Registration Types
When you associate a registration to an application, the registration type of an application dictates how the registration is managed in Calyx RIM.
Registrations are managed by associating them either with package sets created and approved in a product detail set (PDS), or with products from an event associated with the registration.
Package Set Registration Types
Used typically for managing drug registrations, package sets created and approved in a PDS can be associated with registrations. The PDSs must belong to the same application as the registration. Package sets consist of the various configurations and presentations that go into packaging a product. Furthermore, for EU registrations, you can track Sunset Clause marketing status information on a per country, per package set basis.
Product Registration Types
Primarily used for managing medical device registrations, an event can be associated with a registration, and then one or more of the products associated with the event can be associated with the registration. This enables you to identify which products have been approved for an event and granted a license/registration.