# Generating IDMP Data (RIM)

Vault can aggregate Identification of Medicinal Products (IDMP) data for you, offering a simple way to compile product data before submitting it to the European Medicines Agency (EMA). Vault uses a series of algorithms to compile existing submission data in your RIM Registrations Vault into the IDMP object structure.



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      <p><strong>Note</strong>: This feature is only available on RIM Registrations Vaults and must be <a href="/en/lr/60772/">configured</a> by an Admin.</p>
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## Working with Medicinal Products

Before you generate IDMP data, 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. Ensure that all relevant fields are populated on the _Registration_ record.
  * Associate packaging to the _Medicinal Product Registration_ for IDMP generation. Your Admin may configure an action to allow you map _Registered Packaging_ records to _Medicinal Product Registration_ records, or mapping may occur automatically when _Registered Packaging_ records enter specific lifecycle states. See details about [_Medicinal Product Registration_ mapping][2] below.
  * If your product is centrally authorised, create one _Medicinal Product_ record for each licensed product. Create one _Medicinal Product Registration_ record for the European Union and one for each of the following countries: Iceland, Norway and Liechtenstein.
  * 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 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 required for Belgium (Dutch, French, German).
  * Relate at least one _Administered Product_ record and at least one _Medicinal Product Full Name_ record to the target _Medicinal Product_ record.

## Automatic Record Creation with IDMP Accelerators {#record-creation}

When the various IDMP accelerators are [enabled](/en/lr/60772/#accelerators), Vault can automatically create related records when you create new records for certain objects that support IDMP. Automatic record creation helps streamline the data entry process while ensuring that data is more accurate. Vault sends you a notification when creation is complete.

### Medicinal Products

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      <p><strong>Note</strong>: For centralised procedures, Vault will create a <em>Medicinal Product</em> for the EU and a <em>Medicinal Product Registration</em> record for the record identified as the lead market for Medicinal Product details. The field Vault uses to identify the country is configured in Vault Admin. The lead market for Medicinal Product details may not be EU. Vault will not create a <em>Medicinal Product</em> record unless a <em>Registration</em> exists for the lead market.</p>
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When you create _Marketed Drug Product Registration_-type _Registration_ records, Vault references the _Registration_ source record and creates the following related records:

<table class="wbord">
  <tr>
    <td>
      <p>
        <strong>Source Record</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Related Object Record Created</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Populated Fields</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Notes</strong>
      </p>
    </td>
  </tr>
  <tr>
    <td rowspan="2">
      <p>
        <em>Registration</em>
      </p>
    </td>
    <td>
      <p>
        For each unique combination of <em>Country</em>, <em>Product</em>, <em>Product Variant</em>, and <em>Application</em> on the <em>Registration</em> record, Vault creates one (1) <em>Medicinal Product</em> record.
      </p>
    </td>
    <td>
      <ul>
        <li aria-level="1">
          <em>Country</em>
        </li>
        <li aria-level="1">
          <em>Product Family</em>
        </li>
        <li aria-level="1">
          <em>Product</em>
        </li>
        <li aria-level="1">
          <em>Product Variant</em>
        </li>
      </ul>
    </td>
    <td>
      <ul>
        <li aria-level="1">
          All fields must be populated on the <em>Registration</em> record in order for Vault to create <em>Medicinal Products</em>.
        </li>
        <li aria-level="1">
          The <em>Country</em> field is not required if the <em>Procedure Type</em> is <em>Centrally Authorized</em>.
        </li>
        <li aria-level="1">
          The <em>Product Variant</em> field is not required for complex products.
        </li>
        <li aria-level="1">
          For centrally authorized procedures, Vault creates one <em>Medicinal Product</em> with the <em>Country</em> set to <em>EU</em>.
        </li>
      </ul>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Vault creates one (1) <em>Medicinal Product Registration</em> record for each <em>Registration</em> that matches values in the following fields on a <em>Medicinal Product</em> record: <em>Country</em>, <em>Product</em>, <em>Product Variant</em>, and <em>Application</em>.
      </p>
    </td>
    <td>
      <p>
        Fields from <em>Registration</em>:
      </p>
      <ul>
        <li aria-level="1">
          <em>Registration</em>
        </li>
        <li aria-level="1">
          <em>Country</em>
        </li>
        <li aria-level="1">
          <em>Packaging</em>
        </li>
        <li aria-level="1">
          <em>Package Description</em>
        </li>
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      <p>
        Fields from <em>Medicinal Product</em>:
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      <ul>
        <li aria-level="1">
          <em>Medicinal Product</em>
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    <td>
      <p>
        The following fields must be populated in order for Vault to create <em>Medicinal Product Registrations</em>:
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        <li aria-level="1">
          The <em>Country</em> field on the <em>Registration</em> record
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        <li aria-level="1">
          All fields listed above on the related <em>Medicinal Product</em> record
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        If the <em>Procedure Type</em> is <em>Centrally Authorized</em>, Vault only creates <em>Medicinal Product Registration</em> records for the lead market. If the <em>Procedure Type</em> is non-centralised, Vault creates one (1) <em>Medicinal Product Registration</em> record for each <em>Registration</em> related to the <em>Medicinal Product</em>.
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### Registered Details

When you create the following registered details, Vault creates related records and populates fields:

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        <strong>Source Registered Detail Record</strong>
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        <strong>Related Object Record Created</strong>
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    <td>
      <p>
        <strong>Populated Fields</strong>
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      <p>
        <strong>Notes</strong>
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        <em>Registered Packaging</em>
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      <p>
        Vault creates one (1) <em>Registered Packaged Medicinal Product</em> for each unique combination of <em>Registration</em> and <em>Packaging</em>.
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    <td>
      <ul>
        <li aria-level="1">
          <em>Registration</em>
        </li>
        <li aria-level="1">
          <em>Packaging</em>
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    <td>
      <p>
        Both fields must be populated on <em>Registered Packaging</em> in order for Vault to create related <em>Registered Packaged Medicinal Products</em>. If the <em>Registered Packaged Medicinal Product</em> and <em>Registered Packaging</em> objects have object types with the same API name, Vault creates <em>Registered Packaged Medicinal Product</em> records of that object type.
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      <p>
        <em>Registered Packaging</em>
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      <p>
        <em>Registered Active Substance</em>
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      <p>
        <em>Registered Inactive Ingredient</em>
      </p>
      <p>
        <em>Registered Drug Produc</em>t
      </p>
    </td>
    <td>
      <p>
        Vault creates one (1) <em>Registered Site Role</em> for each unique combination of <em>Manufacturer</em> and <em>Manufacturing Site Role</em>.
      </p>
    </td>
    <td>
      <ul>
        <li aria-level="1">
          <em>Registration</em>
        </li>
        <li aria-level="1">
          <em>Manufacturer</em>
        </li>
        <li aria-level="1">
          <em>Role</em>
        </li>
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    <td>
      <p>
        The <em>Registration</em> and <em>Manufacturer</em> fields must be populated on the source record in order for Vault to create <em>Registered Site Roles</em>.
      </p>
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### Medicinal Product Registrations {#mp-mapping}

When configured, Vault can map _Registered Packaging_ records to related _Medicinal Product Registration_ records. If your Admin configured this as an entry action, mapping may occur automatically when _Registered Packaging_ records enter specific lifecycle states. If your Admin configured this as a user action, you can select the **Link Packaging to MP-Registration** action from the _Registered Packaging_ record's **Actions** menu.

When this action runs, Vault checks whether a _Registration_ has related _Medicinal Product Registration_ records. If there are related _Medicinal Product Registration_ records, Vault populates the _Registered Packaging_ field on these records. If the _Registered Packaging_ field is already populated on _Medicinal Product Registration_, Vault creates additional _Medicinal Product Registration_ records as needed based on national licensing requirements. If there are no _Medicinal Product Registration_ records related to the _Registration_ record, no mapping occurs.

If your organization does not track _EV Codes_ at the pack level, mapping may impact _EV Codes_ assigned to the _Medicinal Product Registration_ records.

## Generating IDMP Records {#generating-idmp-records}

To generate IDMP data, Vault first looks at the _Registration_ records related to the _Regulatory Objective_ record. Then, Vault identifies the applicable _Medicinal Product_ records related to those _Registration_ records. For each applicable _Medicinal Product_ record, Vault creates one _IDMP Product Data Submission_ record and generates IDMP elements. 

