Bulk Creating Product 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. This feature is especially important for grouped markets such as the European Union (EU) or Gulf Cooperation Council (GCC) where one marketing application can lead to multiple registrations across multiple countries.

Vault creates unique registrations based on the rules that have been configured for each country. This results in registrations with the appropriate level of granularity for each country, depending on whether the registered product is a drug product or a medical device. Vault can create one registration for a related group of products, one registration per product, one registration per product per manufacturing site, one registration per product variant, or one registration per pack size.

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 Product 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 Product Details and Packaging 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 in all EU and EEA countries, or constrains selections to only those defined for the Application. 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.

Vault automatically selects object types based on your Vault’s Object Type Mapping records and existing source record Name values. See About Object Type Mapping for more information.

1. 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). Vault selects all records by default, but you can use the checkboxes or Deselect All to make changes.
2. Optional: If the submission or regulatory objective (see Note) has both simple and complex products, you can select the checkbox to create separate registrations for all selected products, including simple products that are components of selected complex products. You won’t see this option if the Registration Type you selected has the Marketed Product Group registration scope for all of the countries you selected.
3. If available, select the object type for the Registered Product records, and fill in any other required fields.
4. Click Next.
5. On the Packaging Details page, choose the Submission Packaging or Regulatory Objective Packaging records to register. The available records depend on your Vault’s configuration (see Note). If available, select the object type for the Registered Packaging records, and fill in any other required fields.
6. 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

Registration Naming Patterns

Vault names new Registration records following the naming patterns below:

Registration Scope	Naming Pattern
Marketed Product Variant	{Country > Country Code} – {Product Variant > Product Name} {Country > Country Code} – {Product Variant > Product Variant}
Marketed Pack Size	{Country > Country Code} – {Product > Product Name} – {Packaging > Name} {Country > Country Code} – {Product Variant > Product Variant} – {Packaging > Name}
Marketed Product Group	{Country > Country Code} – {Application > Primary Product Family}
Marketed Product	{Country > Country Code} – {Product > Product Name}
Marketed Product by Site	{Country > Country Code} – {Product > Product Name} – {Manufacturer > Manufacturing Site}

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

The following are registration scope options and their results:

Centralised Application Procedures

Marketed Pack Size or Marketed Product Variant¹

For centralised procedures, Vault creates one (1) Registration record for each combination of Country, Packaging, Product¹, and (if relevant) Product Variant¹.

By default, Vault creates Registration records for all 30 EU and EEA member states unless you deselect any countries in the wizard.

When the related setting is enabled, Vault references the Application’s Procedure Type value to dynamically populate default countries based on Region Specific Entry Constraints for that procedure. When the constraint defines a Health Authority, Vault also populates this value in the resulting registrations.

Non Centralised Application Procedures

Marketed Pack Size

For each Country, Vault creates one (1) Registration record for each valid combination of Country, Product¹, Product Variant¹ (if relevant), and Packaging.

Marketed Product Variant

Vault creates one (1) Registration record for each combination of Country, Product¹, and Product Variant¹.

Marketed Product by Site

For each Country, Vault creates one (1) Registration for each combination of Product¹ and Manufacturing Site.

Marketed Product

Vault creates one (1) Registration record for each combination of Country and Product¹.

Marketed Product Group

Vault creates one (1) Registration for each Country.

If you did not select the Create separate Registrations for any selected Complex Products and their selected component Products checkbox on the Product Details page when selecting details to register, Vault only creates Registration records for the complex products and for any simple products that are not components of the complex products. If you did select this checkbox, Vault creates Registration records for every selected product, including simple products that are components of selected complex products.

Registration Field Auto-Population

When creating Registrations during bulk creation, Vault populates these fields depending on the Registration Scope:

Name

Vault assigns this based on standard, non-editable patterns. 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.

Product¹

This field points to the Product¹ on the Submission Product record selected during bulk creation. Vault only populates this field when the scope is Investigational Product.

Product Variant¹

This field points to the Product Variant¹ on the Submission Product¹ record selected during bulk creation. Vault only populates this field if the registration scope is Marketed Pack Size or Marketed Product Variant and if the Product on the registration is not a complex product.

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.

Manufacturing Site

(For the Marketed Product by Site registration scope only) This field points to the Manufacturer on the Submission Product¹ record related to the Submission record you selected during bulk creation.

Object Relationships

Relationships between Registrations & Product

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

Complex Products

Vault creates one (1) Registered Product record for each combination of complex Product¹, Manufacturing Site Role, Site Product Type, Risk Class, and Product Information URL. If any product components are listed on the Product Details page of the wizard, Vault creates Registered Product records for each applicable combination of Manufacturer, simple Product¹, Product Variant¹, Manufacturing Site Role, Site Product Type, Risk Class, and Product Information URL based on the data on the Submission selected in the wizard.

Simple Products

Vault creates Registered Product records for each combination of Product,¹ Product Variant¹, Manufacturer, Manufacturing Site Role, Site Product Type, Risk Class, and Product Information URL on the Submission selected in the wizard.

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 combination of Active Substance, Manufacturer, Site Product Type, and Manufacturing Site Role on the Submission selected in the wizard.

Vault does not create Registered Active Substance records if the Active Substance is not related to the Product¹ and Product Variant¹ on one of the Registered Product records, or if it is not related to the Product¹ and Product Variant¹ of one of the components of a complex product on one of the Registered Product records. 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, Manufacturer, Site Product Type, and Manufacturing Site Role on the Submission selected in the wizard.

Vault does not create Registered Inactive Ingredient records if the Submission Inactive Ingredient is not related to the Product¹ and Product Variant¹ on one of the Registered Product records, or if it is not related to the Product¹ and Product Variant¹ of one of the components of a complex product on one of the Registered Product 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 & 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 & 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 Product and Product Variant on one of the Registered Product records. For complex products, the Product Variant field on the Registered Packaging record is expected to be blank.

If the registration scope is Marketed Product by Site, Vault only creates Registered Packaging records when the Finished Product Manufacturer is populated on the Submission Product¹ record related to the Submission record you selected during bulk creation.

Relationships between Registrations & Product Classifications

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

Vault creates one (1) Registered Product Classification record for each combination of Product¹, Product Variant¹, and Classification on the Submission selected in the wizard. Vault does not create Registered Product Classification records if:

• A Product Variant¹ is specified and the Product¹ and Product Variant¹ do not match the Product¹ and Product Variant¹ on one of the Registered Product records.
• A Product Variant¹ is not specified and the Product¹ does not match the Product¹ on one of the Registered Product records.

Relationships between Registrations & Product Characteristics

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

Vault creates one (1) Registered Product Characteristic record for each combination of Product¹, Product Variant¹, Characteristic Type, and Characteristic Value on the Submission selected in the wizard. Vault does not create Registered Product Characteristic records if:

• A Product Variant¹ is specified and the Product¹ and Product Variant¹ do not match the Product¹ and Product Variant¹ on one of the Registered Product records.
• A Product Variant¹ is not specified and the Product¹ does not match the Product¹ on one of the Registered Product records.

Relationships between Registrations & Packaging Characteristics

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

For each registration, Vault creates a Registered Packaging Characteristic record for each packaging characteristic related to the Submission selected in the wizard. Vault does not create Registered Packaging Characteristic records if the Packaging does not match the Packaging on one of the Registered Packaging records.

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 or Condition 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

If the registration scope is Marketed Pack Size or Marketed Product Variant, Vault also creates many-to-many relationships between the Registrations and Submission Site Role records when creating Registration 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.

Relationships between Registrations & Organizations

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

For each registration, Vault creates a Registered Organization record for each organization related to the Submission selected in the wizard. Vault does not create Registered Organization records if the Product does not match the Product on one of the Registered Product records.

Relationships between Registrations & Regulatory Text

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

For each registration, Vault creates a Registered Regulatory Text record for each regulatory text record related to the Submission selected in the wizard.

Vault does not create Registered Regulatory Text records if:

• Packaging does not match the Packaging on one of the Registered Packaging records.
• Packaging is not specified and the Product Variant does not match the Product Variant on one of the Registered Product records.
• Packaging and Product Variant are not specified and the Product does not match the Product on one of the Registered Product records.

Relationships between Registrations & Authorizations

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

For each registration, Vault creates a Registered Authorization record when the Product Variant field on the Submission Authorization record matches the Product Variant on one of the Registered Product records. Vault does not create Registered Authorization records if a Product Variant is not specified and the Product does not match the Product on one of the Registered Product records.

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.