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 |
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 |
|
|
|
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 |
|
|
| 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.
