Entity Fields, Columns and Options Added: Ennov InSight 7.3.1

The following tables describe fields, columns and options that were modified in this release.

Events

Table 1. Pending Changes
Field/Column/Option Name Field Type Description Business Rules
Apply Pending Changes N/A The Apply Pending Changes icon is added to the Pending Changes tab on the Events Attributes page.

If no pending changes are selected, using the Apply Pending Changes option results in the following alert message displayed: At least one value must be selected.

If one or more pending changes are selected, using the Apply Pending Changes option results in the following message displayed: You are about to apply pending changes. Click OK to continue.

Applied pending changes are not displayed on the Pending Changes tab.

If two pending changes are created for the same entity, the Pending Changes tab shows only one, the newest, value.

Country N/A The Pending Changes tab now includes the respective column. Improves the usability of the application
Table 2. Create Pending Changes
Field/Column/Option Name Field Type Description Business Rules
Application Reviewing Countries Multi-select The Full Product Presentation flow is added to the Create Pending Changes > Select Pending Changes Entities > Change Scope and includes all the respective fields.

After Full Product Presentation flow is selected, the Application Reviewing Countries field is displayed. Once it populated, the Registrations field appears. The Full Product Presentation appears after registrations values are selected.

All other fields are displayed on the Enter values for Pending Changes page available after clicking on the Next button on the Select Pending Changes Entities page. If no values are selected for the fields Application Reviewing Countries, Registrations or Full Product Presentation, it is impossible to create pending changes.

It is impossible to apply changes to FPP using the Pending Changes tab if the following fields are populated with the same values as the other FPPs applied to the same registration: Concatenation of Full Product Name, EEA Country, Language, Package Description, Authorisation Status, Authorisation/Renewal Date, EVCode.

Registrations Multi-select
Full Product Presentation Multi-select
Full Product Name Text field
Full Product Short Name Text field
Product INN/ Common Name Text field
Product Company Name Text field
Product Strength Text field
Product Form Text field
Authorisation Status Select
Authorized Pharmaceutical Form Selection widget
Authorisation/Renewal Date Date
Withdrawn/Invalidated Date Date
Information Date Date
XEVMPD Comments Text field
Table 3. Create Pending Changes
Field/Column/Option Name Field Type Description Business Rules
License Issue Date Date The Registration flow on the Create Pending Changes > Select Pending Changes Entities page now includes the respective fields. New fields are displayed on the Enter values for Pending Changes page available after clicking on the Next button on the Select Pending Changes Entities page.
Expiration Date/ Registration Valid Until Date
Registered ATC Multi-select

Registration Attachment

Table 4. Create Registration Attachment
Field/Column/Option Name Field Type Description Business Rules
2nd Attachment Language Drop-down The Create Registration Attachment page now includes the respective field. The new 2nd Attachment Language field is displayed under the Attachment Language field. Values for the field are taken from the Other > Language Values DA List.

The 2nd Attachment Language field can be updated on the pages Modify Registration Attachment and Copy Registration Attachment.

Full Product Presentations

Table 5. Registration FPP Attachment
Field/Column/Option Name Field Type Description Business Rules
2nd Attachment Language Select

On the Create Registration FPP Attachment page, the concatenation of fields that displays in the Attached Name field now includes the respective field. The concatenation of fields displays in the following order: Internal Name - Attachment Language - 2nd Attachment Language - Attachment Name - Attachment Version.

Values for the 2nd Attachment Language field are taken from the Other > Language Values Data Administration List.
The 2nd Attachment Language field can be populated only on the Create Registration FPP Attachment page. For the following pages, this field is read-only:
  • Registration FPP Attachment Attributes
  • Copy Registration FPP Attachment
  • Modify Registration FPP Attachment

Wizards

Table 6. XEVMPD Submission
Field/Column/Option Name Field Type Description Business Rules
2nd Attachment Language N/A XEVMPD XML file generated after using XEVMPD Submission wizard now displays the respective value. The 2nd Attachment Language value is displayed in the <attachment> section of the XEVMPD XML file under <languagecode2> tag.

If 2nd Attachment Language field is not populated for the Registration Attachment entity, <languagecode2> tag also remains blank.