HERA - EMA laboratories funding for shelf-life extension programme of selected MCMs - MCM1

This summary outlines a planned procurement opportunity by the European Commission's Health Emergency Preparedness and Response Authority (HERA) for stability testing of selected medical countermeasures (MCMs). The initiative is targeted at Official Medicines Control Laboratories (OMCLs) within EU and EEA member states. The primary aim is to implement a shelf-life extension program to determine if three specific MCMs—Imvanex, Succicaptal, and Cyanokit—can remain safe and effective beyond their original expiration dates.

The procurement structure includes three lots, each focused on one of the MCMs, and seeks to contract 1-3 OMCL laboratories for service contracts to perform rigorous stability testing according to regulatory standards. This represents a straightforward service procurement rather than a traditional grant. Eligible applicants must have OMCL designation or equivalent recognition and will receive compensation for their specialized testing services.

The indicative timeline includes an expression of interest phase starting on October 6, 2025, with a submission deadline of October 18, 2025, followed by a negotiated procedure launch on October 31, 2025. Selected laboratories will focus on validating the shelf life of the MCMs within the rescEU framework, which is part of the EU's emergency response strategy. The overall budget for HERA's procurement activities is outlined, though specifics for this tender are not disclosed.

The project is significant in enhancing sustainability of EU healthcare resources, minimizing waste, and ensuring ongoing availability of critical medicines. Regulatory compliance and Good Laboratory Practice will be essential throughout the testing process, ultimately contributing to the development of a comprehensive shelf-life extension policy framework.

This is a publication announcing the European Commission's, DG HERA European Health Emergency Preparedness and Response Authority intent to launch a future negotiated low or middle value procedure. This is not a call for tenders. The procedure identifier is EC-HERA/2025/LVP/0006-EXA.

The subject of the planned call for tenders is HERA EMA laboratories funding for shelf-life extension programme of selected MCMs MCM1. The main classification CPV code is 73111000. The nature of the contract is services. There is no framework agreement.

The description is as follows: Stockpiling medical countermeasures (MCMs) supports the timely availability of medical resources to protect EU citizens in emergencies. In 2019 the Commission introduced rescEU MCM stockpiles as part of the Union Civil Protection Mechanism (UCPM), which serves as a strategic reserve of Europe's disaster response capabilities and stockpiles, fully funded by the EU. Among the various capabilities included, rescEU notably comprises a substantial inventory of medical countermeasures, with their implementation and coordination being under the mandate of DG ECHO and HERA. Shelf-life extension of selected MCMs is used to enhance stocks sustainability, reduce waste, and optimise stockpile management, while also ensuring that the MCMs still meet applicable standards. A survey of national contact points on medicine availability and shortages conducted by EMA in 2024 highlights that a considerable proportion of Member States already implement shelf-life extension for medicines stockpiled in preparedness for health threats at national/regional level. The extension of shelf life has been promoted by DG ECHO and HERA as part of the overall sustainability strategy for rescEU stockpiling during the calls launched in 2022 and 2023. The European Commission and EMA are piloting a structured shelf-life extension programme so that MCMs in the rescEU stockpiles can remain usable beyond their original expiration date, provided they undergo rigorous scientific testing and regulatory oversight. This pilot will be used to develop a policy framework for a shelf-life extension programme and will consist of testing of three MCMs from the EU stockpile (including at least one biological medicine, e.g. a vaccine). The contracting authority will sign contracts with 1-3 OMCL laboratories to perform stability testing on these three identified MCMs.

There are three lots:

Lot 1: HERA EMA laboratories funding for shelf-life extension programme for selected MCMs Imvanex. The description is the same as the overall description.

Lot 2: HERA EMA funding for laboratories for shelf-life extension programme for selected MCMs Succicaptal. The description is the same as the overall description.

Lot 3: HERA EMA funding for laboratories for shelf-life extension programme for selected MCMs Cyanokit. The description is the same as the overall description.

