July 2022

EMA/737304/2012

How to send submissions via the Syncplicity Web Client

Guidance for applicants

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union

© European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged.
Table of Contents
1. Reset of password ................................................................................. 4
1.1. Reset your password using link from an email from Axway Syncplicity ........................ 4

2. Accessing the Syncplicity Web Client ..................................................... 7

3. Sending Submissions ........................................................................... 10
4. Viewing sent submissions ................................................................... 14
4.1. Viewing sent submission receipts and acknowledgements ....................................... 15

5. Error codes .......................................................................................... 18

6. Important notes: ................................................................................. 18

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The eSubmission Gateway Web Client is an electronic submission channel that allows the applicants to submit documents supporting all types of
applications to the Agency securely over the internet in any electronic format (structured or non-structured). The eSubmission Gateway Web Client users
will benefit from an automated confirmation of the technical validation feedback (eCTD only) and an automated upload to the Agency’s eCTD
review system. The use of the eSubmission Gateway and the Web Client is mandatory for all human and veterinary submissions, including medical
devices.

The various steps that need to be completed in the Syncplicity Web Client submission process are outlined below.

Please note that you will only be able to send submissions via the Syncplicity Web Client if you have successfully registered, received
email confirmation with your login details and subsequently reset your password in Syncplicity.

VERY IMPORTANT:

1. Please do not use the ‘Create Account’ option. If you need to register as a user, please navigate to the registration module here:
https://esubregistration.ema.europa.eu/registration/
2. The system allows you to create new folders and rename the existing ‘archive’, ‘inbox’ and ‘outbox’. Please DO NOT rename or delete any of the
folders. This will lead into malfunctioning of the system and you will not be able to send any submissions.

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1. Reset of password

1.1. Reset your password using link from an email from Axway Syncplicity

If you have previously registered as an eSubmission Gateway Web Client user, you will have received an automated email from Axway Syncplicity to
prompt you to update your password to be able to access the new Web Client UI.

The email will look like the one below;

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a) To reset your password, click to the link in the email. This will take you to a page that looks like this:

b) Enter the email address that you have registered with to use the eSubmission Gateway (the email address into which you received the notification
email to). Please do not use any other email address. If the email address is no longer in use, please contact the EMA Service Desk

Create your password and click submit.

c) Alternatively, navigate to page: https://eu.syncplicity.com/ and click ‘Reset Password’.

IMPORTANT NOTE: Please do not use the ‘Create Account’ option. If you need to register as a user, navigate to the registration module here:
https://esubregistration.ema.europa.eu/registration/

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d) When clicking ‘Reset Password’ you will be taken to this page:

e) This will take you to the same page as the link from the email where you can follow the password reset process.

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2. Accessing the Syncplicity Web Client

a) Please access the Web Client by clicking the link below for the EMA’s Production environment:
https://eu.syncplicity.com/

b) If you have already reset your password/credentials for XCOMP, the same credentials will now work for the production environment.

c) When you login using the ‘login screen’:

d) Please enter the email address and the password which you chose when you reset your password in the portal. 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.

Once you have logged in you will get to a screen as shown below. Please note that you do not need to install anything.

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 d) Please navigate to option ‘Files’:

e) If you have access to both, XCOMP and Production, you will now see 2 ‘RootFolders’ when you click to ‘All Files’
f) Click the ‘RootFolder for the routing ID, for example, in production this will be ‘ESUBPYOURROUTINGID’

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 g) Please ensure you select the RootFolder for your production routing ID to send submissions to the EMA production environment. The
submissions sent to the XCOMP are not considered received. You can recognise the production RootFolder from the letter ‘P’ in the middle of the
Routing ID.

h) You will now be able to view your Web Client account. This is where you will send packages from outbox, you find the archive with your sent
items and the inbox where you will receive acknowledgements and receipts for your submissions to the EMA.

3. Sending Submissions

a) To send a submission to the EMA you will need to navigate to the “outbox” from the RootFolder for your Production Routing ID. Please ensure
you select the correct routing ID for Production, you can recognise this from the letter P in the middle of the Routing ID e.g. ESUBPWONDERDRUGS

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b) When you have navigated into the outbox, click the small ‘cloud’ icon to upload your submission package (zip package including the submission zip
and the delivery file).

c) Select your package from your local drive by clicking ‘Open’

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d) Selecting the package from your local drive will ‘trigger’ the sending. You will see a small ‘Uploads’ window as shown in the screenshot will appear
while the upload (sending) is being automatically done.

e) The system does not automatically refresh, but once the small ‘Uploads’ window has disappeared, the submission is sent. You can now either
manually refresh the window and you can see that the outbox is again empty or you can navigate back to the RootFolder

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f) In the archive folder you can see the packages you have sent

g) In the ‘inbox’ you can find the MDN files (receipts) and the acknowledgements for your packages. It is possible to sort the view by clicking in the
headers.

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4. Viewing sent submissions
a) Once you have uploaded your submission package into the ‘outbox’ the submission is sent. The view doesn’t autorefresh, but you can manually
refresh the browser window or you can navigate back to the ‘RootFolder’ and into the ‘archive’ where you can see your sent submissions.

b) Please note that when navigating from one folder to another you need to click the folder icon, not the text

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4.1. Viewing sent submission receipts and acknowledgements

a) To view receipts (MDN file) and acknowledgements select “Inbox” from the “RootFolder” below:

b) You will be able to see the receipt for the submission that was just sent. Please note that the order of files by default shows the oldest MDN on
top and subsequently the oldest ACK (file) on top. You can sort this order by clicking the headers, for example to show the latest ACKs, please
click ‘Date modified’ first and then ‘Type’:

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 c) To read the MDN file from the inbox folder, select and download the file

d) Once you have downloaded the MDN, you can open the file in a txt editor e.g. Notepad ++. The following screenshot shows an example of a test
file where the users routing ID and the submission filename have been hidden.

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 c) When the submission has been successfully processed by the EMA’s review system you will receive an acknowledgement in the Web Client inbox.
You can download the ACK to see the details:

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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5. Error codes
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 list is regularly updated and is available here: Error codes list

6. Important notes:

1. Please do not use the ‘Create Account’ option. If you need to register as a user, please navigate to the registration module here:
https://esubregistration.ema.europa.eu/registration/
2. The system allows you to create new folders and rename the existing ‘archive’, ‘inbox’ and ‘outbox’. Please DO NOT rename or delete any of the
folders. This will lead into malfunctioning of the system and you will not be able to send any submissions.

If you experience any issues during using the Web Client please contact:

EMA Service Desk portal

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