Ennov InSight 7.1 XEVMPD

Starting with Ennov InSight 7.1, the XEVMPD Submission wizard includes the following updates:

• Instead of Component Active Ingredient/Component Reference Active Ingredient, the values of Active Ingredient will be taken from Pharmaceutical Product Reference Active Ingredient, if present. Else, it will be taken from Pharmaceutical Product Active Ingredient.
• The Pharmaceutical Product information, as well as the entities data associated with it and with a Product, will be taken for XEVMPD submission. This is based on the Pharmaceutical Product association with Full Product Presentation and not from the PDS as it was before the new updates. For details of the Full Product Presentation association with Pharmaceutical Product after migration, see the Full Product Presentation section of this document.

The following rules apply when migrating XEVMPD strength data for Component Active Ingredient/Component Reference Active Ingredient and affects Full Product Presentation when the Use Reference Active Ingredient field is deleted.:

• When there is a Component Active Ingredient with values for XEVMPD strength fields and there is a Full Product Presentation with the Use Reference Active Ingredient for XEVMPD with No or NULL for the EU Country package set registration for the Product where component with active ingredient is assigned to, a Pharmaceutical Product Active Ingredient with XEVMPD data will be created after the migration.
• When there is a Component Active Ingredient with Reference Active Ingredient with values for XEVMPD strength fields and there is a Full Product Presentation with the Use Reference Active Ingredient for XEVMPD with Yes for the EU Country package set registration for the Product where component with active ingredient is assigned to, a Pharmaceutical Product Active Ingredient with Reference Active Ingredient with XEVMPD data will be created after migration.