### 2. the report shall include particular policy recommendations for increasing the level of cybersecurity across the union and a summary of the findings for the particular period from the agency’s eu cybersecurity technical situation reports issued by enisa in accordance with article 7(6) of regulation (eu) 2019/881. ### 2. the report shall include the obstacles identified at the national level , particular policy recommendations for increasing the level of cybersecurity across the union , and a summary of the findings for the particular period from the agency’s eu cybersecurity technical situation reports issued by enisa in accordance with article 7(6) of regulation (eu) 2019/881.


### (iii) the operational capabilities and effectiveness of csirts; ### (iii) the technical capabilities and effectiveness of csirts in executing their tasks;


### 4. peer reviews shall entail actual or virtual on-site visits and off-site exchanges. in view of the principle of good cooperation , the member states being reviewed shall provide the designated experts with the requested information necessary for the assessment of the reviewed aspects. any information obtained through the peer review process shall be used solely for that purpose. the experts participating in the peer review shall not disclose any sensitive or confidential information obtained in the course of that review to any third parties. ### 4. peer reviews shall entail actual or virtual on-site visits and off-site exchanges. in view of the principle of good cooperation , the designated experts tasked with carrying out the peer-review shall communicate the aspects under review as referred to in paragraph 1 , including any additional targeted issues specific to the member state or sectors referred to in paragraph 3 , and request a corresponding self-assessment report from the member states being reviewed. the member states being reviewed shall provide the designated experts with the requested information necessary for the assessment of the reviewed aspects. any information obtained through the peer review process shall be used solely for that purpose.


### 6. member state shall ensure that any risk of conflict of interests concerning the designated experts are revealed to the other member states , the commission and enisa without undue delay. ### 6. member states shall ensure that any risk of conflict of interests concerning the designated experts are revealed to the other member states , the commission and enisa , before the designation of experts referred to in paragraphs 1 and 2.


### incident handling (prevention , detection , and response to incidents); ### incident handling (prevention , detection , mitigation , response to , recovery from , and attribution of incidents);


### business continuity and crisis management; ### business continuity , disaster recovery and crisis management;


### where applicable , those entities shall notify , without undue delay , the recipients of their services that are potentially affected by a significant cyber threat of any measures or remedies that those recipients can take in response to that threat. where appropriate , the entities shall also notify those recipients of the threat itself. the notification shall not make the notifying entity subject to increased liability. ### deleted


### 8. at the request of the competent authority or the csirt , the single point of contact shall forward notifications received pursuant to paragraphs 1 and 2 to the single points of contact of other affected member states. ### 8. at the request of the competent authority or the csirt , the single point of contact shall forward notifications received pursuant to paragraph 1 to the single points of contact of other affected member states. in compliance with union law , or in accordance with member state legislation compliant with union law , the single point of contact shall preserve the security and commercial interests of the essential or important entity reporting the incident , including the confidentiality of the information provided by the reporting entity in the notification of the incident , when forwarding the notification to the single points of contact of other affected member states.


### 9. the single point of contact shall submit to enisa on a monthly basis a summary report including anonymised and aggregated data on incidents , significant cyber threats and near misses notified in accordance with paragraphs 1 and 2 and in accordance with article 27. in order to contribute to the provision of comparable information , enisa may issue technical guidance on the parameters of the information included in the summary report. ### 9. the single point of contact shall submit to enisa on a monthly basis a summary report including anonymised and aggregated data on incidents , significant cyber threats and near misses notified in accordance with paragraph 1 of this article , and article 27. in order to contribute to the provision of comparable information , enisa may issue technical guidance on the parameters of the information included in the summary report.


### 10. competent authorities shall provide to the competent authorities designated pursuant to directive (eu) xxxx/xxxx [resilience of critical entities directive] information on incidents and cyber threats notified in accordance with paragraphs 1 and 2 by essential entities identified as critical entities , or as entities equivalent to critical entities , pursuant to directive (eu) xxxx/xxxx [resilience of critical entities directive]. ### 10. competent authorities shall provide to the competent authorities designated pursuant to directive (eu) xxxx/xxxx [resilience of critical entities directive] information on incidents and cyber threats notified in accordance with paragraph 1 by essential entities identified as critical entities , or as entities equivalent to critical entities , pursuant to directive (eu) xxxx/xxxx [resilience of critical entities directive].


### 1. without prejudice to regulation (eu) 2016/679 , member states shall ensure that essential and important entities may exchange relevant cybersecurity information among themselves including information relating to cyber threats , vulnerabilities , indicators of compromise , tactics , techniques and procedures , cybersecurity alerts and configuration tools , where such information sharing: ### 1. member states shall ensure that essential and important entities may exchange relevant cybersecurity information among themselves including information relating to cyber threats , near misses , vulnerabilities , indicators of compromise , tactics , techniques and procedures , cybersecurity alerts and configuration tools , where such information sharing:


### make a public statement which identifies the legal and natural person(s) responsible for the infringement of an obligation laid down in this directive and the nature of that infringement; ### deleted


### suspend or request a certification or authorisation body to suspend a certification or authorisation concerning part or all the services or activities provided by an essential entity; ### where applicable , temporarily suspend or request a certification or authorisation body to temporarily suspend a certification or authorisation concerning part or all the services or activities provided by an essential entity until the entity takes the necessary action to remedy the deficiencies or comply with the requirements of the competent authority for which such sanctions were applied;


### these sanctions shall be applied only until the entity takes the necessary action to remedy the deficiencies or comply with the requirements of the competent authority for which such sanctions were applied. ### deleted


### the actual damage caused or losses incurred or potential damage or losses that could have been triggered , insofar as they can be determined. where evaluating this aspect , account shall be taken , amongst others , of actual or potential financial or economic losses , effects on other services , number of users affected or potentially affected; ### the actual damage caused or losses incurred including financial or economic losses , effects on other services , and the number of users affected;


### security scans based on objective , fair and transparent risk assessment criteria; ### security scans based on objective , non-discriminatory , fair and transparent risk assessment criteria;


### (7) with the repeal of directive (eu) 2016/1148 , the scope of application by sectors should be extended to a larger part of the economy in light of the considerations set out in recitals (4) to (6). the sectors covered by directive (eu) 2016/1148 should therefore be extended to provide a comprehensive coverage of the sectors and services of vital importance for key societal and economic activities within the internal market. the rules should not be different according to whether the entities are operators of essential services or digital service providers. that differentiation has proven obsolete , since it does not reflect the actual importance of the sectors or services for the societal and economic activities in the internal market. ### (7) with the repeal of directive (eu) 2016/1148 , the scope of application by sectors should be extended to a larger part of the economy in light of the considerations set out in recitals (4) to (6). the sectors covered by directive (eu) 2016/1148 should therefore be extended to provide a comprehensive coverage of the sectors and services of vital importance for key societal and economic activities within the internal market. the risk management requirements and reporting obligations should not be different according to whether the entities are operators of essential services or digital service providers. that differentiation has proven obsolete , since it does not reflect the actual importance of the sectors or services for the societal and economic activities in the internal market.


