Products

A product is a marketed substance that includes a dosage, form, and strength. A product family can have many products.

A product is associated with a product family and is therefore represented under product family in the Ennov InSight registration hierarchy.

For a pharmaceutical product family, a product is the definition of the dosage form and strength, for example,

250 mg tablet, 80 mg/ml solution. For a medical device product family, a product might be a syringe or an inhaler. For example, a syringe would include the products that identify the various kinds of syringes, for example, blood collection syringes, safety syringes, and so on.

Note: To view a product, you must have the appropriate security privileges for the product family. To view all entities associated with a product (applications, events, registrations, and so on), you must have security privileges to the countries associated with the lower-level entities.

You must have one of the following modules to perform product activities:

— Product Detail Management

— Registration Planning and Tracking Pharmaceutical Products

Pharmaceutical products are tracked at the product level. The Pharmaceutical Product entity is required by the European Medicines Agency (EMA) for XEVMPD schema support.