DARWIN EU® Coordination Centre 2

DARWIN EU Coordination Centre 2 is a European Medicines Agency procurement to operate and maintain the DARWIN EU Coordination Centre, onboard and maintain data partners, and conduct non-interventional studies under applicable Union data protection rules. The framework contract is estimated at €65,000,000 for up to 60 months (1 + 2 + 2) and is being procured as a two-stage procedure with electronic submission via the EU Funding & Tenders Portal. Awarding is by best price-quality ratio with a 70% quality and 30% price weighting and the request-to-participate deadline is recorded as 15 June 2026 at 16:00:59 CEST. The tender targets established economic operators or consortia able to demonstrate experience in real-world data platforms, pharmacoepidemiology, federated analytics, robust data governance, GDPR compliance and business continuity arrangements.

Type & Contracting Authority

Procurement tender (framework contract) — European Medicines Agency

Provision of services to operate and maintain the DARWIN EU Coordination Centre, onboard and maintain data partners, and conduct non-interventional studies in compliance with EU data protection rules. Contract duration up to 60 months (initial 12 months plus two possible renewals: 2 + 2 years).

Estimated value:€65,000,000 (estimated overall contract amount) ¹

1. 1Who can apply: economic operators able to provide healthcare data services, non-interventional study delivery, data partner onboarding and IT operations; see tender documents for detailed selection and capacity requirements.
2. 2Form: electronic submission via the EU Funding & Tenders Portal (eSubmission).
3. 3Eligibility & award: quality (70%) and price (30%) weighting indicated; SME suitability flagged as false — consult procurement documents for mandatory criteria and templates.

Main CPV / service codes include 73110000 and related classifications. Lot structure:single lot (LOT-0001).

Apply and download tender documents from the EU Funding & Tenders Portal:DARWIN EU Coordination Centre 2 tender.

Footnotes

1. 1Estimated overall contract amount and contract duration provided in the procurement project summary and tender documents available on the portal.

Basic facts and scope

Opportunity title:DARWIN EU Coordination Centre 2. Contracting authority: European Medicines Agency (EMA). Call identifier: EMA/2025/CPN/0009. Procedure type: procurement (framework contract). Main objective: operation and maintenance of the DARWIN EU Coordination Centre, onboarding and maintenance of data partners, and conduct of non-interventional studies in compliance with applicable Union data protection rules.

Duration and contract model:Framework contract duration: maximum 60 months (described as 1 + 2 + 2 years: initial 12 months plus two renewals). Contracting system: framework agreement. The estimated total procedure value and estimated overall contract amount: €65,000,000. Submission is electronic (eSubmission) via the Funding & Tenders Portal. Two-stage tendering process with an indicated two-stage deadline. ¹

Deadlines and key dates

Invitation to tender publication date:15 May 2026. Submission deadline (end of two-stage reception period): 15 June 2026, 16:00:59 CEST (listed timezone Europe/Amsterdam). Another deadline timestamp visible: 1 January 2026 14:00:59Z (the portal metadata lists two deadline timestamps; the formal two-stage closing date recorded in the procurement dataset is 2026-06-15T16:00:59+02:00). Applicants must consult the official tender documents for exact cut-off used in each tender stage.

Estimated contract value:Estimated overall contract amount: €65,000,000 (currency: EUR). Planned contract duration: 60 months. This figure is the estimated total procedure value and the estimated overall contract amount published on the portal.

Who can apply and eligibility

This is an open procurement tender published by the European Medicines Agency. Eligible applicants are economic operators able to conclude a public services framework contract with an EU agency. Typical eligible applicant types include private companies (large enterprises and SMEs), consortia of companies, research organisations, academic institutions, not-for-profit legal entities, and public-private partnerships that meet the procurement selection and exclusion criteria set out in the tender documents. The tender documents include specific templates and declarations for subcontractors, minimum requirements declarations, and declarations on honour, which indicate that both single legal entities and consortia are contemplated (subcontracting is expressly provided for via a Subcontractors declaration).

