Firstly, what is the PSUR repository?

What should you do, if you do not have access?
If you do not have access, you should register immediately to get a username and password to use the portal system. Guidance for the registration process can be found in the following location: http://esubmission.ema.europa.eu/psur/psur_repository.html Then, you should check all MAs entries within the Article 57 database to ensure the information (MAH, MA number, Product Name, and legal basis) is entered incorrectly. This is very important for when it comes to publishing of the PSUR submission. The PSUR repository used to create the delivery file for the submission of the PSUR via the gateway system is linked to the information entered into the Article 57 database. Thus, if a MA number is entered incorrectly within the Article 57 database, then the MA number will appear incorrect within the PSUR repository. In addition, it is important to note that if the legal basis for a MA is entered incorrectly, then this may result in that MA not appearing in the PSUR repository used to generate the delivery file.
How to Check the PSUR Repository:
Checking what is visible within the PSUR repository for the creation of a delivery file can be done as soon the data lock point has passed. Go to the following URL: https://psur-repo.ema.europa.eu/psur-ui/prepare/submission.html Enter in the associated PSUSA number assigned and click on create delivery file as indicated in the image below.
How To Generate A Delivery File
- Once all entries are confirmed correct, then a delivery file can be generated for the upcoming PSUSA submission. The delivery file creation is linked to the submission deadline published in the EURD list. If the submission deadline passes, then the MAH will be unable to create a delivery file without a late submission ID number provided by the EMA.
- Instruction for requesting a late submission ID number can be found in the “EMA User Guidance for Marketing Authorisation Holders (MAHs) for PSUR Repository.”
- Please keep in mind that any products or presentations not included in the delivery file are not considered as part of the procedure. Therefore, careful selection is needed to ensure all relevant products and presentations are selected from the list in creating the delivery file for the PSUSA submission.
- Finally, when the delivery file is generated, it can be combined with the submission sequence in a zip file to upload to the EMA via Gateway/Web client. Be sure to select the delivery file generated and the submission sequence to send to a zip file. By doing this, it will ensure that the submission sequence and the delivery file remain on the same level.
- When the zip file is created, then it can be submitted to the EMA via Gateway/Web client.