Sequence Attributes
The attribute descriptions will help you to enter appropriate sequence attribute values while creating a sequence. The following table lists all the attributes that are available to you in the Enter Sequence Details page while creating a sequence.
| 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 Name | The name of the application. |
| Assign Workflow | Defines the workflow that will be associated with the sequence automatically when the sequence is created. |
| Closed | Indicates whether the sequence is completed. |
| Concerned Member States (Available/Selected) | For a DCP (Decentralised Procedure) or MRP (Mutual Recognition Procedure) application, the countries that may review the application; cannot be changed.
Note: Withdrawn application countries with the Withdraw Date value equals to today’s date or earlier are not available for selection in the
Concerned Member States multi-select field on the
Create Sequence page.
|
| Concerned Parties | Users who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses. |
| Co-Rapporteur | For a CP application, the co-rapporteur associated with the sequence; cannot be changed. |
| Description | Text that describes the entity. |
| Electronic Output Location | The path name where the published output exists. |
| Events | Events associated with the sequence. |
| 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. |
| Filing Type | The sequence filing type. |
| Included in Grouped Submission | The hyperlinked name of the submission plan that the sequence is associated with. |
| Keywords | Words you can use to search for the entity. |
| Lifecycle Order | The order of this sequence in the lifecycle; cannot be changed. |
| Owner | The person responsible for the sequence. |
| Origination | Text about the item associated with the sequence. |
| Paper Reference | Any text about paper documents associated with the sequence. |
| Procedure Type | Identifies the strategy used in a regulatory approval process for a particular set of regulatory requirements. |
| Rapporteur | For a CP application, the country associated with the sequence; cannot be changed. |
| Reason | Reason for creating, modifying or deleting a sequence. |
| Reason for Comments | Comments related to reason entered by users. |
| Reason for Termination/Withdrawal | The reason that sequence was terminated or withdrawn. |
| Reference Member State | For an MRP application, the member state to perform the initial assessment of a submission for the purposes of attaining a marketing authorization; cannot be changed. |
| Reviewing Country | The country that will review the application. When European Union (EU) is selected, multiple country selections are possible. |
| Selected Events | Events associated with the sequence. |
| Sequence Add Comment | Comments you want to share with others in a discussion thread. Will be displayed in the
Sequence Comments box, stamped with the date and time you enter the information and your user ID.
Note: The
Sequence Add Comment field is available on the Create/Modify
Sequence Attributes pages only.
|
| Sequence Category | The category for the sequence. |
| Sequence Code | A default value for the sequence to be associated with the application.
For the very first sequence in an application, the recommended default is taken from the Application's Starting Sequence Number, however, this number can be changed. For subsequent sequences, all the sequences in the application are considered, though a default of P, followed by four digits is presented and is recommended for eCTD filings. 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 Comments | The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them. |
| Sequence Concerned Parties | Anyone who may be copied on notifications for this sequence. Use semicolons (;) to separate e-mail addresses. |
| Sequence Description | Text that describes the sequence. |
| Sequence Keywords | Words you can use to search for the sequence. |
| Sequence Name | The name of the sequence. |
| Sequence Status | The status of the entity. |
| Sequence Status Date | The date the entity status is effective. |
| User ID | The user name to validate user identity. |
| Password | The user password to validate user identity. |