3 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. Insulin Pen is one of example for single entity combination product, as the product comprises of insulin (drug) and an injector pen (device).

In Oracle Argus Safety, drug and device components can be within the same product to configure Single Entity Combination Products:

1. Click Business Configuration > Products and Licenses > Add New Family.
2. Enter the required mandatory data and save the family.
3. Click Add New Product.
4. Enter the required mandatory data and save the Product, ensuring that the 3-character Device Code is entered for 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. Create a Constituent Device License by clicking Add New License.
8. 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>