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.