9 Configure Single Entity Combination Products

A product comprised of two or more regulated components (e.g. drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined and produced as a single entity is known as a Single Entity Combination Product.

The Tetanus Pen is one of example for single entity combination product, as the product comprises of Tetanus (vaccine) and an injector pen (device).

In Oracle Argus Safety, vaccine and device components can be within the same product to configure Single Entity Combination Products. Follow these steps to configure Single Entity Combination Products:

1. Click Business Configuration > Products and Licenses > Add New Family.
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 the required mandatory data for creating a Vaccine license 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. Create a Constituent Device License by clicking Add New License.
8. Enter required mandatory data for creating a vaccine license as below, and save the License:
   1. Authorization country = UNITED STATES or WORLD
   2. License Type = Marketed Device
   3. License # = <License number>