Package Sets for Registrations

Package sets created and approved in Calyx RIM product detail sets (PDS) of the related product are associated with registrations. The PDS must belong to the same application as the registration.

A package set represents the set of details for which a registration is issued. Package sets consist of the various configurations and presentations that go into packaging a product. For example, a product with a specific dosage form and strength can be sold in different pack sizes, such as a 100 tablet bottle or a 500 tablet bottle. Each pack size translates to one package set in a PDS. You may associate one or more package sets with a PDS, or not associate a package set at all.

A registration for pharmaceuticals can have one or more associated package sets associated. However, you cannot associate the same package set with multiple registrations for the same country under one application.

Each package set associated with a registration is listed under the Package Sets tab. After a registration is created, package sets are associated, modified, and deleted under the Package Sets tab on the Registration Attributes page. Using the Package Sets tab, you can track the EU presentation number and the Sunset Clause marketing status information by country for each package set associated with the registration.