SME suitability indicator in the procurement metadata is false; this means the lot is not specifically designated as SME-only. The contracting authority expects bidders to meet technical and professional capacity criteria and to provide the requested administrative and financial documentation in the procurement annexes.

Beneficiary geographic scope:Procurement is carried out by an EU agency (EMA) and is intended to engage economic operators eligible to contract with EMA. Geographic applicability is the European Union/EEA and other jurisdictions where contracting with EU agencies is permitted by procurement rules; applicants should check the tender specifications for exact rules on eligible countries and nationality/exclusion rules.

Funding type, contract and application model

Primary funding type:public procurement — service contract (framework agreement). This is not a grant, loan, or equity instrument but a tender for delivery of services under a framework contract for the EMA. Payments to the successful contractor will be via the service contract terms set out in the framework contract and subsequent call-offs or task orders under that framework.

Submission method and application type:Application type: open Invitation to tender published on the EU Funding & Tenders Portal. Submission method: compulsory electronic submission (ESUBMISSION) via the Funding & Tenders Portal/Funding and Tenders eForms tools. The procurement documents and annexes must be submitted according to the portal rules and the instructions in the Invitation to tender.

Consortium requirement and structure

The procurement allows participation of single tenderers and also contemplates the use of subcontractors and consortia. Tender annexes include a Subcontractors declaration and templates for applicant information and declarations. The documentation includes instructions for legal/technical capacity demonstration and for joint bids where applicable. The tender is organized as a single lot (LOT-0001), and bidders may form consortia or use subcontracting to meet technical requirements. The metadata indicates a two-stage procurement process (requests to participate / full tender), which is typical when an initial pre-selection may be performed before the award stage.

Scope of work and technical focus

Core services to be provided under the framework contract include:operation and maintenance of the DARWIN EU Coordination Centre; onboarding and maintenance of data partners (data providers); execution and management of non-interventional (observational) studies using real-world data; ensuring full compliance with Union data protection rules (including the need to apply appropriate contractual and technical safeguards and standard contractual clauses); business continuity and disaster recovery planning; and supporting exit and data transition planning as required in the Framework Contract annexes.

1. 1Operate and maintain the DARWIN EU Coordination Centre platform and services for a maximum of five years (1 + 2 + 2).
2. 2Onboard and manage data partners and their data contributions for real-world evidence generation.
3. 3Design, execute and deliver non-interventional (observational) studies in compliance with EU data protection and legal requirements.
4. 4Provide disaster recovery and business continuity measures as specified in Annex XIII to the Framework Contract.
5. 5Provide exit planning and data transition measures as specified in Annex XI to the Framework Contract.

Target sector and expertise required:Primary sector: health / pharmaceutical regulatory science. Technical and professional expertise required: pharmacoepidemiology, observational study design and execution, health data management, data partner onboarding and governance, secure data handling and processing, compliance with GDPR and other Union data protection law, IT operation and maintenance for health-data platforms, quality management, and contingency/disaster recovery capabilities.

CPV codes and classification

Main CPV codes and additional CPVs listed in the procurement metadata describe the nature of services requested and support activities. These include: 73110000 (research and experimental development on natural sciences and engineering — mainCode in metadata), and additional codes 72316000, 72322000, 73200000, 73300000, 79330000 which relate to IT services, data management, software services, maintenance and related consultancy.

