Single Framework contract for supporting joint work of Member States in the field of Substances of Human Origin

This opportunity is a call for tenders identified as HADEA/2025/OP/0045, issued by the Health and Digital Executive Agency (HaDEA) of the European Commission. The purpose of this tender is to establish a Single Framework Contract that supports the joint work of EU Member States in the field of Substances of Human Origin (SoHO). The estimated total value of the contract is 4,000,000 EUR, and it has a maximum duration of 48 months.

The tender seeks organizations capable of providing research consultancy services to facilitate the implementation of the SoHO Regulation and related guidelines issued by the SoHO Coordination Board. The application process is an open procedure that requires electronic submissions, with the deadline for tender submission set for October 23, 2025, at 16:00 Europe/Brussels time. The public opening of tenders will occur on October 27, 2025, at 11:00 Europe/Brussels time.

Eligible applicants can include research institutes, consulting firms, and other entities with relevant expertise, although the structure of the procurement suggests a preference for a single applicant rather than a consortium. Geographic eligibility primarily focuses on EU Member States, as the contract is EU-funded.

The tender documents provide comprehensive information, including an invitation to tender, a draft framework contract, tender specifications, a declaration of honor, and a financial offer form. The application process stipulates that a Personal Identification Code (PIC) is mandatory for participation in the call for tenders, be it as a sole candidate or as part of a consortium.

This procurement operates under a framework agreement without reopening competition, with the award criteria based on the best price-quality ratio. The deadline for submitting inquiries is October 15, 2025, after which the contracting authority will not respond to questions.

The nature of the support provided is through payment for services, differing from grant funding, as the contractor will be compensated for services delivered to support regulatory implementation across EU Member States in the health sector.

The opportunity is a call for tenders with the procedure identifier HADEA/2025/OP/0045. It is an open procedure with electronic submission. The call is for a single framework contract to support the joint work of Member States in the field of Substances of Human Origin (SoHO) in accordance with the conditions and procedures set out in the SoHO Regulation, the Commission implementing and delegated acts to be adopted, as well as the guidance, detailed procedural steps and the timeframe and templates to be adopted by the SoHO Coordination Board (SCB). The estimated total value is 4,000,000 EUR. The TED publication date is 04/08/2025. The lead contracting authority is the Health and Digital Executive Agency (HaDEA). The main classification (CPV) code is 73210000, which refers to research consultancy services. The nature of the contract is for services, and the maximum contract duration is 48 months. The award method is best price-quality ratio. It is a framework agreement without reopening of competition. The date and time of public opening is 27/10/2025 at 11:00 Europe/Brussels time. The deadline for receipt of tenders is 23/10/2025 at 16:00 Europe/Brussels time. The contracting authority is not bound to reply to questions submitted after 15/10/2025 at 06:00 Europe/Brussels time.

The available documents are:
EN1. HADEA2025OP0045 Invitation to Tender, Invitation letter, published on 04/08/2025, Version 1, No translations available.
EN2. HaDEA2025OP0045 Framework Contract, Draft contract, published on 04/08/2025, Version 1, No translations available.
EN3. HADEA2025OP0045 Tender Specifications, Tender specifications, published on 04/08/2025, Version 1, No translations available.
EN4. HADEA2025OP0045 Declaration of honour, Declaration on honour (tender), published on 04/08/2025, Version 1, No translations available.
EN5. HADEA2025OP0045 Financial Offer Form, Financial offer form, published on 04/08/2025, Version 1, No translations available.

Submissions must be sent exclusively at the address for submission given through the electronic submission method.