### (38) for the purposes of this directive , the term ‘risk’ should refer to the potential for loss or disruption caused by a cybersecurity incident and should be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of said incident. ### deleted


### (39) for the purposes of this directive , the term ‘near misses’ should refer to an event which could potentially have caused harm , but was successfully prevented from fully transpiring. ### deleted


### (40) risk-management measures should include measures to identify any risks of incidents , to prevent , detect and handle incidents and to mitigate their impact. the security of network and information systems should comprise the security of stored , transmitted and processed data. ### (40) risk-management measures should include measures to identify any risks of incidents , to prevent , detect , respond to , attribute , and recover from incidents , and to mitigate their impact. the security of network and information systems should comprise the security of stored , transmitted and processed data.


### (50) given the growing importance of number-independent interpersonal communications services , it is necessary to ensure that such services are also subject to appropriate security requirements in view of their specific nature and economic importance. providers of such services should thus also ensure a level of security of network and information systems appropriate to the risk posed. given that providers of number-independent interpersonal communications services normally do not exercise actual control over the transmission of signals over networks , the degree of risk for such services can be considered in some respects to be lower than for traditional electronic communications services. the same applies to interpersonal communications services which make use of numbers and which do not exercise actual control over signal transmission. ### (50) given the growing importance of number-independent interpersonal communications services , it is necessary to ensure that such services are also subject to appropriate security requirements in view of their specific nature and economic importance. providers of such services should thus also ensure a level of security of network and information systems appropriate to the risk posed. given that providers of number-independent interpersonal communications services normally do not exercise actual control over the transmission of signals over networks , the degree of risk to network security for such services can be considered in some respects to be lower than for traditional electronic communications services. the same applies to interpersonal communications services which make use of numbers and which do not exercise actual control over signal transmission. however , as the attack surface continues to expand , number-independent interpersonal communications services including , but not limited to , social media messengers , are becoming popular attack vectors. malicious actors use platforms to communicate and attract victims to open compromised web pages , therefore increasing the likelihood of incidents involving the exploitation of personal data , and by extension , the security of information systems.


### (71) in order to make enforcement effective , a minimum list of administrative sanctions for breach of the cybersecurity risk management and reporting obligations provided by this directive should be laid down , setting up a clear and consistent framework for such sanctions across the union. due regard should be given to the nature , gravity and duration of the infringement , the actual damage caused or losses incurred or potential damage or losses that could have been triggered , the intentional or negligent character of the infringement , actions taken to prevent or mitigate the damage and/or losses suffered , the degree of responsibility or any relevant previous infringements , the degree of cooperation with the competent authority and any other aggravating or mitigating factor. the imposition of penalties including administrative fines should be subject to appropriate procedural safeguards in accordance with the general principles of union law and the charter of fundamental rights of the european union , including effective judicial protection and due process. ### (71) in order to make enforcement effective , a minimum list of administrative sanctions for breach of the cybersecurity risk management and reporting obligations provided by this directive should be laid down , setting up a clear and consistent framework for such sanctions across the union. due regard should be given to the nature , gravity and duration of the infringement , the actual damage caused or losses incurred , the intentional or negligent character of the infringement , actions taken to prevent or mitigate the damage and/or losses suffered , the degree of responsibility or any relevant previous infringements , the degree of cooperation with the competent authority and any other aggravating or mitigating factor. the imposition of penalties including administrative fines should be subject to appropriate procedural safeguards in accordance with the general principles of union law and the charter of fundamental rights of the european union , including effective judicial protection and due process.


### (6) ‘incident handling’ means all actions and procedures aiming at detection , analysis and containment of and a response to an incident; ### (6) ‘incident handling’ means all actions and procedures aiming at prevention , detection , analysis , attribution , and containment of and response to an incident;


### (13) ‘domain name system (dns)’ means a hierarchical distributed naming system which allows end-users to reach services and resources on the internet; ### (13) ‘domain name system (dns)’ means a hierarchical distributed naming system which enables the identification of internet services and resources , allowing end-user devices to utilise internet routing and connectivity services , to reach those services and resources;


### (14) ‘dns service provider’ means an entity that provides recursive or authoritative domain name resolution services to internet end-users and other dns service providers; ### (14) ‘dns service provider’ means an entity that provides: a) open and public recursive domain name resolution services; or b) authoritative domain name resolution services as a service procurable by third-party entities;


### (15) ‘top–level domain name registry’ means an entity which has been delegated a specific tld and is responsible for administering the tld including the registration of domain names under the tld and the technical operation of the tld , including the operation of its name servers , the maintenance of its databases and the distribution of tld zone files across name servers; ### (15) ‘top–level domain name registry’ means an entity which has been delegated a specific tld and is responsible for administering the tld including the registration of domain names under the tld and the technical operation of the tld , including the operation of its name servers , the maintenance of its databases and the distribution of tld zone files across name servers , irrespective of whether any of those operations are being performed by the entity or are outsourced;


### (22) ‘social networking services platform’ means a platform that enables end-users to connect , share , discover and communicate with each other across multiple devices , and in particular , via chats , posts , videos and recommendations); ### (22) ‘social networking services platform’ means a platform that enables end-users to connect , share , discover and communicate with each other via number-independent interpersonal communications services across multiple devices , and in particular , via chats , posts , videos and recommendations;


### 1. each member state shall adopt a national cybersecurity strategy defining the strategic objectives and appropriate policy and regulatory measures , with a view to achieving and maintaining a high level of cybersecurity. the national cybersecurity strategy shall include , in particular , the following: ### 1. each member state shall adopt a national cybersecurity strategy defining the strategic objectives , the required technical , organisational , and financial resources to achieve those objectives , and the appropriate policy and regulatory measures , with a view to achieving and maintaining a high level of cybersecurity. the national cybersecurity strategy shall include , in particular , the following:


### 4. member states shall assess their national cybersecurity strategies at least every four years on the basis of key performance indicators and , where necessary , amend them. the european union agency for cybersecurity (enisa) shall assist member states , upon request , in the development of a national strategy and of key performance indicators for the assessment of the strategy. ### 4. member states shall assess their national cybersecurity strategies at least every four years on the basis of key performance indicators and , where necessary , amend them. the european union agency for cybersecurity (enisa) shall assist member states , upon request , in the development of a national strategy and of key performance indicators for the assessment of the strategy. enisa shall provide guidance to member states in order to align their already formulated national cybersecurity strategies with the requirements and obligations set out in this directive.


### 2. member states shall ensure that each csirt has adequate resources to carry out effectively their tasks as set out in article 10(2). ### 2. member states shall ensure that each csirt has adequate resources and the technical capabilities necessary to carry out effectively their tasks as set out in article 10(3).


