# 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][1]. 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 {#selecting-details}
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 {#about-the-use-for-registrations-field} When [configured](/en/lr/57203/#about-the-use-for-registrations-field) 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 : When [system-managed naming](/en/lr/30986/) is enabled for the _Registration_ object, Vault follows the configured naming pattern. Otherwise, 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-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 _Product[^1]_ records. Vault creates one (1) _Registered Product_ record for each _Product[^1]_ on the _Submission_ selected in the wizard when the _Product[^1]_ and _Product Variant[^1]_ 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 _Product[^1]_ and _Product Variant[^1]_ on one of the _Registered Product_ records do not match the _Product[^1]_ and _Product Variant[^1]_ 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_, _Product[^1]_, _Product Variant[^1]_, _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 _Product[^1]_ and _Product Variant[^1]_ do not match the _Product[^1]_ and _Product Variant[^1]_ 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](/en/lr/39108/) 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. [^1]: In Vaults created after the 19R1 release, the following objects are relabeled to support medical devices. The _Product_ (`product__v`) object is now _Product Family_. The _Drug Product_ (`drug_product__v`) object is now _Product_. The _Product Detail_ (`product_detail__v`) object is now _Product Variant_. In existing Vaults, Admins can [update these objects manually](/en/lr/15057/#customizestandardobjects). [1]: #selecting-details