Support the implementation of the new Substances of Human Origin (SoHO) Regulation 1938/2024, including dissemination and training of SoHO professionals to comply with the new technical and regulatory requirements

The call for tenders HADEA/2025/OP/0043, published by the Health and Digital Executive Agency (HaDEA), represents an open procurement opportunity aimed at supporting the preparation of Substances of Human Origin (SoHO) professionals throughout the EU for the implementation of Regulation (EU) 2024/1938 by 2027. This tender is focused on developing training programs, capacity building activities, awareness campaigns, and technical assistance specific to scientific societies and associations involved in the healthcare sector.

The estimated total value of the contract is 3,500,000 EUR, and the maximum contract duration is set at 30 months. The award of the contract will be based on the best price-quality ratio, with submissions required to be made electronically. Key milestones include a submission deadline of November 11, 2025, and a public opening event on November 12, 2025.

Contractors will receive financial support through a service contract, which requires the delivery of specified services in return for payment. The submission method involves the use of the EU's eSubmission system, which supports all 24 official EU languages and employs encryption to ensure data integrity and confidentiality. Participants must obtain a Participant Identification Code (PIC) to engage in the procurement process.

Applications must be submitted electronically, and the system allows for up to 200 file attachments per submission, with a maximum size of 50 MB for each file. While exact success rates for tender applications are not specified, typical competitive rates for similar EU procurements may range between 10% and 39%. Importantly, there are no explicit co-funding requirements mentioned, placing the onus on applicants to manage operational costs through contract payments.

This procurement opportunity is directed toward larger consulting firms, research institutions, and possibly consistencies of scientific societies, emphasizing a need for substantial capacity and expertise in regulatory affairs, training program development, and stakeholder engagement across diverse healthcare systems within the EU member states.

The call for tenders HADEA/2025/OP/0043, with TED reference 178/2025 607246-2025, is an open procedure published on 17/09/2025 by the Health and Digital Executive Agency (HaDEA). The submission method is electronic and the call is currently open for submission.

The scope of this call is to prepare Substances of Human Origin (SoHO) professionals across the EU for the 2027 implementation of Regulation (EU) 2024/1938 on Substances of Human Origin. The objectives are to develop training programmes, awareness and capacity building activities, technical assistance, and supporting measures to facilitate the implementation of the new SoHO Regulation by the professional sector, specifically scientific societies and associations.

The estimated total value of the tender is 3,500,000 EUR. The nature of the contract is for services, with a maximum contract duration of 30 months. The award method will be based on the best price-quality ratio. No framework agreement is mentioned.

Key milestones include:
TED publication date: 17/09/2025
Date and time of public opening: 12/11/2025 11:00 Europe/Brussels
Deadline for receipt of tenders: 11/11/2025 16:00 Europe/Brussels
Deadline for questions: Contracting authority is not bound to reply to questions submitted after 03/11/2025 07:00 Europe/Brussels

The following documents are available for download:
EN01. HADEA2025OP0043 Invitation to tender Invitation letter, published on 17/09/2025, Version 1, No translations available
EN02. HADEA2025OP0043 Direct Service Contract Draft contract, published on 17/09/2025, Version 1, No translations available
EN02a.HADEA2025OP0043-Appendix 1-Direct Service Contract Draft contract annex, published on 17/09/2025, Version 1, No translations available
EN03a.HADEA2025OP0043 TS Support Scientific Societies final Technical specifications, published on 17/09/2025, Version 1, No translations available
EN03b. HADEA2025OP0043 TS Annexes 3,4,5 word Technical specifications, published on 17/09/2025, Version 1, No translations available
EN04. HADEA2025OP0043 DOH tenderers Declaration on honour (tender), published on 17/09/2025, Version 1, No translations available
EN05. HADEA 2025 OP 0043 Financial Offer Financial offer form, published on 17/09/2025, Version 1, No translations available

Submissions must be sent exclusively via electronic submission.

