Legalize / European Union / Implementing Regulation

Commission Implementing Regulation (EU) 2023/1808 of 21 September 2023 setting out the template for the provision of information on prevention, preparedness and response planning in relation to serious cross-border threats to health in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council

Type Implementing Regulation

Publication 2023-09-22

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API


	Question	Question	Indicator
B.13.1	Do your Member State’s legal instruments for health response to a public health emergency incorporate coordination and cooperation at national-Union interface during a public health emergency? (yes/no/other) — If other, please describe:	Do your Member State’s legal instruments for health response to a public health emergency incorporate coordination and cooperation at national-Union interface during a public health emergency? (yes/no/other) — If other, please describe:	N/A
B.13.2	During a health emergency, is your Member State’s HSC representative incorporated into national level coordination structures, notably to support the flow of information between your Member State and the HSC? (yes/no/other) — If no, what is the role of the HSC representative in the national emergency response and if they do not act as the liaison with the HSC during public health emergencies, who does? — If other, please describe:	During a health emergency, is your Member State’s HSC representative incorporated into national level coordination structures, notably to support the flow of information between your Member State and the HSC? (yes/no/other) — If no, what is the role of the HSC representative in the national emergency response and if they do not act as the liaison with the HSC during public health emergencies, who does? — If other, please describe:	N/A
B.13.3	Is your Member State’s Public Health Emergency Operation Center or IMS interoperable with the Early Warning and Response System module for incident and/or crisis management? (yes/no/other) — If other, please describe:	Is your Member State’s Public Health Emergency Operation Center or IMS interoperable with the Early Warning and Response System module for incident and/or crisis management? (yes/no/other) — If other, please describe:	N/A
B.13.4	Over the last 3 years, has your Member State incorporated or factored in opinions and guidance from HSC for the prevention and control of serious cross-border threats to health? (yes/no/other/partial) — If yes, please describe how — If no, why — If other, please describe: — If partial, please describe:	Over the last 3 years, has your Member State incorporated or factored in opinions and guidance from HSC for the prevention and control of serious cross-border threats to health? (yes/no/other/partial) — If yes, please describe how — If no, why — If other, please describe: — If partial, please describe:	N/A
B.13.5	Over the last 3 years, has your Member State incorporated or factored in Commission’s recommendations on common temporary public health measures? (yes/no/other/partial) — If yes, please describe how — If no, why — If other, please describe: — If partial, please describe:	Over the last 3 years, has your Member State incorporated or factored in Commission’s recommendations on common temporary public health measures? (yes/no/other/partial) — If yes, please describe how — If no, why — If other, please describe: — If partial, please describe:	N/A
B.13.6	Over the last 3 years, has your Member State incorporated or factored in recommendations from the ECDC on response to health threats? (yes/no/other/partial) — If yes, please describe how — If no, why — If other, please describe: — If partial, please describe:	Over the last 3 years, has your Member State incorporated or factored in recommendations from the ECDC on response to health threats? (yes/no/other/partial) — If yes, please describe how — If no, why — If other, please describe: — If partial, please describe:	N/A
B.13.7	Please indicate if the following support roles, functions and instruments of the Commission and relevant Union agencies and bodies are considered in your Member State’s preparedness and response planning process:	Please indicate if the following support roles, functions and instruments of the Commission and relevant Union agencies and bodies are considered in your Member State’s preparedness and response planning process:	N/A
B.13.7		yes/no	N/A
B.13.7	Medical Evacuation Support via EWRS		N/A
B.13.7	European External Action Service (EEAS) for consular and repatriation support		N/A
B.13.7	Directorate-General for European Civil Protection and Humanitarian Aid Operations (DG ECHO) and its support capacities, including those in the ResEU reserve as well as the union Civil Protection Mechanism Prevention and Preparedness Projects (e.g. tenders and grants on developing cross-border health projects)		N/A
B.13.7	Directorate-General for Health Emergency and Response to support to medical countermeasures research and development, manufacturing, production, stockpiling and deployment (DG HERA)		N/A
B.13.7	DG HERA’s Emergency Office		N/A
B.13.7	Instruments for the mobilisation of EU funding for rapid research		N/A
B.13.7	Risk Assessment of the ECDC		N/A
B.13.7	Risk Assessment of the European Medicines Agency (EMA)		N/A
B.13.7	Risk Assessment of the European Food Safety Authority (EFSA)		N/A
B.13.7	Risk Assessment of the European Chemicals Agency (ECHA)		N/A
B.13.7	Risk Assessment of the European Environment Agency (EEA)		N/A
B.13.7	Risk Assessment of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)		N/A
B.13.7	Risk assessments carried out in cooperation with the European Union Agency for Law Enforcement Cooperation (Europol) where the threat is emanating from terrorist or criminal activity		N/A
B.13.7	Technical reports and guidance of the ECDC		N/A
B.13.7	Risk Assessment of the European Agency for occupational safety and health		N/A
B.13.7	ECDC’s ad-hoc support in preparedness and outbreak response (e.g. EU Health Task Force)		N/A
B.13.7	EU reference laboratories		N/A
B.13.7	Other, please specify:		N/A
B.13.7	— Additional comments:	— Additional comments:	N/A
B.13.8	— Does your Member State take into account the Union prevention, preparedness and response plan established in accordance with Article 5 () of Regulation (EU) 2022/2371, by including also cross-border interregional preparedness elements into your Member’s State preparedness and response plan or equivalent document(s)? If yes, please describe how — If no, why — If other, please describe:	— Does your Member State take into account the Union prevention, preparedness and response plan established in accordance with Article 5 () of Regulation (EU) 2022/2371, by including also cross-border interregional preparedness elements into your Member’s State preparedness and response plan or equivalent document(s)? If yes, please describe how — If no, why — If other, please describe:	N/A

