Market Authorization Lifecycle

Market Registration automatically creates a market authorization and its associated market authorization change when a submission project that uses the Initial Submission regulatory activity category reaches the Assigned state. A separate market authorization is created for each combination of product and country associated with that submission project. The market authorization is also associated with the submission master record that manages the submission project. Market Registration assigns the market authorization and market authorization change to the owner or the submission project.

For submission projects that use different regulatory activity categories, a new market authorization change is created and associated with the original market authorization for that combination of product and country.

All related items are attached to the market authorization change. You do not attach items to the market authorization itself.

When the related market authorization change is promoted to the Approved state, Market Registration automatically promotes the market authorization to the Authorized state, and the relevant content is copied from the market authorization change item to the market authorization item. This content includes the authorization number, effective date, and so on. If the market authorization defined the expiration and sunset clause dates as mandatory, those dates must be included.

For an Initial Submission, Market Registration automatically promotes the market authorization to Released on the effective date.

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

For a specific product and country combination, Market Registration only allows one market authorization in the Released state.

The regulatory authority can suspend the market authorization if sufficient issues related to the product are found. The regulatory authority would require the company to complete certain actions prior to re-activating the market authorization. In this case, the Regulatory Lead suspends the market authorization, and when the issues are resolved, promote it back to Released.

If a market authorization includes an expiration or sunset clause date, Market Registration automatically promotes the market authorization from Released to Obsolete on that date.

When you promote a market authorization change associated with a submission project that uses the Repeal regulatory activity category to the Complete state, Market Registration automatically promotes the related market authorization to Obsolete.

The app promotes the market authorization to Obsolete if the Result is changed to any of these values:

• Withdrawn
• Cancelled
• Rejected
• Sunset Clause
• Repeal