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OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Health Board legally represented by (Name of the legal representative) Birgit Lao is the eligible Competent Authority/Affiliated Entity (delete as applicable) 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 2022 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP Ref: CP-g-22-02.01) – EUR 50 000 000 EU co- funding. EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01) – EUR 75 000 000 EU co-funding. EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed). EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR- g-22-10.03) – EUR 1 000 000 EU co-funding. EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Ministry of Social Affairs legally represented by (Name of the legal representative) Maarjo Mändmaa is the eligible Competent Authority/Affiliated Entity (delete as applicable) 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 2022 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP Ref: CP-g-22-02.01) – EUR 50 000 000 EU co- funding. EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01) – EUR 75 000 000 EU co-funding. EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed). EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR- g-22-10.03) – EUR 1 000 000 EU co-funding. EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Ministry of Social Affairs legally represented by (Name of the legal representative) Maarjo Mändmaa is the eligible Competent Authority/Affiliated Entity (delete as applicable) 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 2022 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP Ref: CP-g-22-02.01) – EUR 50 000 000 EU co- funding. EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01) – EUR 75 000 000 EU co-funding. EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed). EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR- g-22-10.03) – EUR 1 000 000 EU co-funding. EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Ministry of Social Affairs legally represented by (Name of the legal representative) Maarjo Mändmaa is the eligible Competent Authority/Affiliated Entity (delete as applicable) 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 2022 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP Ref: CP-g-22-02.01) – EUR 50 000 000 EU co- funding. EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01) – EUR 75 000 000 EU co-funding. EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed). EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR- g-22-10.03) – EUR 1 000 000 EU co-funding. EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Tartu University Hospital legally represented by (Name of the legal representative) Priit Perens is the eligible Competent Authority/Affiliated Entity (delete as applicable) 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 2022 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP Ref: CP-g-22-02.01) – EUR 50 000 000 EU co- funding. EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01) – EUR 75 000 000 EU co-funding. EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed). EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR- g-22-10.03) – EUR 1 000 000 EU co-funding. EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) National Institute for Health Development legally represented by (Name of the legal representative) Annika Veimer is the eligible Competent Authority/Affiliated Entity (delete as applicable) 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 2022 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP Ref: CP-g-22-02.01) – EUR 50 000 000 EU co- funding. EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01) – EUR 75 000 000 EU co-funding. EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed). EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR- g-22-10.03) – EUR 1 000 000 EU co-funding. EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Health Board legally represented by (Name of the legal representative) Birgit Lao is the eligible Competent Authority/Affiliated Entity (delete as applicable) 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 2022 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP Ref: CP-g-22-02.01) – EUR 50 000 000 EU co- funding. EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01) – EUR 75 000 000 EU co-funding. EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed). EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR- g-22-10.03) – EUR 1 000 000 EU co-funding. EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding. EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature Memo Kellele: FORMTEXT Ma a r jo Mändmaa Koopia: FORMTEXT Triin Uusberg , Heidi Alasepp, Nele Labi, Kersti Esnar , Heli Laarmann , Eda Lopato Kellelt: FORMTEXT Elen Ohov Kuupäev: FORMTEXT 25. 