Ennov InSight Registrations 7.2

Product Families

A product family is the highest level in the Ennov InSight registration hierarchy. Product families are the umbrella under which all other entities, such as products, components, applications, and registrations reside.

Product families are further differentiated by product family type. Product family types include pharmaceutical, medical device, a pharmaceutical-medical device combination, flu vaccines, and veterinary.

Pharmaceutical, pharmaceutical-medical device, and veterinary product families are further characterized by the active ingredients. Flu vaccine product families are characterized by active ingredient placeholders for which actual active ingredients can be assigned at the product detail set level. By nature, medical device product families are not characterized by an active ingredient, so no association is needed.

Note: As a best practice, assign active ingredients when creating a pharmaceutical, pharmaceutical-medical device, or veterinary product family. When creating a flu vaccine product family, assign active ingredient place holders. If you created a product without the components, PDSs, or PDS templates related to this product before assigning an active ingredient, you can associate or disassociate the active ingredients in a product family. If there are multiple products associated to a product family and one of them has a component, PDS, or PDS template, you will not be able to associate or disassociate active ingredients on the Product Family Attributes page.

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

  • Registration Planning and Tracking (RPT)
  • Product Detail Management (PDM)

You may also view product families if you have the following modules:

  • Electronic Lifecycle Publishing (ELP)
  • Registered Document Analysis (RDA)
  • Submission Planning and Tracking (SPT)

Creating Product Families

Only an administrator can create a product family. Product families are created in Liquent Data Administration. See: Create a Product Family in the Adminstrative Activites section of the Liquent InSight Administration guide.

After a product family is created, and if you have the appropriate security privileges, you can use the Modify Product Family page to define attributes for the product family, like active ingredients or PSUR attributes.