License Modules: Registrations, Full Product Presentations, Registration FPP Attachments and FPP Previous EV Codes
| Subfeature | Subfeature Description | License Modules |
|---|---|---|
| Registration detail | Define registration details, including those that vary by country for MRP applications. |
|
| Copy Package Set Registration | Copy a package set registration.
At least WRITE permissions for the Registrations and Full Product Presentation (FPP) (applicable to the New Package Set specific Registration(s) flow) in Entity Security section. |
|
| Full product presentation detail | Define detailed information about the product (for example Special Measures, Product Strength). |
|
| FPP previous EV code detail | Define the previous EV code for the full product presentation. |
|
| Registration FPP attachment detail | Presents an attachment for the detailed product information. |
|
| Copy full product presentation | Copy a full product presentation under the same registration, or under different registrations.
Requires at least WRITE permissions for the Full Product Presentation (FPP) in the Entity Security section. |
|
| Medicinal Product detail | Medicinal product for registration.
At least WRITE permissions for the Medicinal Product in Entity Security section. |
|
| Medicinal Product Action detail | Medicinal product action for registration.
At least WRITE permissions for the Medicinal Product Action in Entity Security section. |
|
Related information
- License Modules: Product Families, Clinical Trial Shared Data
- License Modules: Products, Pharmaceutical Products
- License Modules: Registration Attachment
- License Modules: Applications
- License Modules: Comparators
- License Modules: Events
- License Modules: Sequences
- License Modules: Product Detail Sets (PDS)
- License Modules: Assembly Types
- License Modules: Activity Workflow
- License Modules: Projects
- License Modules: Tasks, Notifications, and References
- License Modules: Change, Change Details
- License Modules: Reports
- License Modules: Approval Management
- License Modules: Submittal Management and Lifecycle
- License Modules: General Assembly
- License Modules: Planning and Tracking
- License Modules: Review and Approval
- License Modules: Document Analysis
- License Modules: General Publishing
- License Modules: eCTD Publishing
- License Modules: Paper Publishing
- License Modules: Administration
- Ennov InSight License Components