Vault can aggregate eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data, offering users a simple way to compile and validate product data before submitting it to the European Medicines Agency (EMA).
Admins must perform the configurations in this article for users to work with XEVMPD data. See XEVMPD Data Review & Validation for detailed information about aggregating, validating, and submitting XEVMPD data from Vault.
Note: This feature is only available on RIM Registrations Vaults.
To set up XEVMPD data review:
- Create a Product Data Submission object lifecycle and associate it with the Product Data Submission object. See Configuring Object Lifecycles for more information.
- Configure XEVMPD user actions and entry actions.
- Configure the necessary object and object type page layouts.
- Set necessary shared document fields to Active and associate them with any document types that you might use as attachments on the XEVMPD report.
- Enable attachments on any document types that users might submit to the EMA via an attachment-only XEVMPD submission. See Configuring Attachments for more information.
- Create a custom tab and sub-tabs for the Product Data Submission, Product Data Message and Product Report Validation Result objects to allow relevant users to access validation result messages and information. See Configuring Custom Tabs for more information.
- On the Active Substance object, ensure the EV Code field is associated with the Substance object type. You’ll need to update your Substance records to include the relevant EV Codes from the EMA-provided list.
- Ensure the Administrable Dosage Form object reference field is associated with the Administered as Manufactured object type on the Administered Product object.
- For any countries that require submission of multiple languages, associate the languages with each country by navigating to the Country record and selecting the appropriate languages in the Country Languages section.
- Load the updated controlled vocabulary files to support XEVMPD data.
- Set up the XEVMPD Gateway Profile to allow users to submit the XEVPRM to the EMA Gateway. See Configuring Gateway Integration for more information.
- Configure Bulk XEVMPD Update to allow users to update and submit XEVMPD data in bulk.
- Configure Attachment-Only Submissions to allow users to create and submit an attachment-only submission before the document is related to any product data submissions.
- Update the criteria VQL for units of presentation.
You need to configure the following user actions on the Product Data Submission object lifecycle:
- Generate Product Report
- View Product Report
- Validate Product Report Structure; we recommend configuring this action to be available only when the Product Report field is not blank to ensure that Vault always has a product report structure to validate.
- Generate XEVPRM
- Submit XEVPRM; we also recommend adding this user action on the Product Data Message object.
You can also choose to configure a conditional entry action on any Product Data Message lifecycle state on which you’ve configured the Submit XEVPRM user action to only allow users to submit to the EMA when the XEVPRM Message Status field is blank.
First, you must configure the following object page layouts:
- On the Medicinal Product object, add related object sections for Product Data Submission and Medicinal Product Registration. Modify the columns in the Medicinal Product Registration section to list the following fields: Registration, Packaging, Package Description, Country, Language, Medicinal Product Full Name, EV Code, and Previous EV Codes.
- On the Product Data Submission object page layout, add the Authorisation Type field and related object sections for Product Report Validation Result and Product Data Message.
- On the Product Report Validation Result page layout, add a related object section for Validation Result Details.
- On the Strength Unit and Denominator page layout, display the following fields: XEVMPD Numerator Prefix, XEVMPD Numerator Unit, XEVMPD Denominator Prefix, and XEVMPD Denominator Unit.
- On the Product Data Message page layout, add the following fields: Message Dispatch Date, Submitted By, MDN Received, Level 1 Acknowledgement Received, Level 1 Result, Level 2 Acknowledgement Received, Level 2 Result, Level 3 Acknowledgement Received, Level 3 Result, XEVPRM Submission Status.
- On the Product Data Message page layout, add a related object section for XEVMPD Acknowledgements.
- On the Registration page layout, add the IDMP Procedure Number field. In Vaults with IDMP functionality configured, this field may already be configured.
- On the Country Language page layout, add the Use for XEVMPD/IDMP field.
- On the Medicinal Product Full Name object, add the Alias field.
Next, add the following object type page layouts to the Product Report and Product Report Item objects:
- Active Substance (on Product Report only)
- Adjuvant (on Product Report only)
- Administration Route
- Attachment Element
- Authorisation Element
- Authorised Product Element
- Classification Element
- Development Product Element
- Development Presentation Name Element (on Product Report Item only)
- Development Classification Element (on Product Report Item only)
- Excipient (on Product Report only)
- Pharmaceutical Product Element (on Product Report only)
- Presentation Name Element
- Previous EV Code
- Therapeutic Indication Element
- XEV Root Product Report (on Product Report only)
In some situations, you may want Vault to ignore certain Country Language records related to the submission when generating XEVMPD 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 XEVMPD data.
Set the following shared document fields to Active and associate them with any document types that you might use as attachments on the XEVMPD report:
- AS2 Message
- Attachment Format
- Attachment Version
- Attachment Version Date
- EV Code
- Level 1 Acknowledgement Received
- Level 1 Acknowledgment Result
- Level 2 Acknowledgement Received
- Level 2 Acknowledgment Result
- Medicinal Product
- MDN Received
- XEVMPD Attachment Only Submission Status
- XEVPRM Message Integrity Check
- XEVPRM Message Receiver
For any document type that leverages these fields, you’ll need to configure the document lifecycle states to clear the EV Code field when a user creates a new draft version. This ensures the EV Code field is empty so Vault can pull the latest document version when creating the corresponding XEVPRM XML.
