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 valid case criteria before you can promote the Inbox Item 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 |
Case |
|
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 |
|
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 |
|
|
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 |
|
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 |
|
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 |