Calyx RIM for Registrations

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 Calyx RIM 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.

Components

Products can be tracked at a component level of detail. Components are the parts that build the final product. A product may be made up of one or multiple components, and those components may or may not contain active ingredients. As best practice, it is recommended to always create one component for every product.

Active Ingredients

The active ingredients for a product are tracked at the component level, including the strength measure of the active ingredient in a component. When you define active ingredients for the components of a product, you are limited to the active ingredients that were defined at the product family level.

Reference Active Ingredients

The reference active ingredients for a component active ingredients are tracked at the components level, including the strength measure of the reference active ingredient in a component. You must have at least one active ingredient associated with a component to be able to associate a reference active ingredient.