### csirts shall be equipped with an appropriate system for managing and routing requests , in particular , to facilitate effective and efficient handovers; ### csirts shall be equipped with an appropriate system for classifying , routing , and tracking requests , in particular , to facilitate effective and efficient handovers;


### csirts shall be equipped with redundant systems and backup working space to ensure continuity of its services; ### csirts shall be equipped with redundant systems and backup working space to ensure continuity of its services , including full-spectrum connectivity across networks , information systems and services , and devices;


### contribution to the national cybersecurity incident and crisis response plan referred to in article 7 (3); ### contribution to the national cybersecurity incident and crisis response plan referred to in article 7 (4);


### 10. the competent authority shall review regularly , and at least every three years , whether the conditions for the authorisation under paragraph 6 still are met. the authorisation may be revoked when the collection target set out in paragraph 4 is not met or the producer or producer responsibility organisation is in material breach of its obligations according to paragraphs 1 to 3. ### 10. the competent authority shall review regularly , and at least every five years , whether the conditions for the authorisation under paragraph 6 still are met. the authorisation may be revoked when the collection target set out in paragraph 4 is not met or the producer or producer responsibility organisation is in material breach of its obligations according to paragraphs 1 to 3.


### 65 % by 31 december 2025; ### 50 % by 31 december 2025;


### chapter vii shall apply from 1 july 2023. ### chapter vii shall apply from 1 january 2024.


### 2. calls on the commission to continue strengthening intellectual property rights (ipr) protection and enforcement in non-eu countries through eu-funded technical cooperation programmes; welcomes in particular the intention to promote better generation and management of intellectual property (ip) on the african continent as part of a joint partnership building on the current four-year cooperation programme for africa; ### 2. calls on the commission to continue strengthening intellectual property rights (ipr) protection and enforcement in non-eu countries through eu-funded technical cooperation programmes by increasing funding for targeted technical assistance and capacity-building around ipr; welcomes in particular the intention to promote better generation and management of intellectual property (ip) on the african continent as part of a joint partnership building on the current four-year cooperation programme for africa;


### 3. strongly encourages the commission to assist producers and their associations as well as local authorities in developing countries in unlocking the potential of ip and reaping the economic value of local innovations , geographical indications and traditional knowledge; reiterates its call , in this regard , to respect the progress achieved in the international protection of indigenous peoples’ rights over their genetic resources and associated traditional knowledge; ### 3. calls on the commission to boost research to determine how the ip strategies of companies based in developing countries differ from firms located in developed countries , and how legal systems in developing countries address ip protection; strongly encourages the commission to assist producers and their associations as well as local authorities in developing countries in unlocking the potential of ip and reaping the economic value of local innovations , geographical indications and traditional knowledge; reiterates its call , in this regard , to respect the progress achieved in the international protection of indigenous peoples’ rights over their genetic resources and associated traditional knowledge;


### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; notes that strong iprs may limit access to medicines in developing countries while not necessarily encouraging pharmaceutical innovation that responds to the needs of developing countries; ### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; notes that strong iprs may limit access to medicines in developing countries while not necessarily encouraging pharmaceutical innovation that responds to the needs of developing countries; underlines , in this regard , that the current legal system on iprs is not boosting enough research on diseases that are recurrent in developing countries , such as malaria or zika , due to lack of potential profitability; calls on the commission and member states to increase efforts to offer qualified technical assistance and research funding in view of developing vaccines that prevent future outbreaks of such diseases;


### 5. welcomes , as a positive step , the recently announced us support for a proposal to temporarily waive certain provisions of the agreement on trade-related aspects of intellectual property rights for the prevention , containment and treatment of covid-19; urges the commission , therefore , to follow through on its promise to engage in active and constructive text-based negotiations at world trade organization level. ### 5. welcomes , as a positive step , the recently announced us support for a proposal to temporarily waive certain provisions of the agreement on trade-related aspects of intellectual property rights for the prevention , containment and treatment of covid-19; urges the commission , therefore , to follow through on its promise to engage in active and constructive text-based negotiations at world trade organization level and support the temporary waiver of sections 1 , 4 , 5 and 7 of part ii of the trips agreement in order to increase the production of covid-19 vaccines in the shortest time possible;


### 2. stresses that the proper functioning of the single market is key to safeguarding agri-food supplies across the eu and is the best tool to ensure recovery for all; notes that in some member states the covid-19 pandemic has led to certain types of local restrictions; recalls that national measures cannot undermine the fundamental principles of the single market; ### 2. stresses that the proper functioning of the single market is key to safeguarding sufficient , affordable and high quality agri-food supplies across the eu and is the best tool to ensure competitiveness , vibrant rural areas , decent incomes , a fair standard of living and a prompt recovery for the european agricultural community; notes that in some member states the covid-19 pandemic has led to certain types of local restrictions; recalls that national measures cannot undermine the fundamental principles of the single market;


### 3. highlights the importance of enhancing the resilience of regional and local food systems , as well as of short supply chains , as set out in the farm to fork strategy; stresses , however , that the strategy should not lead to additional barriers and greater fragmentation within the single market; ### 3. highlights the importance of enhancing the resilience of eu agri-food systems , including regional and local food systems , as well as of short supply chains , as set out in the farm to fork strategy; stresses , however , that the strategy should be based on a comprehensive ex-ante , scientific and cumulative impact assessment based on public consultations with representatives of the agri-food chain and other relevant stakeholders , and not lead to additional barriers and greater fragmentation within the single market;


### 4. notes the recent increase in national labelling requirements for food and drink products; underlines that these requirements must be justified and proportional , and should not create obstacles to the smooth movement of food products across the eu; ### 4. notes the recent increase in national labelling requirements for food and drink products; underlines that these requirements must be justified , proportional and in line with eu harmonized food and drink regulatory framework , especially with regard to safety issues , and should not create obstacles to the smooth movement of food products across the eu;


### 5. considers it unacceptable that quality differences exist between food products which are advertised and distributed in the single market under the same brand name and with the same packaging; welcomes the commission’s incentives to address the issue of dual food quality in the single market. ### 5. considers it unacceptable that differences , which are not due to legitimate factors such as consumers preferences , the place of manufacturing , specific local requirements , differences in technologies or in sourcing of raw materials , exist in the quality of food products which are advertised and distributed in the single market under the same brand name and with the same packaging; welcomes the commission’s incentives to address the issue of dual food quality and calls for the implementation of all the necessary measures in order to avoid any obastacle to the functioning of the european single market , taking into due account the existing differences in market conditions , purchasing powers and fiscal regimes among member states.


