Ennov InSight Registrations 7.2

Product Detail Management Queries

The query links related to product details are defined on the Product Detail Management tab.

For easy reference, the query descriptions are arranged alphabetically by query name.

Query Name Description
Application History The Application History Query enables you to list the history of events and types of product details affected for an application that you specify. Clicking the Y under any product detail displays details about the change that occurred.
Application QC Status History The Application QC Status History Query enables you to view the history of QC status changes for an application that you specify.

To use the QC status feature, go to Data Administration and set the default QC status to a value that enables you to use this feature.

If you can use the QC status feature, the Application QC Status History Query enables you to list the following for an application that you specify:

  • The history of QC status changes
  • The PDS details that passed a QC check
  • The PDS details that failed a QC check
  • The PDS details that require a QC check

In the results, a Y under a PDS detail indicates that the detail passed a QC check. Clicking a Y displays details about the QC check. An N under a PDS detail indicates that the detail failed a check or was not checked.

When you are viewing the PDS details in the query, a QC Status of "Not Applicable" means the QC verification process is not being used.

Flu Strain with Registration and PDS Details The Flu Strain with Registration and PDS Details Query shows the following for flu vaccine products:
  • The flu strains in the products
  • The applications for the products
  • The countries where the products have been marketed and whether the products are currently marketed in these countries
  • The registrations for the products
  • The product detail sets (PDSs) that contain information about the products 
Labeled Indications The Labeled Indications Query enables you to determine the following for the labeled indication created for one or more products of a specific product family type:
  • The products developed to treat the labeled indication
  • The applications and registrations for the products
  • The PDSs that contain the labeled indication
  • The indications/intended uses for the products
List of Active Ingredient Manufacturers The List of Active Ingredient Manufacturers query enables you to determine the manufacturers for one or more active ingredients. The query includes only approved and pending approval manufacturers.
List of Active Ingredient Function Manufacturers The List of Active Ingredient Function Manufacturers enables you to determine the manufacturers that perform specific functions for an active ingredient (for example, quality testing). The query includes only approved and pending approval manufacturers.
List of Active Ingredient Material Manufacturers The List of Active Ingredient Material Manufacturers query enables you to determine the manufacturers that provide materials for an active ingredient manufacturing process. The query includes only approved and pending approval manufacturers.
List of Application Countries with PDS Country and Registration Details The List of Application Countries with PDS Country and Registration Details query enables you to query for the list of countries based on the following information:
  • Application Country
  • PDS Country
  • Registration
  • Registration Package Set
  • Registration Package Set Country

The following filters are available on the Enter Search Criteria page:

  • Family Type, drop-down list
  • Family Name, drop-down list
  • Product, multi-select list
  • Application Name, multi-select list
  • Application Status, multi-select list
  • Application Country, multi-select list
  • Application With Withdrawn Country, drop-down list
  • Application Country Role, multi-select list
  • License Code, text field
  • MAH/Organisation, multi-select list
  • Annual Report Date, date field
  • License Issue Date, date field
  • Neat Renewal Date, date field
  • Last Renewal Date, date field
  • Expiration Date/Registration Valid Until, date field
  • License Status, multi-select list
  • License Status Date, date field
  • Reason for Termination/Withdrawal, multi-select list
  • In-Licensing, text field
  • Out-Licensing, text field

The values displayed in the following columns on the query Search Result page are hyperlinks to the corresponding entity attributes page:

  • Family Code and Family Name lead to the related Product Family
  • Product leads to the related Product
  • Application Name, Application Code and Application Internal Code lead to the related Application
  • Application Country leads to the related Application Country
  • Country Trade Name leads to the related PDS Country Detail
  • License Code leads to the related Registration

The query Search Results page displays one row per Application Country, per PDS Country, per Registration.

