Get Submissions To The Psur Repository Using Ema Gateway

This guide provides a clear and comprehensive overview to assist users with submitting documents to the PSUR Repository using the EMA Gateway. Whether you are new to the process or need a refresher, this guide aims to support you through each step.

Follow the steps to successfully complete your submission online.

1. Click the ‘Get Form’ button to obtain and access the form in the editor.
2. Fill out the relevant sections of the form, ensuring that all required fields are completed accurately. Pay special attention to the naming conventions for zip packages, as these must be meaningful and comply with the provided examples.
3. Create a delivery file containing submission metadata in XML format, and insert this file within your zip package.
4. Select the correct regulatory activity and type of assessment in the delivery file screen. If necessary, provide details such as the member state and data lock point.
5. Enter a minimum of four characters of the procedure number and select the appropriate procedure from the filtered list. Ensure the submission format (eCTD or NeeS) is correct and note that multiple formats require separate delivery files.
6. Choose the products/presentations related to the PSUR submission. Ensure correct entries are made to avoid errors and confirm the details before proceeding.
7. Enter the routing information as directed, and click the 'Generate Delivery File' button to finalize the delivery file.
8. Navigate to your submission package and ensure all files follow the required structure. Save your delivery file as 'delivery.xml' without renaming it.
9. After completing all steps, submit your application through the appropriate channel, ensuring to use the advanced mode if submissions exceed 10MB.
10. Monitor your submissions for automated messages regarding receipt and acknowledgements to ensure successful validation and processing.

Start your submissions online today and ensure compliance with the latest requirements.