Vault can aggregate Identification of Medicinal Products (IDMP) data for you, offering a simple way to compile product data before submitting it to the European Medicines Agency (EMA). Vault uses a series of algorithms to compile existing submission data in your RIM Registrations Vault into the IDMP object structure.

RIM Registrations Vaults include all IDMP objects and the IDMP aggregation algorithm automatically. You must perform the configurations in this article for users to work with IDMP data. See Generating IDMP Data for detailed information about generating the IDMP elements.

Configuration Overview

To set up IDMP data review:

  1. Configure the Generate IDMP Records action on the Regulatory Objective object lifecycle. See details about configuring this action below.
  2. Create an IDMP Product Data Submission object lifecycle and associate it with the IDMP Product Data Submission object.
  3. Configure the Generate IDMP Elements user action on the IDMP Product Data Submission object lifecycle. You can’t assign this action to the Active state; instead you must create a new lifecycle state on which to add this action.
  4. Configure the necessary object and object type page layouts.
  5. Set necessary shared document fields to Active and associate them with any document types that you might use as attachments on the IDMP report.
  6. Load the necessary controlled vocabulary files to support IDMP data.
  7. Optional: Enable IDMP and UDI accelerators. These allow Vault to automatically generate related records for certain IDMP objects. We also recommend configuring the Link Packaging to MP-Registration action on the Registered Packaging object lifecycle.
  8. Optional: Configure the Pending Withdrawal lifecycle state type to allow Vault to exclude source records from IDMP data aggregation.
  9. Optional: Activate object types and configure object page layouts to support regulatory text with multiple translations.
  10. Enable and configure eAF output reports to allow users to generate variation and product reports for working with eAF web forms in the EMA portal. As part of this configuration, you can also allow users to view complex XML FHIR messages in the IDMP Viewer.

Configuring IDMP Record Generation

The Generate IDMP Records action allows Vault to generate all IDMP data related to a Regulatory Objective record’s registrations at once. You can configure this as either a user action or an entry action on Regulatory Objective object lifecycle states. Do not configure this as an event action, or Vault will not be able to create records.

If you are configuring this as a user action, you must first assign the Generate IDMP Records object action to the Regulatory Objective object. Do not select the Available in All Lifecycle States checkbox when you assign the object action.

In order for this action to run successfully, you must also:

  • Assign the IDMP Job ID field to the Regulatory Objective object’s Regulatory Objective object type.
  • Ensure that there are no required fields configured on the IDMP Product Data Submission object.

Object Page Layouts

The IDMP data model object page layout configuration workbook details the object page layout configurations available to align your Vault to the IDMP data model.

The Related Object Sections tab details the source object page layouts requiring related output object sections. The Object Fields tab details which fields you can add to or remove from the indicated object’s page layout.

In both tabs, you can also:

  • Consult the Additional Instructions column for configuration considerations, which can include information about the fields Vault automatically adds to object page layouts.
  • Filter the Release column to determine when a given component was added or last updated.

The Object Fields tab also details whether an object contains source or output data, as this may determine your organization’s configuration requirements. If your organization’s data management strategy requires submission data to be edited at the source, you may consider omitting term and term text fields from the corresponding output records, such as Legal Basis Term and Legal Basis Term Text from the IDMP Classification System object.

About the Use for XEVMPD/IDMP Field

In some situations, you may want Vault to ignore certain Country Language records related to the submission when generating IDMP data. When this field is configured on the Country Language object page layout, users can indicate that Vault should ignore specific records by setting the Use for XEVMPD/IDMP field to No on each Country Language record. When the field is blank or set to Yes, Vault includes the record when generating IDMP data.

Supporting Regulatory Text with Multiple Translations

The IDMP data aggregation algorithm supports regulatory text records with multiple translations. To configure this in your Vault, we recommend the below configuration.

  1. Review the object page layout configuration workbook and configure the Related Object Section and Object Field configurations for supporting regulatory text with multiple translations. You can find them by filtering the Release column to 23R3 and reviewing the Additional Instructions column.
  2. Ensure the Device Description, Device Trade Name, and Device Intended Use object types are active within the below objects, then create a corresponding page layout for each:
    • Regulatory Text
    • Regulatory Text Translation
    • Event Regulatory Text
    • Application Regulatory Text
    • Submission Regulatory Text
    • Regulatory Objective Regulatory Text
    • Registered Regulatory Text
  3. Optional: Configure a Regulatory Text tab to allow users to view Regulatory Text object records.

Shared Document Fields

Set the following shared document fields to Active and associate them with any document types that you might use as attachments on the IDMP element:

  • IDMP Document Type
  • IDMP Effective Date
  • IDMP File Type
  • Medicinal Product

Controlled Vocabularies

Vault uses Controlled Vocabulary records to populate certain fields on IDMP Product Data Submission records. You must upload these controlled vocabulary files to your Vault using Vault Loader before users can begin the IDMP data collection and review process.

