# Troubleshoot EMA Gateway Submissions

Learn how to identify and resolve common EMA Gateway Submission issues.


## Minimum Submission Requirements 

Ensure that cases meet the following minimum requirements to be accepted by the European Medicines Agency (EMA): 

* A date entered in the **New Info Date** field. 
* One identifiable patient. For example, you can identify a patient by entering their age, initials, or sex
* One identifiable reporter. For example, you can identify a reporter by entering their initials, address, or qualifications. When you create a Case from an Inbox Item, Vault checks for <a href="/en/lr/01285/#qualifications">case qualification</a> before you can <a href="/en/lr/01141/">promote the _Inbox Item_ to a _Case_</a>.
* At least one adverse event or reaction that includes values entered in the following fields:
  * **Event (Reported)**
  * **Event (Reported) - Language**
  * **Outcome**
* One suspect or interacting drug that must have a reported product

## EMA Transmission Size Limits

For EMA E2B submissions, attachment file size cannot exceed 15 MB. All Vault Safety E2B transmissions have a maximum total size limit of 100 MB.

## Common Data Entry Issues

The following table describes common data entry issues that can prevent EMA Submissions from being accepted.

<table>
    <thead>
        <tr>
            <th>Object Name(s)</th>
            <th>Field(s)</th>
            <th>Requirement</th>
            <th>Issue Impact</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Case</td>
            <td>MedDRA version</td>
            <td>The EMA does not support "-" as a MeDDRA version code. You must enter the MedDRA version number.</td>
            <td>Not Processed with Warnings</td>
        </tr>
        <tr>
            <td>Case</td>
            <td>
                <ul>
                    <li>Gender</li>
                    <li>Last Menstrual Period</li>
                </ul>
            </td>
            <td>If the <strong>Gender</strong> field is set to <strong>Male</strong>, you must not enter a value in the <strong>Last Menstrual Period</strong> field.</td>
            <td>Rejected</td>
        </tr>
        <tr>
            <td>Multiple</td>
            <td>Units of Measurement Fields</td>
            <td>For any field with a unit of measurement, the unit should comply with the EMA Unified Code of Units of Measure (UCUM) list.</td>
            <td>Accepted with Warnings</td>
        </tr>
        <tr>
            <td>Multiple</td>
            <td>Date Fields</td>
            <td>Per EMA requirements, for any field with a date, you use the format <code>CCYYMMDD</code> to enter a date.</td>
            <td>Rejected</td>
        </tr>
        <tr>
            <td>Case Adverse Event</td>
            <td>
                <ul>
                    <li>Seriousness</li>
                    <li>Outcome</li>
                </ul>
            </td>
            <td>The value entered in the <strong>Seriousness</strong> field should be consistent with the value entered in the <strong>Outcome</strong> field.
                <br>For example, if the outcome is <strong>fatal</strong> the seriousness should be <strong>results in death</strong>.</td>
            <td>Not Processed with Warnings</td>
    </tr>
    <tr>
        <td>Case Product</td>
        <td>Product (Reported)</td>
        <td>The product name entered in the <strong>Product (Reported)</strong> field must match a valid product registered with WHODrug or the EMA.</td>
            <td>Not Processed with Warnings</td>
        </tr>
        <tr>
            <td>
                <ul>
                    <li>Study Registration</li>
                    <li>Transmission Profile</li>
                </ul>
            </td>
            <td>
                <ul>
                    <li>Country</li>
                    <li>Transmission Profile Name</li>
                </ul>
            </td>
            <td>The export action replaces country codes within the jurisdiction of EMA with <strong>EU</strong> in the resulting E2B file. To be accepted, the country code must equal <strong>EU</strong> in the E2B file.</td>
            <td>Not processed</td>
        </tr>
        <tr>
            <td>Case Test Result</td>
            <td>
                <ul>
                    <li>Name (MedDRA)</li>
                    <li>All Test Result Fields</li>
                </ul>
            </td>
            <td>To correctly enter test results, you must use the test result field appropriate to the MedDRA value for the test type to correctly enter the test results.
                <br>For example, you cannot enter the <strong>Result</strong> value as <strong>20 grams</strong> with the <strong>Name (MedDRA)</strong>value set to <strong>Abscess Jaw</strong>. In this case, you must enter a <strong>Result (Code)</strong> or <strong>Result (Text)</strong> value to indicate the test result.
            </td>
            <td>Not Processed with Warnings</td>
        </tr>
        <tr>
            <td>Case Test Result</td>
            <td>
                <ul>
                    <li>Normal High Value</li>
                    <li>Normal Low Value</li>
                    <li>Result</li>
                </ul>
            </td>
            <td>If you entered a value in either the <strong>Normal High Value</strong> or <strong>Normal Low Value</strong> field, you must select a unit of measurement in the <strong>Result</strong> field.</td>
            <td>Rejected</td>
        </tr>
        <tr>
            <td>Document (Case Attachment)</td>
            <td>Description</td>
            <td>You must enter a description for any case attachments in each document's <strong>Description</strong> field. </td>
            <td>Not Processed</td>
        </tr>
        <tr>
            <td>Submission</td>
            <td>Transmission Date</td>
            <td>You must enter the date of transmission in the <strong>Transmission Date</strong> field.</td>
            <td>Not Processed</td>
        </tr>
    </tbody>
   </table>