Identification of Medicinal Products (IDMP) data uses controlled vocabularies to harmonize terms across markets. Each controlled vocabulary can have hundreds of terms, and the EMA updates and replaces terms regularly, requiring frequent reconciliation between the Controlled Vocabulary records in Vault and the EMA’s SPOR Referentials Management System (RMS) database.

The Vault integration with the EMA’s SPOR RMS database can update Controlled Vocabulary records automatically, keeping terms consistent with the master SPOR database and helping your organization stay compliant.

How the EMA RMS Integration Works

The integration with the SPOR RMS database allows Vault to update Controlled Vocabulary records through an asynchronous job that you can schedule to fit your organization’s business processes. Each time the job runs, Vault uses the SPOR referential ID to match the Controlled Vocabulary records in your Vault against the latest SPOR terms in the RMS database. Vault creates and updates Controlled Vocabulary records as needed and sends you a notification when the job is complete.

If the SPOR referential ID matches, Vault updates the following fields on existing Controlled Vocabulary records:

  • EV Code
  • SPOR Domain
  • SPOR List ID
  • SPOR List Name
  • SPOR Referential ID
  • SPOR Status
  • SPOR Term Name
  • SPOR Version
  • Valid as Of

If your Vault doesn’t contain matching SPOR referential IDs, Vault creates a new Controlled Vocabulary record for each unmatched ID.

Configuring the EMA RMS Integration

The following sections explain how to set up the integration between your Vault and the SPOR RMS database.

Retrieving EMA SPOR User Credentials

First, you must get login credentials for the SPOR RMS database. You will likely need to create accounts using the EMA’s identity management solution.

  1. Request access to the EMA’s UAT (User Acceptance Testing) environment. The EMA Service Desk will instruct you on the appropriate process to follow.
  2. Download the SPOR RMS API Test Cases file provided by the EMA. In the file’s RMS Test Cases tab, find TestID 018. Enter the test case into Postman and copy the results from Postman back into the file.
  3. Send the updated SPOR RMS API Test Cases file with the Postman results to the EMA Service Desk to request access to the production SPOR RMS API. When you send the file, we recommend including the following note to inform the EMA about the API calls you tested: “We are connecting a software application with a programmatic interface to the RMS API. The Vault RMS Sync feature uses only one endpoint. It is a one-way, pull-only feature to sync predetermined lists of terms from the RMS database to Vault.”
  4. The EMA Service Desk will grant production SPOR RMS API access to your existing production account. You will use this account to create an external connection in Vault.

See the EMA’s SPOR website for more information.

Creating an External Connection

After you have your username and password for the SPOR RMS database, navigate to the Admin > Connections page in your Vault to create an external connection. See Creating & Managing Connections for more information about setting up an external connection.

Preparing Controlled Vocabularies in Vault

Before you schedule the RMS Integration and Synchronization job, you need to map the existing Controlled Vocabulary records in your Vault to the terms in the SPOR RMS database. To do this, use Vault Loader to update the SPOR List ID field on the appropriate Controlled Vocabulary records with the SPOR referential ID for each term. See IDMP Configuration for more information about the controlled vocabulary files to load to your Vault.

Certain lists have the same name but different SPOR referential IDs due to the term hierarchies. We recommend updating the Name field on the Controlled Vocabulary records for these terms to reflect the hierarchy, for example, “Biological Testing for Testing of Medicinal Product” and “Biological Testing for Testing of Active Substance”.

Activating & Scheduling the Synchronization Job

After you have created the connection and mapped Controlled Vocabulary records to the terms in the SPOR RMS database, you can activate and schedule the RMS Integration and Synchronization job.

  1. Navigate to Admin > Operations > Job Definitions.
  2. Open the RMS Integration and Synchronization job and click Edit.
  3. Optional: Edit the Title and Job Owner. The Job Owner will receive the notification and CSV results file each time the job runs.
  4. Set the job’s schedule. See Configuring Job Definitions for more information about scheduling jobs.
  5. Set the Status to Active.
  6. In the Connection Details field, select the external connection that you created on the Admin > Connections page.
  7. Optional: Clear the Update Inactive Terms checkbox if you don’t want Vault to update inactive Controlled Vocabulary records when the job runs.
  8. Optional: Review the RMS List for Compare and deselect any terms that you don’t want Vault to compare and update. If you want to restore the original selections after you’ve made changes, click Restore defaults.
  9. Optional: Review the Term Filters for Selected Lists and deselect any Domain or Term Status values that you don’t want Vault to update.
  10. Click Save to activate and schedule the job.

Maintaining the Synchronization Job

You may need to update the job’s RMS List for Compare based upon your organization’s requirements as the EMA expands its referential data with additional lists.

Vault supports the below RMS lists as of the 22R3 release. Lists added after the 22R3 release are indicated by the release number.

  • Marketing Authorisation Application Legal Basis
  • Application Submission Type
  • Combination Package
  • Combined Pharmaceutical Dose Form
  • Combined Term
  • Contact Party Role
  • Country
  • Country Grouping
  • Data Classification (23R1)
  • Domain
  • eCTD EU Context of Use (23R1)
  • EU Regulatory Authorisation Procedure
  • Ingredient Role
  • Language
  • Legal Status of the Supply
  • Manufacturing Activity
  • Marketing Status
  • Master File Type
  • Material
  • Medical Device Classification (23R1)
  • Medical Device Legislation Category (23R1)
  • Medicinal Product Name Part Type
  • Medicinal Product Type (23R1)
  • Packaging
  • Pharmaceutical Dose Form
  • Product Category (23R1)
  • Product Cross Reference Type
  • Product Information Document Type
  • Quantity Operator
  • Reason for Marketing Unavailability (23R1)
  • Regulating Authority Submission Unit Type (23R1)
  • Regulatory Entitlement Status
  • Regulatory Entitlement Type
  • Routes and Methods of Administration
  • Shelf Life Type
  • Source of Information (23R1)
  • Special Precaution for Storage
  • Target Species
  • Tissue
  • Units of Measurement
  • Units of Measurement Prefix
  • Units of Presentation
  • Variation Classification (23R1)
  • Variation Classification - Veterinary (23R1)
  • XEVMPD Medical Device
  • XEVMPD Medicinal Product Type

Job Results

Each time the RMS Integration and Synchronization job runs, Vault sends the Job Owner an email and a Vault notification with a link to download a CSV file containing the job results. The CSV file includes:

  • New terms that were created
  • Existing Controlled Vocabulary records that were updated
  • Terms on which updates failed
  • Existing terms on which the SPOR status has changed to non-current; note that this process doesn’t make any changes to Controlled Vocabulary records in your Vault