14. Research development and evaluations to inform and accelerate emergency preparedness


	Question	Question	Question	Question	Indicator
B.14.1	Regarding the role of research in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level:	Regarding the role of research in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level:	Regarding the role of research in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level:	Regarding the role of research in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level:	Indicator 1-5 or N/A
B.14.1				Level	Indicator 1-5 or N/A
B.14.1	Member State cannot answer question as the Member State does not have preparedness and response plan or equivalent document(s)	Member State cannot answer question as the Member State does not have preparedness and response plan or equivalent document(s)	Member State cannot answer question as the Member State does not have preparedness and response plan or equivalent document(s)	N/A	Indicator 1-5 or N/A
B.14.1	A preparedness and response plan or equivalent document(s) is in place, but it does not include a strategy for emergency research and innovation	A preparedness and response plan or equivalent document(s) is in place, but it does not include a strategy for emergency research and innovation	A preparedness and response plan or equivalent document(s) is in place, but it does not include a strategy for emergency research and innovation	1	Indicator 1-5 or N/A
B.14.1	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, but no funding has been set aside for conducting research during health emergencies	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, but no funding has been set aside for conducting research during health emergencies	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, but no funding has been set aside for conducting research during health emergencies	2	Indicator 1-5 or N/A
B.14.1	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, and funding has been set aside for conducting research during health emergencies	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, and funding has been set aside for conducting research during health emergencies	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, and funding has been set aside for conducting research during health emergencies	3	Indicator 1-5 or N/A
B.14.1	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, funds have been set aside for conducting research during health emergencies and a process is in place for their swift mobilisation	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, funds have been set aside for conducting research during health emergencies and a process is in place for their swift mobilisation	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, funds have been set aside for conducting research during health emergencies and a process is in place for their swift mobilisation	4	Indicator 1-5 or N/A
B.14.1	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, funds have been set aside for health emergencies, a process is in place for their swift mobilisation and research and innovation capacities have been strengthened	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, funds have been set aside for health emergencies, a process is in place for their swift mobilisation and research and innovation capacities have been strengthened	A preparedness and response plan or equivalent document(s) that includes a strategy for emergency research and innovation is in place, funds have been set aside for health emergencies, a process is in place for their swift mobilisation and research and innovation capacities have been strengthened	5	Indicator 1-5 or N/A
B.14.1	— If level 2 or above: does the strategy for emergency research and innovation (in the preparedness and response plan or equivalent document(s)) include a process to link public health needs with research priorities and needs? (yes/no/other) — If yes, please describe this process — If other, please describe: — Additional comments:	— If level 2 or above: does the strategy for emergency research and innovation (in the preparedness and response plan or equivalent document(s)) include a process to link public health needs with research priorities and needs? (yes/no/other) — If yes, please describe this process — If other, please describe: — Additional comments:	— If level 2 or above: does the strategy for emergency research and innovation (in the preparedness and response plan or equivalent document(s)) include a process to link public health needs with research priorities and needs? (yes/no/other) — If yes, please describe this process — If other, please describe: — Additional comments:	— If level 2 or above: does the strategy for emergency research and innovation (in the preparedness and response plan or equivalent document(s)) include a process to link public health needs with research priorities and needs? (yes/no/other) — If yes, please describe this process — If other, please describe: — Additional comments:	Indicator 1-5 or N/A
