Substances and Reference Substances

Substances are associated to entities to provide additional data points for the product structure.

Substances are associated to entities. Reference substances are associated to the substances of an entity. It is not mandatory for an entity to have substances and reference substances. Substances are associated to the following entities:

— Pharmaceutical Product — Manufactured Item

The following guidelines apply when associating a substance to an entity:

— You must have the same user privileges required for adding a product.

— The entity type must be pharmaceutical, pharmaceutical-medical device, or veterinary, and the product family type for the associated product family must be flu vaccine, pharmaceutical, pharmaceuticalmedical device, or veterinary.

— Associating substances to an entity allows Identification of Medicinal Product (IDMP) data standards to maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data. Ennov InSight enables you to view, create, modify, and delete the substances entity.

— The component type must be pharmaceutical, pharmaceutical-medical device, or veterinary, and the product family type for the associated product family must also be pharmaceutical, pharmaceutical-medical device, or veterinary.

— Multiple substances can be added to the entity.

— A substance can have only one reference substance.