Create a Package Set Registration

Typically used for managing drug registrations, package sets created and approved in a PDS can be associated with registrations.

To create a package set registration:

1. Click a link for the application for which you are creating the registration. The application must be of the package set registration type.
2. On the Application Attributes page, click Registrations.
3. On the Registrations tab, click Create.The Create Registration page appears.
4. Enter values for the registration attributes. While doing so, be aware of the following:

   ◦ When creating registrations for CP type applications, the country available for selection is the European Union country. The European Union country should be a country on the related CP application.

   ◦ When creating registration for DCP or MRP type applications, withdrawn application countries with the Withdraw Date value equal to the current date or earlier are not available for selection.

   ◦ Use the Available Package Set list box to select package sets created and approved in the product detail sets (PDSs) of the products related to the application that is associated with the registration.

5. Do one of the following: