The Common European Single Submission Portal (CESSP)

Essentials

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Background

CESSP is a programme to implement an online authoring tool for application forms and to enhance the current PDF based electronic application

forms. The first phase of this programme called “CESSP Phase 1” will deliver a new format for creation of Marketing Authorisation Applications

with the goal to replace the relevant PDF forms with a web based interface. This will cover both, human and veterinary application forms for new

marketing authorisations and extension applications.

The programme is part of the eSubmission Roadmap which also describes the concept of a Single Submission Portal which will provide online

service for stakeholders and will integrate the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway. The

EU Telematics Management Board has agreed that this single portal shall be built using the current CESP portal. During the development project

this system has been referred to as the CESSP but will be implemented within the current CESP as a new module called “CESP Application

Dataset Management Module (CESP Dataset Module).

As detailed in the eSubmission Roadmap but independent of the integration of EMA Gateway and CESP, the CESP Dataset Module integrates the

current content of the eAFs. The application form content will be integrated into this new web based solution with a stepwise approach.

CESSP essentials 1

Statement of Intent

CESSP Phase 1 - implementation

• The first implementation project step, CESSP Phase 1, will deliver a user interface to make use of

integrated human and veterinary Marketing Authorisation Application datasets for new marketing

authorisation and extension applications. It is expected that the first version of the system will be

available for use by end of 2018. This will be followed by the integration of the Variation and Renewal

form into the CESP Dataset Module. The current eAFs will be withdrawn after a transitional period and

the use of the new CESP Dataset Module will become mandatory at a future date which will be

communicated right in advance but at a later stage.

• The CESP Dataset Module will make it possible to reuse the application form content. Applicants will also

be able to use pre-registered organisation data and controlled vocabulary terms provided by EMA SPOR

(Substances, Products, Organisations, Referentials) data services.

CESSP essentials 2

Statement of Intent

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eSubmission Roadmap - Version 2.0 (24.02.2017)

Source: http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

CESSP essentials

*) The SPOR project will stepwise (see specific Roadmap) deliver master data services (RMS, OMS, SMS, PMS) to be

integrated with the eAF and CESSP during the roadmap period. Ongoing or optional

Mandatory

2017 2018 2019 2020

Application Form – Past and Future

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Word form

• Free text only • Copy/paste only (error prone) • No validation rules • No data export / import

eAF - PDF • Higher data quality

• Free text reduced to minimum • Controlled terms are mandatory • Context-dependent structured

layout with built-in business rules • Built-in form validation

• Data export / import

CESP Dataset Module –

web based application • Improved usability and

performance • Fundamental change of

data collection concept • Use of SPOR master data

• Marketing Authorisation Application form (human) • Marketing Authorisation Application form (veterinary) • Renewal form (human and veterinary) • Variation form (human and veterinary)

for decentralised, mutual recognition, national and centralised procedures

replaced 2012-2016

stepwise replacement planned for 2018-2020

CESSP essentials

Overview of the CESSP Programme and ongoing Phase 1

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Project CESSP Phase 1.0 is ongoing for replacement of the eAF MAA Human and Vet Online application dataset module available by end of 2018

Project CESSP Phase 2 – not yet started Replacement of the eAF for Variation and Renewal

Further implementation phases – not yet started

CESSP programme

CESSP programme also monitors other initiatives (including Vet-Regulation, SPOR) to ensure compatibility and future improvements CESSP essentials

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CESSP - Process flow

“Dataset”

CESSP phase 1 will use data from OMS and RMS (O and R in SPOR) in a way that organisations and referentials can be selected during the authoring process.

manual data entry /update

IT supported data upload

anticipated

applicant level

integrates

CESP Application Dataset Management Module

SPOR

creates

CESSP essentials

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Concept of data use

“Dataset” The dataset contains information to be used in the application form and can also be reused for other purposes

Human readable application data

CESP delivery file

Electronic data format for automated data import

Draft cover letter, Draft EMA formatted table template

CESSP essentials

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Future process after implementation of CESSP Phase 1

CESSP essentials

Import file for IT systems

Draft Cover Letter

Dossier

Finalise dossier

submission

CESP

EMA Gateway

Submit Process

submission

EMA/ NCA

CESP Application Dataset Management Module

Start and Finalise

Dataset (eAF etc.)

SPOR

Dataset

Essential functions implemented by CESSP Phase 1

at applicant level

IUnknown

eAF XML aus

eAFFdB

PHAROS

SAP

DOXIS

DocuBridge

- Datenprüfung

- Prozeßinitialisierung

- Datenanreicherung

- Verteilung auf Zielsysteme

- Erfassung

- Prüfung gegen EMEA-eAF-Validator

EMEA

eAF-Validator-Service

• Download dataset Applicants need to put this dataset into eCTD

sequence (or VNeeS or NeeS)

CESP

Dataset

Module

• Create/clone/save/modify/export/import datasets

• Retrieve OMS and RMS (SPOR data)

• Validate data completion and business rules

• View dataset in human readable layout

• Export the eAF for use in submissions

• Reuse dataset for CESP delivery file, draft cover letter /

EMA 'formatted table template‘ for usage in submissions

XML-upload (not in Phase 1)

manual data input

Dataset

IUnknown

eAF XML aus

eAFFdB

PHAROS

SAP

DOXIS

DocuBridge

- Datenprüfung

- Prozeßinitialisierung

- Datenanreicherung

- Verteilung auf Zielsysteme

- Erfassung

- Prüfung gegen EMEA-eAF-Validator

EMEA

eAF-Validator-Service

at NCA/EMA level

Dataset

• View the eAF via PDF and stylesheets

Import dataset into NCA databases

Data import

readable representation

10 CESSP essentials

CESSP Phase 1 - Out of scope

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• “CESSP Phase 1” is not a long term repository for datasets

• “CESSP Phase 1” doesn’t replace variation and renewal forms

• Datasets created by “CESSP Phase 1” will not be completely compatible with

IDMP-standards

CESSP Phase 1 - Project Organisation & Milestones

Project Organisation

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Stefanie Huber

PM: Georg Neuwirther

ITDEC

Sponsor

legend

NCA, EMA

Industry

External

Gary Wilson

CESSP Implementation team

Klaus Menges

Alistair Nixon

Jeroen Veen

Leigh Sandwell

Kevin Horan

Remco Munnik

Noel Diamant

Kristiina Puusaari

Karin Gröndahl

Kristiina Puusaari

Dalle Frederic

CESSP Full Group

Joris Kampmeijer

Manuela Copier

Jose Simarro

Monique Lanson

Menaka Subramanyam

Christelle Exbrayat

Alenoosh Abedi

Alenoosh Abedi

Virginie Bacquet

Mathilde Geynet

Anne Christine Lantin

Anne Christine Lantin

Klaus Menges

Karin Gröndahl

Kristiina Puusaari

Sonja Königshofer

Karin Gröndahl

Victoria Girones

Jose Simarro

Gary Wilson

Kate Harper

Lee Bridgen

Marja van Schie

Noel Diamant

Planned release dates:

• UAT 1 - 05/2017

• UAT 2 - 12/2017 to be confirmed

• Final UAT - 06/2018

• Go live - by end of 2018

• Mandatory use - 6 months after go-live

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Milestones

CESSP essentials

Contact

For any question about the project please contact: cesspproject@hma.eu

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