The European Health and Digital Executive Agency (HaDEA) has released a Prior Information Notice (PIN) under the EU4Health programme, announcing an upcoming call for tenders to support the implementation of Regulation (EU) 2024/1938 on Substances of Human Origin (SoHO) regulation
This SoHO regulation introduces an improved legal and technical framework across the EU to govern the safety, quality, and availability of substances such as blood, tissues, cells, and other human-derived materials used in medical care.
Scheduled for complete implementation in 2027, the SoHO regulation will require huge adjustments within the professional sector. The tender named HADEA/2025/OP/0043 is expected to offer a budget of €3.5 million to support these efforts.
Professional readiness
The upcoming call for tenders will focus on preparing SoHO professionals across Europe for the regulatory transition. Key objectives include the development of:
- Comprehensive training programmes
- Awareness-raising and capacity-building initiatives
- Technical assistance and support measures for compliance
These actions will mainly target scientific societies, professional associations, and other organisations involved in the handling of human-origin substances. The aim is to make sure that all relevant professionals understand and are ready to meet the technical and regulatory demands of the new framework.
Improving health system resilience
This tender is part of the EU4Health programme’s hopes to strengthen health systems by making them more resilient and resource-efficient. By helping with early and thorough preparation, the initiative looks to reduce the risk of non-compliance, minimise implementation burdens, and protect the continuity and safety of SoHO-based treatments.
SoHO professionals are essential to public health, ensuring that important substances are safely collected, processed, and distributed. Supporting them through this regulatory transition is seen as vital to maintaining trust in healthcare systems and improving overall patient outcomes.
Funding opportunities
Organisations interested in contributing to the implementation of the SoHO regulation are encouraged to monitor the EU Funding and Tenders Portal for the official publication of the call. Once launched, eligible entities will be able to submit proposals outlining their plans to deliver the required training, support, and technical expertise across the EU.
HaDEA, which manages most of the EU4Health budget, will oversee the selection and contracting process, ensuring effective use of public funds to achieve regulatory readiness.
About EU4Health
The EU4Health programme is the European Union’s most ambitious health funding initiative to date. Launched in response to the COVID-19 pandemic, it has since evolved into a comprehensive framework to address long-term health challenges, promote disease prevention, and improve access to healthcare services across Member States.
Running from 2021 to 2027, the programme supports national authorities, public health organisations, and other stakeholders through grants and public procurement. The upcoming SoHO-related tender is a key component of this wider strategy to build a stronger, safer, and more unified European Health Union.
