Regulatory Decisions

The Regulatory Decisions page lists the details related to the authority decisions that are provided when a market authorization is approved.

Required Access Roles:

  • App-specific: Regulatory Lead
  • Baseline: Leader

To access this page:

  • Open the required market authorization. For more information, see Opening a Market Authorization.
  • In the page, click the Regulatory Decision tab.

You can also access the Regulatory Decision page from the Properties page of a MA, which is connected to the context MAC.

Or

  • Open the required ASPI. For more information, see Product Identifications.
  • In the page, click the Regulatory Decision tab.

This topic describes:

Columns

Column Name Description
Name The name of the regulatory decision.
Title The title of the regulatory decision.
State The lifecycle state of the regulatory decision.
MAC The market authorization change for which the decision has added.
Decision Date The date on which the authorization has approved.
Decision Actor The preson who is either reviewer or authority.
Owner The person responsible for the regulatory decision.