Fast Healthcare Interoperability Resources (FHIR) messages are structured XML files that detail product data in service of various Health Authority data standardization initiatives.
When you generate regulatory data in your Vault, the accompanying FHIR messages are mapped to the objects and fields Vault uses to store source and output data. Once generated, Vault stores the output according to the selected Submission Mode:
- For eCTD submissions, messages are stored as XML files in the Vault Library for submission with the eCTD dossier through the EMA’s gateway.
- For Product Management Service (PMS) submissions, Vault generates a ZIP file along with any applicable attachment files for export and submission to the PMS.
Note: This feature is available in RIM Registrations Vaults only and must be configured by an Admin.
Generating FHIR Messages
After creating a Product Data Submission record and generating IDMP elements, you can generate FHIR messages individually from a Product Data Submission record, or in bulk from a Regulatory Objective.
To generate an individual FHIR message, navigate to a Product Data Submission record, then select Generate FHIR Message from the record’s All Actions menu.
To generate FHIR messages in bulk:
- Navigate to a Regulatory Objective record.
- Select Bulk create FHIR Messages from the record’s All Actions menu. Depending on your Vault’s configuration, the action may only be conditionally available in a certain state, for example the Planned and In Progress states.
- Select an IDMP Submission Mode, Operation Type, and Sender, then click Next.
- Select or deselect Medicinal Product records as required, then click Next.
- On the Confirmation page, Vault summarizes the selected records and updates. Click Back to make adjustments to your selections, or Finish to begin creating messages.
Once you’ve completed this process for either method, Vault initiates a job to create messages, then:
- Sends you an email and notification with a link to a CSV file confirming the status of each referenced Medicinal Product.
- Stores the related output according to the Vault Library. The FHIR message is also linked to the Product Data Submission and saved as an Attachment.
Note: FHIR messages generated for manufacturing enrichment do not include attachments.
About eAF FHIR Messages
The IDMP Viewer supports viewing FHIR message XML in human-readable format. For more information, see Generating eAF Output Reports.
Exporting FHIR Messages
To export FHIR messages for one or more Medicinal Products:
- Navigate to a Regulatory Objective record.
- Select the Bulk Export FHIR Messages action. Depending on your Vault’s configuration, the action may only be conditionally available in a certain state.
- Select or deselect Medicinal Product records as required.
- Click Finish.
Once Vault completes generating the XML messages, you’ll receive an email and notification with a link to a ZIP file.
Baselining IDMP Records for FHIR Message Submission
Important: As of 25R3, this feature is for Early Adopters only. Contact your Veeva representative or Veeva Support for further assistance.
When Vault is configured to submit FHIR messages to PMS, IDMP records must first be baselined, or populated with all critical PMS identifiers such as the PMS ID, pack-level PMS ID, PCID, and MPID to RIM via API. This process maps and updates the returned identifiers to the Medicinal Product and related Registered Packaged Product records, based on the Medicinal Product record’s EV Code.
To do this, use the Populate PMS Identifiers action from a Medicinal Product record. When viewing a Medicinal Product record in Business Admin, you can additionally use the Bulk Populate PMS Identifiers action. These actions are generally available only when the Medicinal Product:
- Has an Authorisation Type field referencing the Authorised Medicinal Product Controlled Vocabulary record.
- References the appropriate Country record, via that record’s Region. The action appears only when a country’s Region is “European Union”.
- References a Medicinal Product Registration record with an EV Code field value.
Additionally, these actions may be configured as entry actions only, meaning they are unavailable for manual execution in your Vault.
Upon completion, Vault sends you an email and notification with a link to a CSV file confirming the status of each related Medicinal Product.
- When you select a large number of Medicinal Product records for bulk population, Vault processes them in groups of 500 and sends an email and notification with a results CSV for each group.
- In the event PMS is down at the time you execute the action, Vault notifies you and generates a “No packaging indicated” error.
Note: When a Medicinal Product Registration record does not have a Packaging field value, Vault populates the PMS ID and MPID identifiers on the Medicinal Product record only. Additionally, Vault maps identifiers to existing Medical Product records only. Vault does not create new records when there is not a match with PMS data.
Submitting FHIR Messages to PMS
Important: As of 25R3, this feature is for Early Adopters only. Contact your Veeva representative or Veeva Support for further assistance.
You can submit FHIR messages to the EMA Product Management Service (PMS) individually from a Product Data Submission record (idmp_product_data_submission__v), or in bulk from a Regulatory Objective.
Note: This feature currently supports manufacturing enrichment submissions only. It must be configured by an Admin, and include a prerequisite to baseline the related IDMP records.
The Product Data Submission records selected for either individual or bulk submission must be active and have:
- The Operation Type field set to “Manufacturing Enrichment”
- The IDMP Submission Mode field set to “PMS”
- The Submission Status set to “Not Submitted”, or the field is blank.
To submit an individual FHIR message, navigate to a Product Data Submission record, then select Submit FHIR Message from the record’s All Actions menu.
To submit FHIR messages in bulk:
- Navigate to a Regulatory Objective record.
- Select Bulk Submit FHIR Messages from the record’s All Actions menu.
- Select or deselect Medicinal Product records as required.
- Click Finish.
Once you’ve completed this process for either method, Vault initiates the Submit FHIR Messages to PMS SDK job, then:
- Sends you an email and notification with a link to a CSV file confirming the status of each related Medicinal Product.
- Updates the impacted records’ Submission Status field to indicate transmission progress to PMS. Vault sends an additional email and notification once the message reaches a final status.
About Submission Status & Manual Polling
Vault uses the Product Data Submission record’s Submission Status field to track the record’s transmission progress from Vault to PMS, as well as control the available actions for that record.
To do this, Vault polls the PMS API, then updates the Submission Status when a response is received. While the status of most transmissions is typically available within seconds, you can use the Product Data Submission record’s Update Submission Status action to manually poll the API in the event a record’s status remains as “Message Sent”. This action is only available for individual Product Data Submission records and cannot be executed in bulk.
| Submission Status | Meaning | Available Actions |
|---|---|---|
| Not Submitted | The default status, populated upon creation of a Product Data Submission record. | Submit FHIR Message Bulk Submit FHIR Messages |
| Queued for Submission | A user successfully ran the Submit FHIR Message or Bulk Submit FHIR Messages action. | None |
| Message Sent | Transmission is complete and Vault is awaiting a status response from PMS. | Update Submission Status |
| Submission Rejected | A final status indicating PMS rejected the transmission. | None. See additional details about resubmission. |
| Submission Accepted | A final status indicating PMS accepted the transmission. | None |
About Failures & Resubmission
Once a given Product Data Submission reaches a final Submission Status, Vault sends an email and notification with a link to a CSV file confirming the transmission details, including any errors.
In the event a submission is rejected, review the CSV file to determine the cause.
- When a failure is due to non-technical reasons, we recommend creating a new Product Data Submission record to track and manage subsequent submissions.
- When a failure is due to technical issues (such as with the PMS API), a Vault Admin or other user with appropriate permissions can update the record’s Submission Status field to the default “Not Submitted” status, then users can repeat the submission process.