Nimetamine

Annex I Instructions for the nomination process.pdf

ANNEX I

INSTRUCTIONS FOR THE NOMINATION PROCESS

The nominations of the competent authorities and, where applicable, affiliated entities per Action

must be submitted by the competent authorities responsible for health in the Member States and in

third countries associated to the EU4Health Programme via the EU Survey platform.

The deadline for nomination submission is strict and final.

1) Submission of nominations for participation in Joint Actions (single wave):

The submission of nominations shall be made via the EU Survey platform at the following link:

https://ec.europa.eu/eusurvey/runner/EU4HEALTH_JA2025

Access password is: 2025JA#

The deadline for submission of nominations is 16/10/2025.

List of Joint Actions

- EU4H-2026-JA-HERA-IBA-01 – Direct grants to Member States’ authorities for the scaling

up of national systems for vector threat detection and control capacities (HERA) (CP-g-25-

02) – EUR 10 000 000 EU co-funding

- EU4H-2026-JA-HERA-IBA-02 – Direct grants to Member States’ authorities to implement

HERA’s training and exercise programme for management of medical countermeasures

(HERA) (CP-g-25-07) – EUR 2 947 923 EU co-funding

- EU4H-2026-JA-SANTE-IBA-01 – Direct grants to Member States’ authorities to support

the implementation of the strategic agenda for medical ionising radiation applications

(SAMIRA) (CR/CV&NCD-g-25-15) – EUR 11 500 000 EU co-funding

- EU4H-2026-JA-SANTE-IBA-02 – Direct grants to Member States’ authorities to support

lifelong prevention for a healthy life, including through screening, with focus on

cardiovascular diseases (CR/CV&NCD-g-25-17) – EUR 5 000 000 EU co-funding

- EU4H-2026-JA-SANTE-IBA-03 – Direct grants to Member States’ authorities to support

the implementation of a common standard for medical product identification and AI

capabilities across Member States (HS-g-25-19) – EUR 9 000 000 EU co-funding

- EU4H-2026-JA-SANTE-IBA-04 – Direct grants to Member States’ authorities on quality of

medicines and implementation of the pharmaceutical legislation and the Pharmaceutical

Strategy for Europe (HS-g-25-21) – EUR 2 300 000 EU co-funding

- EU4H-2026-JA-SANTE-IBA-05 – Direct grant to Member States to provide regulatory or

scientific advice to small and micro-enterprises to support the development and carrying out

of the conformity assessment of devices, particularly innovative devices, and to facilitate the

Union level coordination on medical device safety issues (HS-g-25-25) – EUR 4 000 000

EU co-funding

- EU4H-2026-JA-SANTE-IBA-06 – Direct grants to Member States’ authorities to support

implementation of the Clinical Trials Regulation and to improve the clinical trials landscape

with Member States and EEA countries, including through pilots and training (HS-g-25-27)

– EUR 4 700 000 EU co-funding

- EU4H-2026-JA-SANTE-IBA-07 – Direct grants to Member States’ authorities to support

non-commercial sponsors active in clinical trials (HS-g-25-28) – EUR 1 800 000 EU co-

funding

- EU4H-2026-JA-SANTE-IBA-08 – Direct grants to Member States’ authorities to maximise

the impact of the EU Global Health Strategy (HS-g-25-29) – EUR 2 500 000 EU co-funding

The indicative timeline for proposal submission is as follows:

- Opening submission date: 12/11/2025

- Submission deadline: 12/02/2026

2) Submission of nominations for participation in Direct Grants other than Joint Actions (single

wave):

The submission of nominations shall be made via the EUSurvey platform at the following link:

https://ec.europa.eu/eusurvey/runner/EU4HEALTH_DG2025

Access password is: 2025DG#

The deadline for submission of nominations is 20/11/2025

List of Direct Grants

- EU4H-2026-DGA-MS-HERA-IBA – Direct grant to Member States’ authorities for

enhancing whole genome sequencing (WGS) and/or reverse transcription polymerase chain

reaction (RT-PCR) national infrastructures and capacities to respond to the COVID-19

pandemic and future health threats (HERA) (CP-g-25-06) – EUR 5 000 000 EU co-funding

- EU4H-2026-DGA-MS-SANTE-IBA-01 – Direct grants to Member States’ authorities for

setting up a coordinated surveillance system under the One Health approach for cross-border

pathogens that threaten the Union (CP-g-25-08) – EUR 15 000 000 EU co-funding

- EU4H-2026-DGA-MS-SANTE-IBA-02 – Direct grants to Member States’ authorities for

supporting the maintenance of the European Medical Device Nomenclature (HS-g-25-23) –

EUR 1 500 000 EU co-funding

- EU4H-2026-DGA-MS-SANTE-IBA-03 – Direct grants to Member States’ authorities for

enhancing Health Data Access Bodies with particular focus on the secondary use of health

data (DI-g-25-30) – EUR 14 400 000 EU co-funding.

