Create an Update Product Detail Set Project

Use this procedure to create an Update Detail Set Project in the Global Project Plan wizard. You can use the GPP wizard to manage and track bulk updates to PDS details.

To create an update PDS project:

  1. Click Wizards > Global Project Plan.The GPP wizard opens to the Project Details page.
  2. For the Project Type attribute, select Update Product Detail Sets or a type that maps to the internal project type of Product Detail Set Updates Project as defined in data administration.
  3. Enter values for the project attributes. The wizard requires entries for project type, project name, project status, and project status date.
  4. Click Next.
  5. Select a family type.
  6. Click Next.The Select Search Option or Summary page opens.
  7. Do one of the following:

    ◦ Select Active Ingredient.

    ◦ Select Assemblies Where Used Query, if this option is available.

    ◦ Select Substance.

    ◦ Select PDS Code/PDS Name.

    ◦ Select Product and Country.

    ◦ Select Trade Name.

    ◦ Select View Cumulative Summary of Selected PDSs. This option is available only if you returned to this step from step 19, after selecting PDSs.

  8. Click Next.

    ◦ If the Input Query Filter Criteria page opens, continue at step 12.

    ◦ If the Cumulative Summary of Selected PDSs page opens, showing the PDSs that you selected for the project, continue at step 9.

  9. On the Cumulative Summary of Selected PDSs page, if you want to remove PDSs from the project, select these PDSs.
  10. Click Next.A confirmation message tells you that the PDSs that you selected were removed from the project.
  11. Click Next again. Go to step 18.
  12. On the Input Query Filter Criteria page, define search criteria for locating the applications for which you want to update PDSs:

◦ If you selected Active Ingredient in step 7, define criteria to search for PDSs. Optionally, to limit the search, select the famil name. Select the active ingredient. Optionally, select one or more countries. Optionally, select one or more application types. Select one or more application statuses and one or more PDS statuses. Go to step 14 to choose display options.

◦ If you selected Assemblies Where Used Query in step 7, browse for the location of the document that you want to use as the basis for your query. Click Next, and go to step 13.

◦ If you selected Substance in step 7, define criteria to search for PDSs. Optionally, to limit the search, select the family name. Select the substance. Optionally, select one or more countries. Optionally, select one or more application types. Select one or more application statuses and one or more PDS statuses. Go to step 14 to choose display options.

◦ If you selected PDS Code/PDS Name in step 7, define criteria to search for PDSs. Optionally, to limit the search, enter the product detail code, the product detail set name, or both. Optionally, select one or more countries. Optionally, select one or more application types. Select one or more application statuses and one or more PDS statuses. Go to step 14 to choose display options.

◦ If you selected Product and Country in step 7, define criteria to search for PDSs. Optionally, limit the search results by selecting one or more products. Select one or more application statuses and one or more PDS statuses. Optionally, select one or more countries. Optionally, select one or more application types. Click Next, and go to step 14 to choose display options.

◦ If you selected Trade Name in step 7, define criteria to search for PDSs. Optionally, to limit the search, select the family name. Select the trade name. Optionally, select one or more countries. Optionally, select one or more application types. Select one or more application statuses and one or more PDS statuses. Go to step 14 to choose display options.

  1. If you selected Assemblies Where Used Query in step 7, you can optionally do the following:

    ◦ By default, Working and Sequence assembly types are included in the Assemblies Where Used Query search. If you want to limit your search results, deselect one of those options. Working status means the assembly was changed, but not added to the submission lifecycle. Sequence status means that the assembly is added to the submission lifecycle.

    ◦ To search for only one version of the document, deselect All Versions of Document.

    ◦ Change the Document Currency Status. If you use the default setting of Current Status Only, the results include only PDSs that include the document currently relevant for a submission. If you select All Statuses, the results include every PDS in which the document version appeared, regardless of whether the document is current. In other words, the search will return PDSs that have the document which has been superseded for reasons of being appended, revised, replaced, or withdrawn.

