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
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.
| Question | Question | Question | Question | Question | Question | Question | Indicator | |
| A.6.1 | Regarding your Member State’s prevention, preparedness, and response planning for public health emergencies, please indicate if your country uses: — A generic [prevention, preparedness and response plan? (yes/no) — Equivalent documents? (yes/no) — If yes, please describe: — Other, please describe: | Regarding your Member State’s prevention, preparedness, and response planning for public health emergencies, please indicate if your country uses: — A generic [prevention, preparedness and response plan? (yes/no) — Equivalent documents? (yes/no) — If yes, please describe: — Other, please describe: | Regarding your Member State’s prevention, preparedness, and response planning for public health emergencies, please indicate if your country uses: — A generic [prevention, preparedness and response plan? (yes/no) — Equivalent documents? (yes/no) — If yes, please describe: — Other, please describe: | Regarding your Member State’s prevention, preparedness, and response planning for public health emergencies, please indicate if your country uses: — A generic [prevention, preparedness and response plan? (yes/no) — Equivalent documents? (yes/no) — If yes, please describe: — Other, please describe: | Regarding your Member State’s prevention, preparedness, and response planning for public health emergencies, please indicate if your country uses: — A generic [prevention, preparedness and response plan? (yes/no) — Equivalent documents? (yes/no) — If yes, please describe: — Other, please describe: | Regarding your Member State’s prevention, preparedness, and response planning for public health emergencies, please indicate if your country uses: — A generic [prevention, preparedness and response plan? (yes/no) — Equivalent documents? (yes/no) — If yes, please describe: — Other, please describe: | Regarding your Member State’s prevention, preparedness, and response planning for public health emergencies, please indicate if your country uses: — A generic [prevention, preparedness and response plan? (yes/no) — Equivalent documents? (yes/no) — If yes, please describe: — Other, please describe: | N/A |
| A.6.2 | Regarding health emergency risk profiling and specific epidemic response plans, please indicate your Member State’s level: | Regarding health emergency risk profiling and specific epidemic response plans, please indicate your Member State’s level: | Regarding health emergency risk profiling and specific epidemic response plans, please indicate your Member State’s level: | Regarding health emergency risk profiling and specific epidemic response plans, please indicate your Member State’s level: | Regarding health emergency risk profiling and specific epidemic response plans, please indicate your Member State’s level: | Regarding health emergency risk profiling and specific epidemic response plans, please indicate your Member State’s level: | Regarding health emergency risk profiling and specific epidemic response plans, please indicate your Member State’s level: | Indicator 1-5 |
| A.6.2 | Level | Indicator 1-5 | ||||||
| A.6.2 | There is no routine health emergency risk profiling for serious cross-border threats to health | There is no routine health emergency risk profiling for serious cross-border threats to health | There is no routine health emergency risk profiling for serious cross-border threats to health | There is no routine health emergency risk profiling for serious cross-border threats to health | There is no routine health emergency risk profiling for serious cross-border threats to health | There is no routine health emergency risk profiling for serious cross-border threats to health | 1 | Indicator 1-5 |
| A.6.2 | There is routine health emergency risk profiling for serious cross-border threats to health | There is routine health emergency risk profiling for serious cross-border threats to health | There is routine health emergency risk profiling for serious cross-border threats to health | There is routine health emergency risk profiling for serious cross-border threats to health | There is routine health emergency risk profiling for serious cross-border threats to health | There is routine health emergency risk profiling for serious cross-border threats to health | 2 | Indicator 1-5 |
| A.6.2 | There is routine health emergency risk profiling for serious cross-border threats to health and this is undertaken at least once every 3 years | There is routine health emergency risk profiling for serious cross-border threats to health and this is undertaken at least once every 3 years | There is routine health emergency risk profiling for serious cross-border threats to health and this is undertaken at least once every 3 years | There is routine health emergency risk profiling for serious cross-border threats to health and this is undertaken at least once every 3 years | There is routine health emergency risk profiling for serious cross-border threats to health and this is undertaken at least once every 3 years | There is routine health emergency risk profiling for serious cross-border threats to health and this is undertaken at least once every 3 years | 3 | Indicator 1-5 |
