Submission Properties | |||
| |||
Fields
| Field Name | Description | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Type | The object type: Submission. | ||||||||
| Name | The name of this submission project. | ||||||||
| Title | A descriptive title for the submission project. | ||||||||
| Policy | The policy that governs the submission project's lifecycle. | ||||||||
| Owner | The person responsible for the submission project. | ||||||||
| Description | Details about the submission project. | ||||||||
| Base Currency | The currency used for monetary values within the submission project. | ||||||||
| Project Status | The current lifecycle state of the submission project. | ||||||||
| Visibility | Who can view the submission project details:
| ||||||||
| Creation Date | The date the submission project was created. | ||||||||
| Company Name | The company responsible for the project. | ||||||||
| Business Unit | A business unit within the above Company, if specified. | ||||||||
| Program | Any program that manages the submission project. | ||||||||
| Schedule From | Shows either Project Start Date (schedules calculated from when the project starts) or Project Finish Date (schedules calculated from when the project must be finished). | ||||||||
| Dynamic Attributes | |||||||||
| Authority Application Number | The application number assigned when the regulatory authority receives the dossier. This number should be used on all subsequent correspondence. | ||||||||
| Cancellation Type | If the submission project was cancelled, the type of cancellation:
| ||||||||
| Contract Number | The contract number of the restricted authorization. Only has a value if the submission type is Restricted. | ||||||||
| Dossier Submitted | The type of submission evaluation:
Regulatory Request Responders take this dossier evaluation type into consideration when preparing documents. | ||||||||
| Follows Leading Country | Indicates whether the countries associated with this submission project follow the regulatory lead of another country.
| ||||||||
| Hold Cancellation Date | If the submission project was placed on hold or cancelled, the date of that action. | ||||||||
| Publishing File Format | The file format required by the regulatory authority:
| ||||||||
| Reason For Change | Justification for changes made to the regulatory information for a submission
after it is started. Only has a value if the submission is beyond the Draft state. | ||||||||
| Reason For Hold Cancel | If the submission project was placed on hold or cancelled, the reason for that action. | ||||||||
| Regulatory Activity Category | The regulatory activity category defined for this submission. | ||||||||
| Regulatory Activity Sub Category | The subcategory for the activity category. | ||||||||
| Regulatory Milestone Auto Complete | True or False: Indicates whether the regulatory milestone will automatically complete when a market authorization with the milestone is completed on the submission. | ||||||||
| Restricted Authorization Request Date | The date that the regulatory authority grants restricted authorization. Only has a value if the submission type is Restricted. | ||||||||
| Wave Reference | The wave reference for a submission that uses the Mutual Recognition Procedure (MRP). If you derive a submission project from this one, you need to manually edit this value. Only has a value if the submission type is Initial submission. | ||||||||
| Default Constraint | The default constraint type for project tasks:
| ||||||||
