Medicinal Product Action Attributes
The following table includes the Medicinal Product Action attributes.
| Attribute | Description |
| Action Name | Name of the action. |
|
Application Code |
The code of the associated application. |
|
Application Name |
The name of the associated application. |
|
Content of Change |
The content of change provided for the IDMP attachment. Data Administration values assigned from Registration Maintenance > Content of Change Values. |
| Event | All the events from the related sequence. |
| Event EU Grouping/Worksharing | Event EU Grouping/Worksharing from the related events. |
|
Event Variation Number |
Variation numbers from related events. |
|
FHIR Protocol Type |
Fast Healthcare Interoperability Resources Protocol Type. You can select FHIR XML for CP applications or FHIR API for other application types. |
| License Code | License code to which the combination of registration and package set is associated. |
| MAH/Organisation | The organization that holds the marketing authorization granted by the European Medicines Agency (EMA). |
| Medicinal Product Action Comments | Comments for the medicinal product action. Any comments entered will have the stamp of the date/time/user id of the person entering the comments. |
| Medicinal Product Action Description | Description for the medicinal product action. |
| Attribute | Description |
| Medicinal Product Action Keywords | Keywords for searching medicinal product action. |
| Medicinal Product | All the medicinal products used for the parent registration. |
| Provenance Reason | The reason of provenance to provide additional clarity on requirements for Postmarketing surveillance (PMS) submissions. Data Administration values assigned from Registration Maintenance > Provenance Reason Values. |
| Regulatory Application End Date | The end date for the regulatory application. This value is taken from the Event Status Date. |
|
Regulatory Application Identifi er/Number |
Variation Number or EU Grouping/Worksharing from the selected event. |
| Regulatory Application Submission Type | Default value with short name matching sequence filing type eCTD code. Data Administration values with Application Submission Type values assigned from Other > Application Submission Types Values. |
| Sequence | All the sequences from the application. |
| Status | Indicates the status. |
| Status Date | Indicates the date the status is changed. |