XEVMPD Data Review & Validation (RIM)

Vault can aggregate eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data for you, offering a simple way to compile product data before submitting it to the European Medicines Agency (EMA). Vault parses data from Medicinal Product and other objects and organizes it according to the Article 57 guidance defined by the EMA. Data displays in a hierarchical report for easy review. When generating the report structure, Vault performs validation to verify that the data adheres to business rules based on the XEVMPD validation criteria.

Vault can also aggregate XEVMPD data into the Extended Eudravigilance Product Report Messages (XEVPRM) format. Organizations can then electronically submit medicinal product data to the XEVMPD through the EMA gateway directly from Vault.

Admins must perform configurations before you can work with XEVMPD data. See XEVMPD Configuration for details.

XEVMPD Objects

Vault uses several objects to track, compile, and organize product data:

• Product Data Submissions track product reports.
• Product Reports gather data from various other RIM objects (Medicinal Product, Registration, Classification, etc.) and display it in a hierarchical report.
• Product Report Items house product information such as labels and attachments.
• Ingredient Product Report Items track data related to the ingredients of an authorised product.
• Medicinal Product Registrations link the registration and packaging information to medicinal products.
• Controlled Vocabularies store lists of industry terms owned by and sourced from various global health authorities.
• Publishing Validation Criteria stores the XEVMPD business validation rules as defined in Article 57 guidance.
• Product Report Validation Result is a child object of Product Data Submission and tracks the number of validation results discovered per Product Report Item section.
• Validation Result Detail tracks the detailed validation rules violated in the product report data.
• Product Data Message is a child object of Product Data Submission and captures the message specific details. This object also serves as a location to attach the generated XEVPRM ZIP file and contains fields for tracking progress and EMA responses after submitting XEVMPD data to the EMA gateway.
• XEVMPD Acknowledgement allows you to see all acknowledgement responses in the same place after submitting XEVMPD data to the EMA gateway.

Working with Medicinal Products

Before you generate a product report, you’ll need to do the following:

• Relate the Medicinal Product record you want to report on to at least one Registration record using the Medicinal Product Registration join object, as well as Packaging information if your EV Codes exist at the packaging level.
• If your product is centrally authorised, create one Medicinal Product record for each licensed product and one Medicinal Product Registration record for each combination of Registration and Packaging for for the European Union, Iceland, Norway, and Liechtenstein, as well as one Medicinal Product Registration record for each combination of Registration and Packaging for each of these countries. A centrally authorised product with one packaging configuration should have four Medicinal Product Registration records.
• If your product is authorised through a mutual recognition procedure (MRP), decentralised procedure (DCP), or national procedure, create one Medicinal Product record for each authorised product in each country, and related Medicinal Product Registration records for each packaging configuration and local language. For example, a product registered in Belgium through DCP with two packaging configurations should have six Medicinal Product Registration records, one for each combination of packaging configuration and language (Dutch, French, German) required for Belgium.
• Relate at least one Administered Product record and at least one Medicinal Product Full Name record to the target Medicinal Product record.

Working with Product Reports

A Product Report consists of two levels of detail: Product Report records are the structural elements that make up the sections of the report, while Product Report Item records house detailed data.

Creating a Product Report

To generate a product report:

1. Create a Product Data Submission record from the target Medicinal Product record detail page.
2. Enter required information. Vault uses Controlled Vocabulary records to populate the default Operation Type for all product reports generated from this Product Data Submission record. You can override this information on the Product Report Item records if needed, for example, if withdrawing or nullifying one packaging configuration.
3. From the Product Data Submission record’s Actions menu, click Create Product Report. This action may have a different name depending on your Vault’s configuration. This process is asynchronous, allowing you to perform other tasks while Vault generates your report.

Vault sends you a success or failure notification after generating your product report, including a detailed CSV file that indicates which elements have missing or incorrect data. Note that this is simply a set of warnings, and some missing fields may be expected for your specific product. Vault also validates the aggregated data against Article 57 business validation rules while generating your product report. See validation details below.

Viewing a Product Report

Click View Product Report from the Product Data Submission record’s Actions menu to view your report. This action may have a different name depending on your Vault configuration.

