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 European Commission's Health and Digital Executive Agency (HaDEA) is preparing to release a call for tenders under the identifier HADEA/2025/OP/0043-PIN. This procurement opportunity aims to support the implementation of the new Substances of Human Origin (SoHO) Regulation (EU) 2024/1938. It focuses on disseminating information and training SoHO professionals to ensure compliance with the upcoming technical and regulatory requirements.

The scope of this call encompasses preparing SoHO professionals across the EU for the regulatory implementation intended for 2027. The objectives include the development of training programs, awareness and capacity-building activities, technical assistance, and other supporting measures specifically targeting scientific societies and associations within the professional sector.

The estimated value of the project is €3.5 million, with an expected contract duration of 30 months. The tender is classified under CPV code 73210000, which pertains to research consultancy services. The publication date for this tender is planned for July 30, 2025, with the official contract notice set for September 16, 2025. There are no indications of a framework agreement associated with this tender.

Eligible applicants for this opportunity primarily consist of service providers, consultancies, and training organizations with the capability to deliver comprehensive training and capacity-building initiatives related to healthcare regulation. The specifics indicate that eligible entities could include large enterprises and professional organizations with relevant expertise, while small and medium enterprises may not find this opportunity within their operational scope.

While the detailed requirements for consortium applications are not specified, the complexity of the contract suggests that partnerships may enhance the competitiveness of proposals. The initiative targets a broad EU-wide beneficiary scope, affirming that services must be deliverable across all member states.

Currently, the tender is at the Prior Information Notice stage, indicating that while the details are still being finalized, interested parties can start preparing for the forthcoming competitive procurement process. The nature of support will involve direct monetary compensation for specific services rendered, aligning with the contract's character as a procurement opportunity rather than a grant.

In summary, stakeholders in the healthcare regulation space, particularly those engaged with substances of human origin, may find this upcoming tender a significant opportunity to contribute to establishing compliance frameworks ahead of the regulation's implementation deadline in 2027.

The European Commission, specifically the Health and Digital Executive Agency (HaDEA), is planning a call for tenders with the procedure identifier HADEA/2025/OP/0043-PIN. This call aims to support the implementation of the new Substances of Human Origin (SoHO) Regulation (EU) 2024/1938, including dissemination and training of SoHO professionals to comply with the new technical and regulatory requirements. The TED reference for this planned call for tenders is 144/2025 498550-2025.

The scope of the call is to prepare SoHO professionals across the EU for the 2027 implementation of the Regulation (EU) 2024/1938 on Substances of Human Origin. The objectives of this call for tenders 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 targeting scientific societies and associations.

The procedure type is a planned call for tenders with OJ S publication. The estimated total value of the call is 3,500,000 EUR. The TED publication date is scheduled for 30/07/2025, and the estimated date of publication of a contract notice is 16/09/2025. The nature of the contract is for services, with a maximum contract duration of 30 months. No framework agreement is mentioned. The main classification (CPV) code is 73210000, which corresponds to research consultancy services.

According to a public question and answer, the procurement documents for this call for tenders are not yet available. The contracting authority intends to publish a future call for tenders, and no other information or documents are available other than what has already been published. This answer was published on 16/02/2024 at 23:54.

In summary, this is a forthcoming call for tenders from the European Commission's Health and Digital Executive Agency (HaDEA) focused on supporting the implementation of the new Substances of Human Origin (SoHO) Regulation across the EU. The goal is to prepare SoHO professionals for the regulation's implementation in 2027 by developing training programs, awareness campaigns, capacity building activities, and technical assistance. The call is specifically targeted at scientific societies and associations within the professional sector. The estimated budget is 3.5 million EUR, and the contract will be for services lasting up to 30 months. The official contract notice is expected to be published around September 16, 2025, with the TED publication occurring on July 30, 2025. Currently, the procurement documents are not yet available.

Eligible Applicant Types: The call for tenders is aimed at preparing SoHO professionals across the EU. The objectives include developing 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. Therefore, eligible applicant types include scientific societies and associations involved in the Substances of Human Origin (SoHO) sector.

Funding Type: This is a procurement opportunity, specifically a call for tenders. The nature of the contract is for services.

Consortium Requirement: The information does not explicitly state whether a single applicant or a consortium is required. It is possible that either single entities or consortia of scientific societies and associations could be eligible, but this needs to be confirmed in the official call documents when published.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is EU, as the scope of the call is to prepare SoHO professionals across the EU for the implementation of the Regulation (EU) 2024/1938.

Target Sector: The target sector is health, specifically related to Substances of Human Origin (SoHO). This includes areas like biotech/medtech and pharma/healthcare, focusing on the regulatory and technical aspects of SoHO.

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 new regulation, which suggests activities related to development, training, awareness, and capacity building. This implies a stage geared towards validation and demonstration of methods for compliance with the upcoming regulation.

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

Application Type: The application type is a planned call for tenders with OJ S publication.

Nature of Support: The beneficiaries will receive funding in the form of a service contract to deliver training programmes, awareness campaigns, capacity building activities, and technical assistance. This implies a monetary compensation for services rendered.

Application Stages: The number of application stages is not explicitly mentioned, but given that it is a call for tenders, it is likely to involve at least two stages: submission of a proposal and potential negotiation/contract award. Further stages may be involved.

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

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

Summary:

This is a planned call for tenders by the Health and Digital Executive Agency (HaDEA) to support the implementation of the new Substances of Human Origin (SoHO) Regulation (EU) 2024/1938. The call aims to prepare SoHO professionals across the EU for the 2027 implementation of the regulation. The total estimated value is 3,500,000 EUR. The call is directed towards scientific societies and associations, who will be expected to develop training programmes, awareness and capacity building activities, technical assistance, and supporting measures. The TED publication date is planned for 30/07/2025, and the estimated date of publication of a contract notice is 16/09/2025. The maximum contract duration is 30 months. The call falls under the health sector, specifically concerning the regulation of Substances of Human Origin. The main classification (CPV) is 73210000 - Research consultancy services. The selected entities will receive a service contract to deliver the outlined activities. The opportunity is geared towards preparing the professional sector for the new regulatory requirements, focusing on training and capacity building.