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 AER, the system checks for valid case criteria before you can promote the AER to a Case.
  • 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.

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

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