The Common European Single Submission Portal (CESSP) Essentials

Statement of Intent Background CESSP Phase 1 - implementation As outlined in the eSubmission Roadmap, the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway will eventually be integrated into a Single Submission Portal. The EU Telematics Management Board have agreed that this single portal shall be built on the current CESP. This future system is meanwhile referred to as the Common European Single Submission Portal (CESSP). As detailed in the eSubmission Roadmap but independent of the integration of EMA Gateway and CESP, CESSP is also envisaged to integrate the current content of the eAFs. The application content (further on referred to as the application datasets) will be integrated into this new web based solution with a stepwise approach. 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 Q1 2018. This will be followed by the delivery of the Variation and Renewal form datasets into the CESSP. The current eAFs will be withdrawn after a transitional period and the use of the new, integrated application dataset within the portal will become mandatory at a future date which will be communicated right in advance but at a later stage. The CESSP will make it possible to reuse the application datasets. Applicants will also be able to use preregistered organisation data and controlled vocabulary terms provided by EMA SPOR (Substances, Products, Organisations, Referentials) data services. CESSP essentials

eSubmission Roadmap - Version 2.0 (24.02.2017) 2017 2018 2019 2020 Ongoing or optional Mandatory *) 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. Source: http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html CESSP essentials

Application Form – Past and Future 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 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 CESSP – web based application Improved usability and performance Fundamental change of data collection concept Use of SPOR master data   replaced 2012-2016 stepwise replacement planned for 2018-2020 CESSP essentials

Overview of the CESSP Programme and ongoing Phase 1 05 December 2017 Overview of the CESSP Programme and ongoing Phase 1

CESSP programme Project CESSP Phase 1.0 is ongoing for replacement of the eAF MAA Human and Vet Online application dataset available by Q1/2018 Further implementation phases – not yet started Project CESSP Phase 2 – not yet started Replacement of the eAF for Variation and Renewal CESSP programme also monitors other initiatives (including Vet-Regulation, SPOR) to ensure compatibility and future improvements 5 CESSP essentials

IT supported data upload CESSP - Process flow manual data entry /update IT supported data upload applicant level CESSP Online-Tool “application dataset” creates integrates SPOR 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. CESSP essentials

CESSP – Concept of the application dataset Human readable application data Electronic data format for automated data import “application dataset” (= eAF and even MORE) contains information used in the application form and can also be reused for other purposes Draft cover letter, Draft EMA formatted table template CESP delivery file CESSP essentials

Future process after implementation of CESSP Phase 1 05 December 2017 Future process after implementation of CESSP Phase 1 Import file for IT systems Draft Cover Letter, Dossier Finalise dossier submission CESP EMA Gateway Submit CESSP Start and Finalise Application Dataset Process submission EMA/ NCA Draft a business and technical scenario how PMS could consume and utilise application data SPOR CESSP essentials

Essential functions implemented by CESSP Phase 1 at applicant level Download dataset Applicants need to put this dataset into eCTD sequence (or VNeeS or NeeS) CESSP Create/clone/save/open datasets Grant access to application datasets Retrieve SPOR data Validate data completion and business rules View dataset in human readable layout Export dataset (application data) for use in submissions Reuse dataset for draft cover letter / EMA 'formatted table template‘ for usage in submissions XML-upload (not in Phase 1) manual data input Application dataset at NCA/EMA level Application dataset View application dataset via stylesheets Import dataset into NCA databases Data import readable representation View dataset via stylesheet (getting rid of PDF requires commission decision) http://www.w3schools.com/xml/tryxslt.asp?xmlfile=simple&xsltfile=simple 9 CESSP essentials

CESSP Phase 1 - Out of scope “CESSP Phase 1” is not a long term repository for application 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 View dataset via stylesheet (getting rid of PDF requires commission decision) http://www.w3schools.com/xml/tryxslt.asp?xmlfile=simple&xsltfile=simple 10 CESSP essentials

CESSP Phase 1 - Project Organisation & Milestones 05 December 2017 CESSP Phase 1 - Project Organisation & Milestones

Project Organisation CESSP Implementation team CESSP Full Group Sponsor ITDEC Noel Diamant PM: Georg Neuwirther Karin Gröndahl Jose Simarro Anne Christine Lantin CESSP Implementation team Alenoosh Abedi Sonja Königshofer Klaus Menges Kevin Horan Jeroen Veen Karin Gröndahl Kate Harper Stefanie Huber Kristiina Puusaari Karin Gröndahl Gary Wilson Mathilde Geynet Kristiina Puusaari Marja van Schie Victoria Girones Virginie Bacquet Dalle Frederic Alenoosh Abedi Leigh Sandwell Joris Kampmeijer Anne Christine Lantin Manuela Copier Alistair Nixon Noel Diamant Menaka Subramanyam Remco Munnik Klaus Menges Kristiina Puusaari Monique Lanson Jose Simarro Data and Requirements Documentation Virginie Woerly Gary Wilson Guidance Documents legend NCA, EMA Industry External Lee Bridgen IT Development & Technical Support Communication and Training CESSP Full Group

Milestones Planned release dates: UAT 1 - 05/2017 UAT 2 - 09/2017 to be confirmed Final UAT - 12/2017 Go live - 03/2018 Mandatory use - 09/2018 (6 months after go-live) CESSP essentials

05 December 2017 Contact Kristiina

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