Implementation of the new SoHO Regulation: training and networking of SoHO Competent Authorities’ staff for oversight

HaDEA has published tender HADEA/2026/OP/0001 for a framework service contract to design, develop and deliver blended e-learning and face-to-face training and networking for SoHO competent authority staff to support implementation of Regulation (EU) 2024/1938. The estimated ceiling is €4,000,000 with a maximum duration of 48 months, award by best price-quality ratio, and electronic submission via the EU Funding & Tenders Portal with deadline 27 April 2026 16:00 Europe/Brussels. Eligible legal persons from EU Member States, EFTA states and associated third countries may apply, including consortia, subject to PIC registration and exclusion/selection rules and data protection requirements. The scope covers platform adaptation, development of six e-learning and six three-day F2F programmes, delivery of training to around 2400 e-learners and 360 F2F participants, reporting, dissemination and IP/data hosting obligations as specified in the tender documents.

Who can apply

Open call for tenders led by the Health and Digital Executive Agency (HaDEA). Eligible tenderers are economic operators (sole bidders or consortia) able to deliver EU-level training, e-learning platform services and face-to-face training events. Activities target competent authority staff (inspectors, vigilance officers, preparation-process assessors) from EU Member States, EFTA and candidate countries.

What it funds

A framework service contract to develop, host and maintain an IT e-learning platform; create and update blended training curricula and materials (e-learning + 3-day face-to-face courses) for junior and senior CA staff; deliver repeated online and in-person training rounds; produce dissemination kits and reports to support consistent implementation and cooperation under the new SoHO Regulation.

Estimated total value:€4,000,000 (framework ceiling). Maximum contract duration 48 months; payments linked to delivery of specified reports and training outputs. ¹

1. 1Eligible applicants: service providers, training organisations, consortia with IT and subject-matter expertise (public or private legal persons).
2. 2Key dates: tender deadline 27 April 2026 (electronic submission); public opening 28 April 2026; Q&A cutoff 17 April 2026.

Apply and submit tenders electronically via the EU Funding & Tenders Portal. The call requires registration (EU Login, Participant Register/PIC) and submission through eSubmission. See procurement documents and tender specifications for detailed eligibility, exclusion and selection requirements.

Footnotes

1. 1Procurement documents and submission portal: Implementation of the new SoHO Regulation: training and networking of SoHO Competent Authorities’ staff for oversight || ec.europa.eu

Opportunity summary

Tender reference HADEA/2026/OP/0001. Contracting authority:European Health and Digital Executive Agency (HaDEA). Procedure: Open procedure to conclude a single framework service contract (framework contract without reopening of competition). Subject: design, development, delivery and maintenance of training and networking activities for national SoHO competent authority staff (inspectors, vigilance officers and preparation process assessors) to support implementation and oversight of Regulation (EU) 2024/1938 on Substances of Human Origin (SoHO). Framework contract ceiling: €4 000 000. Maximum duration: 48 months. Nature of contract: services; CPV main classification 80000000 Education and training services. Award method: best price-quality ratio. Submission method: electronic via eSubmission (EU Login required). Tender deadline: 27 April 2026 16:00 Europe/Brussels. Public opening: 28 April 2026 14:00 Europe/Brussels.

Objectives and expected results

Objective:strengthen and harmonise the oversight capacity of competent authorities across EU Member States, EFTA countries and candidate countries to implement the new SoHO Regulation by 2027. Expected results: increased and standardised competencies of inspectors, vigilance officers and preparation-process assessors; a functioning network of junior and senior competent authority staff to facilitate joint inspections, joint assessments of preparation processes, peer audits and trust to facilitate safe exchange of SoHO; a repository and IT platform for learning and exchange; validated training curricula and materials; measurable uptake and dissemination by national authorities.

Scope of services to be provided

The framework contract covers multiple recurring activities and deliverables across up to 48 months. Core tasks include establishment and maintenance of an IT e-learning and collaboration platform (based on the previously developed SIGHTSoHO Moodle platform where useful), development and updating of blended learning curricula (basic and advanced), creation of e-learning modules and face-to-face (F2F) 3-day training programs, delivery of recurring live weekly online training sessions, delivery of F2F workshops in EU locations, creation and update of dissemination kits, preparation and delivery of training evaluation (pre/post tests, participant feedback, three-month follow-up questionnaires), reporting, and support to networking and joint inspection/assessment activities. The contractor will reuse and adapt materials produced under the previous EU4Health action HS-p-17.1 and coordinate with the SoHO Coordination Board and DG SANTE. Specific deliverables and milestones (datasheets, program documents, reports, participant counts, DPN templates and final reports) are defined in the tender specifications and financial offer template.