Documents and templates provided

The procurement release includes a comprehensive set of annexes and templates that bidders must use. Key documents available in the procurement dossier include (non-exhaustive list): Invitation to tender DARWIN EU Coordination Centre 2 (Annex 1), Technical Specifications (Annex 2), Applicant information sheet and declaration (Annex I), Costing sheet / Financial offer form (Annex II), Declaration on honour (Annex III), Minimum requirements declaration (Annex IV), Power of Attorney (Annex V), Subcontractors declaration (Annex VI), Response template for technical and professional capacity criteria (Annex X), Standard Contractual Clauses for Data Protection (Annex XI), Non-disclosure undertaking (Annex XIV), Response template for qualitative award criteria, Draft Framework Contract and a set of contract annexes including Exit Plan (Annex XI to Framework Contract), Service Level Agreement annexes, Disaster Recovery and Business Continuity Plan (Annex XIII to Framework Contract). ¹

1. 11. Invitation to tender (document 1).
2. 22. Technical Specifications (document 2).
3. 33. Applicant information sheet and declaration (Annex I).
4. 44. Costing sheet — Annex II (financial offer form, Excel).
5. 55. Declaration on honour (Annex III).
6. 66. Minimum requirements declaration (Annex IV).
7. 77. Power of Attorney (Annex V).
8. 88. Subcontractors declaration (Annex VI).
9. 99. Draft Framework Contract and Draft Contract annexes (Annexes VII, XI, XII, XIII etc.).
10. 1010. Response templates for award and capacity criteria (Annexes X and XIII).
11. 1111. Standard Contractual Clauses for Data Protection and Non-disclosure Undertaking.

Evaluation, award criteria and weighting

The awarding criteria are quality and price with weighting indicated in the procurement metadata: quality 70 and price 30 (parameterNumeric values shown in tender metadata). Bidders must provide responses to qualitative award criteria using the provided response templates. The authority will apply the quantitative weighting shown and assess proposals against the technical and professional capacity templates and minimum requirements. Specific qualitative criteria and scoring rules are provided in the tender specifications and associated response templates.

Application stages:The procurement metadata indicates a two-stage process: an initial request to participate / pre-qualification phase followed by submission of final bids (two-stage deadline date is present). Therefore applicants should prepare to pass at least two stages: stage 1 — requests to participate/selection; stage 2 — submission of full tender and award.

Financial and contractual requirements

Estimated overall contract amount:€65,000,000. The procurement is a paid contractual service — successful bidders will be remunerated under the terms of the framework contract. There is no standard co-funding requirement typical of grants; the contractor is paid by the contracting authority via the service contract. Financial offers must be submitted using the provided costing sheet (Annex II — Excel). The authority requires financial and administrative evidence via the applicant information sheet and declaration and other annexes.

Co-funding and subcontracts:Co-funding from applicants is not required in the manner of grants. Subcontracting is permitted subject to the Subcontractors declaration and the rules in the tender documents. Bidders must declare subcontractors and provide relevant supporting documentation.

Practical considerations and key requirements

Essential technical expectations include:demonstrable experience in running observational study infrastructures or coordination centres; capacity to onboard and manage multiple data partners; strong data governance and GDPR compliance capabilities; secure IT operations, disaster recovery and business continuity arrangements; clear exit planning; and financial stability to operate at the scale required by the estimated contract value. The tender includes templates for proof of capacity and experience, and bidders must complete and sign the required administrative forms.

Mentioned countries and geographic references

The procurement is issued by the European Medicines Agency (Amsterdam, the Netherlands) and operates in the EU regulatory context. The metadata and portal context indicate European Union / EEA applicability. No specific third countries are explicitly named in the scraped metadata; applicants should consult the tender documents for any limitations or permitted nationalities.

Project maturity and target stage

Expected project maturity:operational/implementation stage. The contract is to operate and maintain an established Coordination Centre and to execute non-interventional studies and partner onboarding; therefore bidders should present mature, operational capabilities (not early-stage research).

Success rates and co-funding

Success rates are not provided in the procurement metadata and typically depend on the number of bidders and the competitiveness of proposals. There is no grant-style co-funding requirement; contractors will be remunerated under the contract. Bidders should provide full financial offers and meet the minimum administrative and technical requirements.