08 .20 2 2 Teema: FORMTEXT 202 2 .a EL terviseprogrammi ühistegevustes ja otsetoetuse projektides osalemine (teine laine) FORMCHECKBOX otsustamiseks FORMCHECKBOX teadmiseks Sisu/faktid EL terviseprogrammi 2021-2027 „EL tervise heaks“ raames viiakse läbi liikmesriikide pädevate asutuste koostööprojekte ehk ühistegevus i ( joint actions ) . Lisaks on pädevatel asustustel võimalik tööprogrammis kindlaks määratud teemadel taotleda otsetoetusi ( direct grants ). 2022.a tööprogrammi raames välja kuulutatud t eises laines on ühistegevustega liitumiseks ja otsetoetuste taotlemiseks p ädevate asutuse nimetamise tähtaeg 01.09.2022 . EL ü histegevustes osalemiseks nimetatakse iga liikmesriigi kohta üks pädev asutus põhipartnerina. Lisaks on võimalik projektides osaleda teistel organisatsioonidel seotud partnerina ( affiliated entity ) . Huvitatud liikmesriikide seast valitakse koordineeriv liikmesriik ja pädev asutus, kes korraldab taotlusdokumentide ettevalmistamise. T aotlus t e esitamise tähtaeg on jaanuaris 202 3 , grandilepingud sõlmitakse ja projekti de tegevused algavad augustis 2023 . Ühistegevuste kestus on üldjuhul 3 aastat. 202 2 .a algatatakse teises laines üheksa ühistegevust: EU4H-2022-JA-01: Direct grants to Member States’ authorities: implementation of AMR measures in Member States (AWP1 Ref: CP-g-22-02.01) – EUR 50 000 000 EU co-funding Peami sed tegevused : riiklike tegevuskavade väljatöötamine, EL infektsioonkontrolli standardi te rakendamine, strateegiad esmatasandi tervishoius, haiglates ja pikaajalise hoolduse asutustes, teadlikkuse tõstmine Eesti osalus: osaleme (põhipartner Terviseamet, kaasatud SoM ) EU4H-2022-JA-02: Direct grants to Member States’ authorities: Cancer and other NCDs prevention – action on health determinants (AWP Ref: CR-g-22-08.01)– EUR 75 000 000 EU co-funding Peami sed tegevused : 1) vähi esmane ja teisene ennetus - rahvastikupõhiseid ja/või suunatud ennetuskampaaniaid alkoholi- ja tubakatarbimi se vähendamiseks , kokkupuute vähendamine muude riskiteguritega , vähiskriining, uudsed käitumuslikud ja geneetilistel andmetel põhinevad ennetusmeetodid. 2) muud mittenakkushaigused – ennetamise parimad tavad, uurimistulemuste ja uuenduslike praktikate katsetamine, rahvatervise suuniste koostami ne , koolituse d ja mestimine, kommunikatsioon ja tervisealane kirjaoskus, tervis t edenda vad keskkonnad Eesti osalus: osaleme (põhipartner TAI, kaasatud SoM , EHK , Terviseamet ) EU4H-2022-JA-03: Direct grants to Member States’ authorities: prevention of NCDs – cardiovascular diseases and diabetes (AWP Ref: DP-g-22-06.03) – EUR 55 000 000 EU co-funding. One or two thematic joint actions (to be confirmed) Peami sed tegevused : parimate tavade rakendamine, uuenduslike meetodite katsetamine (sh varaja ne diagnoosimi ne), rahvatervise suuniste koostamine, uute poliitika meetmete väljatöötamine , koolitus, kommunikatsioon ja tervisealane kirjaoskus, tervisealase ebavõrdsuse vähendamine Eesti osalus: osaleme (põhipartner SoM, kaasatud TAI , Terviseamet ja EHK ) EU4H-2022-JA-04: Direct grant to Member States’ authorities: contribution to the Cancer Inequalities Registry to monitor national cancer control policies (AWP Ref: CR-g-22-10.03) – EUR 1 000 000 EU co-funding Peami sed tegevused : riiklike vähitõrje plaanide ja olukorra kvalitatiivne analüüs võrreldaval ja ajakohastatud kujul, andmed ja arusaamad sotsiaal-majandusliku ebavõrdsuse kohta Eesti osalus: osaleme ( põhipartner SoM, kaasatud TAI , Terviseamet ja EHK ) EU4H-2022-JA-05: Direct grants to Member States’ authorities: support ERNs integration to the national healthcare systems of Member States (AWP Ref: HS-g-22- 16.02) – EUR 11 200 000 EU co-funding. Peam ised tegevused : parimate tavade ja konkreetsete ettepanekute, suuniste, mudelite vahetamine ja soovitused ERN-ide paremaks integreerimiseks riiklikesse tervishoiusüsteemidesse, sealhulgas patsienditee konnad , suunamisprotseduurid, riiklike haruldaste haiguste võrgustikud ja suunised riiklike telekonsultatsioonivahendite väljatöötamiseks Eesti osalus: osaleme (põhipartner SA