### (2) in light of the lessons learnt during the ongoing covid-19 pandemic and in order to facilitate adequate union-wide preparedness and response to all cross-border threats to health , the legal framework for epidemiological surveillance , monitoring , early warning of , and combating serious cross-border threats to health , as set out in decision no 1082/2013/eu , needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators , and cooperation by member states with the european centre for disease prevention and control (ecdc). moreover , in order to ensure effective union response to novel cross- border threats to health , the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of eu reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. the capacity for contact tracing should be strengthened via the creation of an automated system , using modern technologies. ### (2) in light of the lessons learnt during the ongoing covid-19 pandemic and in order to facilitate adequate union-wide preparedness and response to all cross-border threats to health , the legal framework for epidemiological surveillance , monitoring , early warning of , and combating serious cross-border threats to health , as set out in decision no 1082/2013/eu , needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators , and cooperation by member states with the european centre for disease prevention and control (ecdc). moreover , in order to ensure effective union response to novel cross- border threats to health , the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of eu reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. the capacity for contact tracing should be strengthened via the creation of an automated system , using modern technologies. further learning on the lessons from the covid-19 pandemic , the legal framework should set the basis to ensure supply chain resilience of critical medicines.


### (5) this regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods , which provide for special obligations and tools for monitoring , early warning and combatting specific threats of a cross-border nature. those measures include , in particular , relevant union legislation in the area of common safety concerns in public health matters , covering goods such as pharmaceutical products , medical devices and foodstuffs , substances of human origin (blood , tissues and cells , organs) , and exposure to ionising radiation. ### (5) this regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods , which provide for special obligations and tools for monitoring , early warning and combatting specific threats of a cross-border nature. those measures include , in particular , relevant union legislation in the area of common safety concerns in public health matters , covering goods such as pharmaceutical products , medical devices and foodstuffs , in vitro diagnostic medical devices and applications , substances of human origin (blood , plasma , tissues and cells , organs) , and exposure to ionising radiation.


### (6) the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec. ### (6) the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous union policies and activities. in order to achieve a high level of human health protection , and to avoid any overlap of activities , duplication or conflicting actions , the commission , in liaison with the member states , should ensure coordination and exchange of information between the mechanisms and structures established under this regulation , and other mechanisms and structures established at union level and under the treaty establishing the european atomic energy community (the euratom treaty) , the activities of which are relevant to the preparedness and response planning , monitoring , early warning of , and combating serious cross-border threats to health. in particular , the commission should ensure that relevant information from the various rapid alert and information systems at union level and under the euratom treaty is gathered and communicated to the member states through the early warning and response system (‘ewrs’) set up by decision no 2119/98/ec. all actions should be consistent with the who’s one health approach , as well as with the health in all policies principle , recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies.


### (7) preparedness and response planning are essential elements for effective monitoring , early warning of and combatting serious cross-border threats to health. as such , a union health crisis and pandemic preparedness plan needs to be established by the commission and approved by the hsc. this should be coupled with updates to member states’ preparedness and response plans so as to ensure they are compatible within the regional level structures. to support member states in this endeavour , targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the commission and union agencies. to ensure the putting into operation and the running of these plans , the commission should conduct stress tests , exercises and in-action and after-action reviews with member states. these plans should be coordinated , be functional and updated , and have sufficient resources for their operationalisation. following stress tests and reviews of the plans , corrective actions should be implemented and the commission should be kept informed of all updates. ### (7) preparedness and response planning are essential elements for effective monitoring , early warning of and combatting serious cross-border threats to health. as such , a union health crisis and pandemic preparedness plan needs to be established by the commission and approved by the hsc. this should be coupled with updates to member states’ preparedness and response plans so as to ensure they are compatible within the regional level structures. where appropriate , regional authorities should participate in the drawing of these plans. to support member states in this endeavour , targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the commission and union agencies , facilitating the sharing of best practices. to ensure the putting into operation and the running of these plans , the commission should conduct stress tests , exercises and in-action and after-action reviews with member states. these plans should be coordinated , be functional and updated , and have sufficient resources for their operationalisation. following stress tests and reviews of the plans , corrective actions should be implemented and the commission should be kept informed of all updates.


### (8) to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national preparedness and response plans are adequate. in order to support the assessment of these plans , eu audits in member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical sectors of society , such as energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. ### (8) to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level , and regional level where applicable. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national and regional preparedness and response plans are adequate. in order to support the assessment of these plans , eu audits in member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical sectors of society , such as energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning.


### (1) a network for the epidemiological surveillance and control of communicable diseases was set up by decision no 2119/98/ec of the european parliament and of the council.13 its scope was extended by decision no 1082/2013/eu of the european parliament and of the council14 to strengthen and provide for a further coordinated and wider approach to health security at union level. the implementation of that legislation confirmed that coordinated union action on monitoring , early warning of and combating those threats adds value to the protection and improvement of human health. ### (1) a network for the epidemiological surveillance and control of communicable diseases was set up by decision no 2119/98/ec of the european parliament and of the council.13 its scope was extended by decision no 1082/2013/eu of the european parliament and of the council14 to strengthen and provide for a further coordinated and wider approach to health security at union level. the implementation of that legislation confirmed that coordinated union action on monitoring , early warning of and combating those threats adds value to the protection and improvement of human health. the implementation of this legislation is another sign with which the union is committed to the conclusions of the global conference on primary health care of astana of 25 and 26 october 2018.


### (3) an important role in the coordination of preparedness and response planning for serious cross-border threats to health is being played by the health security committee (hsc) , as formally established by decision no 1082/2013/eu. this committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support member states in the prevention and control of serious cross-border threats to health. ### (3) an important role in the coordination of preparedness and response planning for serious cross-border threats to health is being played by the health security committee (hsc) , as formally established by decision no 1082/2013/eu. this committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support member states in the prevention and control of serious cross-border threats to health. the european parliament should nominate observers for the hsc.


### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 . ### (9) as serious cross-border threats to health are not limited to union borders , joint procurement of medical countermeasures should be extended to include european free trade association states and union candidate countries , in accordance with the applicable union legislation. the joint procurement agreement , determining the practical arrangements governing the joint procurement procedure established under article 5 of decision no 1082/2013/eu , should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure , to allow for better coordination within the eu. this exclusivity clause should entail that the member states participating in the joint procurement procedure will not be allowed to negotiate and sign parallel contracts with producers. in case these member states negotiate and sign parallel contracts , they should be excluded from the group of participating countries. the commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this regulation and other relevant union structures related to procurement and stockpiling of medical countermeasures , such as the strategic resceu reserve under decision no 1313/2013/eu of the european parliament and of the council16 .


### (10) unlike for communicable diseases , the surveillance of which at union level is carried out on a permanent basis by the ecdc , other potentially serious cross-border threats to health do not currently necessitate monitoring by eu agencies. a risk-based approach , whereby monitoring is carried out by member states and available information is exchanged through ewrs , is therefore more appropriate for such threats. ### (10) unlike for communicable diseases , the surveillance of which at union level is carried out on a permanent basis by the ecdc , other potentially serious cross-border threats to health do not currently necessitate monitoring by eu agencies. a risk-based approach , whereby monitoring is carried out by member states and available information is exchanged through ewrs , is therefore more appropriate for such threats. the ecdc should also monitor the impact of communicable diseases on diseases that are not communicable(such as mental diseases) , taking into account existing datasets , tools and registers.