B.14.2	Is your Member State part of a i) national, ii) Union-wide or iii) international network of clinical trial sites or cohorts to promote the participation in large-scale trials that have more chance to reach meaningful results in limited timeframes? (yes/no/other) — If yes, please specify (name and level)	Is your Member State part of a i) national, ii) Union-wide or iii) international network of clinical trial sites or cohorts to promote the participation in large-scale trials that have more chance to reach meaningful results in limited timeframes? (yes/no/other) — If yes, please specify (name and level)	Is your Member State part of a i) national, ii) Union-wide or iii) international network of clinical trial sites or cohorts to promote the participation in large-scale trials that have more chance to reach meaningful results in limited timeframes? (yes/no/other) — If yes, please specify (name and level)	Is your Member State part of a i) national, ii) Union-wide or iii) international network of clinical trial sites or cohorts to promote the participation in large-scale trials that have more chance to reach meaningful results in limited timeframes? (yes/no/other) — If yes, please specify (name and level)	N/A
		National	Union-wide	International
	Clinical Trial sites
	International network of cohorts
	— If other, please describe:	— If other, please describe:	— If other, please describe:	— If other, please describe:
B.14.3	Does your Member State have processes in place for the establishment of harmonised protocols and data collection within these networks? (yes/no/other) — If yes, please specify which ones: — If other, please describe:	Does your Member State have processes in place for the establishment of harmonised protocols and data collection within these networks? (yes/no/other) — If yes, please specify which ones: — If other, please describe:	Does your Member State have processes in place for the establishment of harmonised protocols and data collection within these networks? (yes/no/other) — If yes, please specify which ones: — If other, please describe:	Does your Member State have processes in place for the establishment of harmonised protocols and data collection within these networks? (yes/no/other) — If yes, please specify which ones: — If other, please describe:	N/A
B.14.4	Does your Member State have procedures in place for rapid site accreditation and for expedited coordinated (between the national competent authorities and ethics committees) clinical trial assessment and authorisation in the case of a public health emergency? (yes/no/other) — If yes, please specify, including cooperation with ethics committees: — If other, please describe:	Does your Member State have procedures in place for rapid site accreditation and for expedited coordinated (between the national competent authorities and ethics committees) clinical trial assessment and authorisation in the case of a public health emergency? (yes/no/other) — If yes, please specify, including cooperation with ethics committees: — If other, please describe:	Does your Member State have procedures in place for rapid site accreditation and for expedited coordinated (between the national competent authorities and ethics committees) clinical trial assessment and authorisation in the case of a public health emergency? (yes/no/other) — If yes, please specify, including cooperation with ethics committees: — If other, please describe:	Does your Member State have procedures in place for rapid site accreditation and for expedited coordinated (between the national competent authorities and ethics committees) clinical trial assessment and authorisation in the case of a public health emergency? (yes/no/other) — If yes, please specify, including cooperation with ethics committees: — If other, please describe:	N/A
B.14.5	Please advise if your Member State has an approach to operational (e.g. in action) research which includes:	Please advise if your Member State has an approach to operational (e.g. in action) research which includes:	Please advise if your Member State has an approach to operational (e.g. in action) research which includes:	Please advise if your Member State has an approach to operational (e.g. in action) research which includes:	N/A
			Yes	No
	Research preparedness, including predesigned protocols, partnerships, roles, and responsibilities in place in advance of a health emergency	Research preparedness, including predesigned protocols, partnerships, roles, and responsibilities in place in advance of a health emergency
	In case of a public health emergency, operational instruments in place so needed resources are available with means for rapid funding	In case of a public health emergency, operational instruments in place so needed resources are available with means for rapid funding
	In case of a public health emergency, operational instruments in place for rapid ethical clearance and data sharing	In case of a public health emergency, operational instruments in place for rapid ethical clearance and data sharing
	— Additional comments:	— Additional comments:	— Additional comments:	— Additional comments:

15. Recovery elements


	Question	Question	Indicator
B.15.1	Regarding your Member State’s recovery plan or the recovery section in your prevention preparedness and response plan or equivalent document(s), please indicate your Member State’s level:	Regarding your Member State’s recovery plan or the recovery section in your prevention preparedness and response plan or equivalent document(s), please indicate your Member State’s level:	Indicator 1-5
B.15.1		Level	Indicator 1-5
B.15.1	No recovery plan or recovery section in the preparedness and response plan or equivalent document(s) available	1	Indicator 1-5
B.15.1	Recovery plan or section available	2	Indicator 1-5
B.15.1	Recovery plan or section includes or links to a process of capturing lessons using After Actions Reviews (AARs) or Inter Action Reviews (IARs), and embedding them in practice through an action plan	3	Indicator 1-5
B.15.1	Recovery plan includes or links to a process of capturing lessons using AARs or IARS and embedding them in practice under an overarching framework such as the National Action Planning for Health Security (NAPHS) or equivalent. This process is implemented and regularly monitored at national level	4	Indicator 1-5
B.15.1	Recovery includes or links to a process of capturing lessons using AARs or IARS and embedding them in practice through NAPHS or equivalent. This process is implemented and regularly monitored at national and regional (sub-national) level	5	Indicator 1-5
B.15.1	— Additional comments:	— Additional comments:	Indicator 1-5

16. Actions taken to improve gaps found in the implementation of prevention, preparedness and response plans


	Question	Question	Indicator
B.16.1	Please upload your Member State’s most recent IHR State Party Annual Report as submitted by the National IHR Focal Point to WHO in pdf format	Please upload your Member State’s most recent IHR State Party Annual Report as submitted by the National IHR Focal Point to WHO in pdf format	Indicators IHR
B.16.2	Please indicate whether your Member State has used any of the following complementary mechanisms to assess the implementation of IHR capacities and prevention, preparedness, and response planning in the last 3 years: Tick where appropriate:	Please indicate whether your Member State has used any of the following complementary mechanisms to assess the implementation of IHR capacities and prevention, preparedness, and response planning in the last 3 years: Tick where appropriate:	N/A
B.16.2		Completed in the last 3 years? (Yes/No) (If published, please provide link)	N/A
B.16.2	Joint External Evaluation		N/A
B.16.2	In-action reviews		N/A
B.16.2	After action reviews		N/A
B.16.2	SimEx		N/A
B.16.2	Joint Assessment and Detection of Events		N/A
B.16.2	Other: please specify		N/A
B.16.2			N/A
B.16.3	Please indicate your Member State’s corresponding level regarding the NAPHS proposed by WHO or equivalent system:	Please indicate your Member State’s corresponding level regarding the NAPHS proposed by WHO or equivalent system:	Indicator 1-5
B.16.3		level	Indicator 1-5
B.16.3	NAPHS or equivalent system is not developed or under development	1	Indicator 1-5
B.16.3	NAPHS or equivalent system developed but not yet whole of government and one health for all hazards approach aligned	2	Indicator 1-5
B.16.3	NAPHS or equivalent system is developed and aligned with whole of government and one health for all hazards approach including defined roles, responsibilities, and collaborative mechanism	3	Indicator 1-5
B.16.3	NAPHS or equivalent system is developed and aligned with whole of government and one health for all hazards approach including definitions of roles, responsibilities, and collaborative mechanisms. In addition, the National Action Planning for Health Security or equivalent system has been costed	4	Indicator 1-5
B.16.3	As per level 4 and, in addition, at least one activity planned is being implemented	5	Indicator 1-5
B.16.3	— Additional comments: — If level 1: please advise if your Member State is planning to start a National Action Plan for Health Security or equivalent system: — All levels: if your Member State does not use the National Action Planning for Health Security, please describe the equivalent system:	— Additional comments: — If level 1: please advise if your Member State is planning to start a National Action Plan for Health Security or equivalent system: — All levels: if your Member State does not use the National Action Planning for Health Security, please describe the equivalent system:	Indicator 1-5

C. OTHER


C.1	Please describe your ideas on what further actions the Commission could undertake to support the implementation of prevention, preparedness, response, and recovery planning to serious cross-border threats to health:
C.2	Please provide any comments or clarifications in relation to the questions above and, if considered necessary, list any relevant activities that your country has conducted or provide additional information which is relevant to the topic of this questionnaire:

Here, in this question an organisation refers to an officially mandated group responsible for implementing the emergency plan

Automation refers to the surveillance process being embedded in the healthcare provision system with automatic extraction and sharing of relevant information, or other type of automation that reduces the dependency on human resources.

Here this refers to coordination between sectors such as security, justice, defence and civil protection that allows a specific mechanism for preparing and responding to an intentional release.

Stock of pharmaceuticals and medical equipment held by Member States to save lives in crisis.

Such as the hospital response and operational plan

This may include the health, civil protection and border control sectors for implementation, if needed, of dedicated measures such as quarantine, screening, NPIs, etc.

https://www.who.int/publications/m/item/tripartite-amr-country-self-assessment-survey---tracss-(6.0)-2022

Joint External Evaluation tool developed by the World Health Organization third edition, 2022

Ibid

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.