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. |
| Country | Country on the application for which the details are being displayed/modified. |
|
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. |
|
Last Role Change Date |
The date when the country's role for the application changed. |
|
Local Early Termination/Withdrawal/Suspension Date |
The local early termination, withdrawal or suspension date of a clinical trial by a sponsor for reasons of subject safety in relation to a Member State through the EU portal. This field is available for CTR applications only. |
| Attribute | Description |
|
Local Early Termination/Withdrawal/Suspension Reason |
the local early termination, withdrawal or suspension reason of a clinical trial by a sponsor for subject safety in relation to a Member State through the EU portal. This field is available for CTR applications only. |
| Local End of Recruitment Date | The local end date for recruitment of subjects of a clinical trial in relation to a Member State through the EU portal.. This field is available for CTR applications only. |
|
Local End of Trial Date |
The local end date of a clinical trial in relation to a Member State through the EU portal. This field is available for CTR applications only. |
|
Local First Visit of First Subject Date |
The local first visit date of the first subject of a clinical trial in relation to a Member State through the EU portal.. This field is available for CTR applications only. |
| Local Restart of Temporarily Halted Trial Date | The local restart date of the temporary halted clinical trial in relation to a Member State through the EU portal. This field is available for CTR applications only. |
|
Local Start of Trial Date |
The local start date of a clinical trial in relation to a Member State through the EU portal. This field is available for CTR applications only. |
|
Local Temporary Halt Date |
The local temporary halt date of a clinical trial in relation to a Member State through the EU portal. This field is available for CTR applications only. |
|
Member States Concerned |
Countries added to the application from the Countries tab. |
| 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. |
| Withdrawn 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. |