June 2013 EMA/737304/2012 How to send submissions via the Web Client Guidance for applicants 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union Table of Contents 1. Accessing the Web Client......................................................................... 3 2. Sending Submissions ............................................................................... 4 3. Viewing sent submissions ....................................................................... 7 3.1. Viewing sent submission receipts and acknowledgements .......................................... 7 4. Error codes .............................................................................................. 9 How to send submissions via the Web Client EMA/737304/2012 Page 2/10 The various steps that need to be completed in the Web Client submission process are outlined below. Please note that you will only be able to access the Web Client if you have successfully registered and received email confirmation that registration has been completed. 1. Accessing the Web Client a) Please access the Web Client by clicking the link below for the EMA’s Production environment: http://pgateway.ema.europa.eu b) You will see the screen below: c) Please enter the User ID and Password which you chose when you completed the online registration form. This information can be found in the bottom section of the PDF attachment you received with the email confirming your registration for the Web Client. How to send submissions via the Web Client EMA/737304/2012 Page 3/10 d) You will now be able to view the Web Client Document Inbox. This is the location where you will receive acknowledgements and receipts for your submissions to the EMA. 2. Sending Submissions a) To send a submission to the EMA you will need to select “Send document” from the menu as shown below: b) Next, you will be shown a screen which allows you to select the receiver of the submission. In the production environment the receiver should be set to ESUBMISSION. How to send submissions via the Web Client EMA/737304/2012 Page 4/10 c) To send your zipped files please select “Click to send documents totalling more than 10 megabytes”. You can use this option to send submissions of any size. The documents can be less than 10 megabytes. d) By selecting this option you will receive both a receipt and an acknowledgement for your submission via the webclient. e) Next, click the How to send submissions via the Web Client EMA/737304/2012 button and select the file you wish to submit as shown below: Page 5/10 f) Click to submit your files to the EMA. g) During the upload process you will see the following message: h) Click on the button. How to send submissions via the Web Client EMA/737304/2012 Page 6/10 3. Viewing sent submissions a) You will be taken to the sent items folder as shown below: 3.1. Viewing sent submission receipts and acknowledgements a) Next, select “Inbox” from the “Open folder” menu in the top right of the screen as shown below: b) You will now be able to see the receipt for the submission that was just sent: How to send submissions via the Web Client EMA/737304/2012 Page 7/10 c) When the submission has been successfully processed by the EMA’s review system you will receive an acknowledgement in the Web Client inbox as shown below: d) If your submission was processed unsuccessfully a failure acknowledment will be shown in the Web Client inbox as shown below: How to send submissions via the Web Client EMA/737304/2012 Page 8/10 4. Error codes a) If your submission was unsuccessful you will be able to find out the reason for this by viewing the error code inside the acknowledgement message. The error codes below reflect common errors which might be received when sending submissions via the Web Client.: Error Code 2 Error Code Message Problem Description  Failed to unzip (unrecognised format).  Failed to unzip.  Errors related to the filename format or a basic error in the structure of the submission (index file is missing.)  Error while creating the submission definition... Submission has not been processed correctly Unknown submission type Error while creating the submission definition... Unknown submission format Error while creating the submission definition... A required value is missing Submission has an invalid ectd structure Could not find sequence directory Cannot have an ectd and Nees format at the same time Submission has an unknown structure  The path is not of a legal form  Illegal attempt to associate a collection with two open sessions Error related to the automatic validation / import to the EMA review system.  The dossier \'{DossierTitle}\' already contains the submission \'{SequenceNumber}\'.No submission imported.  Submission \'{SequenceNumber}\' must be imported as first submission.  Plus any of the ECTD errors that the validation might produce. 36  Error while creating Eurs automation file (System internal error) Error while creating Eurs automation file 38  Error while generating filemaker input file (System internal error) Error while generating filemaker input 40     Could not move archive to the invalid area Error while removing the staging directory. Error in initialisation...required field is empty Filename cannot contain any form of whitespace... The filename cannot exceed 255 characters. Wrong extension used in file name. Internal system error 31       34 42   How to send submissions via the Web Client EMA/737304/2012 Problem with the unzipping of the submission. Errors related to the filename convention Page 9/10 Error Code     44    45  Error Code Message Wrong number of file name parts. Error while creating the submission definition... FileNamePartEnum should not be null. Wrong format in filename Problem Description Submission type has not been properly defined. Product number should contain a 6 digit id. Wrong sender routing id used. No Ack has been sent. Errors related to file validations Internal system error, archived file not found or already moved to the invalid area... Internal system error If you experience any issues during using the Web Client please contact: eCTD@ema.europa.eu How to send submissions via the Web Client EMA/737304/2012 Page 10/10