Calyx RIM 7.0 Publishing

Create Submission Wizard

The Create Submission wizard enables you to create an assembly within the context of its appropriate Calyx RIM 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 Calyx RIM. Except for template assemblies, every assembly in Calyx RIM 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.