# XEVMPD Configuration (RIM) 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.
## Configuration Overview To set up XEVMPD data review: 1. Create a _Product Data Submission object_ lifecycle and associate it with the _Product Data Submission_ object. See Configuring Object Lifecycles for more information. 2. Configure [XEVMPD user actions and entry actions][3]. 3. Configure the necessary [object and object type page layouts][4]. 4. Set necessary [shared document fields][5] to _Active_ and associate them with any document types that you might use as attachments on the XEVMPD report. 5. 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. 6. 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. 7. 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. 8. Ensure the _Administrable Dosage Form_ object reference field is associated with the _Administered as Manufactured_ object type on the _Administered Product_ object. 9. 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. 10. Load the updated [controlled vocabulary files][7] to support XEVMPD data. 11. Set up the XEVMPD Gateway Profile to allow users to submit the XEVPRM to the EMA Gateway. See Configuring Gateway Integration for more information. 12. Configure [Bulk XEVMPD Update][21] to allow users to update and submit XEVMPD data in bulk. 13. Configure [Attachment-Only Submissions][22] to allow users to create and submit an attachment-only submission before the document is related to any product data submissions. 14. Update the [criteria VQL for units of presentation][23]. ### User Actions & Entry Actions {#actions} 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. ### Object & Object Type Page Layouts {#page-layouts} 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][24]. * 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) #### About the Use for XEVMPD/IDMP Field {#use-for-xevmpd-idmp} 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. ### Shared Document Fields {#shared-fields} 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_ * _Language_ * _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. ## Controlled Vocabularies & Validation Criteria {#controlled-vocabulary} 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 ## Configuring Bulk XEVMPD Update {#bulk-update} 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. ## Configuring Attachment-Only Submissions {#attachment-only-submissions} 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_ * _MDN_ * _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. ## Criteria VQL Updates (21R1) {#criteria-vql} 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: |Object|Fields| |--- |--- | |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| ## Related Permissions {#permissions} You must have the following permissions to configure Vault to generate and validate XEVMPD 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|Objects: Publishing Validation Criteria: Create|Ability to create _Publishing Validation Criteria_ records.| |Security Profile|Tabs: Loader: View|Ability to see the Loader tab.| [3]: #actions [4]: #page-layouts [5]: #shared-fields [7]: #controlled-vocabulary [21]: #bulk-update [22]: #attachment-only-submissions [23]: #criteria-vql [24]: #use-for-xevmpd-idmp