# Generating eAF Output Reports

In 2022, the European Medicines Agency (EMA) introduced its Digital Application Dataset Integration (DADI) project to replace PDF-based electronic application forms (eAFs) used for regulatory submissions with web forms in a new portal. In RIM Registrations, you can download a series of reports containing available variation and product data presented in the order in which you'll enter it into the eAF.

Visit the <a class="external-link " href="https://esubmission.ema.europa.eu/cessp/cessp.htm" target="_blank" rel="noopener">EMA's eSubmission portal<i class="fa fa-external-link" aria-hidden="true"></i></a> for more information about the DADI project and the <a class="external-link " href="https://plm-portal.ema.europa.eu/" target="_blank" rel="noopener">Product Lifecycle Management (PLM) Portal<i class="fa fa-external-link" aria-hidden="true"></i></a>.



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      <p><strong>Note</strong>: This feature was formerly known as DADI output reports and was rebranded in 23R2. They are only available on RIM Registrations Vaults and must be <a href="/en/lr/5062581/">configured</a> by an Admin. Vault currently supports the variations form for human medicinal products, and we will continue to support DADI as the EMA releases eAFs for additional procedures.</p>
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##  About eAF Output Reports

eAF Reports are Vault reports you can generate directly from a _Regulatory Objective_ record with related _Medicinal Products_. They contain the variation and product output data in your Vault that you'll use to input the proposed data values in the eAF portal. The reports are configurable, and the structure and content can be updated to meet your organization's requirements.

Each time you execute the **Generate eAF Report** action, Vault refreshes the data in the existing report and sends a notification and email with a link. The latest-generated version is also stored in your Vault's **Reports** tab.

Depending on your Vault's configuration, you'll receive one or more of the following eAF output reports when you execute the action:
* Human Variations
* Product
* Manufacturers
* Packaging
* Indication
* Administered Product
* Product Variant

## Generating an eAF Output Report

1. Navigate to a _Regulatory Objective_ record containing the data you'd like to view. eAF output reports are available for _Regulatory Objectives_ with related _Medicinal Products_.
2. From the **Actions** menu, select **Generate eAF Report**. Depending on your Vault's configuration, the action may be available only in relevant lifecycle states, such as _Planned_. Use the **Select Report Types for eAF Product Reports** setting to select which reports will run.


Vault begins processing the request. When finished, you'll receive a Vault notification and email containing a CSV file with links to each successfully-created report, as well as error details for reports Vault could not create. You can also find the latest-generated version directly in your Vault's **Reports** tab. Any configured Human Variation Report(s) will run in addition to the selected product report types.

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      <p><strong>Note</strong>: When you apply filters for <em>Medicinal Product</em>, multi-pass eAF reports display all records which do not meet the filter criteria. For example, when filtering by <em>Medicinal Product</em> &gt; <em>ID</em>, Vault returns all <em>Medicinal Product</em> records regardless of the records’ <em>ID</em> values. This behavior is due to a relationship constraint limitation in Vault multi-pass report types.</p>
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## Viewing & Comparing eAF FHIR Messages

When you input and export proposed data using the eAF portal, the related FHIR XML messages are added to the PDF export as attachments. When [configured](/en/lr/5062581/#configuring-fhir-message-viewing) by an Admin, you can upload the attachments to your Vault's Library and view and compare the complex XML in the [IDMP Viewer](/en/lr/76688/).


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      <p><strong>Note</strong>: Vault generates FHIR messages using FHIR v5.0.0 only. Similarly, the IDMP Viewer only displays complete comparison data for FHIR v5.0.0. See <a href="/en/lr/48830/#fhir-version-support">additional details</a> about FHIR version support.</p>
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To view FHIR messages in the IDMP Viewer:

  1. Navigate to the **Library** and [upload](/en/lr/15085/) the FHIR message document. Depending on your Vault's configuration, documents of this type may be filed under the _IDMP_ > _eAF FHIR Output_ document subtype.
  2. If required, set the **FHIR Message Version** document field, then move the document to the steady state according to your Vault's configuration for this document type.
  3. From the **Actions** menu, select **Generate Data Viewer File** or **Open Data Viewer**. If you see only **Generate Data Viewer File**, select this option and wait for Vault to generate the view and make the **Open in Data Viewer** action available. Both actions are only available for documents in the steady state.

Vault opens the IDMP Viewer and displays the selected message in read-only format.

When [enabled](/en/lr/60772/#idmp-viewer-enhancements), the IDMP Viewer allows you to select FHIR messages for viewing and comparison alongside other [IDMP data sets](/en/lr/76688/#idmp-data-sets).