How to apply and required templates

Apply via the EU Funding & Tenders Portal using electronic submission. Mandatory templates and documents to prepare and upload include: the Applicant information sheet and declaration (Annex I), the Costing sheet/financial offer (Annex II in Excel), Declaration on honour (Annex III), Minimum requirements declaration (Annex IV), Power of attorney (Annex V), Subcontractors declaration (Annex VI), response templates for technical capacity and qualitative award criteria (Annexes X and XIII), draft contract and contractual annexes (for review), Standard Contractual Clauses for Data Protection and Non-disclosure Undertaking. Follow the instructions in the Invitation to tender and the Technical Specifications for page limits, format, and supporting evidence requirements.

1. 1Complete and sign Applicant information sheet and declaration (Annex I).
2. 2Prepare financial offer using Annex II — Costing sheet (Excel).
3. 3Complete Declaration on honour (Annex III).
4. 4Provide Minimum requirements declaration (Annex IV) to demonstrate eligibility.
5. 5If bidding as a consortium, provide Power of Attorney and consortium agreement details; declare subcontractors using Annex VI.
6. 6Respond to technical and professional capacity criteria using provided response templates (Annex X).
7. 7Answer qualitative award criteria using the Response template (Annex XIII).
8. 8Review and accept Draft Framework Contract and its annexes; prepare any required clarifications before submission.

Risk, compliance and data protection

Tender places strong emphasis on compliance with Union data protection rules. Annexes include Standard Contractual Clauses for Data Protection and a Non-disclosure undertaking. The contractor must implement robust technical and organisational measures for secure data processing, meet GDPR obligations and likely act under specific contractual data processing arrangements. Disaster recovery and business continuity planning are contractual requirements (Annex XIII to Framework Contract).

Summary — What this opportunity is about

DARWIN EU Coordination Centre 2 is an EU agency procurement tender led by the European Medicines Agency to award a framework contract for the operation, maintenance and management of the DARWIN EU Coordination Centre and the conduct of non-interventional (observational) studies using real-world data, including onboarding and managing data partners, for up to five years (1 + 2 + 2). The procurement value is estimated at €65 million. The tender is an open Invitation to tender published on the EU Funding & Tenders Portal. Applicants must submit electronically, using the provided annex templates (applicant declaration, costing sheet, response templates for capacity and award criteria, subcontractor declarations, data protection clauses, etc.). Evaluation weighting is quality 70 and price 30. The procurement requires mature technical capabilities in pharmacoepidemiology, health data operations, GDPR-compliant data processing, IT operations and disaster recovery, and the ability to manage multi-partner data networks. Interested economic operators (companies, consortia, research organisations and other legal entities able to contract with EMA) should consult the full set of tender documents and annexes on the Funding & Tenders Portal and prepare submissions according to the portal’s eSubmission rules and the tender specification instructions.

Footnotes

1. 1The procurement dossier includes numerous annexes and draft contract documents (Invitation to tender, Technical Specifications, Annexes I-XIV, costing sheet, draft framework contract and contract annexes including disaster recovery and exit plan). These are available from the tender page on the EU Funding & Tenders Portal: ec.europa.eu.

DARWIN EU Coordination Centre 2 is a European Medicines Agency procurement for the continuation of the DARWIN EU real-world evidence network. The contract covers operation and maintenance of the Coordination Centre, onboarding and maintenance of data partners, and the conduct of non-interventional studies in compliance with applicable Union data protection rules. This is a services tender, not a grant, so there is no funding rate or co-financing percentage. The relevant financial figure is the estimated contract value.

What the opportunity is about

DARWIN EU is the Data Analysis and Real World Interrogation Network established by EMA and the European Medicines Regulatory Network to provide timely, trustworthy real-world evidence on the use, safety and effectiveness of medicines, including vaccines. The Coordination Centre runs the federated data network, supports the standardisation of healthcare data sources, and delivers scientific studies requested by EMA and national competent authorities. The published information indicates that the network is built around real-world healthcare databases, common data standards such as the OMOP Common Data Model, and regulatory-grade evidence generation.