Centralised Procedure Controlled Vocabulary Requirements

To ensure that Vault can generate IDMP elements correctly and automatically create Medicinal Product and Medicinal Product Registration records, you also need to update the Centralised Procedure controlled vocabulary:

  1. Navigate to Admin > Business Admin > Controlled Vocabularies.
  2. Search to find the Centralised Procedure Controlled Vocabulary record in the grid.
  3. Select Edit Columns from the grid’s Actions menu and add the SPOR RMS ID and UUID fields as columns.
  4. Using inline editing, set the SPOR RMS ID field to 100000155059. Set the UUID field to 7aa0df44-87b9-4309-91a5-20185cdd2415.

Provenance Controlled Vocabulary Requirements

To ensure that Vault can determine critical aggregation and validation criteria, Provenance Controlled Vocabulary records must have an indicated Vault RIM UUID.

Enabling IDMP Accelerators

To enable IDMP accelerators, navigate to Admin > Settings > Application Settings and set the Enable IDMP and UDI Accelerators checkbox. Then, select the checkboxes for the accelerators that you want to enable:

  • Automatically Generate Medicinal Product Records: When users create new Registrations records, Vault automatically creates Medicinal Product and Medicinal Product Registration records. After setting this checkbox, select the Regions for which Vault should create records (for example, European Union), as well as the appropriate Lead Market Field (the Application object field that indicates the rapporteur for centralised procedures).
  • Automatically Generate Registered Packaged Product Records: When users create certain related records, Vault automatically creates Registered Packaged Medicinal Product records.
  • Automatically Generate Registered Site Role Records: When users create certain related records, Vault creates Registered Site Role records automatically.

System-managed naming must be configured on the Medicinal Product, Medicinal Product Registration, Registered Packaged Medicinal Product, and Registered Site Role objects in order for you to enable these features. See Generating IDMP Data for details about record creation. If you have any mandatory fields on these objects, they must have a default value defined or record creation will fail.

Enabling Medicinal Product Registration Mapping

After you enable IDMP accelerators, we recommend configuring the Link Packaging to MP-Registration action as a user action or an entry action on Registered Packaging object lifecycle states. This action maps Registered Packaging records to related Medicinal Product Registration records.

If you are configuring this as an entry action, do not configure the action on the Starting state, or bulk record creation issues could occur. If you are configuring this as a user action, you must first assign the Link Packaging to MP-Registration object action to the Registered Packaging object. Do not select the Available in All Lifecycle States checkbox when you assign the object action.

Configuring the Pending Withdrawal State Type

Using the Pending Withdrawal state type, you can configure various registered details object lifecycles to exclude records from the IDMP data aggregation algorithm. This can be useful, for example, when a Registered Active Substance record is in the process of being withdrawn but whose withdrawal is not yet complete, or when a registered detail’s Full Indication Text was submitted for update but is not yet approved.

To configure this:

  1. Review your Vault’s available object lifecycles, then create a lifecycle for any of the desired registered details objects which do not already have one.
  2. Within the source object lifecycle, confirm or create the lifecycle state your organization uses to indicate a record is being withdrawn. We recommend using a Pending Withdrawal label to match the state type.
  3. Map the new or existing lifecycle state to the Pending Withdrawal state type.
  4. Where required, configure the source object lifecycle to allow Vault or Vault users to move the source object record to the state mapped to the Pending Withdrawal state type. For example, you can add a manual user action to move Registered Active Substance records in the Planned state to the Pending Withdrawal state. Ensure your chosen method aligns with any existing object lifecycle logic.

You need the following permissions to configure IDMP data:

Type Permission Label Controls
Security Profile Application: Vault Owner Actions: Vault Loader Ability to use Vault Loader to load Controlled Vocabulary and Publishing Validation Criteria records.
Security Profile Objects: Controlled Vocabulary: Create Ability to create Controlled Vocabulary records.
Security Profile Tabs: Loader: View Ability to see the Loader tab.

In addition, you must have at least Read access on all IDMP Element objects: IDMP Admin Ingredient Manufacturer, IDMP Admin Product Ingredient Element, IDMP Attachment, IDMP Component, IDMP Component Material, IDMP Container, IDMP Container Data Carrier, IDMP Container Material, IDMP Container Reference Item, IDMP Manuf. Item Ingredient Manufacturer, IDMP Manufactured Item, IDMP Manufactured Item Ingredient, IDMP Manufacturing Site, IDMP Marketing Authorisation Element, IDMP Master File, IDMP Medicinal Product Element, IDMP Medicinal Product Full Name, IDMP Medicinal Product Indication, IDMP Name Part, IDMP Package Authorisation Status, IDMP Package Description, IDMP Package Marketing Status, IDMP Packaged Medicinal Product Element, IDMP Pharmaceutical Product Element, IDMP Product Cross Reference, IDMP Regulatory Authorisation, IDMP Shelf Life, IDMP Storage Precautions, and IDMP Therapeutic Indication Element.