Indicative timeline for proposal submission

Opening submission date: 17/12/2025

Submission deadline: 12/03/2026

Annex II Background information for the nomination process.pdf

ANNEX II

BACKGROUND INFORMATION FOR THE NOMINATION PROCESS

Nomination of Multiple Competent Authorities and Affiliated Entities

Each country participating in the EU4Health Programme is invited to nominate one or more

competent authority(ies) in Joint Actions and Direct Grants to Member States other than Joint

Actions. The nominated authority(ies) shall act as grant beneficiary(ies) 1 and shall bear

responsibility for implementing the action on behalf of the nominating country.

The competent authority(ies) manage and carry out the action together with the project

coordinator (lead competent authority for the action) contributing with their own co-funding

and ensuring that the objectives of the action are met.

The nominated competent authority(ies) may involve in the grant under their responsibility

other participants such as affiliated entities and subcontractors. The names of the affiliated

entities shall be indicated by the competent authorities in the project proposal, together with the

activities they will perform2. Their names shall be indicated by the competent authorities in the

project proposal, together with the activities they will perform.

Legal Entities Eligibility

In order to be eligible for funding under the EU4Health Programme, competent authorities and

affiliated entities shall, in addition to the criteria set out in Article 200 of the Financial

Regulation3, be established in a Member State or an overseas country or territory linked to it, or

a third country associated to the Programme4. The invitation to submit proposals for the action in

question may also include additional specific eligibility criteria for the given action.

Direct grants to Member States in the framework of the implementation of the EU4Health

Programme5 are co-financed by the competent authorities that are responsible for health in the

Member States or in third countries associated to the Programme, or by public sector bodies, by

relevant international health organisations or non-governmental bodies that are mandated by

those competent authorities, regardless of whether those bodies act individually or as a network6

Understanding the Concept of Affiliated Entities

An entity affiliated to a beneficiary is an entity that fulfils the following conditions7:

a) complies with the eligibility and non-exclusion criteria applying to applicants, specifically,

1 Article 7 of the EU4H Model Grant Agreement. 2 It is worth noting that while the specific tasks of the affiliated entities and subcontractors shall be detailed in the proposal, only the affiliated

entities need to be explicitly identified in the proposal, due to their special status, as outlined in Article 8 of the EU4H Model Grant Agreement. 3 Article 200 of the Regulation - EU, Euratom - 2024/2509 - EN - EUR-Lex (Financial Regulation). 4 Article 13(1) of the Regulation (EU) 2021/522 of 24 March 2021 establishing a Programme for the Union’s action in the field of health

(‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014. 5 A direct grant to Member States (MS) in the form of a Joint Action is a grant consisting of a collaborative action among MS and third countries associated to the EU4Health Programme, inter alia, to develop, share, refine and test tools, methods and approaches to specific health

issues, and engage in capacity building in key areas of interest for several MS. A direct grant, without necessarily being a JA, can also be awarded to nominated competent authorities from the MS or third countries

associated to the EU4Health Programme, in line with the relevant rules set up in the EU4Health Regulation.

Direct grants involve co-financing by the Union, at the rates defined in Article 8(3) of the EU4Health Programme Regulation (EU) 2021/522. 6 Article 13(5) of EU4Health Programme Regulation (EU) 2021/522. 7 Article 190 of the Regulation - EU, Euratom - 2024/2509 - EN - EUR-Lex (Financial Regulation).

does not fall within one of the situations referred to in Articles 138(1) and 143(1) of the

Financial Regulation8.

b) has a structural link with a beneficiary, in particular a legal or capital link.

c) the structural link is neither limited to the action nor established for the sole purpose of its

implementation. This means that the link would exist independently of the award of the

grant; it should exist before the call for proposals and remain valid after the end of the

action.

Affiliated entities are entities with a legal link to the beneficiaries which implement parts of

the action and are allowed to charge costs directly to the grant.

