Ausschreibungen Health and Digital Executive Agency (HaDEA)

This call for tenders aims to ensure clinical trial preparedness for Filovirus outbreaks through the establishment of an EU-based reserve of investigational vaccines as a critical preparedness measure, given the sporadic yet high-consequence nature of these pathogens. Specifically, the call aims to establish, pilot and maintain an investigational reserve of Filovirus candidate vaccines against Ebola Sudan (SUDV), Ebola Bundibugyo (BDBV) and/or Marburg (MARV), which – in case of an outbreak – could be used to advance their development by embedding them in outbreak-associated clinical trials, facilitated through international agreements and frameworks to support such preparedness. These provisions will allow for the rapid deployment of candidate vaccines for their later-stage development. Tenderers will further have to ensure the rapid deployment of the investigational doses, subject to specific conditions being met (such as the occurrence of an outbreak and the expressed consent of the Contracting Authority).

Fourniture avec installation de rayonnages fixes et mobiles et de services associés pour les besoins de la Commission et des Pouvoirs adjudicateurs participants.

Assurer les prestations de déménagement et de manutention pour la Commission et les autres Pouvoirs Adjudicateurs installés dans la Région de Bruxelles-Capitale. Le marché est divisé en deux lots: un pour les Services de déménagements et services associés, l'autre pour les Services logistiques et services associés dans le domaine de la gestion du courrier, des archives, de l’imprimerie, de la création visuelle et signalétique.

The subject of this call for tenders is “Implementation of the new SoHO Regulation: training and networking of SoHO Competent Authorities’ staff for oversight”. The training activities are addressed in particular to inspectors, vigilance officers and preparation process assessors, for strengthening the implementation of oversight in the field of Substances of Human Origin (SoHO) in the EU Member States, EFTA countries and candidate countries. The expected results aim at increasing and standardising the competences of inspectors, vigilance officers and assessors in this sector across the EU as well as building a network of junior and senior competent authority staff, facilitating possible joint inspections, joint assessment of preparation processes and peer audits among Member States, and reinforcing trust between them to facilitate the exchange of SoHO.

The subject of this call for tenders is “Implementation of the new SoHO Regulation: training and networking of SoHO Competent Authorities’ staff for oversight”. The training activities are addressed in particular to inspectors, vigilance officers and preparation process assessors, for strengthening the implementation of oversight in the field of Substances of Human Origin (SoHO) in the EU Member States, EFTA countries and candidate countries. The expected results aim at increasing and standardising the competences of inspectors, vigilance officers and assessors in this sector across the EU as well as building a network of junior and senior competent authority staff, facilitating possible joint inspections, joint assessment of preparation processes and peer audits among Member States, and reinforcing trust between them to facilitate the exchange of SoHO.

The European Health and Digital Executive Agency (HaDEA) is planning to launch a call for tenders on "Long-term API stockpiling and rapid finished dose form manufacture", a feasibility project to assess its application in crisis preparedness. This project aims to support the development of and access to technologies that can prolong the shelf-life of Active Pharmaceutical Ingredients (APIs) stored in bulk and advanced manufacturing technologies to produce finished dose forms from those bulk APIs rapidly, enhancing crisis preparedness by exploring potential gains in sustainability, resiliency, and flexibility to respond to future health emergencies. The upcoming call for tenders will request the development of a pilot feasibility project to test this concept, assess its viability, and provide recommendations on how to operationalise the approach.

This call for tenders aims at enhancing the accessibility and availability of Medical Counter-Measures (MCMs) in the EU/EEA. The subject of this call for tenders is to conclude contracts for the reservation of manufacturing capacity and of vendor-managed stockpiles of nitrile examination gloves (lot 1) and FFP2 respiratory masks (lot 2) (hereinafter ‘EU FAB+ PPE Pilot’). The contractor with manufacturing capacity in the EU/EEA will be requested to set up vendor-managed stockpiles (VMS) with an associated priority right to purchase. Purchased stocks would have to be either replenished in the stockpile or would give rise to an equivalent reservation of manufacturing capacity for the remainder of the contract. The contracting authority and/or the European Commission must have the right to activate the right to purchase the stockpiled or manufactured MCMs, when deemed necessary for preparedness or crisis purposes. Each lot would be awarded to a maximum of three tenderers with each contract awarded lasting for 3 years (36 months). Purchase of the products in scope of this call for tenders shall be done by the contracting authority and/or the European Commission, if needed on behalf of any EU/EEA countries or any EU4Health associated countries, via a separate procedure.

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 (Scientific societies and associations).

This call for tenders aims to ensure clinical trial preparedness for Filovirus outbreaks through the establishment of an EU-based reserve of investigational vaccines as a critical preparedness measure, given the sporadic yet high-consequence nature of these pathogens. Specifically, the call aims to establish, pilot and maintain an investigational reserve of Filovirus candidate vaccines against Marburg (MARV) and/or Ebola Sudan (SUDV), which – in case of an outbreak – could be used to advance their development by embedding them in outbreak-associated clinical trials, facilitated through international agreements and frameworks to support such preparedness. These provisions will allow for the rapid deployment of candidate vaccines for their later-stage development (phase 2 onwards). Tenderers will further have to ensure the rapid deployment of the investigational doses, subject to specific conditions being met (such as the occurrence of an outbreak and the expressed consent of the Contracting Authority).

This call for tenders aims to advance the clinical trial preparedness and readiness for Filovirus outbreaks within the European Union and globally as a critical preparedness measure, given the sporadic yet high-consequence nature of these pathogens. Specifically, the call aims to establish, pilot and maintain an investigational reserve of Filovirus candidate vaccines against Marburg (MARV) and/or Ebola Sudan (SUDV) to support such preparedness. Readiness for phase 2 and/or phase 2/3 clinical trials of Filovirus vaccines will be ensured through the advance preparation of key clinical trial activities, including the establishment of an EU-based reserve of those investigational vaccines. Subject to specific conditions being met (such as the occurrence of an outbreak and the expressed consent of the Contracting Authority), this call for tenders also provisions for the use of the reserved investigational vaccine candidates to enable clinical trials up to the number of doses held in reserve.