Frequently Asked Questions (FAQ)
How to proceed if the system is slow or doesn’t work while uploading/downloading documents? Make sure you use the latest versions of Google Chrome or Mozilla Firefox. If the issue persists, clear the cache and cookies on the Internet browser. Published on 13/02/2025 21:52
Which Internet browsers does eSubmission support? Use the latest versions of Google Chrome or Mozilla Firefox. For the most up-to-date technical recommendations, click on the link System Requirements. Published on 13/02/2025 21:52
Is it possible to view the details of the submission after the deadline? No, the content of the submission is not accessible after submitting the tender as the system encrypts all attachments upon upload. Published on 13/02/2025 21:50
Where can I find my submissions in Manage My Area, in the Funding & Tenders portal? Submissions can be found in ‘My Submission(s)’: tenders in response to open calls for tenders, requests to participate. Published on 17/10/2024 21:40
Which size should attachments have? eSubmission accepts files that are less than 50 MB in size. Published on 17/10/2024 21:36
How should I name attachments in eSubmision? Name the attachments for your tender draft following the System Requirements. Published on 03/10/2024 17:39
Can I submit a video in eSbmission? Which formats are supported? 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). 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? Make sure it follows the technical requirements of the system. 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. 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. Published on 23/04/2024 18:14
How do I register my organisation and get a Participant Identification Code (PIC)? Check if the organisation is already registered using the Search PIC tool under 'How to Participate' > Participant Register. 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. 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 EU call for tenders, HADEA/2025/OP/0043, aims to prepare European professionals in the field of Substances of Human Origin for the implementation of a new EU regulation in 2027. It seeks proposals for training programs, awareness campaigns, technical assistance, and other support measures targeted at scientific societies and associations. The Health and Digital Executive Agency (HaDEA) is managing this 3.5 million EUR tender, and the deadline for submitting proposals is November 11, 2025. The tender documents provide detailed technical specifications, contractual information, and submission guidelines. The EU's electronic submission system, eSubmission, is to be used, and applicants must have a Participant Identification Code (PIC). The FAQs address common technical issues related to using the eSubmission platform.

Eligible Applicant Types: The eligible applicant types are Scientific societies and associations.

Funding Type: The funding type is procurement, specifically a service contract.

Consortium Requirement: The text does not explicitly state whether a single applicant or a consortium is required. However, the mention of 'Scientific societies and associations' suggests that both single entities and consortia of such entities might be eligible.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is the EU, as the call aims to prepare SoHO professionals across the EU.

Target Sector: The target sector is health, specifically related to Substances of Human Origin (SoHO) and the implementation of related regulations. It also touches upon research consultancy services.

Mentioned Countries: No specific countries are mentioned, but the geographic scope is the EU.

Project Stage: The project stage is focused on preparing for the implementation of a regulation, which includes development of training programs, awareness and capacity building activities, technical assistance and supporting measures. This suggests a stage of development and implementation rather than basic research.

Funding Amount: The estimated total value of the tender is 3,500,000 EUR.

Application Type: The application type is an open call for tenders.

Nature of Support: The beneficiaries will receive money in exchange for services provided under the direct service contract.

Application Stages: The number of application stages is not explicitly mentioned, but it involves at least one stage of submitting a tender. The evaluation process likely involves multiple stages, but the exact number is not specified in the provided text.

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

Co-funding Requirement: The text does not explicitly mention a co-funding requirement.

Summary:

This is an open call for tenders, HADEA/2025/OP/0043, issued by the Health and Digital Executive Agency (HaDEA). The tender aims to support the implementation of the new Substances of Human Origin (SoHO) Regulation (EU) 2024/1938 across the EU. The primary goal is to prepare SoHO professionals, including those in scientific societies and associations, for the regulation's implementation in 2027. The tender focuses on developing training programs, awareness campaigns, capacity building activities, technical assistance, and other supporting measures. The estimated total value of the contract is 3,500,000 EUR, and the maximum contract duration is 30 months. The award method is based on the best price-quality ratio. The deadline for submitting tenders is November 11, 2025, at 16:00 Europe/Brussels time. Submissions must be sent electronically. Tenderers need a Personal Identification Code (PIC) to participate. The eSubmission system supports various file types, with a maximum attachment size of 50 MB and a limit of 200 files per submission. The system supports all 24 official EU languages and uses encryption to ensure data integrity and confidentiality.