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

In Oracle Argus Safety, drugs and devices can be added to products belonging to different families to then configure a Co-Packaged Combination Product:

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