Market Authorization Change Lifecycle

A market authorization change is defined for each market authorization.

Users do not create or delete market authorization changes. Market Registration creates or deletes them based on activities in the related submission project.

The market authorization change lifecycle includes these states:

This page discusses:

In-Work

Market Registration automatically creates a market authorization change for each market authorization when a submission project that uses the Initial Submission regulatory activity category reaches the Assigned state. The app assigns the market authorization and market authorization change to the owner of the submission project. In this case, the market authorization is also in the In Work state.

Within the context of a submission master record, subsequent submissions for a combination of product and country can be made that affect the market authorization. These submission projects use a different regulatory activity category, such as Variation or Repeal. In this case, when the submission project is created, Market Registration creates a market authorization change for each combination of product and country associated with the submission project. Each market authorization change is associated with the original market authorization for that combination of product and country. In this case, the market authorization is in the Approved or Released state.

The Regulatory Lead updates the market authorization change with the approval notification from the regulatory authority, and enters the authorization details (authorization number, effective date, and so on). The Regulatory Lead then promotes the change to Approved.

A submission project has an associated market authorization and market authorization change for each combination of product and country. You cannot complete the submission project if any associated market authorization change is in the In Work state.

Approved

For an Initial Submission, when the effective date for the change is reached, the app automatically promotes the related market authorization to Released, and promotes this market authorization change to Closed.

Closed

Market Registration automatically promotes a market authorization change from the Approved to the Closed state on the effective date of the authorization. It also promotes the related market authorization from the Approved state to the Released state.