  2. On the Input Query Filter Criteria page, optionally do any of the following to change the displayed results:

    ◦ Change the columns included in the displayed results, or change their order of appearance.

    ◦ Change the order in which the results will be presented.

  3. Click Next.The Select Product Detail Sets page opens, listing the PDSs and associated applications that meet the search criteria.
  4. Select the PDSs that you want to update.
  5. Click Next.The How would like to continue? page opens.
  6. Choose either of these options:

    ◦ Search for additional PDSs or view a summary of selected PDSs

    ◦ Continue on to create an event

  7. Click Next.

    ◦ If you chose to search for additional PDSs or view a summary of selected PDSs, the Select Search Option or Summary page opens. Return to step 7.

    ◦ If you chose to create an event, the Enter Event Details page opens. Continue at step 20.

  8. Enter values for the event attribute options presented.An event will be created for each application included in the project and the following will occur:

    ◦ For CP applications, the wizard automatically assigns the European Union to the created event. ◦ For National applications, the wizard automatically assigns the reviewing country for the event. ◦ For MRP applications, the RMS country will be assigned to the created event.

    ◦ For all application types, the event-country status is assigned to each country when the event is created.

  9. Click Next.The Select Timeline/Event Plan page opens.
  10. On the Select Timeline/Event Plan page, do one of the following:

    ◦ Select a timeline/event plan from the Timeline/Event Plan drop-down list to associate an event plan with the events created by the wizard. An event plan must exist in the system for you to select a timeline/event plan. If a timeline/event plan chosen in the project does not have a country lead time for the reviewing country on the selected application, the lead times in the status schedule table are assumed to be zero. Projected dates are calculated using lead times and the project’s pivot status and status date. Continue at step 23.

    ◦ Do not select a timeline/event plan. A timeline/event plan will not be associated with the project. Click Next as many times as is necessary to open the Confirmation page. Continue at step 30.

  11. Choose the applicable procedure in the table below to enter an electronic signature in wizards:
    Scenario Steps
    When electronic signature is enabled
    1. In the confirmation page, select a reason and enter comments for the reason.
    2. Click Next.
    3. Validate your identity by entering your user credentials in the dialog box.
  1. Click Next after completing each timeline/event plan page.

    ◦ If you select a timeline/event plan the event-country status will be set to the first status in the timeline/ event plan and include an actual date for that status on the event-country status schedule.

    ◦ If you do not select a timeline/event plan the event-country status is set to the default event status set in Data Administration and include an actual date for this status on the event-country status schedule.

    ◦ When all the timeline/event plan pages are completed, the Confirmation page opens.

  2. Click Next.Events are created for the selected applications, and the PDSs you selected are now associated with the events. The Create Sequence(s) page opens.
  3. On the Create Sequence(s) page, do one of the following:

    ◦ To create a sequence, select Yes and click Next. The Sequence Attributes page opens. Go to step 29.

    ◦ To proceed without creating a sequence, select No and click Next. If you select No, the wizard displays a message indicating that you do not need to enter sequence details. Go to step 30.

  4. On the Sequence Attributes page, select or enter values for the sequence attributes.
  5. Click Next.A confirmation page listing the actions that will be taken opens.
  6. Choose the applicable procedure in the table below to enter an electronic signature in wizards:
    Scenario Steps
    When electronic signature is enabled
    1. In the confirmation page, select a reason and enter comments for the reason.
    2. Click Next.
    3. Validate your identity by entering your user credentials in the dialog box.

    30.

    1. Click Next.The Select Action page opens.
    2. Select one of the available options to perform a specific PDS update. After completing the PDS update pages related to the action you chose, the Perform Another PDS Action page appears.
    3. On the Perform Another PDS Action page, do one of the following:

      ◦ Click Yes to return to the Select Action page in step 34 and perform another update PDS action.

      ◦ Click No and the Summary page opens. Proceed to the next step.

    4. 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 to return to the view from which you invoked the GPP wizard.

    5. To view the project after closing the GPP wizard, click Home > Projects tab.
    6. Click the link for the project you just created to open the Project Attributes page.