3 Configure Co-packaged Combination Products

Two or more separate products packaged together in a single package or as a unit comprising of drug and device products, device and biological products, or biological and drug products, is known as Co-Packaged Combination Products.

Inhaler with filled vaccine cartridge is one of example for co-packaged combination product, as it comprises of 2 components, an inhaler device and vaccine that are within a single package.

In Oracle Argus Safety, vaccines and devices can be added to products belonging to different families to configure a Co-Packaged Combination Product. Follow these steps to configure Single Entity Combination Products:

1. Click Business Configuration > Products and Licenses > Add New Family, for creating family for the vaccine.
2. Enter required mandatory data and save the family.
3. Click Add New Product.
4. Enter required mandatory data and save the Product.
5. Create a Primary mode of action product license by clicking Add New License.
6. Enter required mandatory data for creating a Vaccine license such as below, and save the license:
   1. Authorization country = UNITED STATES
   2. License Type = Marketed Vaccine
   3. License Number can be entered in either of the following ways:
      1. License # = BLA<License number>
      2. Application type=BLA
      3. License # = <License number>
7. To create family for the Device, click Business Configuration > Products and Licenses > Add New Family.
   The N/A value can be added in Ingredient codelist and the same can be selected for the Device family.
8. Enter the required mandatory data and save the family.
9. Click Add New Product.
10. Enter required mandatory data and save the Product.
    The N/A value can be added in the Formulation codelist and the same can be selected for the Device Product.
11. Create a Constituent Device License by clicking Add New License.
12. Enter the required mandatory data for creating a Drug license as the below, and save the license.
    1. Authorization country = UNITED STATES or WORLD
    2. License Type = Marketed Device
    3. License # = <License number>