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.
Kick-off/Inception Meeting at HaDEA or Commission's premises in Brussels within 30 calendar days of contract start (unless contracting authority decides online) First Interim Meeting at M10 (at premises of HaDEA or European Commission (HERA) in Brussels, in hybrid mode, or via videoconference) Second Interim Meeting at M32 (at premises of HaDEA or European Commission (HERA) in Brussels, in hybrid mode, or via videoconference) Final Meeting at M36 (at premises of HaDEA or European Commission (HERA) in Brussels, in hybrid mode, or via videoconference) Physical laboratory and manufacturing work (pilot project, analytical testing, container manufacture) at contractor's EU-based facilities Consultation with at least one relevant European regulatory authority (at least once) Progress meetings (to be held via videoconference) at least every six months All meetings (inception, interim, final) may be held via videoconference as an alternative to physical attendance in Brussels
Tenderers can be natural or legal persons. Tenderers are not obliged to take a specific legal form in order to submit their tenders. Where tenderers submit a tender through an entity, which lacks legal personality (e.g., a branch), the compliance with the exclusion criteria, selection criteria, the rules on access to procurement as well as the absence of restrictive measures shall be assessed at the level of the tenderers. Tenderers do not need to prove specific legal and regulatory capacity to perform the contract.
Tenderers must comply with the following selection criteria in order to prove that they have the necessary economic and financial capacity to perform the contract.
The tenderer must prove experience in the field of pharmaceutical manufacturing process and/or novel pharmaceutical product and/or pharmaceutical technology development, including scale-up and/or technology transfer.
The tenderer must demonstrate that technical facilities such as analytical laboratory and/or research and development laboratories and/or manufacturing facilities for performing the necessary activities envisaged within the project are available, technically capable and of an appropriate standard.
The tenderer must demonstrate the ability to provide a core team with experience in project management and medicinal product development. All proposed team members must be available from the start of the Contract period and as far as possible until the end of the project.
Published 24 June 2026 · rebuilt nightly from the official notice.