Geographic and beneficiary scope

Primary geographic scope for training participants:EU Member States, EFTA countries and candidate countries. Contractor legal establishment: any entity eligible to participate under the treaties and the rules described in the procurement documents (EU institutions, bodies and agencies rules apply). Training language: English. Data processing and hosting: personal data and servers must be located within the EU/EEA; transfers to third countries require prior written authorisation and full compliance with Regulation (EU) 2018/1725.

Budget and contract model

Estimated total value of the framework contract:€4,000,000. The procurement will result in a single framework service contract with specific contracts issued under it. The FWC ceiling is the maximum cumulative value. Payment model: milestone/deliverable linked payments. Specific contracts with longer durations may include interim payments (up to 40% and 30% in two stages for long specific contracts as described in the contract). HaDEA may award up to 50% additionally within three years under negotiated procedure in specified circumstances (see tender documents).

Contract form and legal documents

Contract type:Framework service contract (HaDEA/2026/OP/0001) concluded under HaDEA delegated powers. Main contractual documents published: Invitation to tender, Draft framework contract, Tender specifications, Annexes to tender specifications, Declaration on honour, Financial offer form. All obligations, IP and confidentiality rules, data protection and security provisions, payment and warranty provisions are set out in the draft FWC, general conditions and tender specifications.

Who should apply

Eligible tenderers:legal persons (single organisations) or groups of economic operators (joint tenders). Subcontracting is permitted but identified subcontractors must be declared when they exceed 20% or are relied upon for selection criteria. Economic operators from EEA, candidate countries and other third countries associated to EU programmes are eligible where association rules permit. Entities subject to EU restrictive measures or otherwise excluded by Financial Regulation must not be involved. Registration in the Participant Register (PIC) and EU Login are required to submit a tender via eSubmission.

Key technical requirements and minimum content to include

Tenders must propose:a robust IT e-learning and collaboration platform (Moodle-based solution may be adapted), full blended curricula for six staff categories (junior/senior inspectors, assessors, vigilance officers), 3-day F2F training programmes with practical cases and workshops, recorded online sessions and repository of materials, training-of-trainers elements, dissemination kits, DPN templates, participant management and registration, learning assessment methodology (pre/post tests, evaluation metrics), participant follow-up surveys, quality assurance and continuous update process, staffing (CVs), project management and risk mitigation, data protection and hosting in EU/EEA, intellectual property clearing and evidence of rights, and a detailed Gantt/timeline and budget per deliverable as in the Financial Offer Form. Tenderers must accept IP terms (HaDEA/Union ownership of results and royalty-free licence for pre-existing rights) and provide list of pre-existing rights at invoicing of balance.

Mandatory platform and data rules:Platform must be accessible, support synchronous and asynchronous learning, include chat/forum, webinar/Zoom integration, certificate issuance, repository, and analytics. Personal data shall be processed in compliance with Regulation (EU) 2018/1725. Data shall be stored and processed only within EU/EEA data centres unless prior written authorisation is granted by the contracting authority. A Data Protection Notice template (DPN) will be handed over and must be completed by the contractor. ¹

Application and submission

Submission is exclusively electronic through eSubmission via the EU Funding & Tenders Portal. EU Login authentication required. Tenders must contain administrative, exclusion and selection evidence, technical tender including methodology, curricula and deliverables, CVs of key personnel, financial offer using the provided Financial Offer Form (unit prices, amounts and rounding rules apply), and signed Declaration on Honour. Language: any official EU language for the tender, but technical materials and delivery in English. Tender validity: minimum 6 months.

Evaluation and award

Tender evaluation follows exclusion and selection checks, then award on best price-quality ratio. Award criteria, weighting, and detailed scoring rules are in the tender specifications. Candidates will be required to submit evidence for exclusion and selection (financial, technical and professional capacity). HaDEA may request clarifications and corrections during evaluation but not modifications that change the tender substantially.