Lead contracting authority:European Medicines Agency, with the tender published on the EU Funding and Tenders Portal EU Funding and Tenders Portal.

Type of procedure:Two-stage procurement, starting with requests to participate and followed by an invitation to tender for shortlisted candidates.

Who can apply

This tender is open to economic operators able to deliver large-scale, highly regulated health data, analytics and network coordination services. It is not indicated as SME suitable, so the opportunity is likely aimed at established organisations or consortia with strong technical, scientific, legal and operational capacity. Applicants should expect to demonstrate experience in real-world evidence, distributed data networks, healthcare data standardisation, epidemiology, biostatistics, data governance, and regulated study delivery.

• Economic operators with EU market access that can participate in EMA procurement procedures
• Consortia or single bidders with proven capacity in real-world data, analytics and scientific study delivery
• Organisations able to meet technical and professional selection criteria set out in the procurement documents
• Bidders able to comply with Union data protection requirements and confidentiality obligations
• Applicants prepared to provide financial, legal and operational documentation requested in the request-to-participate stage

The documentation indicates that subcontractors may be involved, but the exact consortium structure, role allocation, and qualification evidence are governed by the tender documents. The award documents also include standard contractual clauses for data protection, a non-disclosure undertaking, an exit plan, and a disaster recovery and business continuity plan, which signals a high-compliance procurement with substantial data governance obligations.

Key financial and contractual terms

Because this is a public procurement and not a grant call, there is no reimbursement rate, unit cost, or eligible cost percentage. Bidders compete on technical merit and price, and the successful tenderer will be bound by the framework contract and service level requirements set by EMA.

Requirements applicants should expect

1. 1Demonstrated experience in regulated healthcare data networks and real-world evidence generation
2. 2Capability to maintain and onboard data partners across multiple jurisdictions and data environments
3. 3Ability to run non-interventional studies in line with applicable EU data protection rules
4. 4Strong technical capacity in data harmonisation, metadata management and federated analytics
5. 5Robust governance, confidentiality, business continuity and exit arrangements
6. 6Ability to provide the administrative and legal documentation required for the participation request

The published procurement documents include an invitation to tender, technical specifications, applicant information and declarations, a minimum requirements declaration, costing sheet, subcontractor declaration, standard contractual clauses for data protection, response templates for selection and award criteria, non-disclosure undertaking, draft framework contract annexes, exit plan, and disaster recovery and business continuity plan. Applicants should assume that compliance evidence will be assessed in detail and that the contracting authority will expect mature operating procedures.

How to submit and important deadline information

Submissions must be made electronically through the EU Funding and Tenders Portal. The live tendering process fields identify 15 June 2026 at 16:00:59 CEST as the deadline for requests to participate. The portal metadata also contains an earlier deadline timestamp of 1 January 2026, but that appears inconsistent with the published notice and should not be treated as the operative deadline ¹.

Applicants should check the portal notice and all attached documents carefully, because this is a two-stage procedure and only shortlisted candidates will move to the tender stage. The procurement notice was published on 15 May 2026, and the notice references the official contract notice on the EU Official Journal.

Assessment for potential bidders

This is a strategically important, high-value services contract for organisations with established capability in data-driven health research, regulatory evidence generation, and complex digital infrastructure operations. It is likely most suitable for large research organisations, specialised health data companies, analytics providers, and consortia that can combine scientific, technical, legal and operational expertise. The opportunity is attractive for bidders with prior experience in pan-European health data projects, federated networks, data protection compliance, and public-sector regulated service delivery.

Footnotes

1. 1The opportunity metadata supplied alongside the portal extract includes a deadline of 2026-01-01T14:00:59Z, which is inconsistent with the published notice and the tendering process fields showing 2026-06-15T16:00:59Z. The later date appears to be the operative deadline for requests to participate.