| A.6.2 | There is routine health emergency risk profiling for serious cross-border threats to health, this is undertaken at least once every 3 years and specific plan(s) to these threats have been developed | There is routine health emergency risk profiling for serious cross-border threats to health, this is undertaken at least once every 3 years and specific plan(s) to these threats have been developed | There is routine health emergency risk profiling for serious cross-border threats to health, this is undertaken at least once every 3 years and specific plan(s) to these threats have been developed | There is routine health emergency risk profiling for serious cross-border threats to health, this is undertaken at least once every 3 years and specific plan(s) to these threats have been developed | There is routine health emergency risk profiling for serious cross-border threats to health, this is undertaken at least once every 3 years and specific plan(s) to these threats have been developed | There is routine health emergency risk profiling for serious cross-border threats to health, this is undertaken at least once every 3 years and specific plan(s) to these threats have been developed | 4 | Indicator 1-5 |
| A.6.2 | As per level 4 and, in addition, these plan(s) have been tested and revised as needed | As per level 4 and, in addition, these plan(s) have been tested and revised as needed | As per level 4 and, in addition, these plan(s) have been tested and revised as needed | As per level 4 and, in addition, these plan(s) have been tested and revised as needed | As per level 4 and, in addition, these plan(s) have been tested and revised as needed | As per level 4 and, in addition, these plan(s) have been tested and revised as needed | 5 | Indicator 1-5 |
| A.6.2 | — Additional comments: — If level 2 or above, please advise if your Member State has a plan in place which addresses the availability and use (i.e. development, manufacturing, procurement, stockpiling, and distribution) of threat-specific medical countermeasures (MCMs) in relation to: | — Additional comments: — If level 2 or above, please advise if your Member State has a plan in place which addresses the availability and use (i.e. development, manufacturing, procurement, stockpiling, and distribution) of threat-specific medical countermeasures (MCMs) in relation to: | — Additional comments: — If level 2 or above, please advise if your Member State has a plan in place which addresses the availability and use (i.e. development, manufacturing, procurement, stockpiling, and distribution) of threat-specific medical countermeasures (MCMs) in relation to: | — Additional comments: — If level 2 or above, please advise if your Member State has a plan in place which addresses the availability and use (i.e. development, manufacturing, procurement, stockpiling, and distribution) of threat-specific medical countermeasures (MCMs) in relation to: | — Additional comments: — If level 2 or above, please advise if your Member State has a plan in place which addresses the availability and use (i.e. development, manufacturing, procurement, stockpiling, and distribution) of threat-specific medical countermeasures (MCMs) in relation to: | — Additional comments: — If level 2 or above, please advise if your Member State has a plan in place which addresses the availability and use (i.e. development, manufacturing, procurement, stockpiling, and distribution) of threat-specific medical countermeasures (MCMs) in relation to: | — Additional comments: — If level 2 or above, please advise if your Member State has a plan in place which addresses the availability and use (i.e. development, manufacturing, procurement, stockpiling, and distribution) of threat-specific medical countermeasures (MCMs) in relation to: | Indicator 1-5 |
| A.6.2 | Development (yes/no) | Manufacturing (yes/no) | Procurement (yes/no) | Stockpiling (yes/no) | Distribution (yes/no) | Other: | Indicator 1-5 | |
| A.6.2 | Communicable diseases with epidemic or pandemic potential | Indicator 1-5 | ||||||
| A.6.2 | Chemical and biological-related threats | Indicator 1-5 | ||||||
| A.6.2 | Multi-drug resistant agents in a crisis situation | Indicator 1-5 | ||||||
| A.6.2 | — If yes to any of the above, please specify the agents of concern and related MCMs: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — If yes to any of the above, please specify the agents of concern and related MCMs: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — If yes to any of the above, please specify the agents of concern and related MCMs: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — If yes to any of the above, please specify the agents of concern and related MCMs: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — If yes to any of the above, please specify the agents of concern and related MCMs: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — If yes to any of the above, please specify the agents of concern and related MCMs: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — If yes to any of the above, please specify the agents of concern and related MCMs: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Indicator 1-5 |
| A.6.3 | Regarding your Member State’s specific epidemic response plan(s), please indicate which plan(s) have been developed and, where possible, provide link to the specific epidemic response plan(s): | Regarding your Member State’s specific epidemic response plan(s), please indicate which plan(s) have been developed and, where possible, provide link to the specific epidemic response plan(s): | Regarding your Member State’s specific epidemic response plan(s), please indicate which plan(s) have been developed and, where possible, provide link to the specific epidemic response plan(s): | Regarding your Member State’s specific epidemic response plan(s), please indicate which plan(s) have been developed and, where possible, provide link to the specific epidemic response plan(s): | Regarding your Member State’s specific epidemic response plan(s), please indicate which plan(s) have been developed and, where possible, provide link to the specific epidemic response plan(s): | Regarding your Member State’s specific epidemic response plan(s), please indicate which plan(s) have been developed and, where possible, provide link to the specific epidemic response plan(s): | Regarding your Member State’s specific epidemic response plan(s), please indicate which plan(s) have been developed and, where possible, provide link to the specific epidemic response plan(s): | N/A |
| A.6.4 | Regarding the national level Incident Management System (IMS) or equivalent structure, please indicate your Member State’s corresponding level: | Regarding the national level Incident Management System (IMS) or equivalent structure, please indicate your Member State’s corresponding level: | Regarding the national level Incident Management System (IMS) or equivalent structure, please indicate your Member State’s corresponding level: | Regarding the national level Incident Management System (IMS) or equivalent structure, please indicate your Member State’s corresponding level: | Regarding the national level Incident Management System (IMS) or equivalent structure, please indicate your Member State’s corresponding level: | Regarding the national level Incident Management System (IMS) or equivalent structure, please indicate your Member State’s corresponding level: | Regarding the national level Incident Management System (IMS) or equivalent structure, please indicate your Member State’s corresponding level: | Indicator 1-5 |
| A.6.4 | Level | Indicator 1-5 | ||||||
| A.6.4 | There is no IMS – or equivalent system – linking the public health sector with sectors involved in health preparedness and response planning | There is no IMS – or equivalent system – linking the public health sector with sectors involved in health preparedness and response planning | There is no IMS – or equivalent system – linking the public health sector with sectors involved in health preparedness and response planning | There is no IMS – or equivalent system – linking the public health sector with sectors involved in health preparedness and response planning | There is no IMS – or equivalent system – linking the public health sector with sectors involved in health preparedness and response planning | There is no IMS – or equivalent system – linking the public health sector with sectors involved in health preparedness and response planning | 1 | Indicator 1-5 |
| A.6.4 | There is no IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning there is a plan to create one in the next 3 years | There is no IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning there is a plan to create one in the next 3 years | There is no IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning there is a plan to create one in the next 3 years | There is no IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning there is a plan to create one in the next 3 years | There is no IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning there is a plan to create one in the next 3 years | There is no IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning there is a plan to create one in the next 3 years | 2 | Indicator 1-5 |
| A.6.4 | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning but this has not been tested or it has been tested more than 3 years ago | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning but this has not been tested or it has been tested more than 3 years ago | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning but this has not been tested or it has been tested more than 3 years ago | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning but this has not been tested or it has been tested more than 3 years ago | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning but this has not been tested or it has been tested more than 3 years ago | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning but this has not been tested or it has been tested more than 3 years ago | 3 | Indicator 1-5 |
| A.6.4 | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning and this has been tested in the last 3 years | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning and this has been tested in the last 3 years | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning and this has been tested in the last 3 years | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning and this has been tested in the last 3 years | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning and this has been tested in the last 3 years | There is an IMS or equivalent system linking the public health sector with sectors involved in health preparedness and response planning and this has been tested in the last 3 years | 4 | Indicator 1-5 |
| A.6.4 | As per level 4 and, in addition, the IMS has the capacity to adapt its command and control structure/hierarchy (e.g. its composition, depending on the nature of a potential event) | As per level 4 and, in addition, the IMS has the capacity to adapt its command and control structure/hierarchy (e.g. its composition, depending on the nature of a potential event) | As per level 4 and, in addition, the IMS has the capacity to adapt its command and control structure/hierarchy (e.g. its composition, depending on the nature of a potential event) | As per level 4 and, in addition, the IMS has the capacity to adapt its command and control structure/hierarchy (e.g. its composition, depending on the nature of a potential event) | As per level 4 and, in addition, the IMS has the capacity to adapt its command and control structure/hierarchy (e.g. its composition, depending on the nature of a potential event) | As per level 4 and, in addition, the IMS has the capacity to adapt its command and control structure/hierarchy (e.g. its composition, depending on the nature of a potential event) | 5 | Indicator 1-5 |