Key dates and administrative details

1. 1TED publication date: 23/03/2026
2. 2Call identifier: HADEA/2026/OP/0001
3. 3Deadline to submit questions to contracting authority: 17/04/2026 23:59 Europe/Brussels
4. 4Deadline for receipt of tenders (submission): 27/04/2026 16:00 Europe/Brussels
5. 5Date and time of public opening: 28/04/2026 14:00 Europe/Brussels

Deliverables and measurable outputs (summary)

Deliverables are milestone-based and linked to payments. Examples from tender specifications and financial offer template include: D1 platform datasheet; D2 platform updates and feedback; D3 six e-learning program descriptions (junior/senior across three staff categories); D4 six F2F training program descriptions (3-day each); D5 content report e-learning modules; D6 content report F2F modules; D7 number of e-learning participants (target in financial model 2,400 over FWC); D8 reports on weekly online trainings (example 10 reports); D9 number of F2F participants (example 360 over FWC); D10 F2F delivery reports (example 10 reports); D11 dissemination kit (electronic); D12–D15 update reports; D16 DPNs. Inception, interim and final reports are required per specific contract. All deliverables in English, final reports in Word and PDF, and publishable executive summary and abstract must comply with EU visibility and accessibility rules.

Compliance, IP and audit

HaDEA/Union acquires ownership of newly created results and exclusive exploitation rights; pre-existing materials are licensed royalty-free on a non-exclusive irrevocable basis to HaDEA/Union as described in the draft contract. Contractors must provide lists and documentary evidence of pre-existing rights and ensure freedom to exploit materials. The contracting authority, OLAF, the Court of Auditors, the EPPO and other designated bodies have audit and on-the-spot inspection rights for up to five years after final payment. Contractor must keep records for five years after payment of final balance.

Selection, exclusion and supporting documents

Tenders must include Declaration on Honour (exclusion and selection), evidence of financial capacity where applicable, proof of registration in Participant Register (PIC), CVs of key personnel, evidence of relevant past experience and references, list of identified subcontractors (if >20% or relied upon for selection criteria), power of attorney/agreement for group leaders in joint tenders, Annex IV for VAT split where joint tender. The tender specifications detail which documents are required as supporting evidence and when they must be provided.

Contractual risks and important constraints

Key constraints include strict data protection and EU/EEA hosting, public procurement exclusion rules (restrictive measures), requirements to adapt existing HaDEA materials (copyright and reuse), performance standards, fixed FWC ceiling, and obligations for reporting, audit and records retention. Tenderers should budget for travel and accommodation costs for F2F sessions and platform maintenance. All costs for preparing tenders are borne by tenderer.

Eligible Applicant Types

Eligible applicant types include:universities and research institutes; training organisations and adult education providers; consultancy firms and professional services providers; large enterprises; small and medium-sized enterprises (SMEs); non-profit organisations and NGOs; public bodies and government agencies; international organisations where eligible; consortia / public-private partnerships combining the above. Natural persons: allowed only where tender specification allows but typically organisations tender. Subcontractors and entities on whose capacity tenderer relies are permitted but must be declared as specified.

Funding Type

Primary financial mechanism:procurement – framework service contract funded under EU4Health (public procurement of services). This is not a grant, loan or equity instrument. It is a service contract resulting from a public tender.

Consortium Requirement

Consortium is optional. Tenders can be submitted as single tenderers or as joint tenders (groups of economic operators). Joint tenders must appoint a lead and provide joint and several liability and power of attorney. The FWC is awarded to a single contractor; consortia without legal personality are permitted but must appoint a leader.

Beneficiary Scope (Geographic Eligibility)

Geographic eligibility for participants to the training:EU Member States, EFTA countries and candidate countries. Legal tenderers: entities established within the scope of the EU Treaties and those third countries associated to the relevant programme (EU4Health) or allowed under procurement rules. Data processing and servers must be located in EU/EEA unless otherwise authorised.

Target Sector

Thematic/industry sector:health sector, specifically regulation, quality and safety of Substances of Human Origin (blood, tissues and cells and organs) including oversight, vigilance/biovigilance, inspections, preparation process authorisations, clinical-outcome monitoring and related ICT/training platforms.

Mentioned Countries

Explicitly mentioned region/countries:EU Member States, EFTA countries and candidate countries. Contracting authority and administrative location: Belgium (Brussels).

Project Stage

Project maturity expected:implementation and demonstration stage – converting regulatory requirements into operational oversight and training, delivering e-learning and F2F training, validating processes, and establishing a network of practitioners. Work involves educational design, piloting, delivery, iteration and scale-up of training and networking activities.

Funding Amount

Rough funding range:Framework contract maximum amount €4,000,000 for the full 48-month duration. Financial Offer Form sets unit prices for deliverables and per-participant fees; tenderers must complete the provided financial templates. Example planned participant numbers in the financial form: e-learning participants 2,400; F2F participants 360 (indicative).

