Ennov InSight 7.1 Data Migration Documentation

Ennov InSight 7.1 Registrations (Package Set Type)

New features and fields are included in Ennov InSight 7.1 to conform to the regulatory requirements.

Registration-Package Sets

To support IDMP, Ennov InSight 7.1 now includes:
  • Legal Basis, a new drop-down list under Package Set Name
  • Authorisation Status, a new drop-down list under Legal Basis
  • Authorisation Status Date, a new date field under Authorisation Status
  • Status, a new display-only field with data driven from PDS Package Set Detail
  • Status Date, a new display only field with data driven from PDS Package Set Detail
  • EU Presentation Number renamed to Package Set License Code

The grid view for this entity is updated for Ennov InSight 7.1 release.

Package Set-Country

To support IDMP, Ennov InSight 7.1 now includes:
  • Data Carrier Type, a new drop-down list under Legal Status of Supply
  • Data Carrier Identifier, a new text field under Data Carrier Type
  • Data Carrier Language, a new drop-down list under Data Carrier Identifier
  • Risk of Supply Shortage, a new field with Yes or No selection.
  • Risk of Supply Shortage Comment, a new text field.
  • Marketing Status Reason, a new drop-down list with values from Data Administration > Marketing Status Reasons Values.

Package Set-Package Description

To support IDMP, Ennov InSight 7.1 now includes a new Reference Substance enity, a child entity of Registration Package Sets.