### (11) the commission should strengthen cooperation and activities with the member states , the ecdc , the european medicines agency (‘ema’) , other union agencies , research infrastructures and the who to improve the prevention of communicable diseases , such as vaccine preventable diseases , as well as other health issues , such as antimicrobial resistance. ### (11) the commission should strengthen cooperation and activities with the member states , the ecdc , the european medicines agency (‘ema’) , other union agencies , research infrastructures and the who to improve the prevention of communicable diseases , such as vaccine preventable diseases , as well as other health issues , such as antimicrobial resistance , cancer , and mental health.


### (12) in case of cross-border health threats due to a communicable disease , the blood and transplant services in the member states can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. these services in return are dependent on rapid risk assessments by the ecdc to safeguard patients , in need of a therapy from a substance of human origin , from a transmission of such communicable disease. such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. the ecdc should therefore set up and operate a network of national blood and transplant services and their authorities to serve this dual purpose. ### (12) in case of cross-border health threats due to a communicable disease , the blood and transplant services in the member states can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. these services in return are dependent on rapid risk assessments by the ecdc to safeguard patients , in need of a therapy from a substance of human origin , from a transmission of such communicable disease. such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. the ecdc should therefore set up and operate a network of national and regional blood , plasma and transplant services and their authorities to serve this dual purpose.


### (13) a system enabling the notification at union level of alerts related to serious cross-border threats to health has been put in place by decision no 2119/98/ec in order to ensure that competent public health authorities in member states and the commission are duly informed in a timely manner. all serious cross-border threats to health covered by this regulation are covered by the ewrs. the operation of the ewrs should remain within the remit of the ecdc. the notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one member state and require or could require a coordinated response at the union level. to avoid duplication and ensure coordination across union alert systems , the commission and ecdc should ensure that alert notifications under the ewrs and other rapid alert systems at union level are linked to each other to the extent possible so that the competent authorities of the member states can avoid as much as possible notifying the same alert through different systems at union level and can benefit from receiving all-hazard alerts from a single coordinated source. ### (13) a system enabling the notification at union level of alerts related to serious cross-border threats to health has been put in place by decision no 2119/98/ec in order to ensure that competent public health authorities in member states and the commission are duly informed in a timely manner. all serious cross-border threats to health covered by this regulation are covered by the ewrs. the operation of the ewrs should remain within the remit of the ecdc. the notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one member state and require or could require a coordinated response at the union level. to avoid duplication and ensure coordination across union alert systems , the commission and ecdc should ensure that alert notifications under the ewrs and other rapid alert systems at union level are linked to each other to the extent possible so that the competent authorities of the member states can avoid as much as possible notifying the same alert through different systems at union level and can benefit from receiving all-hazard alerts from a single coordinated source. the notification system of the ewrs should be an electronic , digital , interoperable platform which may also be built upon distributed ledger technology (dlt) and include data from national and regional competent authorities. finally , this platform should also be linked to the health dataspace.


### (14) in order to ensure that the assessment of risks to public health at the union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective , the available scientific expertise should be mobilised in a coordinated manner , through appropriate channels or structures depending on the type of threat concerned. that assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence , independence , impartiality and transparency. the involvement of union agencies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach , via a permanent network of agencies and relevant commission services to support the preparation of risk assessments. ### (14) in order to ensure that the assessment of risks to public health at the union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective , the available scientific expertise should be mobilised in a coordinated manner , through appropriate channels or structures depending on the type of threat concerned. that assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence , independence , impartiality and transparency. the involvement of union agencies and commission bodies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach , via a permanent network of agencies and relevant commission services to support the preparation of risk assessments. in order to achieve a sufficient degree of increased expertise and competences , there should also be an increase of the respective financial and human resources of union agencies and bodies.


### (15) the member states have a responsibility to manage public health crises at national level. however , measures taken by individual member states could affect the interests of other member states if they are inconsistent with one another or based on diverging risk assessments. the aim to coordinate the response at union level should , therefore , seek to ensure , inter alia , that measures taken at national level are proportionate and limited to public health risks related to serious cross-border threats to health , and do not conflict with obligations and rights laid down in the treaty on the functioning of the european union such as those related to free movement of persons , goods and services. ### (15) the member states have a responsibility to manage public health crises at national and regional level. however , measures taken by individual member states could affect the interests of other member states if they are inconsistent with one another or based on diverging risk assessments. the aim to coordinate the response at union level should , therefore , seek to ensure , inter alia , that measures taken at national and regional level are proportionate and limited to public health risks related to serious cross-border threats to health , and do not conflict with obligations and rights laid down in the treaty on the functioning of the european union such as those related to free movement of persons , goods and services.


### (16) to this effect , the hsc responsible for the coordination of response at union level , should assume additional responsibility for the adoption of opinions and guidance for member states related to the prevention and control of a serious cross border threats to health. furthermore , should the coordination of national public health measures prove insufficient to ensure an adequate union response , the commission should further support member states via the adoption of recommendations on temporary public health measures. ### (16) to this effect , the hsc responsible for the coordination of response at union level , should assume additional responsibility for the adoption of opinions and guidance for member states related to the prevention and control of a serious cross border threats to health. furthermore , should the coordination of national and regional public health measures prove insufficient to ensure an adequate union response , the commission should further support member states via the adoption of recommendations on temporary public health measures.


### (17) inconsistent communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. the coordination of the response within the hsc , assisted by relevant subgroups , should , therefore , encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication , based on robust and independent evaluation of public health risks , to be adapted to national needs and circumstances. such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. given the cross-sectoral nature of this type of crises , coordination should also be ensured with other relevant constituencies , such as the union civil protection mechanism established by decision (eu) 2019/420 of the european parliament and of the council17 . ### (17) inconsistent communication with the public and stakeholders such as healthcare professionals as well as those dedicated to research , development and innovation , can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. the coordination of the response within the hsc , assisted by relevant subgroups , should , therefore , encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication , based on robust and independent evaluation of public health risks , to be adapted to national and regional needs and circumstances. in those member states with regions having health competences , the information should also come from these regions towards their member state and the commission. such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. given the cross-sectoral nature of this type of crises , coordination should also be ensured with other relevant constituencies , such as the union civil protection mechanism established by decision (eu) 2019/420 of the european parliament and of the council17 .


### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’. ### (18) the recognition of public health emergency situations and the legal effects of this recognition provided by decision no 1082/2013/eu should be broadened. to this end , this regulation should allow for the commission to formally recognise a public health emergency at union level , taking into account the urgency of the situation where the commission may have to recognise the public health emergency level. in order to recognise such an emergency situation , the commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at union level , and advise on public health response measures and on the termination of this emergency recognition. the advisory committee should consist of independent experts , selected by the commission from the fields of expertise and experience most relevant to the specific threat that is occurring , representatives of the ecdc , of the ema , and of other union bodies or agencies as observers , therefore without any type of decision-making competence in order to guarantee that the commission can act accordingly to the urgent need of recognising the public health emergency at union level. recognition of a public health emergency at union level will provide the basis for introducing operational public health measures for medical products and medical devices , flexible mechanisms to develop , procure , manage and deploy medical countermeasures as well as the activation of support from the ecdc to mobilise and deploy outbreak assistance teams , known as ‘eu health task force’


### (19) before recognising a situation of public health emergency at union level , the commission should liaise with the who in order to share the commission’s analysis of the situation of the outbreak and to inform the who of its intention to adopt such a decision. where such a recognition is adopted , the commission should also inform the who thereof. ### (19) before recognising a situation of public health emergency at union level , the commission should liaise with the who in order to share the commission’s analysis of the situation of the outbreak and to inform the who of its intention to adopt such a decision. where such a recognition is adopted , the commission should also inform the who thereof. the liaison with the who should not question the union’s strategic autonomy in countering the serious cross-border threats or outbreaks within its borders.


### (22) the processing of personal data for the purpose of implementing this regulation should comply with regulation (eu) 2016/679 and regulation (eu) 2018/1725 of the european parliament and of the council19 . in particular , the operation of the ewrs should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by member states at national level. in this regard , the ewrs includes a messaging function in which personal data , including contact and health data , can be communicated to relevant authorities involved in contact tracing measures. ### (22) the processing of personal data for the purpose of implementing this regulation should comply with regulation (eu) 2016/679 and regulation (eu) 2018/1725 of the european parliament and of the council19 . in particular , the operation of the ewrs should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by member states at national and regional level. in this regard , the ewrs includes a messaging function in which personal data , including contact and health data , can be communicated to relevant authorities involved in contact tracing measures.


### (24) as responsibility for public health is not an exclusively national matter in certain member states , but is substantially decentralised , national authorities should , where appropriate , involve the relevant competent authorities in the implementation of this regulation. ### (24) as responsibility for public health is not an exclusively national matter in certain member states , but is substantially decentralised , national and regional authorities should , where appropriate , involve the relevant competent authorities in the implementation of this regulation.


### (25) in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and , where necessary , for other serious cross-border threats to health subject to ad hoc monitoring; the procedures for the operation of the ewrs; the functioning of the surveillance platform; the designation of eu reference laboratories to provide support to national reference laboratories; the procedures for the information exchange on and the coordination of the responses of the member states; the recognition of situations of public health emergency at union level and the termination of such a recognition and procedures necessary to ensure that the operation of the ewrs and the processing of data are in accordance with the data protection legislation. ### (25) in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and , where necessary , for other serious cross-border threats to health subject to ad hoc monitoring; the procedures for the operation of the ewrs; the functioning of the surveillance platform; the designation of eu reference laboratories to provide support to national and regional reference laboratories; the procedures for the information exchange on and the coordination of the responses of the member states; the recognition of situations of public health emergency at union level and the termination of such a recognition and procedures necessary to ensure that the operation of the ewrs and the processing of data are in accordance with the data protection legislation.


### (28) in order to ascertain the state of implementation of the national preparedness plans and their coherence with the union plan , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of procedures , standards and criteria for the audits aimed at the assessment of preparedness and response planning at national level. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law-making of 13 april 201621 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts. ### (28) in order to ascertain the state of implementation of the national and regional preparedness plans and their coherence with the union plan , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of procedures , standards and criteria for the audits aimed at the assessment of preparedness and response planning at national and regional level. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law-making of 13 april 201621 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts.


### preparedness plans at union and national levels; ### preparedness plans at union and national and regional levels;


### 3. the implementation of this regulation shall be supported by funding from relevant union programmes and instruments. ### 3. in order to honour the one health approach and the health in all policies principle , the implementation of this regulation shall be supported by funding from relevant union programmes and instruments. the european health union , with its regulation on a reinforced mandate for the european medicines agency , and its regulation amending regulation (ec) no 851/2004 establishing a european centre for disease prevention and control , strengthen the union health framework in order to address serious cross-border health threats , and shall be funded by the eu4health programme. it shall be complementary to other union policies and funds , namely , but not exclusively , actions implemented under the horizon europe , the digital europe programme , esif. resceu , esi , esf+ , next generation eu , and smp.


### 2. this regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues. ### 2. this regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues , such as non-communicable diseases , or health consequences such as mental health conditions.


### 6. member states shall retain the right to maintain or introduce additional arrangements , procedures and measures for their national systems in the fields covered by this regulation , including arrangements provided for in existing or future bilateral or multilateral agreements or conventions , on condition that such additional arrangements , procedures and measures do not impair the application of this regulation. ### 6. member states shall retain the right to maintain or introduce additional arrangements , procedures and measures for their national and regional systems in the fields covered by this regulation , including arrangements provided for in existing or future bilateral or multilateral agreements or conventions , on condition that such additional arrangements , procedures and measures do not impair the application of this regulation.


### (3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health , and who are in danger of developing or have developed a disease , through manual or other technological means; ### (3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health , and who are in danger of developing or have developed a communicable or infectious disease , through manual or other technological means;


### (4) ‘epidemiological surveillance’ means the systematic collection , recording , analysis , interpretation and dissemination of data and analysis on communicable diseases and related special health issues; ### (4) ‘epidemiological surveillance’ means the systematic collection , recording , analysis , interpretation and dissemination of data and analysis on communicable diseases and related special health issues as well as their impact on non-communicable diseases or health consequences such as mental health conditions;


### 5. the secretariat shall be provided by the commission. ### 5. the secretariat shall be provided by the commission and shall be instituted within the competent directorate general of the commission.


### 7. member states shall designate one representative and not more than two alternate members of the hsc in each working formation referred to in paragraph 1. ### 7. member states shall designate one representative and not more than two alternate members of the hsc in each working formation referred to in paragraph 1. member states shall designate their representatives and alternate members within 30 days after the entry into force of this regulation. in case a representative or an alternate representative cedes her or his responsibilities within the hsc , the member state shall designate a substitute or substitutes within 30 days.


### 2. the union preparedness and response plan shall complement the national preparedness and response plans established in accordance with article 6. ### 2. the union preparedness and response plan shall complement the national and regional preparedness and response plans established in accordance with article 6.


### the timely cooperation between the commission , the member states and the union agencies; ### the timely cooperation between the commission , the member states , regions with health competences , and the union agencies;


### the secure exchange of information between the commission , union agencies and the member states; ### the secure exchange of information between the commission , union agencies , regions with health competences , and the member states;


### the epidemiological surveillance and monitoring; ### the epidemiological surveillance and monitoring , as well as the impact of communicable diseases on non-communicable diseases;


### national preparedness and response plans ### national and regional preparedness and response plans


### 1. when preparing national preparedness and response plans each member state shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national plan. ### 1. when preparing national and regional preparedness and response plans each member state and region with health competences shall coordinate with the commission in order to reach consistency with the union preparedness and response plan , also inform without delay the commission and the hsc of any substantial revision of the national and regional plan.


