) is populated with the incorrect Manufacturer.

The E2B is pulling the incorrect MAH from the Product tab instead of the correct information as configured in Product Configuration.

STEPS TO REPEAT:
Created Study SJH_Study1 with two Arms
1st Arm (SJH_STDY_BLND) with five Products
Primary License: IND1234  
Sea Breeze PROD (Aerosol / 100 / milligram)                  - License: IND1234     - Manufacture: Oracle
Sea Breeze PROD (Aerosol / 25 / milligram)                  - License: IND1234     - Manufacture: Oracle
Crab Patty (Tablet / 15 / milligram/kilogram)                 - License: NDA123456 - Manufacture: Lisa Limited
Magic nebulizer (Aerosol / / )                                - License: USA      - Manufacture: Antibiotice Iasi
Metformin 500 mg (Aerosol / 500 / mega-international unit)   - License:SJH500       - Manufacture: OraclePharma

2nd Arm (Part2) with three products
Primary License: Null  
Sea Breeze PROD (Aerosol / 100 / milligram)                   - License: IND1234     - Manufacture: Oracle
Sea Breeze PROD (Aerosol / 25 / milligram)                    - License: IND1234     - Manufacture: Oracle
Metformin 500 mg (Aerosol / 500 / mega-international unit)   - License:SJH500       - Manufacture: OraclePharma

The MAH and Manufacturer were both configured the same

Create new Study Case: 24US001653
Products tab
Market Authorization Holder is populated with Oracle
Select Study Drug: Crab Patty
Expect MAH to change to Lisa Limited, it does not change

Solution

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