eSubmissions via EMA Gateway and Web Client

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eSubmissions via EMA Gateway and Web Client

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The Gateway

• What is the Gateway?
• Gateway Options
• Key features of Web Client Gateway (AS2/AS3)
• Overview of Gateway Set-up
• Registration
• Using the Web Client
• Filenaming Conventions required to submit via
  Gateway/Web Client

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What is the Gateway?

• An Agency-wide solution and central transmission
  point for accepting secure electronic regulatory
  submissions over the Internet. The EMA
  eSubmission Gateway is a conduit, or "a route",
  along which submissions travel to reach their
  final destination. It does not open or review
  submissions it automatically routes them to the
  relevant EMA Office.

eCTD Compliance check
EMA Gateway (receives submission sends MDN to
sponsor)
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eSubmissions Gateway Options

• EMA Gateway Web Client
• Free option
• Uses applet
• EMA is using European Review System (EURS) to
  validate the eCTD Submissions
• Gateway to Gateway (AS2)
• Applicability Statement 2 (AS2) and AS3
  Gateway-to- Gateway
• Requires an AS2 AS3 compliant gateway software
• EMA is using a product called Axway Synchrony
  Gateway Interchange (version 5.x) EURS to
  validate the eCTD submissions.

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EMA Gateway Web Client Facts

• EMA does not charge for the use of this solution.
• ONE Web Client account is allowed per applicant.
  A second account may be requested though please
  do provide a justification to ectd_at_ema.europa.eu
• Web Client uses Hypertext Transfer Protocol
  Secure (HTTPS) to ensure secure delivery of
  submissions over internet.
• Consultancy companies can register and send on
  behalf of Various Applicants.
• From 1st March 2014 use of Gateway/Web Client is
  mandatory for all eCTD submissions to EMA in
  context of Centralised Procedure.

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Feature comparison of Web Client and Gateway

25 GB
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Electronic Submissions Gateway Process What to
do in order to use the gateway

• Determine the preferred route, i.e. AS2/GW or
  GW/Web Client
• To use the Gateway Web Client you need to ensure
  that online registration has been completed and
  account(s) have been activated.
• Understand and consult guidance documents on the
  eSubmission website http//esubmission.ema.europa.
  eu/
• File naming convention described in the guidance
  document is followed correctly when uploading zip
  files.

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Overview of Gateway Set-up
Apply for Online Registration (Test PROD
simultaneously)

• Testing is strongly recommended for Web Client
  users even though it is stated Optional when
  registering online.

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Web Client Registration - 1
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Web Client Registration - 2
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Web Client Registration - 3

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Web Client Registration - 4

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Using The Web Client

1. Logon with the credentials supplied in
   communication from the registration team
2. Start Submitting!

Always select the send documents more than 10MB
option to use Large file applet, Note that
receipts (MDN) are sent only when you use this
option, and this link will appear only with
correct Java Version JRE 1.5.0_05
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Technical Validation Issues

• eCTD Technical Validation identifies and rates
  the severity of the errors (P/F checks from the
  eCTD criteria) encountered in a typical eCTD
  submission, results are indicated in Final
  Acknowledgement message as SUCCESS or FAILURE.
• eCTD validation criteria valid at present is
  available here http//esubmission.ema.europa.eu/e
  umodule1/index.htm
• Duplicate Submission
• Typo in the product number(HC000xxx), or a
  procedure number for PSURs in Single assessment(8
  digit EURDID).
• If an already existing sequence (in EMA database)
  has been modified and sent to the agency as
  replacement !
• Incorrect Submission structure (4 digit folder
  not at the root of submission package)
• Incorrect submission Type

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Acknowledgement Example
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Key Points during the Web Client Transmission - 1

• There are two automated messages sent during the
  transmission
• Always use the Large File Applet for All
  transmissions via the Web Client.
• You need to run version Java version JRE 1.5.0_05
  http//www.oracle.com/technetwork/java/javasebusin
  ess/downloads/java-archive-downloads-javase5-41941
  0.htmljdk-1.5.0_05-oth-JPR
• The Receipt is sent once the submission has been
  successfully received by the EMA Gateway Web
  Client. It is a simple text file with reception
  timestamp and is merely a receipt - this does not
  indicate a successful technical validation. To
  note Receipt is sent only when using the Large
  File applet.
• The final Acknowledgement is an xml file sent
  after the system has completed the technical
  validation of the submission. It contains the
  result of the validation (SUCCESS or FAILURE). In
  case of a failure, a detailed description of the
  error is included in it.

