Nimetamine

OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) Ministry of Social Affairs (MSAE) legally represented by (Name of the legal representative of the nominated entity) Maarjo Mändmaa is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) Estonian Health Board (EHB) legally represented by (Name of the legal representative of the nominated entity) Birgit Lao is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) Estonian Health Board (EHB) legally represented by (Name of the legal representative of the nominated entity) Birgit Lao is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) Ministry of Climate (MCE) legally represented by (Name of the legal representative of the nominated entity) Marten Kokk, Secretary General is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) Estonian Environmental Board (EEB) legally represented by (Name of the legal representative of the nominated entity) Rainer Vakra, Director-General is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) Tallinn University of Technology (TalTech) legally represented by (Name of the legal representative of the nominated entity) Jana Holmar is the eligible Competent Authority/ ✔ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) National Institute of Health Development (NIHD) legally represented by (Name of the legal representative of the nominated entity) Annika Veimer is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa, Secretary General duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) Health and Welfare Information Systems Centre (TEHIK) legally represented by (Name of the legal representative of the nominated entity) Margus Arm is the eligible Competent Authority/ ✔ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) State Agency of Medicines (SAM) legally represented by (Name of the legal representative of the nominated entity) Katrin Kiisk is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER THE EU4HEALTH ANNUAL WORK PROGRAMME 2025 I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the nominating ministry/ governmental organisation) Ministry of Social Affairs of Estonia Officially notify the European Health and Digital Executive Agency that the entity (Name of the nominated entity and acronym) State Agency of Medicines (SAM) legally represented by (Name of the legal representative of the nominated entity) Katrin Kiisk is the eligible ✔ Competent Authority/ Affiliated Entity to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Joint Action to be co-funded under the Annual Work Programme 2025 1 of the EU4Health Programme 2: (please proceed to the next page) 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) 1  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 Date Place Tallinn, Estonia Name and Signature Maarjo Mändmaa ------------------------------------------------- (signature) 2 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. Saatja: "Tiiu Noobel" <[email protected]> Saaja: "Info - SOM" <[email protected]> Teema: Fwd: Invitation letter to nominate competent authorities for joint actions and other direct grants to MSs' authorities - EU4Health WP2025 - Ares(2025)6247236 Kuupäev: 2025-08-05 04:12 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 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 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Digital, EU4Health and Health systems modernisation Director Brussels, SANTE.C/MM/ (2025) Permanent Representations of EU Member States and Missions to the EU of Norway, Iceland, Ukraine, Moldova and Montenegro and Bosnia and Herzegovina Dear Madam, Dear Sir, I am pleased to inform you that on 23 July 2025, the Commission adopted the EU4Health Annual Work Programme 20251. This Work Programme encompasses two categories of direct grants, awarded without a call for proposals, to the competent authorities responsible for health in the Member States and in third countries associated to the EU4Health Programme, according to Article 13(5) of Regulation (EU) 2021/5222. These are Joint Actions and Direct Grants other than Joint Actions. I kindly invite you to initiate, on behalf of your Country, the process for the formal nomination of one or more competent authorities and, where applicable, their affiliated entities, for participation in these initiatives. The nomination timeline is as follows: Actions Deadline for Nomination Submission Joint Actions (single wave) 16/10/2025 Direct Grants other than JA (single wave) 20/11/2025 The deadline for nomination submission is strict and final. Annex I to this letter provides a comprehensive list of the aforementioned actions, as well as instructions on the procedure for nominating competent authorities. Additionally, Annex II offers an overview of the roles, responsibilities, and legal 1 2025 EU4Health Work Programme - European Commission 2 EUR-Lex - 32021R0522 - EN - EUR-Lex (europa.eu) Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111  requirements applicable to both the competent authorities and their affiliated entities. To support the nomination process, the European Health and Digital Executive Agency (HaDEA)3 will organise a general info day on the 18 September 2025 (tentative date) to provide information on the nomination process and on the relevant Joint Actions and Direct Grants other than Joint Actions. Once the nominations have been received, HaDEA will contact the nominated authorities with further details and invite them to dedicated hands-on workshops as follows (tentative dates): - Joint Actions workshop: 6 November 2025 - Direct Grants other than Joint Actions workshop: 16 December 2025 Questions related to the nomination of the competent authority(ies) can be sent to: [email protected]. To ensure your country’s participation, I would appreciate it if you could kindly forward this letter and the attached annexes to the relevant national authority or authorities. Yours faithfully, (e-signed) Marco MARSELLA Enclosure: Annex I – Instruction for the nomination process Annex II – Background information for the nomination process c.c.: EU4Health Steering Group Members EU4Health Programme Committee Members H. Weller, A. Peres, Z. Somogyi, P. Roux, M. Takki, F. Raffaelli, O. Solomon, B. Gautrais, F. Giorgio, F. Reviriego Gordejo (DG SANTE), D. Von Buxhoeveden, C. Schmaltz, O. Girard, A. Simon, A. Burgos Gutierrez, (HERA), F. Telea, N. Elhaggagi, G. Margetidis, C. Tripepi (HaDEA) 3 Vision, mission and values (europa.eu) Commission Electronically signedeuropéenne/Europese on 30/07/2025Commissie, 1049 Bruxelles/Brussel, 18:41 (UTC+02) in accordanceBELGIQUE/BELGIË with Article- Tel. 11 +32 22991111 of Commission Decision (EU) 2021/2121