Active Ingredients and Reference Active Ingredients

Active Ingredients and Reference Active Ingredients are associated to entities to provide data points for the product structure.

Active ingredients are associated to entities. Reference active ingredients are associated to the active ingredients of an entity. It is not mandatory for an entity to have active ingredients and reference active ingredients. Active Ingredients are associated to the following entities:

— Component

— Pharmaceutical Product — Manufactured Item

The following guidelines apply when associating an active ingredient 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.

— Only active ingredients that are associated to the product family are available to be associated with component active ingredient.

— All active substances from Data Administration are available to be associated with reference active ingredients.

— Active ingredients cannot be associated with a component once a PDS template or application is associated with a product.

— When associating an active ingredient, you enter strength value only for an active ingredient selected from the Active Ingredient Name drop-down list.

— Not all values are required to be populated. However, you must enter the Concentration Measure Type, Low Amount Numerator Value and Low Amount Numerator Unit or any IDMP Strength field values. — Multiple Reference Active Ingredient can be added to:

• Manufactured Item Active Ingredients
• Pharmaceutical Product
• Component Active Ingredients