| A.6.4 | — Additional comments: | — Additional comments: | — Additional comments: | — Additional comments: | — Additional comments: | — Additional comments: | — Additional comments: | Indicator 1-5 |
| A.6.5 | Regarding the implementation and evaluation of public health and social measures (PHSMs) and in the case of a public health emergency, please indicate your Member State’s corresponding level: | Regarding the implementation and evaluation of public health and social measures (PHSMs) and in the case of a public health emergency, please indicate your Member State’s corresponding level: | Regarding the implementation and evaluation of public health and social measures (PHSMs) and in the case of a public health emergency, please indicate your Member State’s corresponding level: | Regarding the implementation and evaluation of public health and social measures (PHSMs) and in the case of a public health emergency, please indicate your Member State’s corresponding level: | Regarding the implementation and evaluation of public health and social measures (PHSMs) and in the case of a public health emergency, please indicate your Member State’s corresponding level: | Regarding the implementation and evaluation of public health and social measures (PHSMs) and in the case of a public health emergency, please indicate your Member State’s corresponding level: | Regarding the implementation and evaluation of public health and social measures (PHSMs) and in the case of a public health emergency, please indicate your Member State’s corresponding level: | Indicator 1-5 |
| A.6.5 | Level | Indicator 1-5 | ||||||
| A.6.5 | There is no mechanism for decision-making for the implementation of PHSMs during a public health emergency | There is no mechanism for decision-making for the implementation of PHSMs during a public health emergency | There is no mechanism for decision-making for the implementation of PHSMs during a public health emergency | There is no mechanism for decision-making for the implementation of PHSMs during a public health emergency | There is no mechanism for decision-making for the implementation of PHSMs during a public health emergency | There is no mechanism for decision-making for the implementation of PHSMs during a public health emergency | 1 | Indicator 1-5 |
| A.6.5 | There is a mechanism in place to support decision-making for the implementation of PHSMs during a public health emergency, but the multi-disciplinary and cross-sectoral nature is not fully defined | There is a mechanism in place to support decision-making for the implementation of PHSMs during a public health emergency, but the multi-disciplinary and cross-sectoral nature is not fully defined | There is a mechanism in place to support decision-making for the implementation of PHSMs during a public health emergency, but the multi-disciplinary and cross-sectoral nature is not fully defined | There is a mechanism in place to support decision-making for the implementation of PHSMs during a public health emergency, but the multi-disciplinary and cross-sectoral nature is not fully defined | There is a mechanism in place to support decision-making for the implementation of PHSMs during a public health emergency, but the multi-disciplinary and cross-sectoral nature is not fully defined | There is a mechanism in place to support decision-making for the implementation of PHSMs during a public health emergency, but the multi-disciplinary and cross-sectoral nature is not fully defined | 2 | Indicator 1-5 |
| A.6.5 | There is a mechanism for the implementation of PHSMs during a public health emergency and the multi-disciplinary and cross-sectoral nature is fully defined | There is a mechanism for the implementation of PHSMs during a public health emergency and the multi-disciplinary and cross-sectoral nature is fully defined | There is a mechanism for the implementation of PHSMs during a public health emergency and the multi-disciplinary and cross-sectoral nature is fully defined | There is a mechanism for the implementation of PHSMs during a public health emergency and the multi-disciplinary and cross-sectoral nature is fully defined | There is a mechanism for the implementation of PHSMs during a public health emergency and the multi-disciplinary and cross-sectoral nature is fully defined | There is a mechanism for the implementation of PHSMs during a public health emergency and the multi-disciplinary and cross-sectoral nature is fully defined | 3 | Indicator 1-5 |
| A.6.5 | There is a mechanism for the implementation of PHSMs during a public health emergency, which is multi-disciplinary and cross-sectoral and includes provisions for evaluating the timeliness and effectiveness of Non Pharmaceutical Interventions (NPIs) | There is a mechanism for the implementation of PHSMs during a public health emergency, which is multi-disciplinary and cross-sectoral and includes provisions for evaluating the timeliness and effectiveness of Non Pharmaceutical Interventions (NPIs) | There is a mechanism for the implementation of PHSMs during a public health emergency, which is multi-disciplinary and cross-sectoral and includes provisions for evaluating the timeliness and effectiveness of Non Pharmaceutical Interventions (NPIs) | There is a mechanism for the implementation of PHSMs during a public health emergency, which is multi-disciplinary and cross-sectoral and includes provisions for evaluating the timeliness and effectiveness of Non Pharmaceutical Interventions (NPIs) | There is a mechanism for the implementation of PHSMs during a public health emergency, which is multi-disciplinary and cross-sectoral and includes provisions for evaluating the timeliness and effectiveness of Non Pharmaceutical Interventions (NPIs) | There is a mechanism for the implementation of PHSMs during a public health emergency, which is multi-disciplinary and cross-sectoral and includes provisions for evaluating the timeliness and effectiveness of Non Pharmaceutical Interventions (NPIs) | 4 | Indicator 1-5 |
