Application Country Attributes
The application country attribute descriptions will help you to select the appropriate values while adding a country to an application.
Use the following descriptions to choose and enter attribute values.
| Attribute | Description |
|---|---|
| Application Code | Agency-identified application number (or identifier); may not be known until submittal time, therefore it may be the same as the internal code. |
| Application Country Add Comments | The information that will be stamped with the date/time/user ID of the person entering the information. |
| Application Country Comments | Additional information you want to save with the country. |
| Application Country Description | Text that describes the information associated with the country. |
| Application Country Keywords | Words you can use to search for the country in the application. |
| Application Name | The name of the application. |
| Actual Approval Date | When approval has been granted by the appropriate regulatory authority for that country. |
| Actual Launch Date | When the product associated with the application is available to consumers for the first time in the new country. |
| Actual Submission Date | When the application is submitted for the first time in the country you are adding. |
| Planned Approval Date | The date on which the application is to be approved for the first time in the country you are adding. |
| Planned Launch Date | The date on which the application is to be launched for the first time in the country you are adding. |
| Planned Submission Date | The date on which the application is to be submitted for the first time in the country you are adding. |
| Concerned Member States | When the Reviewing Country is a member of the European Union (EU), the Concerned Member States attribute is available and enables you to select multiple countries for the submission. This section does not appear if the Reviewing Country is not a member of the EU. |
| Country | The country on the application for which the details are being displayed/modified. |
| Family Code | Code assigned to the product family with which the application is associated. |
| Family Name | Name of the product family to which the application is associated. |
| Last Role Change Date | The date when the country's role for the application changed. |
| Product Family Type | The type of product family: pharmaceutical, medical device, pharma-med device combination, veterinary. |
| Role | The role this country plays with respect to this Application. |
| Sequences | The list of the Sequence Codes of the Sequences the Application Country is associated to. |
| Withdraw Date | The date the application is withdrawn in the country. |
| Reason | Reason for creating, modifying or deleting an Application Country. |
| Reason for Comments | Comments related to reason entered by users. |
| User ID | The user name to validate user identity. |
| Password | The user password to validate user identity. |