HERA RAMP UP

Who can join?

RAMP UP is open to legal entities with a proven role in ensuring access to crisis-relevant MCMs.

Eligible organisations may include:

• Marketing authorisation holders and manufacturers of medicines

• Manufacturers of medical devices, personal protective equipment, and In Vitro Diagnostics (IVDs)

• Contract development and manufacturing organisations (CDMOs and CMOs)

• Suppliers of active pharmaceutical ingredients (APIs), raw and intermediate materials, consumables, drug substances and fill-finish services

• Innovators of advanced manufacturing technologies

For manufacturing and supply chain actors, RAMP UP focuses on organisations with relevance for the EU/EEA health emergency response. This may include organisations with manufacturing capacities or relevant services in the EU/EEA, or in countries with close trade and procurement links with the EU, where these capacities can support access to medical countermeasures for the EU/EEA.

Applications will be assessed by DG HERA on a case-by-case basis, including the organisation’s relevance to crisis-related MCM access and availability, and its compliance with the applicable eligibility requirements.

How will RAMP UP function?

RAMP UP will work through four practical pillars designed to support preparedness before a crisis and faster mobilisation if a health emergency occurs.

First, RAMP UP will provide a secure cooperation framework. Participating organisations will exchange information directly with DG HERA through secure channels, including the HERA Stakeholders Hub. Where relevant, information will be treated as sensitive non-classified and handled in line with applicable Commission rules, Hub terms and conditions, and confidentiality arrangements. Commercially sensitive information will not be exchanged between competitors.

Second, RAMP UP will support strategic knowledge and data sharing. DG HERA will use RAMP UP to build a more structured picture of relevant manufacturing and supply chain capacities, including product areas, manufacturing sites, technologies, geographic footprint and possible surge capacity. This will feed into the RAMP UP registry and help DG HERA identify relevant actors, capabilities and potential bottlenecks in preparedness and crisis situations.

As part of the roll-out, DG HERA will work with onboarded partners to shape the data submission template, format and procedures. The aim is to make data sharing practical, proportionate and useful, while avoiding unnecessary administrative burden. DG HERA will also seek to ensure that RAMP UP data-sharing arrangements are aligned with relevant EU-level processes, including cooperation with EMA and the Executive Steering Group on Shortages and Safety of Medicinal Products, where relevant. RAMP UP will be developed in a way that avoids unnecessary overlap with existing or future reporting channels, including those linked to the implementation of the new pharmaceutical legislation, without anticipating legal obligations before they apply.

Third, RAMP UP will strengthen readiness to supply. The information and exchanges under RAMP UP will help DG HERA better understand operational, manufacturing and contractual considerations before a crisis occurs. This may inform DG HERA’s internal preparedness work that could support faster and more effective procurement procedures in an emergency.

Fourth, RAMP UP will support partnerships and matchmaking. Members will be encouraged to use the HERA Stakeholders Hub to identify potential partners across the medical countermeasure ecosystem, including manufacturing, R&D, supply chain and technology actors. This can help organisations explore cooperation opportunities in preparedness time and support the creation of relevant partnerships if rapid scale-up is needed during a health emergency.

What does the membership involve?

By joining RAMP UP, your organisation becomes part of a voluntary preparedness network with DG HERA and can help shape how the initiative will work in practice.

As RAMP UP is rolled out, onboarded members will be invited to contribute to the development of a phased data submission process. This will help define what information is most useful, how it should be provided, and how future data exchanges can be organised in a practical and proportionate way.

Members may be asked to provide structured information on relevant manufacturing capabilities, technologies, product areas, production sites, supply chain role and possible surge capacity. This information will help DG HERA map industrial and manufacturing capacities, assess scalability and surge capabilities, evaluate supply chain resilience and technological readiness, support preparedness planning and crisis-readiness assessments, and identify relevant operators in health emergency or crisis response situations.

Information submitted through RAMP UP will be handled in line with the RAMP UP Terms and Conditions and the Notice on the handling of confidential information. Where information is identified as confidential, it will be treated as Sensitive Non-Classified information and access to identifiable company-level information will be restricted on a need-to-know basis.

RAMP UP is not designed to allow the exchange of commercially sensitive information between competitors. Information submitted under RAMP UP will be used for the purposes of implementing and operating the initiative, and any external communication based on RAMP UP data will be aggregated and will not disclose confidential information, unless explicitly agreed in advance with the organisation concerned.

Where relevant, and subject to the prior written consent of the organisation concerned, data may also be shared with EMA to help avoid duplicate data requests and support alignment with relevant EU-level processes.

RAMP UP implementation plan

The initial launch of RAMP UP is positioned as a pilot phase, focusing on engaging and onboarding stakeholders whose portfolios include medicinal products relevant for medical countermeasure preparedness. While the application process remains open to all eligible members, the first phase will focus on pharmaceutical companies with portfolios covering pharmacological classes identified for the purpose of this initial RAMP UP pilot phase. This will allow DG HERA and participating partners to test and refine the practical arrangements of the initiative, including data requirements, templates and data-sharing processes, while ensuring that these are proportionate and fit for purpose.

Applicants whose portfolios include medicinal products falling within the list of pharmacological classes for RAMP UP pilot phase are invited to apply. The pharmacological classes are provided solely to support applicants in assessing whether their portfolio falls within the scope of the pilot. These classes do not represent an exhaustive account of medical countermeasures and can be altered in the future. If you are unsure whether your portfolio includes MCMs relevant to RAMP UP initial phase, please contact the RAMP UP team at HERA-RAMP-UP@ec.europa.eu.

Building on the experience gained during this pilot phase, RAMP UP will progressively expand its scope to other medical countermeasure categories, including medical devices, in vitro diagnostics and personal protective equipment (PPE), as appropriate. This phased approach will enable DG HERA and participating partners to consolidate processes, ensure their usability and proportionality, and establish a foundation for scaling up RAMP UP across additional MCM areas.

Why to join RAMP UP

RAMP UP gives relevant organisations the opportunity to be part of a trusted preparedness network with DG HERA and to contribute directly to Europe’s health crisis readiness.

By joining RAMP UP, members can:

• establish a dedicated channel of communication with DG HERA on manufacturing, supply chain and crisis preparedness matters;

• be included in the RAMP UP registry, helping DG HERA identify relevant actors, capabilities and potential bottlenecks in preparedness and crisis situations;

• become more visible to DG HERA as part of the network of key players relevant to EU health crisis preparedness and response;

• help shape practical data submission templates, formats and procedures from the start;

• contribute industry insight that may inform DG HERA’s internal preparedness work;

• support the development of data-sharing procedures that are proportionate, practical and aligned with relevant EU-level processes, including EMA/MSSG-related work and the implementation of the new pharmaceutical legislation, where relevant;

• use the HERA Stakeholders Hub to identify potential partners and explore cooperation opportunities across the medical countermeasure ecosystem.

RAMP UP does not provide automatic access to procurement opportunities, privileged status in procurement procedures or a guarantee of future contracts. It is a preparedness partnership designed to improve mutual understanding, practical readiness and coordination before a crisis occurs. 

How to join

1. Register your organisation on the HERA Stakeholders Hub, if it is not already registered.

2. Complete the RAMP UP application form, including eligibility verification and background information.

3. DG HERA reviews your application and confirms eligibility.

4. Eligible organisations will receive further information in ad-hoc onboarding meeting.

Relevant documents