Application Type

Application method:open call / public procurement – electronic open submission via eSubmission on the EU Funding & Tenders Portal. Not an invitation-only call. Tenderers must register and submit via EU Login and Participant Register (PIC).

Nature of Support

Beneficiaries receive contractual payments for services (monetary) under a public service contract; they will deliver training and services. The support is monetary procurement of services, not grants or vouchers. Non-monetary outputs (training materials, platform, knowledge exchange) are required but payment is monetary against deliverables.

Application Stages

Single-stage submission for the framework award (open procedure). Post-award, ordering is by specific contracts under the FWC (ordering process described in FWC). Evaluation phases: exclusion and selection checks followed by technical and financial evaluation and award. For specific contracts, there will be call/requests and contractor replies and signature phases as defined in the FWC.

Success Rates

No explicit public success rate provided. Framework award will be to a single contractor following open procedure; competition is expected. No statistical success rates available from published documents.

Co-funding Requirement

No co-funding requirement stated. The contract is a public procurement funded by EU4Health; tenderers must offer services within the proposed price. All costs of proposal preparation are borne by tenderers.

Templates and application form structure

The procurement documents include mandatory templates:Declaration on Honour (exclusion and selection), Financial Offer Form (Excel) with specified unit price rules and rounding, HaDEA Framework Contract draft, Tender Specifications and Annexes, List of identified subcontractors template, Agreement/Power of Attorney for joint tenders, Commitment letters for entities on whose capacity tenderer relies. The Financial Offer Form requires per-deliverable unit prices, quantities and totals (examples: D1–D16, D0.1–D0.3). Tenders must follow the form and provide appendices (CVs, evidence of past contracts, legal and financial documents). The tender specifications include a deliverables timetable and performance indicators. The eSubmission system enforces uploaded file naming, maximum sizes and allowed file types per the system requirements.

1. 1Annexes to download and complete: Invitation to tender, Draft framework contract, Tender specifications and annexes, Declaration on honour, Financial Offer Form, Annexes_TS and reference platform materials (SIGHTSoHO technical description and prior training content).
2. 2Mandatory submission packages: Administrative documentation and Declaration on Honour; Evidence for selection criteria (financial statements if required, CVs); Technical proposal (methodology, work plan, platform description, curricula, samples of training materials, case studies and model solutions); Financial offer using provided Excel form.
3. 3Signatures: Qualified Electronic Signature (QES) preferred for Declaration on Honour or handwritten with scanned signed form where QES not available.

Assessment of technical content required

Technical proposal must demonstrate expertise in:design and delivery of blended learning at scale; development and operation of Moodle or equivalent platforms with synchronous webinars and recorded materials; subject-matter expertise in SoHO oversight, vigilance and preparation assessment; inspection methodologies and joint inspection coordination; adult learning, assessment and train-the-trainer approaches; experience running F2F multi-day workshops and practical case-based exercises; GDPR and EU data protection compliance; multilingual and cross-border coordination; and quality assurance and evaluation frameworks. Evidence of prior relevant contracts and staff CVs must be included.

How to find documents and support

All procurement documents, tender specifications, annexes and templates are published on the EU Funding & Tenders Portal at the tender details page. Questions during submission phase must be raised through the portal Questions & Answers section; contracting authority is not bound to reply after 17/04/2026 23:59 Europe/Brussels. eSubmission Helpdesk guidance and system requirements are available on the portal.

Useful links and references

Primary tender page:Funding & Tenders Opportunities Portal tender details (HADEA/2026/OP/0001). Draft framework contract, tender specifications and Financial Offer Form are attached as procurement documents and must be used. The procuring authority is HaDEA; legal and procurement rules follow the Financial Regulation and HaDEA internal rules.

Single key note:This is a procurement for service delivery: the contracting authority will pay for delivered services and expects full compliance with tender, contractual, data protection and IP conditions; read the draft FWC and Tender Specifications carefully and use the mandatory templates. ¹

1. 1Prepare and register organisation in Participant Register and obtain PIC.
2. 2Create EU Login account for authorised submitters.
3. 3Download the Invitation, Tender Specifications, Annexes and Financial Offer Form and complete required templates exactly.
4. 4Assemble administrative, exclusion and selection evidence and sign Declaration on Honour.
5. 5Prepare technical proposal addressing all tasks, deliverables, platform and data rules and provide CVs of key personnel.
6. 6Complete Financial Offer Form with unit prices and totals per the template and rounding rules.
7. 7Upload and submit via eSubmission before the deadline.

