Prepare Test Submissions

Prerequisites

Procedure

  1. Create a new test Marketing Application as follows:

    • Application Name: EU-TEST-[Your Company Name]
    • Lead Market: European Union
    • Region: European Union
    • Application Type: Marketing Authorisation Application (MAA)
    • Procedure Type: Centralised Procedure
    • Primary Product Family: as applicable
    • Application Folder Name: leave blank (will be generated upon save)
    • Applicant: as applicable
    • Primary Health Authority: European Medicines Agency
    • Application UUID: leave blank (will be generated upon save)
    • Dossier Format: eCTD
    • XML Regional DTD / XSD Version: EU 3.0.1
    • XML ICH DTD / XSD Version: ICH 3.2
    • Validation Criteria Version: EU 7.1
    • Create Node Extension: Yes
    • Content Plan Template: CTD Content Plan Template

  2. Create and publish a new submission 0000 as follows:

    • Submission Name: 0000 - Notification 61(3)
    • Sequence ID: 0000
    • Submission Type: Notification 61(3)
    • Submission Subtype: Initial
    • Planned Submission Date: today
    • Procedure Number: leave empty
    • Procedure Tracking Number: EMA/H/123456
    • Submission Description: Test gateway submission

    Create a content plan and add a sample cover letter in 1.0 section in Module 1. Publish the sequence (update of administrative information might be needed to introduce Invented Name and INN).

    • When published and there are no P/F (pass-fail) open validation results, lock the content plan and disable continuous publishing.

  3. Navigate to the following website: https://esubweb.ema.europa.eu/esubmission-ui/#/ and introduce details as per the print screen below:

    Screenshot step 3

    In the Select a Product field, please select one of your products by starting to type the name.

    Click on Generate delivery file and save the generated XML file (do not change the name).

  4. Navigate to the submission record from step 2 and add the downloaded XML delivery file as an attachment:

    Screenshot step 4

  5. Progress the submission to your “Ready for Submission” state.

    From the Actions Menu, select Submit to Gateway.

  6. Verify the Dossier Status shows Transmission In Progress or Transmission Successful.

  7. Review the attachment section and look for the following documents:

    • MDN
    • ACK

    Download the received files and make a print screen of the attachment section.

  8. Send email to eCTD@ema.europa.eu confirming the successful receipt of the MDN and ACK messages. Include the MDN and ACK messages as well as the print screen made as attachment of the email.

  9. EMA will confirm the successful setup of the TEST gateway connection and ask for confirmation that the certificate for Production is the same as for TEST. Confirm or send a new certificate for Production.