Ennov InSight Registrations 7.3

Associate a Reference Active Ingredient with a Component Active Ingredient

This procedure associates a reference active ingredient with a component active ingredient. As with an active ingredient, this procedure applies to pharmaceutical, pharmaceutical-medical device, and veterinary component types.

A reference active ingredient is created for use in the XEVMPD Submission at a later time, when needed.

Reference active ingredient creation process features:
  • When associating a reference active ingredient, you can type Strength values only for those ingredients which you want to see under a component.
  • Not all values are required to be populated. However, if you fill at least one Strength value for a reference active ingredient, you must complete the rest of the values. For example, if you selected Concentration Measure Type, you need to also fill Low Amount Numerator Value and Low Amount Numerator Unit to save the changes.
To associate a reference active ingredient with a component active ingredient:
  1. Click a link for the component for which you want to associate a reference active ingredient.
  2. Click the Reference Active Ingredients tab.
  3. Click Create.
    The Create Reference Active Ingredients page appears. Under Strengths, all active ingredients created for a component and associated with the related product family are available for association with the reference active ingredient.
  4. For each reference active ingredient that you want to associate with the component active ingredient, type values for reference active ingredient concentration and measure fields.
  5. Do one of the following:
    • Save, to save the reference active ingredient settings.
    • Save and Add New Component, to save your settings and create a new component.
    When the reference active ingredient is saved, you are automatically returned to the component attributes page.