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Call key data
Call for proposals to support innovative manufacturing technologies and processes in the Union for medicines production (HERA)
Funding Program
EU4Health programme 2021-2027
Call number
EU4H-2024-PJ-01-3
deadlines
Opening
23.05.2024
Deadline
05.09.2024 17:00
Funding rate
60-80%
Call budget
€ 17,000,000.00
Estimated EU contribution per project
€ 5,600,000.00
Link to the call
Link to the submission
Call content
short description
This action aims at supporting improved manufacturing technologies and processes that allow for a more effective, less expensive, easier to scale up, more sustainable and cleaner production of medicines in the Union.
Call objectives
Innovations developed under this action should be designed to enable rapid scale-up of Union pharmaceutical production in the context of a health emergency or to prevent critical shortages of critical medicines. This action supports the Union’s pharmaceutical industry to be better able to respond to public health needs in the context of health emergencies and critical medicines shortages.
It does so by enabling the development of tools that contribute to the improvement and optimisation of manufacturing of medicines, with the objective of reducing production costs (e.g., related to labour and energy consumption), and facilitating compliance with the Union’s environmental occupational and social requirements, as well as the Union’s current and future needs to scale-up pharmaceutical production. This action supports the policy priority to enhance crisis preparedness and response for future health emergencies in relation to medical countermeasures with an all-threats approach, as well as preventing critical shortages of critical medicines, especially those in a situation of technological vulnerability with regards to the EU market. It implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of crisis-relevant products (Article 3, point (c) of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (b) and (c), of Regulation (EU) 2021/522.
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Expected effects and impacts
This action is expected to result in:
a) more agile, simplified scale-up, sustainable and resilient manufacturing of APIs, their intermediates, finished products and/or excipients, allowing for better capacity to respond to demand surges and prevent critical shortages of critical medicines.
b) improved competitiveness of the Union’s manufacturing industry, improved Union’s strategic autonomy and more resilient Union’s industry in the field of medical countermeasures/medicines.
Expected results
This action covers activities aimed at developing support for or innovations targeting the manufacturing of APIs, their intermediates and/or excipients, namely by developing:
a) novel manufacturing processes and technologies, e.g., additive manufacturing, continuous manufacturing and flow chemistry, and biomanufacturing technologies; combined or not with activities covering:
b) novel industrial manufacturing and facility designs, e.g., modular manufacturing, smart manufacturing execution systems, including automation and robotics, advanced analytics, and smart sensors, among other.
Overall, the action should contribute to increasingly sophisticated enhancements to chemical and/or biological processes or decreasing the production of polluting agents. This action is limited to manufacturing technologies and processes and does not cover innovation exclusively targeting the field of quality control.
Eligibility Criteria
Regions / countries for funding
Moldova (Moldova), Iceland (Ísland), Montenegro (Црна Гора), Norway (Norge), Ukraine (Україна)
eligible entities
Education and training institution, International organization, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnership
No
Project Partnership
Applications may be submitted either by a single applicant or a consortium of at least 3 applicants (beneficiaries; not affiliated entities). In both cases (single applicants or consortium) the proposal must include one eligible applicant with expertise (proven by relevant past projects) in manufacturing technologies or processes.
In order to be eligible, the applicants (beneficiaries and affiliated entities) must:
- be legal entities (public or private bodies)
- be established in one of the eligible countries, i.e.:
- EU Member States (including overseas countries and territories (OCTs
- eligible non-EU countries: listed EEA countries and countries associated to the EU4Health Programme or countries which are in ongoing negotiations for an association agreement and where the agreement enters into force before grant signature (list of participating countries)
Other entities may participate in other consortium roles, such as associated partners, subcontractors, third parties giving in-kind contributions, etc.
Specific cases:
Natural persons — Natural persons are NOT eligible (with the exception of self-employed persons, i.e. sole traders, where the company does not have legal personality separate from that of the natural person).
International organisations — International organisations are eligible. The rules on eligible countries do not apply to them.
Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees for the protection of the EU financial interests equivalent to that offered by legal persons.
EU bodies — EU bodies (with the exception of the European Commission Joint Research Centre) can NOT be part of the consortium.
Associations and interest groupings — Entities composed of members may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. Please note that if the action will be implemented by the members, they should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible).
European Reference Networks (ERNs) — These cover networks between healthcare providers and centres of expertise in the Member States to reinforce healthcare cooperation, in particular in the area of rare diseases, in line with the objectives set out in Article 12 of Directive 2011/24.
other eligibility criteria
Specific eligibility criteria:
- Industrial economic operators, technology developers and applied research stakeholders capable of developing the mentioned manufacturing technologies and processes.
- Established legal entities with a clear track record of development. industrial innovation
- Technical expertise in the area of manufacturing technologies processes relevant to the call.
Financial support to third parties is not allowed.
The costs will be reimbursed at the funding rate fixed in the Grant Agreement (60%).
You can apply for a higher project funding rate (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 or
- 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.
Additional information
Topics
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
project duration
between 24 and 48 months
Additional Information
Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System (accessible via the Topic page in the Search Funding & Tenders section). Paper submissions are NOT possible. Proposals (including annexes and supporting documents) must be submitted using the forms provided inside the Submission System.
Proposals must be complete and contain all the requested information and all required annexes and supporting documents:
-
Application Form Part A — contains administrative information about the participants (future coordinator, beneficiaries and affiliated entities) and the summarised budget for the project (to be filled in directly online)
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Application Form Part B — contains the technical description of the project (to be downloaded from the Portal Submission System, completed and then assembled and re-uploaded)
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mandatory annexes and supporting documents (templates available to be downloaded from the Portal Submission System, completed, assembled and re-uploaded):
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detailed budget table/calculator
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CVs (standard) of core project team
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list of previous projects (key projects for the last 4 years) (template available in Part B)
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Proposals are limited to maximum 70 pages (Part B). Evaluators will not consider any additional pages.
Call documents
Call document EU4H -2024-PJ-01Call document EU4H -2024-PJ-01(1059kB)
Contact
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