Adding or Deleting Regulatory Decision

You can add or delete a regulatory decision to the context MAC.

Required Access Roles:

  • App-specific: Regulatory Lead
  • Baseline: Leader

This task shows you how to:

Before you begin: You cannot add or delete a regulatory decision if the context MAC is promoted to the Closed state.

Add Regulatory Decision

  1. View the Properties page of a MAC. For more information, see Social and Collaborative | Quality and Certification | Market Registration | Market Authorizations | Market Authorization and Market Authorization Change Properties.
  2. From the page toolbar, click Actions > Add Regulatory Decision.

    Important: The Add Regulatory Decision option is present if the regulatory decision has not already added to the context MAC.

  3. Enter these details:

    Column Name Description
    Name Enter the name of the regulatory decision. You can also select the auto name option to add the auto-generated name.
    Title Enter the title of the regulatory decision.
    Decision Date Select the date on which the authorization has approved.
    Decision Actor Select the person who is either reviewer or authority.

  4. Click Done.
    A regulatory context is created and added as the hyperlink in the Decision Comments field of the context MAC.

Delete Regulatory Decision

  1. View the Properties page of a MAC. For more information, see Social and Collaborative | Quality and Certification | Market Registration | Market Authorizations | Market Authorization and Market Authorization Change Properties.
  2. From the page toolbar, click Actions > Delete Regulatory Decision.

    Important: The Delete Regulatory Decision option is present if the regulatory decision is already added to the context MAC.