TÜK harvikhaiguste kompetentsikeskus ) EU4H-2022-JA-06: Direct grants to Member States’ authorities: increasing capacity building of the EU medicines regulatory network (AWP Ref: HS-g-22-17.02) – EUR 8 000 000 EU co-funding. Peami sed tegevused : toetada paremat koostööd ELi liikmesriikide vahel , koolitusmeetmed (koolituskursused ja sümpoosionid), parimate tavade jagamine (nt mentorluse/kõrge riskitaseme/keeruliste aruannete/toimikute hindamise kaudu), vahetusprogrammid ELi reguleeriva võrgustiku partnerite vahel lühikeste lähetuste ning töökoha juhendamise ja koolituse kaudu, samuti tihedas koostöös EMAga. Eesti osalus: ei osale (Ravimiameti hinnangul ei ole kohustuste võtmiseks ressurssi) EU4H-2022-JA-07: Direct grants to Member States’ authorities: piloting a new model approach for assessing and authorising novel Blood, Tissues and Cells (BTC) preparation processes (AWP Ref: HS-g-22-18.01) – EUR 1 500 000 EU co-funding Peami sed tegevused : GAPP metoodikat testimine uute arengute osas BTC erinevates alamsektorites (veri ja plasma transfusiooniks, koed ja rakud siirdamiseks, sugurakud reproduktiivmeditsiinis) Eesti osalus: ei osale (Ravimiameti hinnangul ei ole kohustuste võtmiseks ressurssi) EU4H-2022-JA-08: Direct grants to Member States’ authorities: reinforced market surveillance of medical devices and in vitro medical devices (AWP Ref: HS-g-22-19.01) – EUR 4 000 000 EU co-funding. Peami sed tegevused : toetada korrapärast turujärelevalve teabe vahetamist liikmesriikide pädeva te asutus te vahel, koostöö jõustamistegevus te alal , suutlikkuse tõstmine, ühised inspektsioonid Eesti osalus: osaleme ( põhipartner Terviseamet ) EU4H-2022-JA-09: Direct grants to Member States’ authorities: preparatory actions for a European Health Data Space ; primary use of data (for healthcare) and reuse of data (AWP Ref: DI-g-22-22.06) – EUR 4 000 000 EU co-funding. Peami sed tegevused : koostalitlusvõime suuniste ja tehniliste kirjelduste koostamine ( meditsiinilised ülesvõtted , laboritulemused jms), telemeditsiin, e-id lahenduste suunised, heaolurakenduste kvaliteedi- ja hindamisraamistik, EHR ja muu tarkvara hindamisraamistik Eesti osalus: osaleme (põhipartner SoM, kaasatud Terviseamet ja EHK ) Lisaks on EL terviseprogrammi 2022.a tööprogrammi raames teises laines välja kuulutatud otsetoetuse projektid , milles osalemiseks samuti tuleb nimetada pädevad asutused 01.09.2022 tähtajaks. Otsetoetuste taotluste esitamise tähtaeg on jaanuaris 2023 ja grandilepingud sõlmitakse juunis 2023. Otsetoetuste ( direct grants ) projektid 2022.a teises laines: EU4H-2022-DGA-MS-IBA-03: Direct grants to Member States’ authorities: expansion of MyHealth@EU Digital Service Infrastructure (eHDSI) with new services and to more Member States (AWP Ref: DI-g-22-21.01) – EUR 30 000 000 EU co-funding Peami sed tegevused : uute teenuste väljatöötamine ja juurutamine (meditsiinilised ülesvõtted , laboritulemused, statsionaarse ravi kokkuvõte, patsientide juurdepääs oma terviseandmetele); MyHealth@EU üldteenuste käitamine juba olemasolevate NCPeH-de jaoks Eesti osalus: osaleme (põhipartner TEHIK , kaasatud Terviseamet ) EU4H-2022-DGA-MS-IBA-04: Direct grants to Member States’ authorities: setting up services by Health Data Access Bodies – Secondary use of health data (AWP Ref: DI-g-22-22.01) – EUR 30 000 000 EU co-funding Peami sed tegevused : riiklikud teenused ja infrastruktuurid andmelubade menetlemiseks ja andmete väljastamiseks, turvaliste töötlemiskeskkondade loomine, metaandmete kataloogid; p iiriülesed teenused ja infrastruktuurid ; a ndmete kvaliteet Eesti osalus: osaleme (põhipartner TEHIK , kaasatud Terviseamet ) EU4H-2022-DGA-MS-IBA-05: Direct grants to Member States’ authorities: setting up a coordinated surveillance system under the One Health approach for cross-border pathogens that threaten the Union (AWP Ref: CP-g-22-04.01) – EUR 20 000 000 EU co-funding Peami sed tegevused : meede toetab suutlikkuse suurendamis t ja seiresüsteemide tugevdamist tekkivate ja uuesti esilekerkivate patogeenide avastamiseks loomadel ja keskkonnas . Järelevalvesüsteemi kavandab EFSA koostöös ECDCga, tihedas koostöös liikmesriikidega. Viiakse läbi katseprojektid, liikmesriikidel võimalik osta vajalikke diagnostika seadmeid ja vahendeid, koolituse d ja teadlikkuse tõstmi ne Eesti osalus: osaleme (põhipartner Terviseamet , kaasatud Põllumajandus- ja Toiduamet ) Hinnang/arvamus Pädeva asutuse nimetamisega Eestile rahalisi ja muid kohustusi