| A.6.5 | As per level 4 and, in addition, this mechanism has been tested in the last 3 years | As per level 4 and, in addition, this mechanism has been tested in the last 3 years | As per level 4 and, in addition, this mechanism has been tested in the last 3 years | As per level 4 and, in addition, this mechanism has been tested in the last 3 years | As per level 4 and, in addition, this mechanism has been tested in the last 3 years | As per level 4 and, in addition, this mechanism has been tested in the last 3 years | 5 | Indicator 1-5 |
| A.6.5 | — Additional comments: | — Additional comments: | — Additional comments: | — Additional comments: | — Additional comments: | — Additional comments: | Indicator 1-5 | |
| A.6.6 | Regarding provisions for cross-border mutual aid in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level: | Regarding provisions for cross-border mutual aid in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level: | Regarding provisions for cross-border mutual aid in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level: | Regarding provisions for cross-border mutual aid in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level: | Regarding provisions for cross-border mutual aid in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level: | Regarding provisions for cross-border mutual aid in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level: | Regarding provisions for cross-border mutual aid in the preparedness and response plan or equivalent document(s), please indicate your Member State’s corresponding level: | Indicator 1-5 or N/A |
| A.6.6 | Level | Indicator 1-5 or N/A | ||||||
| A.6.6 | Cannot answer question as Member State does not have a preparedness and response plan or equivalent document(s) | Cannot answer question as Member State does not have a preparedness and response plan or equivalent document(s) | Cannot answer question as Member State does not have a preparedness and response plan or equivalent document(s) | Cannot answer question as Member State does not have a preparedness and response plan or equivalent document(s) | Cannot answer question as Member State does not have a preparedness and response plan or equivalent document(s) | Cannot answer question as Member State does not have a preparedness and response plan or equivalent document(s) | N/A | Indicator 1-5 or N/A |
| A.6.6 | The preparedness and response plan or equivalent document(s) does not include cross-border mutual aid | The preparedness and response plan or equivalent document(s) does not include cross-border mutual aid | The preparedness and response plan or equivalent document(s) does not include cross-border mutual aid | The preparedness and response plan or equivalent document(s) does not include cross-border mutual aid | The preparedness and response plan or equivalent document(s) does not include cross-border mutual aid | The preparedness and response plan or equivalent document(s) does not include cross-border mutual aid | 1 | Indicator 1-5 or N/A |
| A.6.6 | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid | 2 | Indicator 1-5 or N/A |
| A.6.6 | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State | 3 | Indicator 1-5 or N/A |
| A.6.6 | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State and updated where relevant | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State and updated where relevant | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State and updated where relevant | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State and updated where relevant | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State and updated where relevant | The preparedness and response plan or equivalent document(s) includes cross-border mutual aid, and this has been tested with at least one Member State and updated where relevant | 4 | Indicator 1-5 or N/A |
| A.6.6 | As per level 4 and, in addition, information related to the cross-border mutual aid as well as results of the testing have been shared within the Health Security Committee (HSC) | As per level 4 and, in addition, information related to the cross-border mutual aid as well as results of the testing have been shared within the Health Security Committee (HSC) | As per level 4 and, in addition, information related to the cross-border mutual aid as well as results of the testing have been shared within the Health Security Committee (HSC) | As per level 4 and, in addition, information related to the cross-border mutual aid as well as results of the testing have been shared within the Health Security Committee (HSC) | As per level 4 and, in addition, information related to the cross-border mutual aid as well as results of the testing have been shared within the Health Security Committee (HSC) | As per level 4 and, in addition, information related to the cross-border mutual aid as well as results of the testing have been shared within the Health Security Committee (HSC) | 5 | Indicator 1-5 or N/A |