Record creation is asynchronous, allowing you to perform other tasks while Vault generates the data. Once complete, Vault sends you a notification with a CSV file that indicates which records Vault created and what errors occurred, if any. These errors are simply a set of warnings, and Vault still generates the indicated records.



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      <p><strong>Note</strong>: When a <em>Controlled Vocabulary</em> record does not include <em>SPOR Term</em> and <em>SPOR Referential ID</em> (<code class="language-plaintext highlighter-rouge">spor_rms_id__v</code>) field values, users generating IDMP records receive <a href="/en/lr/64159/#generating-idmp-records">configuration errors</a> in the resulting CSV file. These errors may be referencing either the record’s missing SPOR data, or the absence of the <em>SPOR Term</em> at the source.</p>
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### From a Regulatory Objective

Vault can generate IDMP data and all related elements from a _Regulatory Objective_ record. Depending on your Vault's configuration, IDMP record creation may occur automatically when the _Regulatory Objective_ record enters a specific lifecycle state.

If record creation doesn't occur automatically, select **Generate IDMP Records** from the _Regulatory Objective_ record's **Actions** menu. Depending on your Vault's configuration, the action may have a different name, and may only be configured in certain lifecycle states. We recommend the action to be configured for the _In Progress_ and _Planned_ states.

You will not see this action if there are no _Registration_ records related to this _Regulatory Objective_ record. If the _Regulatory Objective_ record has more than one related _IDMP Product Data Submission_ record for the same _Medicinal Product_, Vault will not create new IDMP records and you will receive a notification.

To view the new records, scroll to the _Regulatory Objective_'s _IDMP Product Data Submission_ section. From there, you can [view](/en/lr/76688/#initiating-an-idmp-viewer-session) related IDMP elements.

### From a Medicinal Product

You can also generate only the IDMP elements for a single _Medicinal Product_:

  1. Create an _IDMP Product Data Submission_ record from the target _Medicinal Product_ record detail page.
  2. From the _IDMP Product Data Submission_ record's **Actions** menu, select **Generate IDMP Elements**. Depending on your Vault's configuration, the action may have a different name, and may only be configured in certain lifecycle states. We recommend the action to be configured for the Planned state. This process is asynchronous, allowing you to perform other tasks while Vault generates the data.

After Vault generates the IDMP elements, you can expand the _IDMP Medicinal Product Element_ section on the _IDMP Product Data Submission_ record detail page. The _IDMP Medicinal Product Element_ record that Vault created contains all of the aggregated IDMP element data. Click the record to open it and view element details and related records.

When configured by an Admin, you can also use the [IDMP Viewer](/en/lr/76688/) to review _IDMP Product Data Submission_ records in scope of a given _Regulatory Objective_.

### About IDMP Record Generation with PMS Enrichment

When Vault is [configured](/en/lr/60772/#fhir-message-submission) to generate and submit FHIR messages to PMS, the **Generate IDMP Elements** action functions differently, such that Vault only generates a subset of the full IDMP data set when a selected *Product Data Submission* record's *Operation Type* is "Manufacturer and Pack Size Enrichment".

This means that any attempt to generate IDMP elements individually or in bulk may result in operation type-specific errors: Vault does not generate elements when a selected record's *Operation Type* corresponds to any type (*Controlled Vocabulary* record) with its *HA Code Source* set to "XEVMPD".

Additionally, Vault excludes related pack size records for centralised procedures. This means that IDMP record generation is skipped when the _Medicinal Product_'s related _Application_ has a _Procedure Type_ (`application_procedure__rim`) of "Centralised Procedure" (_Veeva RIM UUID_ 7aa0df44-87b9-4309-91a5-20185cdd2415).

## Generating & Comparing FHIR Messages

You can generate FHIR messages individually from a *Product Data Submission* record using the **Generate FHIR Message** action, or in bulk from a *Regulatory Objective* using the **Bulk Create FHIR Messages** action. See [Working with FHIR Messages](/en/lr/48830/) for additional details.

## Related Permissions

See [IDMP Configuration](/en/lr/60772/#related-permissions) for the permissions required to use this feature.


 [1]: #pds-elements
 [2]: #mp-mapping
 [3]: #view-elements