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Key Points during the Web Client Transmission - 2

• Dependent on the submission size and web client
  gateway queue, both automated messages can take
  up to 24 hours for the Acknowledgment delivery
  back to the sender.
• Where applicable, for multiple submissions,
  please trigger Web Client transmission belonging
  to same product/dossier in sequential order.
• e.g. If you need to send 0033, 0035, 0036 for
  same product please send them in that order and
  allow some gap between those transmissions.
  Failure in following this may result in Negative
  technical validation.
• All submissions should be archived as a zip file.
  The compressed application file must comply with
  the ZIP open format.

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Key Points during Web Client Transmission - 3

• Senders Inbox view showing Acknowledgement and
  Receipt

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Filenaming Conventions for Gateway - 1

• Effective from 1st March 2014 please use
  following File Name Convention for submissions

Example ESUBPXYZ_ESUBPROD_HC000999_Wonderpill_va
r-typeII_0020.zip
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Filename to be used for ASMF

• ESUBPXYZ_ESUBPROD_EMEA-ASMF-xx123_Activesubstance_
  asmf_00xx.zip
• ASMF holders who have on-going ASMF eCTD
  life-cycle (one or multiple) related to Centrally
  Authorised Product(s) are strongly advised to
  apply for the EMEA/ASMF/xxxxx number to ensure
  smooth integration with the eSubmission Gateway.
• You can request to apply new ASMF procedure
  number at the following link http//esubmission.e
  ma.europa.eu/eASMF/index.htm

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I am a supplier of active substance for 4
Centrally Authorised Products, how should I
proceed ?

• Apply for EMEA/ASMF number -request form
• Once you received a number, submit one new eCTD
  sequence explaining in the cover letter which
  current CAP_ASMF you choose to carry on the
  life-cycle of, i.e. CAP A is at sq0003, CAP B is
  at seq0006, CAP C is at seq0004, you would inform
  us that you want to follow the life-cycle of CAP
  B and therefore you are sending seq 0007.
• After this submission you only have to maintain
  this life-cycle and it will cover all products
  (the others will be archived)

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General ASMF submission rules

• Consult ASMF guidance documentation available at
  http//esubmission.ema.europa.eu/eASMF/index.htm
• Always submit Annexes 2 and 3 in Module 1 of the
  eCTD sequence, but ensure that when submitting to
  EMA the relevant EMEA/ASMF/xxxxx numbers are
  quoted.
• Never submit two parts (Restricted and Open
  part)within the same sequence

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Filenaming Convention for Plasma Master Files
(PMF)
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How to Avoid Problems - 1

1. Correct Routing IDs should be used for
   respective environments and reflected correctly
   in the Submissions filename e.g.
   ESUBPXYZ_ESUBPROD_HC000999_Wonderpill_initial-maa_
   0020.zip
2. Incorrect folder structure used in Zipped file
   sent to EMA. Always ensure that Sequence
   Number(0xxx) folder is at the root, as reflected
   below

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How to Avoid Problems - 2

• Submissions should be compressed before
  transmission as a zip file. The compressed
  application file must comply with the ZIP open
  format.
• Duplicate submissions
• Gateway/Web Client only processes the first
  submission not the duplicate.
• If the first submission was in error, contact
  eCTD support team at ectd_at_ema.europa.eu
• Bad characters in the file names (NO Spaces!)
  only underscore is allowed to separate the
  filenames. No other special characters are
  allowed.
• Do not send duplicate submissions using both CD
  or DVD and Web Client.
• Use correct Java version (JRE 1.5.0_05) when
  using Web Client.

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Why should you bother?

• These errors require us to manually process your
  gateway submission
• Manually processed submissions delay access to
  your material
• Sometimes these issues result in us rejecting
  your submission

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Contact Information Useful links

• Registration Link https//esubregistration.ema.eur
  opa.eu/registration
• Registration Documentation (contact info, forms,
  guidance documents) http//esubmission.emea.europ
  a.eu/esubmission.html
• Technical issues during the Gateway / Web Client
  set-up gatewaysupport_at_ema.europa.eu
• for Technical validation issues (e.g. Failure
  Acknowledgements) ectd_at_ema.europa.eu
• TIGes Guidance on eCTD NeeS http//esubmission.
  ema.europa.eu/tiges/tigesdocuments.html

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• Thank You for your
  interest!
• Questions?