Vault uses Controlled Vocabulary records to populate certain fields on Product Data Submission records. You must upload these controlled vocabulary files to your Vault using Vault Loader before users can begin the XEVMPD data collection and review process:
- XEVMPD Controlled Vocabulary New Terms (18R3): After loading these terms, navigate to the Controlled Vocabulary record of Controlled Vocabulary Type DTD XSD Version, named XEVPRM 2.0. Set the CV Value Filter field to Validation Criteria Version. Vault then looks up a value for the Filter Vault RIM UUID field and sets it to da650891-63aa-4bb0-8d8e-b2c571fabda0 automatically. If these fields don’t appear, you’ll need to add them to the object page layout.
- Update to Existing Controlled Vocabulary Terms (18R3): The records in this file already exist in your Vault. You can either manually update the indicated fields with the values in this file or use Vault Loader to update them. If you use Vault Loader, you’ll need to update this file to provide the corresponding record IDs in your Vault. This file lists example IDs only.
- XEVMPD Strength Units New Terms (19R1): After loading these terms, you’ll need to make sure the Strength Unit and Denominator object page layout includes the following fields: XEVMPD Numerator Unit, XEVMPD Numerator Prefix, XEVMPD Denominator Unit, and XEVMPD Denominator Prefix.
- XEVMPD Validation Criteria (19R1): Load these terms to create Publishing Validation Criteria records.
- XEVMPD Validation Criteria (19R2): Load these terms to create the remaining Publishing Validation Criteria records.
You’ll need to upload both the XEVMPD Controlled Vocabulary New Terms and the 19R1 XEVMPD Validation Criteria and perform the associated configurations to load the 19R2 XEVMPD Validation Criteria terms successfully.
After loading all Controlled Vocabulary records, you’ll also need to:
- Update the Controlled Vocabulary records of type Routes of Administration and Administrable Dosage Form to reference the appropriate EV Codes
- Update Active Substance records to reference the appropriate EV Codes
- Update Organization records to reference the appropriate EV Codes, and create new Organization object records for the Master File Location
- Create new Contact records for your organization’s Qualified Person for Pharmacovigilance
XEVMPD for Investigational Products
Vault determines whether a medicinal product is investigational or marketed based on the Authorisation Type value populated in the Medicinal Product object record.
When populating Product Report Item and Ingredient Product Report Item records, Vault references the RMS ID and following UUIDs for Controlled Vocabulary terms of the indicated Authorisation Type:
- Authorised Medicinal Product: 5571e70a-8b16-42cb-924a-1f2d9d3eb41b
- Investigational Medicinal Product: 8426338d-eb50-4e4c-b618-fbe7b94f38dd
To configure your Vault to support bulk update and submission of XEVMPD data:
- Add the XEVMPD Submitted state type to the Product Data Submission lifecycle and associate it with the Submitted lifecycle state.
- Add the Most Recent Submitted field to the Product Data Submission object page layout.
When configured, users can create and submit an attachment-only submission before the attachment is related to any product data submissions. This ensures that an attachment document is only assigned a single EV code and prevents users from needing to maintain multiple EV codes for the same document.
This section explains how to configure attachment-only submissions. You must also configure the XEVMPD Gateway Profile before users can submit attachment-only submissions.
Configuring the Document Action
You can configure the Submit XEVPRM action as a user action or an entry action on appropriate document lifecycle states. When this action runs, Vault compiles the XML and ZIP file, runs technical validation, submits the generated XEVPRM to the EMA XEVMPD gateway, and sends a notification and results to the recipients you select on the Application Settings page.
Enabling Attachment-Only Submission Settings
Navigate to Admin > Setting > Application Settings to enable the settings required for attachment-only submissions:
- Set the XEVMPD Attachment Only Notification Recipients checkbox and select the groups who will receive notifications from the Health Authority for attachment-only submissions.
- Set the XEVPRM Message Sender checkbox and enter the XEVPRM message sender for attachment-only submissions. This is the label that is registered with the EMA.
Configuring Document Lifecycle Entry Actions
On the Draft state of each attachment document lifecycle, we recommend configuring a Set to blank if field has a value entry action for the following submission-related fields:
- AS2 Message ID
- EV Code
- Level 1 Acknowledgement Received
- Level 1 Acknowledgement Result
- Level 2 Acknowledgement Received
- Level 2 Acknowledgement Result
- XEVMPD Attachment Only Submission Status
When configured, Vault will automatically clear the values in these fields when the document moves back to the Draft state so users can generate and submit the XEVPRM again. See Defining Document State Entry Actions for more information.
Starting in the 21R1 release, you must update the criteria VQL on certain object fields in order to use units of presentation. These changes enable Vault to check against a set list of units of measurement. Update the Criteria VQL as follows on all object fields in this table:
|Ingredient Product Report Item||CHR Denominator Unit
CLR Denominator Unit
PHR Denominator Unit
PLR Denominator Unit
|Strength Unit and Denominator||Denominator Unit
XEVMPD Denominator Unit
You must have the following permissions to configure Vault to generate and validate XEVMPD data:
|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||Objects: Publishing Validation Criteria: Create||Ability to create Publishing Validation Criteria records.|
|Security Profile||Tabs: Loader: View||Ability to see the Loader tab.|