List of Application Countries with Registration and Product Details The List of Application Countries with Registration and Product Details query enables you to list countries that are associated with applications, product, or registrations that include attributes that you choose. The query can be one of the following, based on your security privileges:
  • For SPT users, the query shows application, associated countries, and event information. Registered countries and PDSs are not available.
  • For RPT users, the query shows registration properties, application, application countries, event, and registration properties. PDS information is not included.
  • For PDM users, the query shows application, application countries, event, registration, and product detail set detail information.
List of Component Manufacturers The List of Component Manufacturers query enables you to determine the approved and pending approval manufacturers for one or more product components. The query includes only manufacturers associated with the following details in the PDS tree:
  • Component | Function
  • Component | Manufacturing Process | Function
  • Component | Manufacturing Process | Step | Function
  • Component | Manufacturing Process | Step | Material
List of CTA Applications with PDS Details The List of CTA Applications with PDS Details query enables you to determine the approved and pending approval investigational product details for a CTA (clinical trial authorization) application.
List of Dose Schedules For veterinary product families, the List of Dose Schedules query enables you to determine dosing schedules for the criteria that you specify, such as the following: species, species indications, routes of administration, and dosing attributes.
List of Excipient Manufacturers The List of Excipient Manufacturers query enables you to determine the approved and pending approval manufacturers for one or more substances.
List of IND Applications with PDS Details The List of IND Applications with PDS Details query enables you to view a list of IND applications and view the IND application attributes with associated CT shared data, comparators, and PDS details.
List of Package Set Manufacturers The List of Package Set Manufacturers query enables you to determine the approved and pending approval manufacturers for one or more package sets. The query includes only manufacturers associated with the following details in the PDS tree:
  • PDS | Package Set | Function
  • PDS | Package Set | Packaging
  • PDS | Package Set | Component | Packaging
List of Package Set Registrations with Application and Product Detail Properties The List of Package Set Registrations with Application and Product Detail Properties query enables you to list the registrations of package set type for applications and package set registrations that include attributes that you choose. For example, the query can list all package set registrations for Europe for a product family. The query shows all package set registration attributes and some application and product detail attributes.
List of PDS Manufacturers The List of PDF Manufacturers query enables you to determine the approved or pending approval manufacturers for one or more products. The query includes only manufacturers associated with the following details in the PDS tree:
  • PDS | Function
  • PDS | Manufacturing Process | Function
  • PDS | Manufacturing Process | Step | Function
  • PDS | Manufacturing Process | Step | Material
List of Product Detail Set Templates The List of Product Detail Set Templates query enables you to list all product detail set templates associated with the selected product family and product.
List of Product Detail Sets The List of Product Detail Sets query enables you to list PDSs (product detail sets) that have the attributes that you specify. For example, you can list all PDSs associated with an active registration in a country you specify.
List of Products with Registration and Flu Strain Details The List of Products with Registration and Flu Strain Details query enables you to identify products containing flu strains. The query returns the following information about the flu strains that you select:
  • Products, applications, registrations, and PDSs containing the flu strains
  • Countries in which the flu strains are marketed
  • PDSs containing approved package sets for the flu strains
  • Flu strain concentration measures
List of Product Registrations with Application and Product Detail Properties The List of Product Registrations with Application and Product Detail Properties query enables you to list the registrations of product type for applications and product registrations that include attributes that you choose. For example, the query can list all product registrations for Europe for a product family. The query shows all product registration attributes and some application and product detail attributes.
List of Registration Package Sets Withdrawn The List of Registration Package Sets Withdrawn query enables you to determine the registration package sets that have been withdrawn from the market or those that have not been withdrawn from the market. You can limit the returned registration package sets to those for applications that have a specific status or to those for registrations that have a specific license status.

The query also shows information about the applications and registrations related to the registration package sets.

List of Registrations with Packaging The List of Registrations with Packaging query enables you to list only registrations that contain the product details you specify, for example, all products or markets that use the packaging you specify. The query shows all associated PDSs with registration and related attributes.
List of Registrations with Active Ingredients The List of Registrations with Active Ingredients query enables you to list the registrations that contain the product details that you specify, for example, all products or markets that use the active ingredient that you specify. The query shows all associated PDSs with registration and related attributes.
List of Registrations with Excipients The List of Registrations withExcipients query enables you to list the registrations that contain the product details you specify, for example, all products or markets that use the substance that you specify. The query shows all associated PDSs with registration and related attributes.
List of Registrations with Indications/Intended Use The List of Registrations with Indications/Intended Use query enables you to list the registrations that contain approved or pending approval indications/intended uses. The query shows approved PDS details associated with the indication/intended uses.
List of Registrations with Labeling The List of Registrations with Labeling query enables you to list the registrations that contain the product details you specify, for example, all products or markets that use the labeling that you specify. The query shows all associated PDSs with registration and related attributes.
List of Registrations with Local Country Details The List of Registrations with Local Country Details query enables you to list the registrations that contain the product details you specify, for example, all products or markets with the country detail you specify. The query shows all associated PDSs with registration and related attributes.
List of Registrations with Material The List of Registrations with Material query enables you to list the registrations that contain the product details you specify, for example, all products or markets that use the material you specify. The query shows all associated PDSs with registration and related attributes.
List of Species and Indications For veterinary product families, the List of Species and Indications query enables you to list the species and species indications that contain the criteria that you specify, such as the following: products, application countries, PDS statuses, species statuses, sub-indications, and indication statuses.
List of Withdrawal Times For veterinary product families, the List of Withdrawal Times query enables you to list the withdrawal times that contain the criteria that you specify, such as the following: products, application countries, PDS statuses, species statuses, routes of administration, human consumption product, do not use flag, and withdrawal time attributes.
Shelf Life You can track concurrent pending changes to product shelf life information by examining shelf life details. The Shelf Life query enables you to view approved, but not withdrawn, shelf life PDS details for products and where they are currently marketed.
Sunset Clause Marketing Status The Sunset Clause Marketing Status query enables you to view the sunset clause date for each presentation in each country, for the product family that you specify. The query also shows the product family, application, and registration attributes.