Bulk Creating Active Substance Registrations (RIM)

Bulk creation allows you to quickly create Registration records based on the data defined in the Application, Submission, and Regulatory Objective records for easy and consistent data entry. Vault ensures that each active substance results in a unique registration, which facilitates tracking and management at a granular level.

Values for Registration Records

When you use bulk registration creation, Vault creates different Registration records based on:

• Values on the related Application record
• Values on that application’s related records
• Values you select during the bulk action
• The Registration Scope for the Registration Type populated during the bulk action

How to Bulk Create Active Substance Registrations

Before you start the bulk creation process, you must add all appropriate data to your submission or regulatory objective. When you’re ready to create registrations, Vault includes a wizard to guide you through the process. Labels and options in this wizard may vary depending on your Vault’s configuration.

After you run the Create Registrations wizard, you can’t start the wizard from the same record again until record creation is complete. This prevents Vault from creating duplicate records.

Starting Bulk Creation

To create Registration records in bulk, you must first define the registration details:

1. Open the associated Application or Regulatory Objective record from the Application or Regulatory Objective tab, or from Business Admin.
2. Choose Create Registrations from the Actions menu. The action’s availability depends upon your Vault’s configuration (see Note). Additionally, the action is only available if the application has a Lead Market selected or if there are associated Country records through the Application: Country relationship.
3. In the Registration Type field, confirm the defaulted value or select one accordingly.
4. Select a Submission or Application. The required option depends on your Vault’s configuration (see Note). In either configuration, your selection controls what you see on the Active Substance Details and Product Details steps later in the bulk creation process when selecting details to register.
5. If required, select a Regulatory Objective to relate to each created Registration join record. This option is only available if activity and regulatory objective bundling is enabled in your Vault. If available, Vault automatically populates a Regulatory Objective based on the selected Submission.
6. Click Next.
7. On the Registration Details page, select the Countries for which you want to create registrations. You may remove defaulted countries and add others, but only countries associated with the selected application or countries selected by default are available here. If the Application Procedure is Centralised, Vault defaults to all EU and EEA countries. If you want to add the United Kingdom (XU) or United Kingdom (Northern Ireland) (XI) to a Centralised Procedure, they must be associated with the application, as they are no longer in the EU.
8. Fill in any additional required Registration fields.
9. Click Next to continue in the wizard and select the records to register.

Selecting Details to Register

After you fill in the registration details, you’ll see the Detail pages in the wizard, where you can select the individual records to register. On each page, you can click on column headers to sort the records or apply filters to object or lifecycle state fields by clicking the filter icon in the column to find records. If your Vault is configured to use object type mapping, you may not need to select object types for the created records.

1. On the Active Substance Details page, choose the Submission Active Substance or Regulatory Objective Active Substance records to register. The available records depend on your Vault’s configuration (see Note). Vault selects all records by default, but you can use the checkboxes or Deselect All to make changes.
2. If available, select the object type for the Registered Active Substance records, and fill in any other required fields.
3. Click Next.
4. On the Product Details page, choose the Submission Product or Regulatory Objective Product records to register. The available records depend on your Vault’s configuration (see Note). If available, select the object type for the Registered Product records, and fill in any other required fields. If you don’t want to associate any records, you may move to the next step.
5. Click Next.
6. On the Packaging Details page, choose the Submission Packaging or Regulatory Objective Packaging records to register. If available, select the object type for the Registered Packaging records, and fill in any other required fields. If you don’t want to associate any records, you may move to the next step.
7. Click Next to proceed to the Confirmation page.

Completing Bulk Creation

On the Confirmation page, review the details of the Registration records you’re creating. Click Finish to start creating records. The records that Vault creates depend on the variables set throughout this process.

About Record Creation

About the Use for Registrations Field

When configured by an Admin, the Use for Registrations Yes/No field allows your organization to specify which records Vault considers when creating registrations in bulk.

For example, you may want to exclude certain records when an Application Inactive Ingredient consolidated detail record for all manufacturers is included in the dossier. To prevent the wizard from creating a corresponding Registered Inactive Ingredient, you can check No for the field within the Application Inactive Ingredient record.

Depending on your Vault’s configuration, the Use for Registrations field can be used within the below Event, Application, Submission, and Regulatory Objective relationship detail records (for example, Event Product and Regulatory Objective Nonclinical Study):

• Product
• Active Substance
• Inactive Ingredient
• Indication
• Clinical Study
• Nonclinical Study

Copying Custom Fields

Vault can copy custom field values from Submission join records to the new Registration join records as long as custom fields with matching names and field types are configured on both objects. Vault supports copying custom fields for Picklist, Object, Date, DateTime, Yes/No, Text, and Number field types.

Registration Scope Details

Vault creates one (1) Registration record for each combination of Country and Active Substance.

Registration Field Auto-Population

When creating Registrations during bulk creation, Vault populates these fields:

Name

Vault assigns this based on the following standard, non-editable pattern: {Country > Country Code} – {Active Substance > Substance Name}. If another record exists with the same name, Vault appends a five (5) digit number to the end, for example, “UK – MC2039” and “UK – MC2039-00001”.