Some frequently asked questions (FAQ) and their answers are:
How to proceed if the system is slow or doesn’t work while uploading/downloading documents? Please make sure you use the latest versions of Google Chrome or Mozilla Firefox. If the issue persists, try the following steps: 1. Clear the cache and cookies on the Internet browser. Published on 13/02/2025 21:52
Which Internet browsers does eSubmission support? Please use the latest versions of Google Chrome or Mozilla Firefox. For the most up-to-date technical recommendations, click on the link System Requirements. You can access this link. Published on 13/02/2025 21:52
Is it possible to view the details of the submission after the deadline? The content of the submission is not accessible after submitting the tender as the system encrypts all attachments upon upload. Thus, the system will not allow decryption after the upload. Published on 13/02/2025 21:50
Where can I find my submissions in Manage My Area, in the Funding & Tenders portal? Depending on the type or step of procedure, you can find the submissions in one of these sections: In ‘My Submission(s)’: tenders in response to open calls for tenders, requests to. Published on 17/10/2024 21:40
Which size should attachments have? For attaching files to your tender submission, eSubmission accepts files that are less than 50 MB in size. Any larger sizes will not be accepted by the system. For the latest informa. Published on 17/10/2024 21:36
How should I name attachments in eSubmision? In eSubmission, you must name the attachments for your tender draft following the System Requirements. With regards to all attachment names, please see the following conditions: The . Published on 03/10/2024 17:39
Can I submit a video in eSbmission? Which formats are supported? You can check the System Requirements of eSubmission: Published on 03/10/2024 17:37
I received an invitation from the F&T Portal but cannot view the procurement documents. Invited candidates can only see the procurement documents after having selected an organisation. Go to F&T Portal, “My Invitations”. Click on “Select Organisation” from the “Action”. Published on 03/10/2024 17:37
Do I need to validate my PIC in order to submit a tender in eSubmission? The Personal Identification Code (PIC) is mandatory to participate in a call for tenders as a sole candidate/tenderer or as a member of a group (consortium). For subcontractors PIC i. Published on 03/10/2024 17:36
I have an issue uploading a file in eSubmission and it’s giving me an error. What do I do? When uploading a file in eSubmission, you must first make sure it follows the technical requirements of the system, which are as shown below. A)For procurement procedures: B)For req. Published on 03/10/2024 17:36
How many attachments can I upload per submission? The maximum number of documents the system will allow you to upload per tender is 200 files. You are able to check the eSubmission System Requirements in the documentation by clicking. Published on 03/10/2024 17:35
Why do tenderers need a PIC? It is mandatory to register for a PIC if you intend to submit a tender or a request to participate. Only one PIC per organisation must be used. Therefore, if your organisation alread. Published on 23/04/2024 18:14
How do I register my organisation and get a Participant Identification Code (PIC)? First, check if the organisation is already registered using the Search PIC tool under 'How to Participate' > Participant Register. If your organisation is a bigger. Published on 23/04/2024 17:07
How many languages does the system support? The system is multilingual and supports all 24 official EU languages. Published on 01/04/2024 20:56
Which is the character set encoding in the system? The character set encoding is UTF-8. Published on 23/02/2024 00:58
Does the system use encryption to ensure the integrity and the confidentiality of the information? Yes, the system encrypts all uploaded documents, using an asymmetric key as an encryption mechanism. Published on 23/02/2024 00:57
Which file types does the system support? The supported file types depend on the type of submission you want to make. The allowed file types are specified within the system requirements linked to the procedure in question. M. Published on 22/02/2024 00:55
Can I view and edit my draft submission? Until the deadline for the submission has been reached, submissions in the draft status can be edited, viewed and deleted. Published on 24/03/2023 22:32
In the submission report, under the name of our entity, "Legal form: UNKNOWN" is displayed while in the system, our legal form was correctly displayed. Is this a problem for the submission? No, it is just a display issue. This is not blocking for you: you can submit. Published on 03/08/2021 23:07
I sent my submission on time and a few days later, I received an automatic email informing me that the deadline for the reception of submissions had been reached. Does this mean that my submission was not correctly sent? No, this is an auto-generated notification sent when the time limit of receipt defined for the call for tenders has been reached. Until then, you had the possibility of withdrawing. Published on 03/08/2021 23:05