### 1. member states shall by the end of november 2021 and every 2 years thereafter provide the commission with a report on their preparedness and response planning and implementation at national level. ### 1. member states shall by the end of november 2021 and every 2 years thereafter provide the commission with a report on their preparedness and response planning and implementation at national and regional level.


### identification of , and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national level for the health sector , as provided to the who in accordance with the ihr; ### identification of , and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national and regional level for the health sector , as provided to the who in accordance with the ihr;


### implementation of national response plans , including where relevant implementation at the regional and local levels , covering epidemic response; antimicrobial resistance , health care associated infection , and other specific issues. ### implementation of national and regional response plans , including where relevant implementation at the regional and local levels , covering epidemic response; antimicrobial resistance , health care associated infection , mental health , and other specific issues.


### the report shall include , whenever relevant , interregional preparedness and response elements in line with the union and national plans , covering in particular the existing capacities , resources and coordination mechanisms across neighbouring regions. ### the report shall include , whenever relevant , interregional preparedness and response elements in line with the union and national and regional plans , covering in particular the existing capacities , resources and coordination mechanisms across neighbouring regions.


### the report shall include country profiles for monitoring progress and developing action plans to address identified gaps at national level. ### the report shall include country profiles for monitoring progress and developing action plans to address identified gaps at national and regional level.


### 1. every 3 years , the ecdc shall conduct audits in the member states aimed at ascertaining the state of implementation of the national plans and their coherence with the union plan. such audits shall be implemented with the relevant union agencies , aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in article 7(1). ### 1. every 3 years , the ecdc shall conduct audits in the member states aimed at ascertaining the state of implementation of the national and regional plans and their coherence with the union plan. such audits shall be implemented with the relevant union agencies , aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in article 7(1).


### promoting the interoperability of national preparedness planning and the intersectoral dimension of preparedness and response planning at union level; ### promoting the interoperability of national and regional preparedness planning and the intersectoral dimension of preparedness and response planning at union level;


### monitoring progress , identifying gaps and actions to strengthen preparedness and response planning , including in the field of research , at national and at union levels. ### monitoring progress , identifying gaps and actions to strengthen preparedness and response planning , including in the field of research , at national , regional and at union levels.


### 2. the training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in article 6 , implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools. ### 2. the training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national and regional preparedness plans referred to in article 6 , implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools.


### member states , efta states and union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels , and shall not run parallel negotiation processes for that product; ### member states , efta states and union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels , and shall not run parallel negotiation processes for that product. member states that run parallel negotiation processes , having reached the signature or not of such processes , shall be excluded from the group of participating countries;


### 1. the network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of article 2(1) shall ensure a permanent communication between the commission , the ecdc , and the competent authorities responsible at national level for epidemiological surveillance. ### 1. the network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of article 2(1) shall ensure a permanent communication between the commission , the ecdc , the ema and the competent authorities responsible at national , and where applicable regional , level for epidemiological surveillance.


### detect and monitor any multinational communicable disease outbreaks with respect to source , time , population and place in order to provide a rationale for public health action; ### detect and monitor any multinational communicable disease outbreaks with respect to source , time , population and place in order to provide a rationale for public health action , as well as its impact on non-communicable diseases or health consequences like mental health conditions;


### contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve those programmes at the national and union level; ### contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve those programmes at the national , regional and union level;


### identify research priorities and needs , and implement relevant research activities; ### identify research priorities and needs , and implement relevant research activities with the aim of anticipating future health hazards;


### 3. the national competent authorities referred to in paragraph 1 shall communicate the following information to the participating authorities of the epidemiological surveillance network: ### 3. the national and regional competent authorities referred to in paragraph 1 shall communicate the following information to the participating authorities of the epidemiological surveillance network:


### information about contract tracing monitoring systems developed at national level. ### information about contract tracing monitoring systems developed at national and regional level.


### 4. when reporting information on epidemiological surveillance , the national competent authorities shall , where available , use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1. ### 4. when reporting information on epidemiological surveillance , the national and regional competent authorities shall , where available , use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1.


### 1. in the area of public health or for specific areas of public health relevant for the implementation of this regulation or of the national plans referred to in article 6 , the commission may , by means of implementing acts , designate eu reference laboratories to provide support to national reference laboratories to promote good practice and alignment by member states on a voluntary basis on diagnostics , testing methods , use of certain tests for the uniform surveillance , notification and reporting of diseases by member states. ### 1. in the area of public health or for specific areas of public health relevant for the implementation of this regulation or of the national and regional plans referred to in article 6 , the commission may , by means of implementing acts , designate eu reference laboratories to provide support to national and regional reference laboratories to promote good practice and alignment by member states on a voluntary basis on diagnostics , testing methods , use of certain tests for the uniform surveillance , notification and reporting of diseases by member states.


### 2. the eu reference laboratories shall be responsible in particular for the following tasks to coordinate the network of national reference laboratories , in particular , in the following areas: ### 2. the eu reference laboratories shall be responsible in particular for the following tasks to coordinate the network of national and regional reference laboratories , in particular , in the following areas:


### training. ### training in current and innovative research procedures and skills.


### 3. the network of eu reference laboratories shall be operated and coordinated by the ecdc. ### 3. the network of eu reference laboratories shall be operated and coordinated by the ecdc , with a governance structure where national and regional reference laboratories and networks shall cooperate;


### 4. the designations provided for in paragraph 1 shall follow a public selection process , be limited in time , with a minimum period of 5 years , and be reviewed regularly. designations shall establish the responsibilities and tasks of the designated laboratories. ### 4. the designations provided for in paragraph 1 shall follow a public selection process , be limited in time , with a minimum period of 5 years , and be reviewed regularly. designations shall establish the responsibilities and tasks of the designated laboratories. groups or coalitions of laboratories shall also be eligible for such designation.


### 1. following an alert notified pursuant to article 19 concerning a serious cross-border threat to health referred to in point (iii) of point (a) of article 2(1) and in points (b) , (c) or (d) of article 2(1) , member states shall , in liaison with the commission and on the basis of the available information from their monitoring systems , inform each other through the ‘early warning and response system’ (‘ewrs’) and , if the urgency of the situation so requires , through the hsc about developments with regard to the threat concerned at national level. ### 1. following an alert notified pursuant to article 19 concerning a serious cross-border threat to health referred to in point (iii) of point (a) of article 2(1) and in points (b) , (c) or (d) of article 2(1) , member states shall , in liaison with the commission and on the basis of the available information from their monitoring systems , inform each other through the ‘early warning and response system’ (‘ewrs’) and , if the urgency of the situation so requires , through the hsc about developments with regard to the threat concerned at national and regional level.


