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OFFICIAL NOTIFICATION OF NOMINATION OF A COMPETENT AUTHORITY IN A JOINT ACTION UNDER ANNUAL WORK PROGRAMME 2021 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) State Agency of Medicines legally represented by (Name of the legal representative) Katrin Kiisk is the eligible Competent Authority 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 2021 1 of the EU4Health Programme 2: (please proceed next page) 1 C(2021) 4793 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-2021-JA-06: Direct grants to Member States’ authorities: availability of medicines, shortages and security of supply (AWP Ref.: CP-g-01.1.1) – Budget: 10 000 000 EUR EU4H-2021-JA-07: Direct grants to Member States’ authorities: Union and national surveillance systems (AWP Ref.: CP-g-02.1.1) – Budget: 7 000 000 EUR. EU4H-2021-JA-08.1: Direct grants to Member States’ authorities: implementation of best practices and research results on prevention of non-communicable diseases and risk factors (AWP Ref.: DP-g-07.1.1) – Budget: 4 000 000 EUR Thematic area Diabetes: Reverse Diabetes2 Now EU4H-2021-JA-08.2: Direct grants to Member States’ authorities: implementation of best practices and research results on prevention of non-communicable diseases and risk factors (AWP Ref.: DP-g-07.1.1) – Budget: 3 000 000 EUR Thematic area Healthy Lifestyle: - Smart Family - Grünau moves. Community-based health promotion and obesity prevention for children living in a deprived district EU4H-2021-JA-09: Direct grants to Member States’ authorities: transfer of best practices in primary care (AWP Ref.: HS-g-14.3.1) – Budget: 10 000 000 EUR EU4H-2021-JA-10: Direct grants to Member States’ authorities: health workforce to meet health challenges – forecasting and planning for workforce in the healthcare sector (AWP Ref.: HS-g-15.1.1) – Budget: 7 000 000 EUR. EU4H-2021-JA-11: Direct grants to Member States’ authorities: to promote quality of medicines and to increase cooperation between the Member States and between the Union and third countries through trainings, joint audits, reassessments and inspections on good manufacturing and good distribution practices (GDP). Implementation of international mutual recognition agreements on pharmaceutical good manufacturing practices (GMP) with the United States, Switzerland, Australia, Japan, New Zealand, Canada, Israel, the UK, and cooperation with third countries such as China and India (AWP Ref.: HS-g-18.2.1) – Budget: 2 150 000 EUR EU4H-2021-JA-12: Direct grants to Member States’ authorities: safety assessment cooperation and facilitated conduct of clinical trials (AWP Ref.: HS-g-18.3.1) – Budget: 4 500 000 EUR. Date Place 23.09.2022 Tallinn Name and Signature Maarjo Mändmaa Signature