In summary, this is a call for tenders from the Health and Digital Executive Agency (HaDEA) to establish a framework contract for supporting the joint work of EU Member States regarding Substances of Human Origin (SoHO). The goal is to ensure compliance with the SoHO Regulation and related guidelines. The contract, worth an estimated 4 million EUR, will run for 48 months and be awarded based on the best price-quality ratio. Tender submissions must be electronic, and the deadline is October 23, 2025. The tender documents, including the invitation letter, draft contract, tender specifications, declaration of honor, and financial offer form, are available for download. The call is open to any organization capable of providing research consultancy services in the field of SoHO. A PIC (Personal Identification Code) is mandatory for participation. The eSubmission system supports various file types, with a maximum size of 50 MB per attachment and a limit of 200 attachments per submission.

Eligible Applicant Types: The eligible applicant types are not explicitly stated in the provided text. However, given that it is a call for tenders and the subject involves supporting the joint work of Member States, eligible applicants are likely to be organizations capable of providing services related to research consultancy, potentially including research institutes, consulting firms, and other entities with relevant expertise.

Funding Type: The funding type is procurement, specifically a service contract. The call is for a "Single Framework contract for supporting joint work of Member States in the field of Substances of Human Origin," indicating a procurement of services.

Consortium Requirement: The text does not explicitly state whether a consortium is required or if a single applicant is sufficient. However, the FAQ section mentions that a Personal Identification Code (PIC) is mandatory to participate in a call for tenders as a sole candidate/tenderer or as a member of a group (consortium). This suggests that both single applicants and consortia are eligible.

Beneficiary Scope (Geographic Eligibility): The call for tenders is to support the joint work of Member States, implying that the geographic eligibility is focused on EU Member States.

Target Sector: The target sector is health, specifically related to Substances of Human Origin (SoHO). The call falls under the main classification (CPV) 73210000, which is research consultancy services.

Mentioned Countries: The opportunity explicitly mentions EU Member States as the beneficiaries of the joint work to be supported.

Project Stage: The project stage is not explicitly mentioned, but given the nature of the call for tenders, it is likely focused on the implementation and support of existing regulations and frameworks related to SoHO. This suggests a stage of implementation and operational support rather than early-stage research or development.

Funding Amount: The estimated total value of the contract is 4,000,000 EUR.

Application Type: The application type is an open call for tenders, with electronic submission.

Nature of Support: The beneficiaries will receive non-monetary services through this opportunity. The contract is for research consultancy services to support the joint work of Member States.

Application Stages: The number of application stages is not explicitly stated, but based on the documents provided (Invitation to Tender, Framework Contract, Tender Specifications, Declaration of Honour, Financial Offer Form), it is likely a multi-stage process involving submission of a tender, evaluation, and contract award.

Success Rates: The success rates are not mentioned in the provided text.

Co-funding Requirement: The co-funding requirement is not explicitly mentioned in the provided text.

Summary:

This is a call for tenders (HADEA/2025/OP/0045) issued by the Health and Digital Executive Agency (HaDEA) for a Single Framework Contract aimed at supporting the joint work of EU Member States in the field of Substances of Human Origin (SoHO). The tender seeks to procure research consultancy services to facilitate the implementation of the SoHO Regulation and related acts, as well as guidance provided by the SoHO Coordination Board (SCB). The estimated total value of the contract is 4,000,000 EUR, and the maximum contract duration is 48 months. The award method is based on the best price-quality ratio. The submission method is electronic, with a deadline for receipt of tenders on 23/10/2025. The TED publication reference is 147/2025 508205-2025. The contracting authority will not reply to questions submitted after 15/10/2025. The tender documents include an invitation to tender, a draft framework contract, tender specifications, a declaration of honour, and a financial offer form. The eSubmission system supports multiple languages and encrypts uploaded documents. Tenderers need a Participant Identification Code (PIC) and must adhere to specific file size and naming conventions for attachments. The opportunity is open to both single applicants and consortia.