Calyx RIM for Registrations

Add an Active Ingredient Manufacturer

Using the Global Project Planning (GPP) wizard, you can add an active ingredient manufacturer to the PDS.

Table 1. Rules Determining the PDS Details Available for Selection
PDS detail Rules for available selections
Active Ingredients All the approved active ingredients associated with the selected PDSs
Manufacturers
  • Manufacturers with an active association with each of the selected active ingredients in Data Administration > Product Detail Set Maintenance > Manufacturer Values.
  • Manufacturers that do not already exist as a pending or approved manufacturer for any of the selected active ingredients.
Note: This procedure is a continuation of the Update Product Details Sets project in the GPP wizard. The procedure presented in Creating an Update Product Detail Set Project must be initiated first, followed by initiating Adding a Manufacturer PDS Project.
To add an active ingredient manufacturer:
  1. On the Select Flow page of the GPP wizard, select Add Active Ingredient Manufacturer.
  2. Click Next.
    The Select Parent Entities page opens.
  3. On the Select Parent Entities page, do the following:
    1. Select one or more active ingredients.
    2. Select a manufacturer.
  4. Click Next.
    The Perform Another PDS Action page opens.
  5. On the Perform Another PDS Action page, do one of the following:
    • Click Yes to perform another PDS action.
    • Click No to proceed to the Summary page of the GPP wizard.
  6. Click Next.
    One of the following occurs:
    • If you selected Yes in step 5, you return to the Select Action page in the GPP wizard.
    • If you selected No in step 5, the Summary page opens. Proceed to step 7.
  7. On the Summary page, do one of the following:
    • Select the project link on the Summary page to review the new project you created.
    • Click Finish.
    You are returned to the view from which you invoked the GPP wizard. In the PDS tree, the added manufacturer appears as a child node of the active ingredient. The status of the added manufacturer is Pending Add and is displayed in parentheses after the name of the manufacturer.