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CESSP Phase 1

CESSP Phase 1. Essential project information. Statement of Intent. Background CESSP Phase 1 is the first project towards the implementation of the Common European Single Submission Portal (CESSP).

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CESSP Phase 1

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  1. CESSP Phase 1 • Essential project information

  2. Statement of Intent CESSP Phase 1 – essential project information Background CESSP Phase 1 is the first project towards the implementation of the Common European Single Submission Portal (CESSP). This project will deliver a new implementation for creation of Marketing Authorisation Application forms with the goal to replace the relevant PDF forms with a web based interface. This will cover human and veterinary application forms for new marketing authorisations and extension applications. The system was earlier 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). However, the project is referred to as CESSP Phase 1. The main objective of CESSP Phase 1 is to provide a modern user interface with a flexible technical platform for the future. This step will enable future enhancements which would not be possible using the current PDF technology. CESSP Phase 1 is planned to be followed by the addition of the Variation and Renewal form to the CESP Dataset Module.

  3. Statement of Intent CESSP Phase 1 – essential project information CESSP Phase 1 - implementation The first implementation project step, CESSP Phase 1, will deliver an online web-user interface to make use of integrated human and veterinary Marketing Authorisation Application datasets for new marketing authorisation and extension applications. The system will provide data from SPOR (OMS, RMS and Substances). The CESP Dataset Module will make it possible to re-use the application form content. CESSP Phase 1 is planned to be followed by the addition of the Variation and Renewal form to the CESP Dataset Module. The current eAFs will be withdrawn after transition periods and the use of the new CESP Dataset Module will become mandatory at a future date which will be communicated in advance.

  4. eSubmission Roadmap - Version 2.1 (28.02.2018) Timelines to be updated Source: http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html CESSP Phase 1 – essential project information

  5. 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 Application Form – Past and Future • 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 Word form • Free text only • Copy/paste only (error prone) • No validation rules • No data export / import •  •  • stepwise replacement • planned from 2019 • replaced • 2012-2016 CESSP Phase 1 – essential project information

  6. Overview of the CESSP Programme • and ongoing Phase 1

  7. CESSP programme Project CESSP Phase 1 is ongoing for replacement of the eAF MAA Human and Vet Further implementation phases and further integration with SPOR Project CESSP Phase 2 Replacement of the eAF for Variation and Renewal CESSP programme also monitors other initiatives (including Vet-Regulation, SPOR) to ensure compatibility and future improvements 6 CESSP Phase 1 – essential project information

  8. CESSP - Process flow CESP Application Dataset Management Module • creates • manualdataentry /update • “Dataset” • integrates • IT supporteddatauploadanticipated SPOR applicant level CESSP phase 1 will use data from O, R and S in SPOR. CESSP Phase 1 – essential project information

  9. Concept of data use • “Dataset” • The dataset contains information to be used in the application form and might also be reused for other purposes • Human readable application data • CESP delivery file • Electronic data format • for automated data import • Draft cover letter CESSP Phase 1 – essential project information

  10. Future process after implementation of CESSP Phase 1 CESP • Dossier • EMA/NCA • EMA Gateway • Dataset • eAF • CESP • Application • Dataset • Management • Module • Import file for IT systems SPOR Process submission Submit Finalise dossier submission CESSP Phase 1 – essential project information Start and Finalise Dataset (eAF etc.)

  11. Essential functions implemented by CESSP Phase 1 CESP Dataset Module at applicant level • Download dataset • Applicants need to put this dataset into eCTD sequence (or VNeeS or NeeS) manual data input • Create/re-use/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 or • Dataset XML-upload Readable representation at NCA/EMA level • View the eAF via PDF • Import dataset into NCA databases • Dataset Data import 10 CESSP Phase 1 – essential project information

  12. CESSP Phase 1 - Out of scope • The CESP Dataset Module is not a long term repository for datasets • CESSP Phase 1 does not replace variation and renewal forms • Datasets created in the CESP Dataset Module will not be completely compatible with IDMP-standards 11 CESSP Phase 1 – essential project information

  13. CESSP Phase 1 - Project Organisation & Milestones

  14. Sponsor Project Organisation ITDEC PM: Georg Neuwirther Noel Diamant Karin Gröndahl Anne Christine Lantin CESSP Implementation team Karin Gröndahl Kevin Horan Klaus Menges Gary Wilson Mathilde Geynet Sonja Königshofer Virginie Bacquet Hanna Palyszka Jose Simarro Mathilde Geynet Stefanie Huber Alenoosh Abedi Karin Gröndahl Beate Gasser Gary Wilson Manuela Copier Kristiina Puusaari Victoria Girones Jeroen Veen Anne Christine Lantin Paola Kajaste Karin Gröndahl Sabina Uzeirbegovic Leigh Sandwell Anne Christine Lantin Alastair Nixon Remco Munnik Zigmars Sebris Martin Simicek Noel Diamant Christelle Bouygues Klaus Menges EMA IT Laurent Desqueper Virginie Woerly Dagmar Sommer MoniqueLanson Jose Simarro Klaus Menges Sonja Königshofer Kristiina Puusaari Data and Requirements Documentation Christelle Exbrayat Lee Bridgen Regulatory Focus Group GaryWilson Marja van Schie Manuela Copier Technical Guidance Documents IT Development & Technical Support Communication and Training CESSP Full Group

  15. Milestones • UAT 1 - completed 05/2017 • UAT 2 - completed 03/2018 • Draft upgraded XML DES - Q1 2019 • Publication of upgraded XML DES - 06/2019 • UAT 3 - 09/2019 • Go live - Q4 2019 • Mandatory use of CESP Dataset Module and - 6 months after go-liveterminating use of current eAF for new application CESSP Phase 1 – essential project information

  16. Contact

  17. For any question about the project please contact: • cesspproject@hma.eu CESSP Phase 1 – essential project information

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