Registration Package Set Attributes
Package sets created and approved in the product detail set of the related product are associated with registrations.
The PDS must belong to the same application as the registration.
| Attribute | Description |
|
Application Code |
The code of the application which the combination of registration and package set is associated |
|
Application Name |
The name of the application which the combination of registration and package set is associated |
|
Authorization Status |
Regulatory Entitlement Status. |
|
Authorisation Status Date |
Authorisation Status Date |
| Country | The country which the combination of registration and package set is associated. |
| Package Set License Code | The last three digits of the license number. |
| Legal Basis | The legal basis for an authorisation of the product. |
| License Code | The code of the license which the combination of registration and package set is associated |
| MAH/Organisation | The company to which a license is issued to market the product. The Data Administration values are assigned to Other Maintenance > MAH/Development Sponsor/Organisation Values. |
|
Package Set Name |
Package Sets for which this License was issued. The list is filtered to show only Approved and Pending Add package sets that are associated to the application and do not have a registration for the selected country. |
|
Product Detail Set Name |
The PDS which the package set is associated. The name is shown with the product detail set code. For example, AXL PDS 390 could identify a PDS that has the name AXL PDS and the code 390. |
| Attribute | Description |
|
Registration-Package Set Comments |
Information that will be stamped with the date/time/userid of the person |
|
Registration-Package Set Description |
Descriptive information about the association between the registration and package set |
|
Registration-Package Set Keywords |
Text that is inputted for searching. |
|
Package PMS ID |
Unique identifier for a specific packaged medicinal product. |
|
PDS Package Set Status |
Indicates the status taken from PDS Package Set Detail. |
|
PDS Package Set Status Date |
Indicates the status date taken from PDS Package Set Detail. |
| Withdrawn | Indicates whether a registration package set is withdrawn. |
| Withdrawn Date | The date that a registration package set was withdrawn. |