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EU4Health – Call for proposals: action grants on the safety and quality of new Substances of Human Origin (Breast milk, faecal microbiota transplants) – 2024

The "EU for Health" program (EU4health) is the successor to the 3rd EU Health Program. It aims to improve health in the European Union, respond to the COVID-19 health crisis and make healthcare systems more resilient.

2024-06-11
400,000 euro
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Call synthesis

Call reference EU4H-2023-PJ-2
Programme EU4Health Programme
Institution European Commission
Sectors Business & Industry Cooperation & Development Health Research & Innovation
Beneficiaries Association & NGO EU & International Organisation

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Call reference

EU4H-2023-PJ-2



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Priorities and funded actions

Objectives

  • To improve the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and to support innovation regarding such products (Article 3, point (c) of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (c) and (h), of Regulation (EU) 2021/522
  • To bring together sector professionals, for FMT, and to facilitate the implementation of new SoHO Regulation (guidelines and legislative requirements as well as the compliance with oversight tasks), in order to allow the safe, effective and qualitative preparation and use of these SoHO-based therapies

Priorities

  • Priority 1: To contribute to “strengthen the implementation of the legislation on blood, tissues and cells and organs”
    Priority 2:  To support harmonisation across national competent authorities in the field of organs

Among financed actions 

  • Building an expert forum on faecal microbiota transplants
  • Developing, for each SoHO-based therapy, a common set of draft guidelines on the basis of the expert forum and existing initiatives
  • Possible future updating of the guidelines, taking account of the new EU legislative framework
  • Providing an implementation plan for establishments/entities in order to implement SoHO requirements, which will also consider the compliance with technical guidelines as well as with oversight provisions (entity and establishment authorisations, preparation process authorisations, inspections, vigilance and traceability)
  • Training and dissemination programme

Eligibility

  • Be a legal person
  • Be a public or private entity
  • Be established in one of the eligible countries:
    • EU Member States (including overseas countries and territories)
    • eligible non-EU countries: listed EEA countries and countries associated to the EU4Health Programme (Click here)
  • Be a civil society organisation (professional association, foundation, NGO or similar entity) with expertise in the field of gastroenterology

Additional information

  • Initial duration of the action: maximum 18 months
  • Contact : HADEA-HP-CALLS@ec.europa.eu

Useful

Financement
  • Total budget of the call: 400,000 euro
  • Funding rate: 60% of the total eligible costs. You can apply for a funding rate of 80% if your project is of ‘exceptional utility’, i.e. concerns:
    • actions where at least 30 % of the budget is allocated to Member States whose GNI per inhabitant is less than 90% of the EU average
    • actions with bodies from at least 14 Member States and where at least four are from Member States whose GNI per inhabitant is less than 90% of the EU average