| A.6.6 | — Additional comments: — If level 2 or higher, please list the type of cross-border mutual aid included and with which Member State: | — Additional comments: — If level 2 or higher, please list the type of cross-border mutual aid included and with which Member State: | — Additional comments: — If level 2 or higher, please list the type of cross-border mutual aid included and with which Member State: | — Additional comments: — If level 2 or higher, please list the type of cross-border mutual aid included and with which Member State: | — Additional comments: — If level 2 or higher, please list the type of cross-border mutual aid included and with which Member State: | — Additional comments: — If level 2 or higher, please list the type of cross-border mutual aid included and with which Member State: | — Additional comments: — If level 2 or higher, please list the type of cross-border mutual aid included and with which Member State: | Indicator 1-5 or N/A |
| A.6.6 | Country/Grouping of Member State (please specify): | Country/Grouping of Member State (please specify): | Country/Grouping of Member State (please specify): | Country/Grouping of Member State (please specify): | Type of cross-border mutual aid (please specify): | Type of cross-border mutual aid (please specify): | Type of cross-border mutual aid (please specify): | Indicator 1-5 or N/A |
| A.6.6 | — If level 3 or higher, please list the Member States and type of cross-border mutual aid that has been tested: | — If level 3 or higher, please list the Member States and type of cross-border mutual aid that has been tested: | — If level 3 or higher, please list the Member States and type of cross-border mutual aid that has been tested: | — If level 3 or higher, please list the Member States and type of cross-border mutual aid that has been tested: | — If level 3 or higher, please list the Member States and type of cross-border mutual aid that has been tested: | — If level 3 or higher, please list the Member States and type of cross-border mutual aid that has been tested: | — If level 3 or higher, please list the Member States and type of cross-border mutual aid that has been tested: | Indicator 1-5 or N/A |
| A.6.6 | Country/Grouping of countries (please specify): | Country/Grouping of countries (please specify): | Country/Grouping of countries (please specify): | Country/Grouping of countries (please specify): | Type of cross-border mutual aid (please specify): | Type of cross-border mutual aid (please specify): | Type of cross-border mutual aid (please specify): | |
| A.6.6 | Your Member State cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please explain: | Your Member State cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please explain: | Your Member State cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please explain: | Your Member State cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please explain: | Your Member State cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please explain: | Your Member State cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please explain: | Your Member State cannot answer this question at the central state level due to governance and legislative frameworks? (yes) — In this case, please indicate if national level recommendations/guidelines are sent to regional authorities (yes/no) — If yes, please advise if at national level you know if these recommendations/guidelines are implemented at regional level and whether there are gaps or challenges identified: — If not, please explain: | |
| A.6.7 | Does your Member State’s preparedness and response plan or equivalent document(s) ensure specific national coordination mechanisms4 for preparedness and response in case of an intentional release scenario? (yes/no/other) — If yes, is the governance structure for response – between the health sector and other critical sectors for the management of the response – clear and defined? (yes/no) — If yes, please advise which sector leads the response: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State’s preparedness and response plan or equivalent document(s) ensure specific national coordination mechanisms4 for preparedness and response in case of an intentional release scenario? (yes/no/other) — If yes, is the governance structure for response – between the health sector and other critical sectors for the management of the response – clear and defined? (yes/no) — If yes, please advise which sector leads the response: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State’s preparedness and response plan or equivalent document(s) ensure specific national coordination mechanisms4 for preparedness and response in case of an intentional release scenario? (yes/no/other) — If yes, is the governance structure for response – between the health sector and other critical sectors for the management of the response – clear and defined? (yes/no) — If yes, please advise which sector leads the response: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State’s preparedness and response plan or equivalent document(s) ensure specific national coordination mechanisms4 for preparedness and response in case of an intentional release scenario? (yes/no/other) — If yes, is the governance structure for response – between the health sector and other critical sectors for the management of the response – clear and defined? (yes/no) — If yes, please advise which sector leads the response: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State’s preparedness and response plan or equivalent document(s) ensure specific national coordination mechanisms4 for preparedness and response in case of an intentional release scenario? (yes/no/other) — If yes, is the governance structure for response – between the health sector and other critical sectors for the management of the response – clear and defined? (yes/no) — If yes, please advise which sector leads the