Ennov InSight RIM 7.1.15 Release Notes

Ennov InSight 7.1.15 Release Notes

The Release Notes contain information about updated files, new functionality, resolved issues, and any open issues or workarounds in this release of Ennov InSight 7.1.15

The details in these Release Notes supersede all similar details that appear anywhere else in this release of the product or its other documentation.

Regulatory Updates

Ennov InSight 7.1.15 now supports World Health Organization (WHO) v1.0.

For more information about new WHO values, extensions, and rules, see:

  • Ennov InSight Data Migration 7.1 >Ennov InSight 7.1.15 Updates
  • Ennov InSight Publishing 7.1 > Use eCTD Templates > eCTD Template Files
  • Ennov InSight Publishing 7.1 > Submissions > eCTD Attributes World Health Organization
  • Ennov InSight Publishing 7.1 > Extension Type and Usage > Extension Type: Regional Folders > WHO
  • Ennov InSight Publishing 7.1 > Use eCTD Templates > Mapped eCTD Template Profiles
  • Ennov InSight Publishing 7.1 > Extended Attributes Name, Type, and Version
  • Ennov InSight Publishing 7.1 > Extension Types and Usage
  • Ennov InSight Administration 7.1 > Data Administration > Data Administration Selection Lists: Submission Maintenance
  • Ennov InSight Administration 7.1 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for WHO
  • Ennov InSight Administration 7.1 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for WHO > eCTD Sub-Filing Types for WHO (Includes EUL-Abridged (Emergency Use Listing) Application Sub Type Value)
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Groups of Extensions by Version and Country
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Folder Extensions > m1-who v.1.0

Ennov InSight 7.1.15 now supports European Union (EU) v3.1 submissions.

For more information about new EU values, extensions, and rules, see:

  • Ennov InSight Publishing 7.1 > Use eCTD Templates > eCTD Template Files
  • Ennov InSight Publishing 7.1 > Extended Attributes Name, Type, and Version
  • Ennov InSight Administration 7.1 > Administrative Activities> Import eCTD Applications > Prepare for Bulk eCTD Import
  • Ennov InSight Administration 7.1 > eCTD Codes > eCTD Codes for Country Values
  • Ennov InSight Administration 7.1 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for EU
  • Ennov InSight Administration 7.1 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for EU > eCTD Sub-Filing Types for EU
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Groups of Extensions by Version and Country
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Folder Extensions > m1-additional > m1-additional v. 3.1
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Folder Extensions > envelope > envelope v. 3.1
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Folder Extensions > eu_module_1_country_specific_information > eu_module_1_country_specific_information v.3.1
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Folder Extensions > m1-responses > m1-responses v. 3.1
  • Ennov InSight Administration 7.1 > Assembly XML Specification > Extensions > Folder Extensions > m1-3-1-spc-label-pl > m1-3-1spc-label-pl v. 3.1