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The Common European Single Submission Portal (CESSP)

The Common European Single Submission Portal (CESSP). Essentials. Statement of Intent. Background

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The Common European Single Submission Portal (CESSP)

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  1. The Common European Single Submission Portal (CESSP) • Essentials

  2. Statement of Intent CESSP essentials Background 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 The current eAFs will be withdrawn after a transitional period and the use of the new, integrated application dataset within the portal will become mandatory at a future date which will be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.

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

  4. 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 • CESSP– 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 for 2018-2020 • replaced • 2012-2016 CESSP essentials

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

  6. 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

  7. CESSP - Process flow • CESSP • Online-Tool • creates • manualdataentry /update • “application dataset” • integrates • IT supporteddataupload SPOR applicant level 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

  8. CESSP – Concept of the application dataset • “application dataset” • (= eAF and even MORE) • contains information 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

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

  10. Essential functions implemented by CESSP Phase 1 CESSP at applicant level • 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 • Download dataset • Applicants need to put this dataset into eCTD sequence (or VNeeS or NeeS) manual data input • Application dataset XML-upload(not in Phase 1) readablerepresentation at NCA/EMA level • View application dataset via stylesheets • Import dataset into NCA databases • Application dataset Data import 9 CESSP essentials

  11. 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 10 CESSP essentials

  12. CESSP Phase 1 - Project Organisation & Milestones

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

  14. Milestones • Plannedreleasedates: • UAT 1 - 05/2017 • UAT 2 - 09/2017 to be confirmed • Final UAT - 12/2017 • Go live - 03/2018 • Mandatoryuse - 09/2018 (6 months after go-live) CESSP essentials

  15. Contact

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

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