Product Report Values

This table shows a summary of the values Vault uses in a product report:

Product Report Record Label	Action upon Report Generation
Attachment Element	Vault creates a Product Report record and one Product Report Item record within that record for each document that should be attached to the message.
Authorised Product Element	Vault creates a Product Report record and one Product Report Item record of this type for each registration and packaging combination, as well as each language associated with the medicinal product.
Authorisation Element	Vault creates a Product Report record and one Product Report Item record of this type for each registration and packaging combination associated with the medicinal product.
Presentation Name Element	Vault creates a Product Report record and one Product Report Item record of this type for each registration and packaging combination, as well as each language combination associated with the medicinal product.
Pharmaceutical Product Element	Vault creates a Product Report record for each Administered Product.
Active Substance Element*	Vault creates a Product Report record of this type and one Product Report Item record within that record for each active substance referenced by Product Variant (product_detail__v)* or Administered Product.
Adjuvant Element*	Vault creates a Product Report record of this type and one Product Report Item record within that record for each active substance related to Product Variant (product_detail__v)* or Administered Product and marked for adjuvant use.
Excipient Element*	Vault creates a Product Report record of this type and one Product Report Item record within that record for each inactive ingredient referenced by Product Variant (product_detail__v)* or Administered Product.
Administration Route Element*	Vault creates a Product Report record of this type and one Product Report Item within that record for each route of administration referenced by Administered Product.
Therapeutic Indication Element	Vault creates a Product Report record and one Product Report Item record within that record for each Coded Indication record related to Medicinal Product.
Classification Element	Vault creates a Product Report record and one Product Report Item record within that record for each Classification System record related to Medicinal Product.
Previous EV Code Element	Vault creates a Product Report record and one Product Report Item record within that record for each previous EV code listed on Medicinal Product Registration. Vault repeats this for each unique combination of Registration, Packaging, Country, Language, and previous EV Code records.

*Vault creates these records within the Pharmaceutical Product Element record.

See the XEVMPD Field Mapping file for additional information about how Vault creates product reports.

You’ll need to ensure that you populate all necessary fields on the objects indicated above. Vault notifies you of which areas are missing information when you generate the report.

Product Report Validation

When generating a product report, Vault performs validation to verify that the data adheres to business rules based on the XEVMPD validation criteria and Article 57 guidance defined by the EMA. If you or your Admin haven’t loaded validation terms, Vault generates the product report structure but does not perform validation.

Validation Process

When validating product report data, Vault creates a Product Report Validation Result record, which acts as a summary record of all validation failures for the related Product Data Submission record. Within the Product Report Validation Result, Vault creates one Validation Result Detail record for each Product Report Item record within a product report that violated a validation rule.

Each Validation Result Detail record lists the exact validation criteria violated for that Product Report Item record. Vault also increments the number of validation rule failures in the Count field on the Product Report Validation Result record. If no rules were violated, Vault doesn’t create records. Each time validation runs, Vault deletes the existing Product Report Validation Result record and its child Validation Result Details records before creating new records.

Validating Product Report Data

Vault performs validation immediately after creating the product report, as part of the product report generation process.

You can also choose to validate product report data after Vault has generated the product report tree. This allows you to make changes to the product report data to close out initial validation errors without needing to re-generate the product report tree structure.

To validate a product report on demand:

1. Navigate to the Product Data Submission record.
2. From the Actions menu, select Validate Product Report Structure.
3. Vault performs validation and sends you a notification when complete.

Viewing Validation Results

To view the most recent validation results, navigate to the Product Data Submission record and expand the Product Report Validation Result section. Click a result name to view the individual Validation Result Detail record. Vault also includes links to the Product Report Validation Result records in the product report email notification.

XEVPRM Message Generation

Vault can display product data and create discrete XEVPRM messages in the form of a ZIP file with an XML and attachments. Vault transposes the aggregated XEVMPD product report and product report item data into one or more XML files and validates each XML against XSD schema. The XEVPRM comprises field values provided by RIM Registrations users as well as values from controlled vocabularies that are maintained by the EMA, such as terms and EV codes.

Vault pulls data from the Product Report Item record text fields to create one new Product Data Message record and one XEVPRM message for each selected EV Code or Local Number related to the product report structure. Vault validates all data in the product report tree structure against the XEVMPD validation rules in the Publishing Validation Criteria records during XML message generation to log any validation data errors.

Creating the XEVPRM for a Product Data Submission

To generate the XEVPRM:

1. Navigate to the Product Data Submission record.
2. Select Generate XEVPRM from the Actions menu.
3. On the Refine Selection page, use the checkboxes to select all EV Codes or Local Numbers for which you want to generate the XML. Vault lists all EV Codes or Local Numbers from the related Authorised Product type Product Report Item records.
4. Click Next.
5. On the Verify Information page, select the PPI Attachment Format, and set the checkbox below to confirm that the attached PPI is the latest version.
6. Click Next.
7. On the Confirmation page, review and click Finish.

When complete, Vault generates the XML, creates Product Data Message records, and sends a success notification with links to the technical validation results. Vault only creates a technical validation results file when the generated XML contains errors. Vault only sends a failure notification if XML generation fails.

