[O365] Create Submission and Reference
Use the Create Submission and Reference form to start the submission and reference workflow in Ennov InSight .
For successful form submission, the workflow contains the activities and its supporting attributes.
QC and update submission
| Field Name | Description | IM Req (Y/N) |
|---|---|---|
| Family Code | Product Family code associated with the sequence. | N/A |
| Family Name | Product Family associated with the sequence. | N/A |
| Application Code | Application Code associated with the sequence. | N/A |
| Application Name | Application associated with the sequence. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the sequence. | N/A |
| Co-Rapporteur | Current Co-Rapporteur on the CP type application. Displayed only for CP type applications. | N/A |
| Procedure Type | Current Procedure Type for the application associated with the sequence. | N/A |
| Sequence Name | Descriptive name to identify the sequence. | Y |
| Sequence Status | Current status of the sequence. | Y |
| Sequence Status Date | Date the status was set. | Y |
| Filing Type | List of Filing Type is dependent on the selected country and application type for the associated application. | Y |
| Concerned Member States | Displayed for MRP/DCP applications only. | N |
| Owner | Person responsible for the sequence. | N |
| Sequence Category | In the US for Supplements, you must also identify the category. (CBE, CBE30, etc.) | N |
| Electronic Output Location | Location where the electronic output is stored. | N |
| Paper Reference | Reference information/definition for paper submissions. | N |
| Origination | Name of an item the sequence was created in reference to. | N |
| Event | Identifies the Event for which the sequence is related.
Available Events: Multi select. Selected Events: Events currently associated with the sequence. |
N |
| Sequence Concerned Parties | Enter email addresses. | N |
| Sequence Description | Display Sequence Description that was entered in the Add-in form. | N |
| Sequence Add Comments | Enter information that will be stamped with the Date/Time/User ID of the person entering the information. | N |
QC and update reference
| Field Name | Description | IM Req (Y/N) |
|---|---|---|
| Family Code | Code of the product family associated with the reference. | N/A |
| Family Name | Name of the product family associated with the reference. | N/A |
| Application Code | Application Code associated with the reference. | N/A |
| Application Name | Application associated with the reference. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the reference. | N/A |
| Entity Association | Entity type associated with the reference. References can be associated to: Product Family, Product (Full Product Name concatenation), Application, Event, Sequence Assembly, License, Task. | N/A |
| Entity Name | Entity Name associated with the reference. References can be associated to: Product Family, Product (Full Product Name concatenation), Application, Event, Sequence Assembly, License, Task. | N/A |
| Reference Name | Name of the reference. The reference name must be unique within its parent entity. | Y |
| Type | Type of reference. | Y |
| Content | Additional information to identify the type of reference, and what the content references. Examples: Mock-Up, Meeting Minutes, Notes, Time Table, etc. | N |
| Participant | Who the reference was to or from. Examples: Agency/Agency Name, internal departments, affiliates, etc. | N |
| Reference Status | Current status of the reference. | Y |
| Reference Status Date | Date the current status was set. | Y |
| Reference Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Reference Link | Link to the reference. Click Select to locate and choose the reference. | N |
| Origination | Short description, identifies what caused the correspondence contained in the reference. (Examples: questions from authority, request from affiliate, etc.) | N |
| Origination Link Type | Identifies the type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Origination Link | Link to the correspondence. Click Select to locate and choose the correspondence. | N |
| Action | Short description, identifies the Action taken to address the reference/correspondence. | N |
| Action Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Action Link | Link to the item. Click Select to locate and choose the action. | N |
| Reference Concerned Parties | Enter email addresses. | N |
| Reference Description | Enter descriptive information. | N |
| Reference Add Comment | N/A | N/A |
When the workflow is triggered but a reference for the submission is not created, the workflow contains the following activities and their supporting attributes.
QC and update submission - The activity fields are same as described in the QC and update reference table.
Review and create reference - The following activity fields are displayed:
| Field Name | Description | IM Req (Y/N) |
|---|---|---|
| Family Code | Code of the product family associated with the reference. | N/A |
| Family Name | Name of the product family associated with the reference. | N/A |
| Application Code | Application Code associated with the reference. | N/A |
| Application Name | Application associated with the reference. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the reference. | N/A |
| Entity Association | Entity type associated with the reference. References can be associated to: Product Family, Product (Full Product Name concatenation), Application, Event, Sequence Assembly, License, Task. | N/A |
| Entity Name | Entity Name associated with the reference. References can be associated to: Product Family, Product (Full Product Name concatenation), Application, Event, Sequence Assembly, License, Task. | N/A |
| Reference Name | Name of the reference. The reference name must be unique within its parent entity. | Y |
| Type | Type of reference. | Y |
| Content | Additional information to further identify the type of reference as to what is the content in reference to. Examples: Mock-Up, Meeting Minutes, Notes, Time Table, etc. | N |
| Participant | Who the reference was to or from. Examples: Agency/Agency Name, internal departments, affiliates, etc. | N |
| Reference Status | Current status of the reference. | Y |
| Reference Status Date | Date the current status was set. | Y |
| Reference Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Reference Link | Link to the reference. Click Select to locate and choose the reference. | N |
| Origination | Short description, identifies what caused the correspondence contained in the reference. (Examples: questions from authority, request from affiliate, etc.) | N |
| Origination Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Origination Link | Link to the correspondence. Click Select to locate and choose the correspondence. | N |
| Action | Short description, identifies the Action taken to address the reference/correspondence. | N |
| Action Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Action Link | Link to the item> Click Select to locate and choose the action. | N |
| Reference Concerned Parties | Enter email addresses. | N |
| Reference Description | Enter descriptive information. | N |
| Reference Add Comment | N/A | N/A |
When the workflow is triggered but a submission for the application is not created, the workflow contains the following activities and their supporting attributes.
Review and create submission - The following activity fields are displayed:
| Field Name | Description | IM Req (Y/N) |
|---|---|---|
| Family Code | Product Family code associated with the sequence. | N/A |
| Family Name | Product Family associated with the sequence. | N/A |
| Application Code | Application Code associated with the sequence. | N/A |
| Application Name | Application associated with the sequence. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the sequence. | N/A |
| Co-Rapporteur | Current Co-Rapporteur on the CP type application. Displayed only for CP type applications. | N/A |
| Procedure Type | Current Procedure Type for the application associated with the sequence. | N/A |
| Sequence Name | Descriptive name to identify the sequence. | N/A |
| Sequence Status | Current status of the sequence. | N/A |
| Sequence Status Date | Date the status was set. | N/A |
| Filing Type | Available filing types depend on the selected country and application type for the associated application | N/A |
| Concerned Member States | For MRP/DCP type applications only. | N/A |
| Owner | Person responsible for the sequence. | N/A |
| Sequence Category | In the US: for Supplements, you must identify the category. (CBE, CBE30, etc.) | N/A |
| Electronic Output Location | Location where the electronic output is stored. | N/A |
| Paper Reference | Reference information/identification for paper sequences. | N/A |
| Origination | Name of an item the sequence was created in reference to. | N/A |
| Events | IEvent related to the sequence.
Available Events: Multi select Selected Events: Events currently associated with the sequence |
N/A |
| Sequence Concerned Parties | Enter email addresses. | N/A |
| Sequence Description | Sequence description entered in the Add-in form. | N/A |
| Sequence Add Comments | Information entered is stamped with the Date/Time/User ID of the person entering the information. | N/A |
Review and create reference - The fields are same as described in the Review and create submission table.