### 1. the ewrs shall enable the commission and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness , early warning and response , alerting , assessing public health risks and determining the measures that may be required to protect public health. ### 1. the ewrs shall enable the commission and the competent authorities responsible at national and regional level to be in permanent communication for the purposes of preparedness , early warning and response , alerting , assessing public health risks and determining the measures that may be required to protect public health.


### 3. each member state shall designate the competent authority or authorities responsible at national level for notifying alerts and determining the measures required to protect public health , for the purposes of early warning and response. ### 3. each member state shall designate the competent authority or authorities responsible at national and regional level for notifying alerts and determining the measures required to protect public health , for the purposes of early warning and response.


### 1. national competent authorities or the commission shall notify an alert in the ewrs where the emergence or development of a serious cross-border threat to health fulfils the following criteria: ### 1. national and regional competent authorities or the commission shall notify an alert in the ewrs where the emergence or development of a serious cross-border threat to health fulfils the following criteria:


### 2. where the national competent authorities notify the who of events that may constitute public health emergencies of international concern in accordance with article 6 of the ihr , they shall at the latest simultaneously notify an alert in the ewrs , provided that the threat concerned falls within those referred to in article 2(1) of this regulation. ### 2. where the national and regional competent authorities notify the who of events that may constitute public health emergencies of international concern in accordance with article 6 of the ihr , they shall at the latest simultaneously notify an alert in the ewrs , provided that the threat concerned falls within those referred to in article 2(1) of this regulation.


### 3. when notifying an alert , the national competent authorities and the commission shall promptly communicate through the ewrs any available relevant information in their possession that may be useful for coordinating the response such as: ### 3. when notifying an alert , the national and regional competent authorities and the commission shall promptly communicate through the ewrs any available relevant information in their possession that may be useful for coordinating the response such as:


### public health measures implemented or intended to be taken at national level; ### public health measures implemented or intended to be taken at national and regional level;


### 4. the commission shall make available to the national competent authorities through the ewrs any information that may be useful for coordinating the response referred to in article 21 , including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health already transmitted through rapid alert and information systems established under other provisions of union law or the euratom treaty. ### 4. the commission shall make available to the national and regional competent authorities through the ewrs any information that may be useful for coordinating the response referred to in article 21 , including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health already transmitted through rapid alert and information systems established under other provisions of union law or the euratom treaty.


### 1. where an alert is notified pursuant to article 19 , the commission shall , where necessary for the coordination of the response at union level or upon request of the hsc referred to in article 21 or on its own initiative , make promptly available to the national competent authorities and to the hsc , through the ewrs , a risk assessment of the potential severity of the threat to public health , including possible public health measures. that risk assessment shall be carried out by: ### 1. where an alert is notified pursuant to article 19 , the commission shall , where necessary for the coordination of the response at union level or upon request of the hsc referred to in article 21 or on its own initiative , make promptly available to the national , and regional where appropriate , competent authorities and to the hsc , through the ewrs , a risk assessment of the potential severity of the threat to public health , including possible public health measures. that risk assessment shall be carried out by:


### the commission shall make the risk assessment available to the national competent authorities promptly through the ewrs , and , if appropriate , through linked alerts systems. where the risk assessment is to be made public , the national competent authorities shall receive it prior to its publication. ### the commission shall make the risk assessment available to the national , and regional where appropriate , competent authorities promptly through the ewrs , and , if appropriate , through linked alerts systems. where the risk assessment is to be made public , the national , and regional where appropriate , competent authorities shall receive it prior to its publication.


### 4. the commission shall ensure that information that may be relevant for the risk assessment is made available to the national competent authorities through the ewrs and to the hsc. ### 4. the commission shall ensure that information that may be relevant for the risk assessment is made available to the national , and regional where appropriate , competent authorities through the ewrs and to the hsc.


### national responses , including research needs , to the serious cross-border threat to health , including where a public health emergency of international concern is declared in accordance with the ihr and falls within article 2 of this regulation; ### national and regional responses , including research needs , to the serious cross-border threat to health , including where a public health emergency of international concern is declared in accordance with the ihr and falls within article 2 of this regulation;


### 3. where a member state has to adopt , as a matter of urgency , public health measures in response to the appearance or resurgence of a serious cross-border threat to health , it shall , immediately upon adoption , inform the other member states and the commission on the nature , purpose and scope of those measures. ### 3. where a member state has to adopt , as a matter of urgency , public health measures in response to the appearance or resurgence of a serious cross-border threat to health , it shall , immediately upon adoption , inform the other member states and the commission on the nature , purpose and scope of those measures , especially in cross-border regions , who shall also be accordingly informed.


### respect the responsibilities of the member states for the definition of their health policy and for the organisation and delivery of health services and medical care; ### respect the responsibilities of the member states , and the regions where appropriate , for the definition of their health policy and for the organisation and delivery of health services and medical care;


### be proportionate to the public health risks related to the threat in question , avoiding in particular any unnecessary restriction to the free movement of persons , of goods and of services. ### be necessary , suitable and proportionate to the public health risks related to the threat in question , avoiding in particular any unnecessary restriction to the free movement of persons , of goods and of services , and to the rights , freedoms and principles enshrined in the charter of fundamental rights of the european union.


### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis. ### 2. the advisory committee shall be composed of independent experts , selected by the commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. the committee should have multidisciplinary membership so it can advise on biomedical , behavioural , social , economic , cultural and international aspects. the commission shall make public the selected experts and the professional and/or scientific backgrounds that support their nomination. the representatives of the ecdc and of the ema participate as observers in the advisory committee. the representatives of other union bodies or agencies relevant to the specific threat shall participate as observers in this committee as necessary. the commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the advisory committee on an ad-hoc basis.


### mechanisms to monitor shortages of , develop , procure , manage and deploy medical countermeasures; ### mechanisms to monitor shortages of , develop , procure , manufacture , produce , manage , store , distribute and deploy medical countermeasures


### 1. the ewrs shall include a selective messaging functionality allowing personal data , including contact and health data , to be communicated only to national competent authorities involved in the contact tracing measures concerned. that selective messaging functionality shall be designed and operated so as to ensure safe and lawful processing of personal data and to link with contact tracing systems at union level. ### 1. the ewrs shall include a selective messaging functionality allowing personal data , including contact and health data , to be communicated only to national and regional competent authorities involved in the contact tracing measures concerned. that selective messaging functionality shall be designed and operated so as to ensure safe and lawful processing of personal data and to link with contact tracing systems at union level.


### 5. personal data may also be exchanged in the context of automated contact tracing , using contact tracing applications. ### 5. personal data may also be exchanged in the context of automated contact tracing , with the user’s consent , and using contact tracing applications. in order to ensure a sufficient degree of data privacy , the commission shall assess the use of technologies such as blockchain.


### procedures for the interlinking of the ewrs with contact tracing systems at union level; ### procedures for the interlinking of the ewrs with contact tracing systems at union and international level;