XEVPRM Generation

Vault generates the XEVPRM as one ZIP file, with the naming structure {EVCode/Local Number}-{Operation}, for example, 65738-Update.zip. The ZIP file contains the XML file for the generated XEVPRM and includes viewable renditions for all new attachment files in the format you selected. Vault attempts to attach PDF renditions of attachments first. If a PDF isn’t available, Vault uses the source format. You can view the XEVPRM ZIP file and, if available, the XSD validation file from the Product Data Message record.

You cannot generate the XEVPRM if the Product Data Submission record has a related Product Data Message record that is part of an active submission to the EMA Gateway.

XML Validation

Vault stops running XML technical validation if an error occurs, and includes a line item indicating where the error occurred for each failure.

If an XML element is missing, Vault links the error to the next available element. You must ensure that fields associated with that element are populated before re-generating the XML. Subsequent elements may also be missing values. We recommend reviewing the list of missing values after Vault generates the product report structure to ensure successful XML technical validation.

Multi-Language Handling

In some scenarios, the attachment to the XEVPRM should be provided in multiple languages. Attachment Product Report Item records are created for a Product Data Submission when the document fields reference the Medicinal Product. The Language field on the Attachment Product Report Item record is based on the Language field assigned to the document. Vault uses the Attachment Product Report Item records to determine which documents to include in the XEVPRM ZIP file.

For example, in a Centralised procedure, the English language attachments should always be provided along with the EEA country local language attachments.

Vault handles attachment languages as follows:

Centralised Procedure

• Vault always includes the attachment in English.
• Vault also includes attachments in the languages referenced on the Medicinal Product Registration records (Norwegian, Icelandic, and German).
• Vault also includes attachments in any languages related to the Country record through a Country Language join record.

MRP/DCP Procedure

• Vault includes attachments in the languages specified on the Medicinal Product Registration records.
• Vault also includes attachments in any languages related to the Country record through a Country Language join record.
• If no Attachment Product Report Item record is found for the language on the Medicinal Product Registration records, Vault looks for and includes an Attachment Product Report Item record in English, if available.

National Procedure: Vault includes attachments in the languages referenced on the Medicinal Product Registration records.

XEVPRM Message Generation for Attachments

When an XEVMPD attachment document reaches an approved state, Vault can generate and submit the XEVPRM message for only that document. Attachment-only submissions to the EMA ensure that a document is only assigned a single EV code and prevents you from needing to maintain multiple EV codes for the same attachment document. You can then include this document as an attachment on a Medicinal Product record to include it in full XEVMPD submissions from a Product Data Submission record, with the document’s EV code already applied. See XEVMPD Gateway Submission for Attachments for more information.

XEVMPD Gateway Submission

After you finish compiling medicinal product data, Vault’s integration with the EMA Gateway allows you to submit the generated XEVPRM to the Health Authority electronically and receive gateway responses. See XEVMPD Gateway Submission for detailed instructions.

Bulk XEVMPD Update & Submission

When you need to make XEVMPD updates that impact a large number of medicinal products, you can select and update the impacted medicinal products in bulk. You can then submit the updated XML to the EMA. See XEVMPD Bulk Update & Submission for detailed instructions.

Related Permissions

You must have the following permissions to work with XEVMPD data and generate a product report:

Type	Permission Label	Controls
Security Profile	Objects: Ingredient Product Report Item: Create, Edit	Ability to edit Ingredient Product Report Item records.
Security Profile	Objects: Medicinal Product: Create, Edit	Ability to create and edit Medicinal Product records and relate Medicinal Products to Registrations.
Security Profile	Objects: Product Data Message: Read	Ability to view and access the XEVPRM message and ZIP file.
Security Profile	Objects: Product Data Submission: Create, Edit	Ability to create and edit Product Data Submission records.
Security Profile	Objects: Product Report: Create, Edit	Ability to access the Create Product Report action on a Product Data Submission record and edit the Product Report record.
Security Profile	Objects: Product Report Item: Create, Edit	Ability to edit Product Report Item records. If your Vault uses field-level security, you’ll also need at least Read permission on the EV Code Text field to generate the XEVPRM XML.
Security Profile	Objects: Product Report Validation Results: Read	Ability to view Product Report Validation Result records from a Product Data Submission record.
Security Profile	Objects: Validation Results Detail: Read	Ability to view Validation Results Detail records to see the exact validation criteria violated for a Product Report Item record.
Security Profile	Objects: XEVMPD Acknowledgement: Read	Ability to see the acknowledgement details from the EMA.

*In Vaults created after the 19R1 release, the following objects are relabeled to support medical devices: The Product (product__v) object is now Product Family. The Drug Product (drug_product__v) object is now Product. The Product Detail (product_detail__v) object is now Product Variant. In existing Vaults, Admins can update these objects manually.