Amendment Submission Attributes
You can use the attributes to modify an existing submission.
| Attribute | Description |
|---|---|
| Application Code | The agency-identified application number (or identifier), which may not be known until the time of submission, so it may be the same as the internal code. |
| Application Name | The name of the application that is associated with the submission event.The value is a concatenation of [Application Code + Application Name]. |
| Application Type | The type of application associated with the submission event |
| Concerned Member States | When the Reviewing Country is a member of the European Union (EU) or WAHO, the Concerned Member States attribute appears 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 or WAHO. |
| Event Code | The code your organization uses to identify the event. |
| Event Name | The name of the event. |
| Event Type | The type of event. |
| Family Name/Code | The product family with which to associate the application you are updating. |
| Filing Type | The filing type for the application. |
| Reason | Reason for creating, modifying or deleting a submission. |
| Reason for Comments | Comments related to reason entered by users. |
| Reviewing Country | The country performing the submission review. Only the countries associated with the application will be listed. When the Reviewing Country is a member of the European Union (EU) or WAHO, the Concerned Member States attribute appears and enables you to select multiple countries for the submission. |
| Sequence Code | The identifier for the sequence associated with the application, which is required only if a sequence will be created. The sequence code defaults to the next available four-digit sequence number, prepended with the letter P to indicate that this is the planned sequence number. This enables working on multiple planned sequences concurrently. When you mark the sequence as submitted, InSight Manager reconfirms the next available sequence number and removes the P. If you enter a value that deviates from the default format, the wizard displays a message requiring you to confirm that you want to deviate from the default numbering format.For the first sequence in an application, the start sequence code from the application is always used. For subsequent sequences, all the sequences in the application are considered. When the highest existing sequence number has been determined, the default sequence number for the new sequence is the highest plus one. For example, if there are four sequences with the codes P0000, 0001, 0005, and R0006-512, the next sequence number by default is P0006. |
| Sequence Description | Text that describes an entity within the submission. |
| Sequence Keywords | Words used to search for when creating a submission. |
| Sequence Standard Type | The following sequence standard types are available for selection:
|
| User ID | The user name to validate user identity. |
| Password | The user password to validate user identity. |