2 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: