Create Submission Wizard

The Create Submission wizard enables you to create an assembly within the context of its appropriate Ennov InSight relationship. The submission wizards facilitate the creation and/or confirmation of the application event (or activity) and sequence that correspond to the assembly you are creating.

To create an assembly, you must first determine its relationship in Ennov InSight . Except for template assemblies, every assembly in Ennov InSight has a relationship to other entities. Specifically, every assembly has an associated application, event, and sequence number.

The Create Submission wizard enables you to create an application and its associated event and sequence. You can create any of three types of submissions using the wizard:

— An initial application is the original filing event (request for marketing) in the history of a submission application. After a product family and its associated products have been created, you can create a submission.

— A major update is a variation or supplement to an original application. A new request for approval against the application is being made, for example, a new indication or a manufacturing change. Alternatively, a major update can be used for renewals or PSUR reporting. The major update is used for all event types other than the original application.

— An amendment is a change to filing content that supports an existing approval objective for which the application and event already exist. For example, you may be asked to clarify a statement in a previously-submitted document.

The Create Submission wizard controls which countries can be assigned to a sequence based on the submission type for MRP and DCP procedures. For major updates, all countries for the procedure are listed. For an amendment, only countries associated with the application are listed. If a new country is needed in an amendment, it must be added by modifying the application.

You cannot complete the Create Submission wizard without associating a Product.

For European submissions, the wizard displays only the countries that have been selected as part of the sequence. For certain submission procedures such as Centralized, only one country (EMEA) will be available. The common country is treated in a special way by the Create eCTD wizard. It is not included in normal country selections when creating submissions. However, if the common country is found in a section of the regional templates, it is always included as a possible selection in the Create eCTD wizard.

Note: Only the MRP/DCP templates include any folders where the country is common. These appear in the following sections: 1.0, 1.2, 1.3.2, 1.3.3, 1.3.4, 1.3.5, Responses to Questions, and Additional Data. The common option does not apply to CP or NP submissions, which is why separate templates are required for the different procedure types.

Initial Application Submission

You must have at least Write security permissions for one of the following Ennov InSight modules to create an initial application submission using the Create Submission wizard:

— Submission Planning and Tracking (SPT)

— Registration Planning and Tracking (RPT)

— Electronic Lifecycle Publishing (ELP) — Paper Review Publishing (PRP)

When you create a submission using the wizard, you choose a product family with which to associate the submission, and assign several other required properties. The Create Submission wizard automatically creates:

— An application

— An event

— A sequence (optional)

If you are a product detail management (PDM) user, you can also associate products with the application. For PDM users, a link is created so you can create a product detail set (PDS). For submission planning and tracking (SPT) users, a link is created that takes you to the Create Assembly page, so you can create the assembly associated with the sequence. Application countries are set to:

— For MRP, RMS country plus selected CMS countries

— For CP, all countries selected. Role=Other

The Countries attribute on the event is set as follows:

— For National internal procedure type applications, automatically associate the user selected reviewing country with the event

— For CP internal procedure type applications, automatically associate the EU Country with the event

— For MRP internal procedure type applications, countries is set to the RMS and the CMS countries selected in the wizard

Create an Initial Application Submission

se the Create Submission wizard to create an initial application submission for a specific country, set of countries, or region. When an initial application is created, the event-country status schedules will be created for each country included in the application.

Note: The wizard for creating a submission for an initial application does not use the default Application Type and Procedure Type values for the selected Reviewing Country. These defaults are for Copying Applications and the Global Project Planning (GPP) wizard.

To create an initial application submission:

1. Select Wizards > Create Submission.

   The Create Submission wizard opens to the Choose Submission Type page.

2. Click Initial Application.
3. Click Next.

   The Complete Submission Properties (application) page appears.

4. Enter the application properties for the submission.
5. Click Next. The Complete Submission Properties (event/sequence) page appears.
6. On the Complete Submission Properties (event/sequence) page, do any of the following:

   Option	Action
   To create an event:	Enter an Event Code, Keywords and Description. If no entry is made to the event-related fields, the event will still be created with default values.
   To use a timeline/event plan to create the event:	Select a Timeline/Event Plan from the drop-down list.
   To change the event type:	Select the value from Event Type drop-down list. The New Application value is selected by default.
   To create a sequence:	Select the Create sequence? check box.

   Note: If you choose to create a sequence, you can change the default sequence numbering of a P followed by four digits. This numbering scheme is the format recommended for an eCTD submission. The sequence code must be unique within the application. If you change default numbering format, the wizard will issue a message requesting confirmation that you accept the deviation from the default sequence numbering format.

7. Click Next.

   The Create Submission Confirmation page opens, confirming the actions that will be performed based on your selections.

8. Choose the applicable procedure in the table below to enter an electronic signature in wizards:

   Scenario	Steps
   When electronic signature and SSO are enabled	In the confirmation page, select a reason and enter comments for the reason. Click Next. Validate your identity by entering your user credentials in the dialog box.
   When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Next.

1. On the Create Submission Confirmation page, do any of the following:

   Option	Action
   To confirm your selections:	Click Next. The Create Submission Summary page opens, listing the created items. Additional items you can add to the submission may also be listed.
   To return to the previous pages to change your selections:	Click Back.
   Option	Action
   To cancel the submission entirely and return to the view form which you invoked the wizard:	Click Cancel.

2. On the Create Submission Summary page, do any of the following:

Initial Application Submission Attributes

You can use the attributes to describe the details of the initial application submission.

Major Update Submission

When you create a major update submission, you create an event and, optionally, a sequence. Links to create assemblies and edit PDSs (for all but ELP-only users) are provided as well. To create a major update submission, an application must exist for the product family and country. Application countries:

— If additional CMS countries have been added that are not already part of the application, they are added to the application.

— If CMS countries that are part of the application are removed from the CMS list, they are not removed from the application.

The Countries attribute on the event is set as follows:

— For national internal procedure type applications, automatically associate the reviewing country on the selected application with the event.

— For CP internal procedure type applications, automatically associate the EU Country with the event.

— For MRP internal procedure type applications, the Reviewing Country/RMS on the selected application and the CMSs selected in the wizard are associated with the event.

Create a Major Update Submission

You can update an existing application for a new business objective or regulatory activity. When creating a major update submission, an event is created and you can create a sequence, if needed.

Note: To create a major update submission, an application must exist for the product family and associated country, and you must have the appropriate security permissions.

To create a major update submission:

1. Click Wizards > Create Submission.

   The Create Submission wizard opens to the Choose Submission Type page.

2. Click Major Update.
3. Click Next.

   The Complete Submission Properties page appears.

4. Enter the required information for creating an event. Creating a sequence is optional.

   Note: If you choose to create a sequence, you can change the default sequence numbering of a P followed by four digits. This numbering scheme is the format recommended for an eCTD submission. If you change, the format, Ennov InSight will issue a message requesting confirmation that you accept the deviation from the default sequence numbering format.

5. Click Next to confirm your selections.

   The Create Submission Confirmation page appears.

6. Choose the applicable procedure in the table below to enter an electronic signature in wizards:

   Scenario	Steps
   When electronic signature and SSO are enabled	In the confirmation page, select a reason and enter comments for the reason. Click Next. Validate your identity by entering your user credentials in the dialog box.
   When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Next.

1. Do one of the following:

   Option	Action
   To confirm your selections.:	Click Next. The Create Submission Summary page opens, listing the created items. Additional items you can add to the submission may also be listed. Proceed to step 8.
   To return to previous pages to change your selections:	Click Back.
   To cancel the submission entirely and return to the view from which you invoked the wizard:	Click Cancel.

2. On the Create Submission Summary page, do any of the following:

Major Update Submission Attributes

You can use the attributes to modify submission attributes.

Amendment Submission

You can create an amendment submission to change the filing content of an existing approval objective. When you create an amendment submission, you change the filing content of an existing approval objective. For example, you may be asked to clarify a statement in a previously submitted document. A sequence is created to support the amendment.

Create an Amendment Submission

You can create a new sequence for an existing application and event. You must have the appropriate security permissions to create an amendment using the Create Submission wizard.

To create an amendment submission:

1. Click Wizards > Create Submission.

   The Create Submission wizard opens to the Choose Submission Type page.

2. Click Amendment.
3. Click Next.

   The Complete Submission Properties page appears.

4. Choose the applicable procedure in the table below to enter an electronic signature in wizards:

   Scenario	Steps
   When electronic signature and SSO are enabled	In the confirmation page, select a reason and enter comments for the reason. Click Next. Validate your identity by entering your user credentials in the dialog box.
   When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Next.

1. Enter the properties for the submission.

   Concerned Member States will display only if the procedure type is MRP.

   Note: If you choose to create a sequence, you can change the default sequence numbering of a P followed by four digits. This numbering scheme is the format recommended for an eCTD submission. The sequence code must be unique within the application. If you change default numbering format, the wizard will issue a message requesting confirmation that you accept the deviation from the default sequence numbering format.

2. Click Next.

   The Create Submission Confirmation page appears.

3. On the Create Submission Confirmation page, do one of the following:

   Option	Action
   To confirm your selections:	Click Next . The Create Submission Summary page appears, indicating that a sequence has been created. Additional items that you can add to the submission may also be listed. Proceed to step 8.
   To return to previous pages to change your selections:	Click Back.
   To cancel the submission and return to the view form which you invoked the wizard:	Click Cancel..

4. On the Create Submission Summary page, do any of the following:

Amendment Submission Attributes

You can use the attributes to modify an existing submission.