‘Legal link to the beneficiaries’ means a legal or capital link, which is neither limited to the

action nor established for the sole purpose of its implementation. This covers:

• permanent legal structures (e.g., the relationship between an association and its

members);

• contractual cooperation not limited to the action (e.g., a collaboration agreement for

research in a particular field);

• capital link. i.e., direct or indirect control of the beneficiary.

In the public sphere, affiliated entities cover:

• The different levels of the administrative structure in case of decentralised

administration (e.g. national, regional or local administrations), or/and

• Public sector bodies (e.g. national institutes or schools for public health or national

research centres) which are (at least in part) publicly funded to deliver a public or

government service or are in situation of control by a state organization/other public

body.

What is not an affiliated entity?

• Entities that have entered into a (procurement) contract or subcontract with the

competent authority (beneficiary), or who act as concessionaires or delegates for public

services for the beneficiary.

• Entities that cooperate with the beneficiary on the basis of a memorandum of

understanding or share some assets.

While affiliated entities do not sign the grant agreement, they actively contribute to the

implementation of the action. Costs incurred by such entities for implementing the action will

be accepted as eligible costs. Affiliated entities do not have direct access to the Funding &

Tenders Portal, this is done via the beneficiaries to which they are affiliated.

Beneficiaries’ Responsibility for Compliance by Affiliated Entities

Where beneficiaries (competent authorities) involve affiliated entities to implement the action,

they shall retain full and sole responsibility towards the granting authority and the other

beneficiaries for the compliance of such entities with the terms of the Grant Agreement (GA)9.

8 Articles 138 (1) and 143 (1) of the Regulation - EU, Euratom - 2024/2509 - EN - EUR-Lex (Financial Regulation). 9 Articles 8 and 9 of the EU4Health Programme Grant Agreement.

Beneficiaries shall ensure that:

• all obligations arising from the GA are equally binding upon their affiliated entities

involved in the action;

• the bodies referred to in Article 25 of the GA10, including but not limited to the granting

authority, the European Anti-Fraud Office (OLAF), and the European Court of Auditors,

are granted the same rights of access and control in relation to the affiliated entities or

other participants as they have with respect to the beneficiaries themselves.

Any breach of the GA by an affiliated entity is handled in the same manner as breaches

by beneficiaries. Any amounts unduly paid as a result of such breach shall be subject to

recovery from the beneficiary, who shall remain liable for the reimbursement.

Please note that, before signing the Grant Agreement, the beneficiaries will have to sign a

Declaration of Honour where they must acknowledge to be fully responsible for their affiliated

entities which participate in the action.

Submission of the nominations via the EUSurvey Platform

The submission of nominations of competent authority(ies) and affiliated entity(ies) per action

under the EU4Health Programme 2025 shall be done through the EUSurvey platform 11

according to the instructions available there.

The European Health and Digital Executive Agency (HaDEA) reserves its right to assess the

regularity of the nomination procedure and to carry out checks. During this process, HaDEA

may request supporting documents, such as legal acts establishing the nominated organisation.

The two main steps for submission via the EUSurvey platform are as follows:

Step 1 - Instructions and completion of the nomination form:

The editable PDF template of the nomination form must be downloaded, duly completed,

printed, and signed by the nominating authority—typically the Ministry of Health or the national

Health Board.

Please note that the form has a character limit; all completed fields must remain fully visible and

legible prior to signature.

Step 2 - Submission of the nomination form:

The short online registration form must be completed in a manner that is fully consistent with

10 Articles 25 of the EU4Health Programme Grant Agreement. 11 The submission of nominations for Joint Actions shall be made via the EU Survey platform at the following link:

https://ec.europa.eu/eusurvey/runner/EU4HEALTH_JA2025 Access password is: 2025JA#

The submission of nominations for Direct Grants other than Joint Actions shall be made via the EUSurvey platform at the following link:

https://ec.europa.eu/eusurvey/runner/EU4HEALTH_DG2025 Access password is: 2025DG#

the information contained in the completed PDF nomination form. The scanned, signed version

of the nomination form must then be uploaded and the nomination submitted.

In case you need assistance, please contact: [email protected]

Privacy and Data Protection Policy

The nomination of Competent Authorities and their Affiliated Entities via the above EUsurvey

involves the processing of personal data in accordance with Regulation No 2018/172512. To

understand how these personal data will be collected, used and protected, we encourage you to

review the Privacy and Data Protection Statement.

12 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of personal data by the

European Union's institutions and bodies and on the free movement of such data.

E-kiri.eml

Tere!

