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7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 8416 E-mail [email protected] Website www.ema.europa.eu February 2013 EMA/737304/2012 How to send submissions via the Web Client Guidance for applicants

How to send submissions via the Web Client - User …esubmission.ema.europa.eu/gateway/How to send submissions...7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency

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Page 1: How to send submissions via the Web Client - User …esubmission.ema.europa.eu/gateway/How to send submissions...7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency

7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom

An agency of the European Union

Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 8416

E-mail [email protected] Website www.ema.europa.eu

February 2013 EMA/737304/2012

How to send submissions via the Web Client Guidance for applicants

Page 2: How to send submissions via the Web Client - User …esubmission.ema.europa.eu/gateway/How to send submissions...7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency

How to send submissions via the Web Client

EMA/737304/2012 Page 2/9

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

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How to send submissions via the Web Client

EMA/737304/2012 Page 3/9

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.

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EMA/737304/2012 Page 4/9

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.

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How to send submissions via the Web Client

EMA/737304/2012 Page 5/9

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 button and select the file you wish to submit as shown below:

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How to send submissions via the Web Client

EMA/737304/2012 Page 6/9

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.

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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:

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How to send submissions via the Web Client

EMA/737304/2012 Page 8/9

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:

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EMA/737304/2012 Page 9/9

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 Error Code Message Problem Description

2

Failed to unzip (unrecognised format).

Failed to unzip.

Problem with the unzipping

of the submission.

34

The path is not of a legal form

Illegal attempt to associate a collection with

two open sessions

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.

Error related to the

automatic validation / import to the EMA review system.

31

Wrong format: ESUbdEV. Please review file

naming conventions.

FileNamePartEnum ( ) should not be null.

Please review file naming conventions Submission directory has an invalid ectd

structure

FileNamePartEnum ( ) should not be null.

Unknown submission Type. Please review file

naming conventions

Errors related to the filename format or a basic

error in the structure of the submission (index file is missing.)

If you experience any issues during using the Web Client UAT please contact: [email protected]