response: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State’s preparedness and response plan or equivalent document(s) ensure specific national coordination mechanisms4 for preparedness and response in case of an intentional release scenario? (yes/no/other) — If yes, is the governance structure for response – between the health sector and other critical sectors for the management of the response – clear and defined? (yes/no) — If yes, please advise which sector leads the response: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State’s preparedness and response plan or equivalent document(s) ensure specific national coordination mechanisms4 for preparedness and response in case of an intentional release scenario? (yes/no/other) — If yes, is the governance structure for response – between the health sector and other critical sectors for the management of the response – clear and defined? (yes/no) — If yes, please advise which sector leads the response: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | N/A |
Emergency logistic and supply chain management
| Question | Question | Question | Indicator | |
| Critical MCMs demand and supply | Critical MCMs demand and supply | Critical MCMs demand and supply | Critical MCMs demand and supply | Critical MCMs demand and supply |
| A.6.8 | Has your Member State identified critical MCMs for preparedness and response to serious cross-border threats to health? (yes/no/other) — If yes, is there a list? (yes/no) — If yes, please provide a hyperlink or the list itself. (Please include a hyperlink of these MCMs categorized by specific threats, if applicable.) — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Has your Member State identified critical MCMs for preparedness and response to serious cross-border threats to health? (yes/no/other) — If yes, is there a list? (yes/no) — If yes, please provide a hyperlink or the list itself. (Please include a hyperlink of these MCMs categorized by specific threats, if applicable.) — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Has your Member State identified critical MCMs for preparedness and response to serious cross-border threats to health? (yes/no/other) — If yes, is there a list? (yes/no) — If yes, please provide a hyperlink or the list itself. (Please include a hyperlink of these MCMs categorized by specific threats, if applicable.) — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | N/A |
| A.6.9 | Regarding national policies or plans for the monitoring of supply and estimating demand of critical MCMs, please indicate your Member State’s corresponding level: | Regarding national policies or plans for the monitoring of supply and estimating demand of critical MCMs, please indicate your Member State’s corresponding level: | Regarding national policies or plans for the monitoring of supply and estimating demand of critical MCMs, please indicate your Member State’s corresponding level: | Indicator 1-5 |
| A.6.9 | Level | Indicator 1-5 | ||
| A.6.9 | There are no foreseen national policies or plans for the monitoring of supply and estimating demand of critical MCMs | There are no foreseen national policies or plans for the monitoring of supply and estimating demand of critical MCMs | 1 | Indicator 1-5 |
| A.6.9 | National policies or plans for the monitoring of supply and estimating demand of critical MCMs are under consideration | National policies or plans for the monitoring of supply and estimating demand of critical MCMs are under consideration | 2 | Indicator 1-5 |
| A.6.9 | There are national policies or plans for the monitoring of supply and estimating demand of critical MCMs | There are national policies or plans for the monitoring of supply and estimating demand of critical MCMs | 3 | Indicator 1-5 |
| A.6.9 | There are national policies or plans for the monitoring the supply and estimate demand of critical MCMS, which are reviewed, evaluated and updated on a regular basis | There are national policies or plans for the monitoring the supply and estimate demand of critical MCMS, which are reviewed, evaluated and updated on a regular basis | 4 | Indicator 1-5 |
| A.6.9 | There are national policies or plans for the monitoring the supply and estimate demand of critical MCMs, which are reviewed, evaluated and updated on a regular basis including a gap analysis of supply and demand | There are national policies or plans for the monitoring the supply and estimate demand of critical MCMs, which are reviewed, evaluated and updated on a regular basis including a gap analysis of supply and demand | 5 | Indicator 1-5 |
| A.6.9 | — If yes, provide details of how the national policies and plans monitor supply and estimate demand: — Additional comments: | — If yes, provide details of how the national policies and plans monitor supply and estimate demand: — Additional comments: | — If yes, provide details of how the national policies and plans monitor supply and estimate demand: — Additional comments: | Indicator 1-5 |
| A.6.10 | Regarding the inclusion of provisions in the preparedness and response plan or equivalent document(s) or mechanisms to mitigate supply chain vulnerabilities of critical MCMs, please indicate your Member State’s corresponding level: | Regarding the inclusion of provisions in the preparedness and response plan or equivalent document(s) or mechanisms to mitigate supply chain vulnerabilities of critical MCMs, please indicate your Member State’s corresponding level: | Regarding the inclusion of provisions in the preparedness and response plan or equivalent document(s) or mechanisms to mitigate supply chain vulnerabilities of critical MCMs, please indicate your Member State’s corresponding level: | Indicator 1-5 |