ei kaasne, kuid see on eelduseks ühistegevuse ettevalmistuses osalemiseks ja otsetoetuse taotlemiseks . Kohustused võetakse toetuse taotluse ja konsortsiumilepingu allkirjastamisel. Projekti tööpaketid ja täpsem eelarve pannakse paika taotluse ettevalmistamise käigus, sh rahastamine ja omaosalus riikide lõikes. Projekti eelarvest kaetakse näiteks projekti juhtimisega seotud personalikulud, kohtumistel ja koolitustel osalemisega seotud reisi ja majutuskulud. Ühistegevuses osalusega seotud omafinantseeringu kulud (tavaliselt 20%) on võimalik katta ka mitte-rahalise (in-kind) panusena. Ettepanek/järeldus Kinnitada EL ühistegevustes ja otsetoetuse projektides osalemiseks pädevate asutuste nimetami se vormid . OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A DIRECT GRANT TO MEMBER STATES' AUTHORITIES UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Health and Welfare Information Systems Centre legally represented by (Name of the legal representative) Margus Arm is the eligible Competent Authority/Affiliated Entity (delete as applicable) to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Direct Grant to Member States' authorities to be co-funded under the Annual Work Programme 20221 of the EU4Health Programme2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-DGA-MS-IBA-01-01: Direct grants to Member States’ authorities: 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) (AWP Ref: CP-g-22-01.04) – EUR 39 000 000 EU co-funding (aggregate budget for sub-topic 1 and sub-topic 2). Sub-topic 1: Establishment of enhanced WGS and RT-PCR infrastructures and capacities in the Member States that have not already received support for such activities in 2021 from ECDC . EU4H-2022-DGA-MS-IBA-01-02: Direct grants to Member States’ authorities: 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) (AWP Ref: CP-g-22-01.04) – EUR 39 000 000 EU co-funding (aggregate budget for sub-topic1 and sub-topic 2). Sub-topic 2: Consolidation of WGS and RT-PCR activities in countries that received support in 2021 aiming to ensure the sustainable use and integration of enhanced infrastructure into routine surveillance and outbreak investigation activities, in synergy with relevant on-going work at international level. EU4H-2022-DGA-MS-IBA- 2: Direct grants to Member States’ authorities: supporting the maintenance of the European Medical Device Nomenclature (AWP Ref: HS-g-22-19.02) – EUR 1 800 000 EU co-funding It is essential that the Italian Health Ministry continues to provide its support and competences, ensuring adequate maintenance of the EMDN EU4H-2022-DGA-MS-IBA-03: Direct grants to Member States’ authorities: expansion of MyHealth@EU Digital Service Infrastructure (eHDSI) with new services and to more Member States (AWP Ref: DI-g-22-21.01) – EUR 30 000 000 EU co-funding EU4H-2022-DGA-MS-IBA-04: Direct grants to Member States’ authorities: setting up services by Health Data Access Bodies – Secondary use of health data (AWP Ref: DI-g-22-22.01) – EUR 30 000 000 EU co-funding EU4H-2022-DGA-MS-IBA-05: Direct grants to Member States’ authorities: setting up a coordinated surveillance system under the One Health approach for cross- border pathogens that threaten the Union (AWP Ref: CP-g-22-04.01) – EUR 20 000 000 EU co-funding Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A DIRECT GRANT TO MEMBER STATES' AUTHORITIES UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Health Board legally represented by (Name of the legal representative) Birgit Lao is the eligible Competent Authority/Affiliated Entity (delete as applicable) to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Direct Grant to Member States' authorities to be co-funded under the Annual Work Programme 20221 of the EU4Health Programme2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-DGA-MS-IBA-01-01: Direct grants to Member States’ authorities: 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) (AWP Ref: CP-g-22-01.04) – EUR 39 000 000 EU co-funding (aggregate budget for sub-topic 1 and sub-topic 2). Sub-topic 1: Establishment of enhanced WGS and RT-PCR infrastructures and capacities in the Member States that have not already received support for such activities in 2021 from ECDC . EU4H-2022-DGA-MS-IBA-01-02: Direct grants to Member States’ authorities: 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) (AWP Ref: CP-g-22-01.04) – EUR 39 000 000 EU co-funding (aggregate budget for sub-topic1 and sub-topic 2). Sub-topic 