Footnotes

1. 1Data processing and hosting must comply with Regulation (EU) 2018/1725; contractor must ensure servers and processing are within EU/EEA and provide a Data Protection Notice (DPN) and documented technical and organisational measures as required by the tender specifications and draft contract.

Opportunity Overview

This open procedure tender seeks services for training inspectors, vigilance officers, and preparation process assessors from SoHO Competent Authorities in EU Member States, EFTA countries, and candidate countries. The goal is to standardize competencies, build a network for joint inspections, assessments, peer audits, and enhance trust for SoHO exchange under the new Regulation (EU) 2024/1938, applicable from August 2027.

Funded under EU4Health Programme 2025 Work Programme (Action HS-p-25-60), it addresses oversight strengthening in Substances of Human Origin (SoHO), including blood, tissues, cells, and preparations.

Key Dates and Procedure

TED Publication:23 March 2026

Questions Deadline:17 April 2026 23:59 (Europe/Brussels)

Tender Submission Deadline:27 April 2026 16:00 (Europe/Brussels)

Public Opening:28 April 2026 14:00 (Europe/Brussels)

Electronic submission required via EU Funding & Tenders Portal with EU Login. Procedure type: Open, award by best price-quality ratio. Framework agreement without reopening of competition, maximum duration 48 months.

Contracting Authority and Value

Lead:Health and Digital Executive Agency (HaDEA), Unit A2 EU4Health/SMP Food, COV2 Place Charles Rogier 16, 1049 Brussels. Estimated total value: €4,000,000 (excl. VAT). CPV: 80000000 - Education and training services.

Eligibility and Who Can Apply

Open to legal persons from EU Member States, EFTA (Norway, Iceland, Liechtenstein), and associated third countries under EU4Health. Joint tenders allowed; subcontracting permitted with prior approval. Entities subject to EU restrictive measures excluded. PIC registration mandatory.

• No participation if bankrupt, tax/social security defaulter, or guilty of fraud/corruption/grave misconduct.
• SMEs encouraged; self-assessment tool available.
• Tenderers must declare no conflicts of interest.

Scope of Services

Single framework contract for e-learning/F2F training programs, IT platform adaptation (based on prior SIGHTSoHO Moodle), content development/updates, delivery to ~2400 e-learners and ~360 F2F participants (junior/senior inspectors, assessors, vigilance officers). Covers SoHO Regulation oversight: inspections, vigilance, authorizations, risk assessment, guidelines (EDQM/ECDC, EuroGTP II, MIRCA).

Main Tasks and Deliverables

• Task 1: IT e-learning platform (D1 datasheet, D2 updates).
• Task 2: 6 e-learning + 6 F2F programs (D3, D4).
• Task 3-4: Content development (D5 e-learning report, D6 F2F report).
• Task 5-6: Delivery (D7: 2400 e-learners; D8: 10 reports; D9: 360 F2F; D10: 10 reports).
• Task 7: Dissemination kits (D11).
• Task 8: Updates (D12-15 reports).
• D0.1-3: Inception/interim/final reports; D16: DPN.

F2F:3-day sessions in EU venues (contractor covers travel/accommodation for ~40/NCAs). Blended learning with real cases, quizzes, networking. English only.

Financial Model and Payments

Unit prices for deliverables (e.g., per participant for trainings). Max FWC:€4M. Payments: Inception (up to 40% interim for >€9MSCs), interim (up to 30% for >€14M), balance on final report approval (60 days). No pre-financing/performance guarantees.

Key Quantities (Indicative)

Evaluation Criteria

• Exclusion: Bankruptcy, fraud, etc. (Declaration on Honour).
• Selection: Economic/financial capacity (turnover >50% est. value); Technical: 5+ relevant staff (min 3y exp.), 3+ similar contracts last 5y.
• Award: 80% technical (quality, methodology, team); 20% price.

Key Documents and Submission

• Tender Specs, Draft FWC, Financial Form, Declaration on Honour.
• Electronic via Portal; max 150MB, <200 files, <50MB/file.
• Primary URL: EU Funding Portal.

Risks and Considerations

Requires EU servers/data localisation, GDPR compliance (special categories). IP:HaDEA/Union owns results. Detailed specs in Tender Specs (Annex I). Review prior SIGHTSoHO platform/content (Annexes 7-8). Questions via Portal by 17/04/2026.

Applicants should download all 6 documents from Portal, prepare unit prices covering all (travel/accommodation included), ensure team expertise in SoHO oversight/training. No variants. TED ref: 57/2026 196876-2026 ¹.

Footnotes

1. 1Full TED notice: TED Notice. HaDEA site: HaDEA.