| A.6.10 | Level | Indicator 1-5 | ||
| A.6.10 | There are no foreseen provisions in the preparedness and response plan or equivalent document(s) or mechanisms to mitigate supply chain vulnerabilities of critical MCMs | There are no foreseen provisions in the preparedness and response plan or equivalent document(s) or mechanisms to mitigate supply chain vulnerabilities of critical MCMs | 1 | Indicator 1-5 |
| A.6.10 | Provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs are under consideration | Provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs are under consideration | 2 | Indicator 1-5 |
| A.6.10 | There are provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs. However, these provisions are not yet implemented | There are provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs. However, these provisions are not yet implemented | 3 | Indicator 1-5 |
| A.6.10 | There are provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs. However, only some of them are implemented or under implementation | There are provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs. However, only some of them are implemented or under implementation | 4 | Indicator 1-5 |
| A.6.10 | There are provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs. These provisions are all implemented | There are provisions in the preparedness and response plan or equivalent document(s) or mechanism to mitigate supply chain vulnerabilities of critical MCMs. These provisions are all implemented | 5 | Indicator 1-5 |
| A.6.10 | — If yes, please provide details of the national policies: — Additional comments: | — If yes, please provide details of the national policies: — Additional comments: | Indicator 1-5 | |
| Production of MCMs | Production of MCMs | Production of MCMs | Production of MCMs | Production of MCMs |
| A.6.11 | Please indicate the critical MCMs referred in question A.6.8 that are currently produced in your Member State as follows: | Please indicate the critical MCMs referred in question A.6.8 that are currently produced in your Member State as follows: | N/A | |
| A.6.11 | Type of production | Product information (if raw materials or components please also add information on the MCMs for which the products are needed) | Economic operator information including address | N/A |
| A.6.11 | Full production including raw materials/components/active pharmaceutical ingredients (APIs) | N/A | ||
| A.6.11 | Finished products, please identify the MCM, the producer of the finished product and critical suppliers (including location) on which the production relies on | N/A | ||
| A.6.11 | Production of critical raw materials/components/APIs of MCMs: please identify the producer and relevant MCMs that need these materials for its manufacturing process. | N/A | ||
| A.6.11 | — Additional comments: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — Additional comments: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | — Additional comments: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | N/A |
| A.6.12 | Does your Member State have existing or planned arrangements to ensure that manufacturing of crisis-relevant MCMs can be scaled-up in a timely manner in times of crisis, for example through product or capacity reservation contracts or other mechanism.? (yes/no/other) — If yes, provide a list of specific MCMs and of type of arrangement: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State have existing or planned arrangements to ensure that manufacturing of crisis-relevant MCMs can be scaled-up in a timely manner in times of crisis, for example through product or capacity reservation contracts or other mechanism.? (yes/no/other) — If yes, provide a list of specific MCMs and of type of arrangement: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State have existing or planned arrangements to ensure that manufacturing of crisis-relevant MCMs can be scaled-up in a timely manner in times of crisis, for example through product or capacity reservation contracts or other mechanism.? (yes/no/other) — If yes, provide a list of specific MCMs and of type of arrangement: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | N/A |
| Strategic stockpiles 5 | Strategic stockpiles 5 | Strategic stockpiles 5 | Strategic stockpiles 5 | Strategic stockpiles 5 |
| A.6.13 | Does your Member State have national strategic stockpiles of MCMs? (yes/no/other) — If yes, please advise: — which MCMs are covered by this stockpile: — type of stockpile (virtual/physical): — size of the stock — If yes, please indicate how you manage your stockpile and if there are requirements for the deployment of the MCMs held within the stockpile: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State have national strategic stockpiles of MCMs? (yes/no/other) — If yes, please advise: — which MCMs are covered by this stockpile: — type of stockpile (virtual/physical): — size of the stock — If yes, please indicate how you manage your stockpile and if there are requirements for the deployment of the MCMs held within the stockpile: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | Does your Member State have national strategic stockpiles of MCMs? (yes/no/other) — If yes, please advise: — which MCMs are covered by this stockpile: — type of stockpile (virtual/physical): — size of the stock — If yes, please indicate how you manage your stockpile and if there are requirements for the deployment of the MCMs held within the stockpile: — If other, please describe: In accordance with Article 346(1) of the Treaty, no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security | N/A |
7. Health services provision
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.