Edastan.

Välisministeerium | Tiiu Noobel | [email protected]
---------- Forwarded message ----------

From: Raili Lillemets <[email protected]>
Date: 31 July 2025 at 17:25:18 EEST
Subject: Invitation letter to nominate competent authorities for joint actions and other direct grants to MSs' authorities - EU4Health WP2025 - Ares(2025)6247236
To: eko AGRI <[email protected]>,Esindus EL juures (Põllumajandustalitus) <[email protected]>

Tervitab
Raili

Raili LILLEMETS (Ms)
Permanent Representation of Estonia to
the EU
Secretary
+32 22274357 | +32 491357992
eu.mfa.ee | Rue Guimard 11/13,1040
Brussels

-----Original Message-----
From: SANTE CONSULT C4 <[email protected]>
Sent: Thursday, July 31, 2025 3:23 PM
To: (Mission of Bosnia and Herzegovina to the EU = Mission de Bosnie et Herzégovine auprès de l'UE) <[email protected]>; (Mission of Iceland to the EU = Mission de l'Islande auprès de l'UE) <[email protected]>; (Mission of Moldova to the EU = Mission de Moldova auprès de l'UE) <[email protected]>; (Mission of Montenegro to the EU = Mission du Monténégro auprès de l'UE) <[email protected]>; (Mission of Norway to the EU = Mission de la Norvège auprès de l'UE) <[email protected]>; (Mission of Ukraine to the EU = Mission d'Ukraine auprès de l'UE) <[email protected]>; (Permanent Representation of Austria = Représentation permanente de l'Autriche) <[email protected]>; (Permanent Representation of Belgium = Représentation permanente de la Belgique) <[email protected]>; (Permanent Representation of Bulgaria = Représentation permanente de la Bulgarie) <[email protected]>; (Permanent Representation of Croatia = Représentation permanente de la Croatie) <[email protected]>; (Permanent Representation of Cyprus = Représentation permanente de Chypre) <[email protected]>; (Permanent Representation of Denmark = Représentation permanente du Danemark) <[email protected]>; Esindus EL juures üldaadress <[email protected]>; (Permanent Representation of Finland = Représentation permanente de la Finlande) <[email protected]>; (Permanent Representation of France = Représentation permanente de la France) <[email protected]>; (Permanent Representation of Germany = Représentation permanente de l'Allemagne) <[email protected]>; (Permanent Representation of Greece = Représentation permanente de la Grèce) <[email protected]>; (Permanent Representation of Hungary = Représentation permanente de la Hongrie) <[email protected]>; (Permanent Representation of Ireland = Représentation permanente de l'Irlande) <[email protected]>; (Permanent Representation of Italy = Représentation permanente de l'Italie = Rappresentanza Permanente d’Italia presso l’Uni... <[email protected]>; (Permanent Representation of Latvia = Représentation permanente de la Lettonie) <[email protected]>; (Permanent Representation of Lithuania = Représentation permanente de la Lituanie) <[email protected]>; (Permanent Representation of Luxembourg = Représentation permanente du Luxembourg) <[email protected]>; (Permanent Representation of Malta = Représentation permanente de Malte) <[email protected]>; (Permanent Representation of Netherlands = Représentation permanente des Pays-Bas) <[email protected]>; (Permanent Representation of Poland = Représentation permanente de la Pologne) <[email protected]>; (Permanent Representation of Portugal = Représentation permanente du Portugal) <[email protected]>; (Permanent Representation of Romania = Représentation permanente de la Roumanie) <[email protected]>; (Permanent Representation of Slovakia = Représentation permanente de la Slovaquie) <[email protected]>; (Permanent Representation of Slovenia = Représentation permanente de la Slovénie) <[email protected]>; (Permanent Representation of Spain = Représentation permanente d'Espagne) <[email protected]>; (Permanent Representation of Sweden = Représentation permanente de Suède) <[email protected]>; (Permanent Representation of the Czech Republic to the European Union) <[email protected]>
Subject: Invitation letter to nominate competent authorities for joint actions and other direct grants to MSs' authorities - EU4Health WP2025 - Ares(2025)6247236

Dear Representatives of the EU Member States and Associated Countries to the EU4Health Programme,

Please find attached, on behalf of Director Marco Marsella, the invitation letter to nominate competent authorities for joint actions and other direct grants under the EU4Health annual work programme 2025.

Many thanks in advance for your cooperation.
Best regards,

EU4Health Programme Secretariat