PDS Attributes
You create a PDS for an event to maintain the history of regulatory changes to the component and product details.
The attributes describe the specific PDS for an event.
| Attribute | Description |
|
Actual Launch Dates |
The dates when the product was actually launched in each of the countries associated with the application. Dates are stored in the application countries associated with the application. This attribute appears on the Product Detail Set Attributes page. |
|
Application Code |
Agency-identified application number (or identifier). The application code may not be known until submittal time, therefore it may be the same as the internal code. |
|
Application Internal Code |
Your organization's internal tracking identifier for the application. |
|
Application Name |
The name of the application. |
|
Event Name |
The event to which the PDS is associated. |
|
Exemp tion Date |
The date an exemption from the application of the Sunset Clause was granted. |
|
Family Code |
Code assigned to the product family with which the application is associated. |
|
Family Name |
Name of the product family with which the application is associated. |
| Local Route of Administration | The configured Local Route of Administration field is used for XEVMPD (Extended EudraVigilance medicinal product dictionary) and is hidden by default. Can be configured to be available for the PDS via overrides.When configured, it is used for tracking country Route of Administration on the PDS level. The Local Route of Administration field is a multi-select list. The values available for selection are displayed as a concatenation of Product Route of Administration and Component Route of Administration values. The values are sorted in ascending alphanumeric order. |
| Attribute | Description |
|
Local Trade Names |
The local brand or trade names associated with the PDS. This attribute appears on the Product Detail Set Attributes page. |
|
PDS Add Comment |
Comments you want to share with others in a discussion thread. Comments are stamped with the date and time you enter the information, and your user ID. This attribute appears on the Modify Product Detail Set page. |
| PDS Comments | The discussion thread that includes all comments entered by users. This includes the date and time the comments were entered and the user ID of the person who entered them.Comments are displayed when you modify the entity. |
| PDS Concerned Parties | Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses. |
| PDS Description | Text that describes the PDS. |
| PDS Keywords | Words you can use to search for the PDS. |
|
PDS Status |
The status of the PDS. |
|
PDS Status Date |
The date the status is effective. |
|
Planned Launch Dates |
The dates when the product is expected to be launched in each of the countries associated with the application. Dates are stored in the countries associated with the application. This attribute appears on the Product Detail Set Attributes page. |
|
Product De tail Set Code |
Your organization's code for the PDS. On some PDS pages, the product detail set name is shown with the product detail set code to identify a PDS. For example, AXL PDS 390 could identify a PDS that has the name AXL PDS and the code 390. |
| Attribute | Description |
|
Product De tail Set Name |
The name of the PDS. On some PDS pages, the product detail set name is shown with the product detail set code to identify a PDS. For example, AXL PDS 390 could identify a PDS that has the name AXL PDS and the code 390. The name of the PDS must be unique within an application. |
|
Product Name |
The product for which you are creating a detail set. The list of products from which you can choose is limited to the products associated with the event. |
| Reason | Reason for creating, modifying or deleting a PDS. |
|
Reason for Comments |
Comments related to reason entered by users. |
|
Spe ciality Number |
A part of mrpnumber for XEVMPD. The value is taken as a concatenation of the Procedure Identifier/Application Code and Speciality Number for MRP (Mutual Recognition Procedure) and DCP (Decentralised Procedure) Types. The concatenation formula is: [Procedure Identifier/Application Code][Speciality Number1]'-'[Speciality Number2], if there are two PDSs under the Full Product Presentation and the Speciality Number2 value is different from Speciality Number1 value. |
| User ID | The user name to validate user identity. |
| Password | The user password to validate user identity. |