Milestones:

Start date for expression of interest: 2025-10-06 Europe/Brussels
Deadline for expression of interest: 18/10/2025 05:59 Europe/Brussels
Indicative date of launch of the negotiated procedure: 2025-10-31 Europe/Brussels

Submissions must be sent exclusively at the address for submission given below. The method of expression of interest is electronic.

FAQ: References that feature an ‘ExA’ are not calls for tenders. They are a publication announcing the contracting authority’s intent to launch in the future a low or middle negotiated procedure.

In summary, this publication announces the European Commission's intention to launch a negotiated procedure for funding Official Medicines Control Laboratories (OMCL) to perform stability testing on three selected medical countermeasures (MCMs) from the rescEU stockpile. The goal is to support the shelf-life extension of these MCMs, ensuring their usability beyond the original expiration date through rigorous scientific testing and regulatory oversight. This pilot program aims to develop a policy framework for a broader shelf-life extension program. The expression of interest is planned for October 2025. The project falls under the Union Civil Protection Mechanism, specifically focusing on medical countermeasures. The selected laboratories will contribute to a pilot program designed to create a policy framework for extending the shelf life of critical medical supplies.

Eligible Applicant Types: OMCL laboratories (Official Medicines Control Laboratories) are explicitly mentioned as potential beneficiaries. Other types of laboratories might be eligible, but this is not specified.

Funding Type: Service contract. The contracting authority intends to sign contracts with selected laboratories to perform stability testing.

Consortium Requirement: The opportunity mentions signing contracts with 1-3 OMCL laboratories, implying that single applicants are eligible, and potentially multiple laboratories could be selected across different lots. It is not explicitly stated whether consortia are required or permitted.

Beneficiary Scope (Geographic Eligibility): The text does not explicitly define geographic eligibility. However, given that it is an EU funding opportunity related to rescEU stockpiles, it is highly likely that eligible applicants should be based in the EU or countries associated with the Union Civil Protection Mechanism (UCPM).

Target Sector: Health, specifically related to medical countermeasures (MCMs), pharmaceuticals, and the extension of shelf life for stockpiled medicines.

Mentioned Countries: No specific countries are mentioned, but the context implies EU member states due to the reference to rescEU and the Union Civil Protection Mechanism (UCPM).

Project Stage: Validation. The project focuses on testing the shelf-life extension of already stockpiled MCMs, indicating a validation or demonstration stage.

Funding Amount: The opportunity is described as a "low or middle value procedure," but the estimated total value is not provided in the text.

Application Type: Planned negotiated procedure. This means that after the expression of interest, the contracting authority will negotiate directly with selected candidates.

Nature of Support: Money. The selected laboratories will receive contracts for performing stability testing services.

Application Stages: At least two stages: expression of interest and a subsequent negotiated procedure for selected candidates.

Success Rates: Success rates are not mentioned.

Co-funding Requirement: Co-funding is not mentioned, so it is likely not required.

Summary:

This is a pre-announcement for a forthcoming negotiated procedure, not a call for tenders. The European Commission, specifically DG HERA and EMA, intends to launch a low or middle value contract to fund Official Medicines Control Laboratories (OMCLs) for shelf-life extension testing of medical countermeasures (MCMs) within the rescEU stockpile. The goal is to develop a policy framework for extending the shelf life of MCMs beyond their original expiration date through rigorous scientific testing and regulatory oversight. The pilot program will involve testing three specific MCMs: Imvanex, Succicaptal, and Cyanokit. The procedure will involve an initial expression of interest, followed by a negotiated procedure with a limited number of candidates. The indicative start date for expression of interest is 2025-10-06, with a deadline of 2025-10-18. The indicative date for the launch of the negotiated procedure is 2025-10-31. The selected laboratories will perform stability testing services. This initiative aims to enhance the sustainability of EU MCM stockpiles, reduce waste, and optimize stockpile management while ensuring the continued quality and efficacy of these critical medical resources. The CPV code is 73111000, related to laboratory services.