Application

A reference relationship is automatically created between new Registrations and the Application from which you started the process.

Submission

This field points to the Submission record selected during bulk creation.

Country

Vault creates Registration records for each selected Country. This field will point to one of the selected Country records.

Health Authority

This field defaults only if there is a single health authority associated with the selected Country.

Active Substance

This field points to the Active Substance on the Submission Active Substance record related to the Submission record you selected during bulk creation.

Status

This field defaults to the Registration object lifecycle’s starting state.

Registration Status Date

This field defaults to the date when you created the Registration.

Regulatory Objective

This field defaults to the Regulatory Objective you selected in the first step of the creation process or to the Regulatory Objective associated with the Submission you selected.

Object Relationships

Relationships between Registrations & Active Substance

When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Active Substance records.

Vault creates one (1) Registered Active Substance record for each active substance detail on the Submission selected in the wizard that matches the active substance on that registration.

Relationships between Registrations & Product

When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Product¹ records.

Vault creates one (1) Registered Product record for each Product¹ on the Submission selected in the wizard when the Product¹ and Product Variant¹ is related to the Active Substance on the Registration. Active substances are related to products and product variants through related Product Variant Active Substance records on the Active Substance record detail page.

Relationships between Registrations & Inactive Ingredient

When creating Registration records, Vault also creates many-to-many relationships between the registrations and Inactive Ingredient records.

Vault creates one (1) Registered Inactive Ingredient record for each combination of Inactive Ingredient and Manufacturer, Site Product Type, and Manufacturing Site Role related to the Submission. Vault does not create Registered Inactive Ingredient records if the Product¹ and Product Variant¹ on one of the Registered Product records do not match the Product¹ and Product Variant¹ related to one of the Submission Inactive Ingredient records. Inactive ingredients are related to products and product variants through related Product Variant Inactive Ingredient records on the Inactive Ingredient record detail page.

Relationships between Registrations & Packaging

When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Packaging records.

Vault creates one (1) Registered Packaging record for each combination of Packaging, Packaging Site, Shelf Life, Product¹, Product Variant¹, Finished Product Code, Site Product Type, Packaging UDI-DI, and DI Contained Within on the Submission selected in the wizard. Vault does not create Registered Packaging records if the Product¹ and Product Variant¹ do not match the Product¹ and Product Variant¹ on one of the Registered Product records. For complex products, the Product Variant field on the Registered Packaging record is expected to be blank.

Relationships between Registrations & Indication

When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Indication records.

Vault creates one (1) Registered Indication record for each Indication on the Submission selected in the wizard.

Relationships between Registrations & Shelf Life

When creating Registration records, Vault also creates many-to-many relationships between the Registration and Shelf Life records.

Vault creates one (1) Registered Shelf Life and Storage record for each combination of Packaging, Shelf Life, Storage Conditions, Container, Product, Product Variant, Inactive ingredient, and Active Substance on the Submission selected in the wizard.

Relationships between Registrations & Submission Site Role

When creating Registration records, Vault also creates many-to-many relationships between the Registrations and Submission Site Role records.

Vault creates one (1) Registered Site Role record for each combination of Manufacturing Site, Site Role, and Site Product Type on the Submission Site Role related to the Submission selected in the wizard.

Relationships between Registrations & Regulatory Objectives

If activity and regulatory objective bundling is enabled in your Vault, Vault also creates many-to-many relationships between the created Registrations and the Regulatory Objective record you selected in the wizard. Vault creates a Registration Regulatory Objective join record for each registration created.

If activity and regulatory objective bundling is not enabled in your Vault but the Submission record you selected in the wizard has a related regulatory objective, Vault creates many-to-many relationships between the created Registration records and the submission’s related regulatory objective. Vault creates a Registration Regulatory Objective join record for each registration created.

Bulk Action Processing Time & Notifications

Bulk creation occurs asynchronously, meaning that there may be a delay before you see the new records, particularly on Vaults with a lot of activity. Once you confirm a bulk creation, Vault puts the action in a queue with other asynchronous tasks. When the changes are complete, a note appears in your Notifications page and Vault sends you an email with a link to download the CSV summary file.

If Vault is unable to complete any of the creation tasks, the CSV file will include an explanation of the errors. Known reasons for these errors include:

• Records that are in an active workflow will not be modified
• Records already in the specified state will not be modified
• No Registration Scope records match the selected Country and Registration Type

Related Permissions

Bulk creation requires that your security profile grant Create permission on the objects you’re creating, for example, Registration,Registered Product,Registered Packaging, and more. Note that Vault checks for the required permissions during the asynchronous record creation phase of the process. You may be able to view the action even if it is not available to you. Any field-level security your Admin has configured on these objects may impact record creation as well.

You must also have Read permission on the source records from which you initiate the wizard, for example, Event, Application, or Regulatory Objective, and the records from which the wizard pulls data, for example, Regulatory Objective Product, Regulatory Objective Packaging, and more. If the objects use Dynamic Access Control, you must also have at least the Viewer role on the specific records. If your Vault uses field-level security, you must have Read permission on the fields from which Vault pulls data.