Ennov InSight 7.2 Release Notes (Cumulative)

Entity Fields and Columns Added: Ennov InSight 7.2

The following tables describe fields and columns that were added in this release. These include the fields and column that were added to support IDMP data capture.

Tabs

Table 1. My Home
Field/Column/Option Name Field Type Description Business Rules
  • Application Code
  • Application Name
  • Registration
  • Medicinal Product Name
  • Product
  • Authorised Pharmaceutical Form
Hyperlink, read-only text (populated automatically) The Medicinal Products tab is added on the My Home page and includes all the respective columns.
  • Application Code
  • Application Name
  • Sequence
  • Medicinal Product
  • Product
  • Medicinal Product Action
  • Regulatory Submission Type
Hyperlink, read-only text (populated automatically) The Medicinal Product Actions tab is added on the My Home page and includes all the respective columns.

Entities

Table 2. Product Family
Field/Column/Option Name Field Type Description Business Rules
EU CT Number Text field The CT Shared Data Attributes page now includes this field.
Table 3. Application
Field/Column/Option Name Field Type Description Business Rules
  • License Root Number
  • PMSID
  • Registration Country
  • Related MAH(s)
  • Related Registration(s)
  • Related Sequence(
Read-only text (populated automatically) The IDMP read-only tab is removed from the Registration and added at the Application level. The Application Attributes page now includes this tab with the new respective columns.
Medicinal Product N/A The Medicinal Product entity and all the associated child entities are moved from the Registration to the Application level. The Application Attributes page now includes the Medicinal Product tab with:
  • Medicinal Product Names
  • Pharmaceutical Products
  • Product Cross-References
  • MPIDs
  • Tasks
  • References
  • Notifications
Medicinal Product Action N/A The Medicinal Product Action and Attached Document entities are removed from the Registration and added at the Application level.
Medicinal Product Action N/A The Medicinal Product Action Attributes page now includes Tasks, References and Notifications.
Table 4. Events
Field/Column/Option Name Field Type Description Business Rules
  • Entity Name
  • Sub Entity Name
  • Attribute Name
  • Change Value
  • Approval Status
  • Approval Status Date
Hyperlink, read-only text (populated automatically) The Event Attributes page now includes the Pending Changes tab with respective columns. For IDMP data generation: in the Pending Changes tab you can enter values for pending changes for Application, Medicinal Product and Registration, Registration Package Set, Registration Package Set Country.
Table 5. Component
Field/Option Name Field Type Description Business Rules
Concentration Measure Type Drop-down list The Component > Active Ingredient Attributes and Reference Active Ingredient Attributes pages now include this field under IDMP Concentration Strength. All the active values from Data Administration > Other > Concentration Measure Type Values are displayed for this field.
Table 6. Pharmaceutical Product
Field/Option Name Field Type Description Business Rules
Concentration Measure Type Drop-down list This field is now available under IDMP Concentration Strength section for the following pages:
  • Pharmaceutical Product > Active Ingredient Attributes and Reference Active Ingredient Attributes.
  • Pharmaceutical Product > Substance Attributes and Reference Substance Attributes.
All the active values from Data Administration > Other > Concentration Measure Type Values are displayed for this field.
  • Version
  • Version Date
Text field, date The PhPIDs tab and PhPID Attributes page now includes the respective fields and columns.
Table 7. Manufactured Item
Field/Column/Option Name Field Type Description Business Rules
Unit of Presentation Read-only text (populated automatically) The Manufactured Items entity tab (Component ) includes this column.
Concentration Measure Type Drop-down list The Manufactured Item > Active Ingredient Attributes and Reference Active Ingredient Attributes pages now include this field under IDMP Concentration Strength. This field is now available under IDMP Concentration Strength section for the following pages:
  • Manufactured Item > Active Ingredient Attributes and Reference Active Ingredient Attributes
  • Manufactured Item > Substance Attributes and Reference Substance Attributes.
All the active values from Data Administration > Other > Concentration Measure Type Values are displayed for this field.
Table 8. Medicinal Product
Field/Column/Option Name Field Type Description Business Rules
  • Full Indication Text
  • Full Indication Language
  • Country
  • Registrations
  • License Root Number
Date, multi-select, drop-down list, text field The Medicinal Product Attributes page now includes these fields.
  • Application Code
  • Application Name
  • Medicinal Product Name
  • PMSID
  • Country
  • Date of First Approval
  • Procedure Start Date
  • Procedure End Date
Hyperlink, text field, drop-down list, read-only text (populated automatically), date The Medicinal Product Attributes page now includes the PMSID tab with the respective fields and columns.
Table 9. Medicinal Product Name
Field/Option Name Field Type Description Business Rules
  • Date of First Approval
  • Full Indication Text
Date The Medicinal Product Name Attributes page now includes the respective fields.
Table 10. Product Detail Sets
Field/Option Name Field Type Description Business Rules
  • Origin of Substance
  • Composition Grouping Description
Drop-down list, text field The following pages now include the respective fields:
  • Active Ingredient Detail Attributes
  • Substance Detail Attributes
Device Quantity Unit Drop-down list The Package Detail Attributes page now includes the respective field. All the active values from Data Administration > Other > Unit of Presentation Values are displayed for this field.
Concentration Measure Type Drop-down list This field is now available under IDMP Concentration Strength section for the following pages:
  • Product Detail Set > Substance Detail Attributes
  • Product Detail Set Template > Substance Detail Attributes
  • Product Detail Set > Flu Strain Attributes
  • Product Detail Set Template > Flu Strain Attributes
All the active values from Data Administration > Other > Concentration Measure Type Values are displayed for this field.
Table 11. Registrations
Field/Option Name Field Type Description Business Rules
  • Application Code
  • Application Name
  • License Code
  • Product Detail Set Name
  • Package Set Name
  • Country
  • PCID
  • Version
  • Version Date
Hyperlink, drop-down list, text field, date The Registration- Package Sets Attributes page now includes the PCID tab with the respective fields and columns.
  • Application Code
  • Application Name
  • License Code
  • Product Detail Set Name
  • Package Set Name
  • Country
  • Currently marketed in this country?
  • Data Carrier Type
  • Data Carrier ID
  • Data Carrier Description
  • Data Carrier Language
  • Status
  • Status Date
Hyperlink, drop-down list, text field, date The Registrations Package Set-Country Attributes page now includes a new Data Carrier Identifiers tab with the respective fields and columns. N/A
MAH/Organisation Drop-down list The Registration- Package Sets Attributes page now includes the respective field.
Table 12. Reference Active Ingredient
Field/Option Name Field Type Description Business Rules
  • Use for xEVMPD
  • Create Another Reference Active Ingredient
Drop-down list, button The Create Reference Active Ingredient page now includes the respective fields.

The Use for xEVMPD field is available for Reference Active Ingredient Attributes for Pharmaceutical Product only and is added to the XEVMPD Submission Wizard logic to take into consideration only that Pharmaceutical Product Reference Active Ingredient which has a field value as a Yes.