Ennov InSight Registrations 7.2

Copy Applications

Create an application by using an existing National type application as a template.

Note: You must have at least WRITE privileges for the product family and the countries for which the application is copied. The name and code of the application you are copying must be different to the existing application name and code.

The following attributes are copied from the source application to the copies:

  • Legal Status
  • Application Description
  • Application Keywords
  • Application Owner
  • Orphan Drug
  • Dossier Language
  • Products
  • Registration Type

The Reviewing Country and Region(s) for the copied applications is based on the countries selected when using the Copy Application wizard.

The following attributes are also populated in the copy based on the country selected and the default settings for the country set by your data administrator:

  • Application Type
  • Procedure Type
  • Application Code
  • Application Name
  • Internal Code
  • Current Status
  • Current Status Date

An event is created for each new application with the event attributes you define. The following additional conditions apply to events and the event-country relationship:

  • The newly created events are open, not closed.
  • For countries that are mapped to National application types, the reviewing country on the copied application is automatically associated with the event.
  • For countries mapped to MRP application types, the RMS on the new application is automatically associated with the event.
  • For countries mapped to CP application types, the EU country is automatically associated with the event.
  • The event-country status schedule created for the new application is unlocked and has a default entry with the status selected by the user and the user entered status date. 

The new UUID is generated automatically. It is unique across all the applications.

If the application you are copying has any product detail sets, they are also copied to the new application with the exception of label details.

If you copy an application for the same country, the Copy Application wizard assigns the applicant ID from the first application to the new application.

When you copy an application for a different country:

  • If a default applicant ID is defined for the region associated with the new application, the Copy Application wizard assigns the default applicant ID to the new application.
  • If a default applicant ID is not defined for the region associated with the new application, the Copy Application wizard does not assign an applicant ID to the new application.
  • To set the default, go to Data Administration > Submission Maintenance > Applicant ID Values. This default is not shown in the Copy Application wizard.

To differentiate the application copies, the original application name is appended by the country code. For example, if you copy RR-APP001-NATIONAL and choose St. Lucia for the country, the name of the new application is RR-APP001-NATIONALLC.

After the application without a product is copied with the Copy Application wizard:
  • The copy of that application is displayed on the Applications tab of the Product Family Attributes page the initial application was created for.
  • The copy of that application is displayed under the Product Family node the initial Application was created for on the Product Family or Countries tree.

If the application without a product and product family was created and copied through the Copy Application wizard, the copy of that application is displayed under the NOT DEFINED on the Product Family or Countries tree.