Ennov InSight Registrations 7.2

Pending Changes and Entity Attributes

Use the following descriptions when working with Pending Changes.

Table 1. Pending Changes Attributes
Attribute Description
Approval Status Current approval status of the Pending Changes.
Approval Status Date Displays the approval status date of the event.
Attribute Name Name of the Attribute.
  • For Application: Procedure Type value or Legal Status of Supply value or both.
  • For Registration: MAH/Organisation, QPPV, MFL, Subject to Additional Monitoring, Next Renewal Date, Last Renewal Date, License Status, License Status Date, Enquiry Email, Enquiry Phone Number.
  • Registration Package Set: MAH/Organization, Authorisation Status, Authorisation Status Date, Withdrawn Date.
  • For Registration Package Set Country: Legal Status of Supply
  • For Medicinal Product: Pediatric Use Indicator or Full Indication Text or both.
Change Value Targeted value for the entity which needs to be updated.
Entity Name Name of the Entity. Examples: Hyperlinked Application or Medicinal Product name.
Sub Entity Name Name of the sub-entity. Used for Package- Set- Country only.
Table 2. Entity Attributes for Pending Changes
Attribute Description
Actual Launch Date Actual date of the product launch.
Actual Submission Date When the application is submitted.
Annual Report Date The date that the next annual report is due. This attribute is only for a CTA and CTR application.
Application Code Agency-identified application number (or identifier). May not be available until submittal time. Hence, an internal code can be used for an application code.
Application Name The name of the application.
Application Reviewing Country The associated country.
Authorisation Status Regulatory Entitlement Status. The pending change result for this field can be found on the Registration - Package Set Attributes page.
Authorisation Status Date Authorisation Status Date. The pending change result for this field

be found on the Registration - Package Set Attributes page.

Change Scope Targeted entity which needs to be updated. Options are: Application, Medicinal Product, Registration, Registration Package Set, Registration Package Set Country.
Country The European Union countries available for selection. This attribute is available on the Pending Changes wizard for Registration Package Set Country.
Enquiry Email The e-mail address of the person or the agency registering the product. The pending change result for this field can be found on the Registration Attributes page.
Enquiry Phone Number The phone number of the person or the agency registering the product. The pending change result for this field can be found on the Registration Attributes page.
Entity Type The type of an Entity.
Full Indication Text The medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease. The pending change result for this field can be found on the Medicinal Product Attributes page.
Last Renewal Date Date when it was last renewedThe pending change result for this field can be found on the Registration Attributes page.
Legal Status of Supply The legal status of the medicinal product that includes the conditions and restrictions under which it should be made available to patients. The pending change result for this field can be found on the Application Attributes and on the Package- Set- Country Attributes page for Registration- Package Set.
License Status The current renewal status. The pending change result for this field can be found on the Registration Attributes page.
License Status Date The effective date of the status. The pending change result for this field can be found on the Registration Attributes page.
Medicinal Product List of the Medicinal Products. This attribute is available on the Pending Changes wizard for Medicinal Product, Registration Package Set and Registration Package Set Country.
MAH/Organization The company to which a license is given to market the product. The Data Administration values assigned in Other Maintenance > MAH/Development Sponsor/Organisation Values. The pending change result for this field can be found on the Registration Attributes and on the Registration-Package Set Attributes pages.
MFL (Master File Location) The name and address information for master file location company. The pending change result for this field can be found on the Registration Attributes page.
Next Renewal Date Date of the next renewal. The pending change result for this field can be found on the Registration Attributes page.
Pediatric Use Indicator Indicates whether a medicinal product is authorised and explicitly intended for pediatric use. The pending change result for this field can be found on the Medicinal Product Attributes page.
Procedure Type Defines the strategy being used when applying for market approval. The pending change result for this field can be found on the Application Attributes page.
QPPV List of the Qualified Person for Pharmacovigilance (QPPV). The pending change result for this field can be found on the Registration Attributes page.
Registrations List of the Registrations. This attribute is available on the Pending Changes wizard for Medicinal Product, Registration, Registration Package Set and Registration Package Set Country.
Subject to Additional Monitoring Indicates whether the product requires close monitoring. The pending change result for this field can be found on the Registration Attributes page.
Withdrawn Date The date that a registration package set was withdrawn. The pending change result for this field can be found on the Registration - Package Set Attributes page.