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.
Attribute Package Set specific Registration(s) Product specific Registration(s)
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/Reg­

istration Valid Un­

til

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.
Attribute Package Set specific Registration(s) Product specific Registration(s)
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

The value is taken from the source Registration. The value is taken from the source Registration.
Attribute Package Set specific Registration(s) Product specific Registration(s)
File Location)
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.
Attribute Package Set specific Registration(s) Product specific Registration(s)

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.