Ennov InSight Registrations 7.2

Copied Package Set Registration Attributes

When a registration is copied, some attributes remain the same while some are updated.

The following table describes the attributes of the copied Registration.

Attribute Package Set specific Registration(s) Product specific Registration(s)
Annual Report Date The value is taken from the source Registration. The value is taken from the source Registration.
Application Code The value is taken from the source Registration.
Note: The copied Registration appears under the same Application.
The value is taken from the source Registration.
Note: The copied Registration appears under the same Application.
Application Name The value is taken from the source Registration.
Note: The copied Registration appears under the same Application.
The value is taken from the source Registration.
Note: The copied Registration appears under the same Application.
Country The value is taken from the source Registration.
Note: The copied Registration appears under the same Application.
The value is taken from the source Registration.
Note: The copied Registration appears under the same Application.
Enquiry Email The value is taken from the source Registration. The value is taken from the source Registration.
Enquiry Phone Number The value is taken from the source Registration. The value is taken from the source Registration.
Expiration Date/Registration Valid Until The value is taken from the source Registration. The value is taken from the source Registration.
Family Code The value is taken from the source Registration. The value is taken from the source Registration.
Family Name The value is taken from the source Registration. The value is taken from the source Registration.
In-Licensing The value is taken from the source Registration. The value is taken from the source Registration.
Last Renewal Date The value is taken from the source Registration. The value is taken from the source Registration.
Legal Basis The value is taken from the source Registration. The value is taken from the source Registration.
License Code The value you have entered on the Select Package Set(s) page. The value you have entered on the Select Product Name page.
License Comments Appears blank. Appears blank.
License Concerned Parties Appears blank. Appears blank.
License Description Appears blank. Appears blank.
License Issue Date The value is taken from the source Registration. The value is taken from the source Registration.
License Keywords Appears blank. Appears blank.
License Status The value is taken from the source Registration. The value is taken from the source Registration.
License Status Date The value is taken from the source Registration. The value is taken from the source Registration.
MAH/Organisation The value is taken from the source Registration. The value is taken from the source Registration.
MAH/Organisation Last Updated
  • If the MAH/Organisation Last Updated attribute of the source Registration is populated, this value is updated to be equal to the current date.
  • If the MAH/Organisation Last Updated attribute of the source Registration is not populated, this attribute appears blank.
  • If the MAH/Organisation Last Updated attribute of the source Registration is populated, this value is updated to be equal to the current date.
  • If the MAH/Organisation Last Updated attribute of the source Registration is not populated, this attribute appears blank.
Medicinal Product Type The value is taken from the source Registration. The value is taken from the source Registration.
Medicines Regulatory Agency The value is taken from the source Registration. The value is taken from the source Registration.
MFL (Master File Location) The value is taken from the source Registration. The value is taken from the source Registration.
Next Renewal Date The value is taken from the source Registration. The value is taken from the source Registration.
Out-Licensing The value is taken from the source Registration. The value is taken from the source Registration.
Package Sets The field is populated with the Package Set Name of Package Set you have selected on the Select Package Set(s) page. The field is populated with the Package Set Names of all available Package Sets assigned to the selected Product > PDS.
Note: The Package Set must be Approved and must not be associated to any Registration.
Perpetual License The value is taken from the source Registration. The value is taken from the source Registration.
Product Family Type The value is taken from the source Registration. The value is taken from the source Registration.
QPPV The value is taken from the source Registration. The value is taken from the source Registration.
Reason for Termination/Withdrawal The value is taken from the source Registration. The value is taken from the source Registration.
Registered ATC The value is taken from the source Registration. The value is taken from the source Registration.
Registered ATC Last Updated
  • If the Registered ATC Last Updated attribute of the source Registration is populated, this value is updated to be equal to the current date.
  • If the Registered ATC Last Updated attribute of the source Registration is not populated, this attribute appears blank.
  • If the Registered ATC Last Updated attribute of the source Registration is populated, this value is updated to be equal to the current date.
  • If the Registered ATC Last Updated attribute of the source Registration is not populated, this attribute appears blank.
Sender Local Code The value is taken from the source Registration. The value is taken from the source Registration.
Subject to Additional Monitoring The value is taken from the source Registration. The value is taken from the source Registration.
The following rules apply for the copied Package Set specific Registration(s):
  • The Package Set entity for the copied Registration is created with the Package Set Name from the source Package Set selected on the Select Package Set(s) page.
  • The Country entity for the created Package Set depends on the application type:
    • For applications of any type except Centralised Procedure (CP) type, the Package Set Country is the same as for the source Package Set selected on the Select Package Set(s) page.
    • For applications of CP type, the Country is taken from the Application level.
The following rules apply for the copied Product specific Registration(s):
  • The Package Set entity for the copied Registration is created with only the Package Set Name field populated.
  • The Country entity for the created Package Set is created with only the Country field populated:
    • For applications of any type except Centralised Procedure (CP) type, the Package Set Country is the same as the source Registration Country.
    • For applications of CP type, the Country is taken from the Application level.