2: Consolidation of WGS and RT-PCR activities in countries that received support in 2021 aiming to ensure the sustainable use and integration of enhanced infrastructure into routine surveillance and outbreak investigation activities, in synergy with relevant on-going work at international level. EU4H-2022-DGA-MS-IBA- 2: Direct grants to Member States’ authorities: supporting the maintenance of the European Medical Device Nomenclature (AWP Ref: HS-g-22-19.02) – EUR 1 800 000 EU co-funding It is essential that the Italian Health Ministry continues to provide its support and competences, ensuring adequate maintenance of the EMDN EU4H-2022-DGA-MS-IBA-03: Direct grants to Member States’ authorities: expansion of MyHealth@EU Digital Service Infrastructure (eHDSI) with new services and to more Member States (AWP Ref: DI-g-22-21.01) – EUR 30 000 000 EU co-funding EU4H-2022-DGA-MS-IBA-04: Direct grants to Member States’ authorities: setting up services by Health Data Access Bodies – Secondary use of health data (AWP Ref: DI-g-22-22.01) – EUR 30 000 000 EU co-funding EU4H-2022-DGA-MS-IBA-05: Direct grants to Member States’ authorities: setting up a coordinated surveillance system under the One Health approach for cross- border pathogens that threaten the Union (AWP Ref: CP-g-22-04.01) – EUR 20 000 000 EU co-funding Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY OR AN AFFILIATED ENTITY IN A DIRECT GRANT TO MEMBER STATES' AUTHORITIES UNDER ANNUAL WORK PROGRAMME 2022 OF THE EU4HEALTH PROGRAMME I, Ms/Mr (Name, title, function) Maarjo Mändmaa duly authorised to sign this notification on behalf of the (Name of the ministry/ governmental organisation) Ministry of Social Affairs Officially notify the European Health and Digital Executive Agency that the organisation (Name of the participating organisation and Acronym) Health and Welfare Information Systems Centre legally represented by (Name of the legal representative) Margus Arm is the eligible Competent Authority/Affiliated Entity (delete as applicable) to participate on behalf of (Country, Regional entity) ESTONIA and under its responsibility in the following Direct Grant to Member States' authorities to be co-funded under the Annual Work Programme 20221 of the EU4Health Programme2: (please proceed next page) 1 C(2022) 317 final and its Annex 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.107.01.0001.01.ENG  EU4H-2022-DGA-MS-IBA-01-01: Direct grants to Member States’ authorities: 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) (AWP Ref: CP-g-22-01.04) – EUR 39 000 000 EU co-funding (aggregate budget for sub-topic 1 and sub-topic 2). Sub-topic 1: Establishment of enhanced WGS and RT-PCR infrastructures and capacities in the Member States that have not already received support for such activities in 2021 from ECDC . EU4H-2022-DGA-MS-IBA-01-02: Direct grants to Member States’ authorities: 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) (AWP Ref: CP-g-22-01.04) – EUR 39 000 000 EU co-funding (aggregate budget for sub-topic1 and sub-topic 2). Sub-topic 2: Consolidation of WGS and RT-PCR activities in countries that received support in 2021 aiming to ensure the sustainable use and integration of enhanced infrastructure into routine surveillance and outbreak investigation activities, in synergy with relevant on-going work at international level. EU4H-2022-DGA-MS-IBA- 2: Direct grants to Member States’ authorities: supporting the maintenance of the European Medical Device Nomenclature (AWP Ref: HS-g-22-19.02) – EUR 1 800 000 EU co-funding It is essential that the Italian Health Ministry continues to provide its support and competences, ensuring adequate maintenance of the EMDN EU4H-2022-DGA-MS-IBA-03: Direct grants to Member States’ authorities: expansion of MyHealth@EU Digital Service Infrastructure (eHDSI) with new services and to more Member States (AWP Ref: DI-g-22-21.01) – EUR 30 000 000 EU co-funding EU4H-2022-DGA-MS-IBA-04: Direct grants to Member States’ authorities: setting up services by Health Data Access Bodies – Secondary use of health data (AWP Ref: DI-g-22-22.01) – EUR 30 000 000 EU co-funding EU4H-2022-DGA-MS-IBA-05: Direct grants to Member States’ authorities: setting up a coordinated surveillance system under the One Health approach for cross- border pathogens that threaten the Union (AWP Ref: CP-g-22-04.01) – EUR 20 000 000 EU co-funding Date Place 30.08.2022 Tallinn Name and Signature Maarjo Mändmaa Signature