### 7. invites the eea to continue promoting cooperation with other union agencies and international organisations , and fostering dialogue with stakeholders and citizens; ### 7. invites the eea to continue promoting cooperation with other union agencies and international organisations , and fostering dialogue with stakeholders and citizens; highlights that a perfect example of such cooperation would be a layperson/citizen science project around the copernicus programme , as the existing data could be used , together with trained staff , to bring citizens and the institutions of the union together;


### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states. ### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health from an early stage and in coordination with the national authorities , the industry and other entities of the pharmaceutical supply chain. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states.


### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states. ### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , insufficient mandates of its health agencies and also by the limited degree of union and member states preparedness in case of a public health emergency impacting a majority of member states.


### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states. ### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union must be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , insufficient mandates of its health agencies and also by the limited degree of union and member states preparedness in case of a public health emergency impacting a majority of member states.


### (3) the often complex supply chains of medicinal products and medical devices , national export restrictions and bans , border closures impeding the free movement of those goods , and uncertainty related to their supply and demand in the context of the covid-19 pandemic have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the union. ### (3) the often complex supply chains of medicinal products and medical devices , national export restrictions and bans , border closures impeding the free movement of those goods , and uncertainty related to their supply and demand in the context of the covid-19 pandemic have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the union , with dire consequences for its citizens.


### (4) dealing with the issue of shortages of medicinal products has been a long-standing priority for the member states and european parliament as illustrated by several reports from the european parliament11 as well as discussions under recent presidencies of the council of the european union. ### (4) the issue of shortages of medicinal products has been a long-standing and insufficiently addressed priority for the member states and european parliament as illustrated by several reports from the european parliament11 as well as discussions under recent presidencies of the council of the european union.


### (4) dealing with the issue of shortages of medicinal products has been a long-standing priority for the member states and european parliament as illustrated by several reports from the european parliament11 as well as discussions under recent presidencies of the council of the european union. ### (4) dealing with the issue of shortages of medicinal products has been a long-standing but unresolved problem for the member states and european parliament as illustrated by several reports from the european parliament11 as well as discussions under recent presidencies of the council of the european union.


### (5) the covid-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic , and has highlighted the structural limitations in the union’s ability to rapidly and effectively react to such challenges during public health crises. ### (5) the covid-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic , and has highlighted the structural limitations in the union’s and member states' ability to rapidly and effectively react to such challenges during public health crises. effective communication among member states about both anticipated and actual shortages and available stocks is essential. to ensure such information exchange , the single point of contact network (spoc) should become an established monitoring system.


### (5) the covid-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic , and has highlighted the structural limitations in the union’s ability to rapidly and effectively react to such challenges during public health crises. ### (5) the covid-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic , and has highlighted the structural limitations in the union’s and the member states’ ability to rapidly and effectively react to such challenges during public health crises.


### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. ### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply and placed member states in competition with each other to respond to the legitimate needs of their citizens , contributing to uncoordinated actions at national levels such as national hoarding and stockpiling. those issues further resulted in new entities being involved in the rushed production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency , as well as increased and early dialogue with the industry to prevent and mitigate these shortages.


### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. ### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of over-priced , non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.


### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. ### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of overpriced , non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.


### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices. ### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices in the most efficient way and so as to avoid creating unnecessary burdens for stakeholders which may strain resources and cause additional delays.


### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices. ### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause fatalities , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.


### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices. ### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause fatalities , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks or being protected doing so. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.


### (8) safe and efficacious medicinal products that treat , prevent or diagnose diseases which cause public health emergencies , should be developed and made available within the union as soon as possible during such emergencies. the covid-19 pandemic has also highlighted sub-optimal coordination and decision-making as regards multinational clinical trials , and union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the union , causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines. ### (8) safe and efficacious medicinal products that treat , prevent or diagnose diseases which cause public health emergencies , should be developed , if necessary , and made available within the union as soon as possible during such emergencies. the covid-19 pandemic has also highlighted lacking coordination and decision-making as regards multinational clinical trials , and missing union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the union , causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines.


### (10) in order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection , it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices , and to facilitate the research and development of medicinal products , which may have the potential to treat , prevent , or diagnose diseases that cause public health crises. ### (10) in order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection , it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices , and to facilitate the research and development of medicinal products , which may have the potential to treat , prevent , or diagnose diseases that cause public health crises , with a view to strategically complement the efforts of the commission and other existing agencies to that end , as well as that of future key agencies such as the proposed european health emergency preparedness and response authority (hera).


### (11) this regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices , with a high level of human health protection being fundamental in those aims. moreover , this regulation aims to ensure the quality , safety and efficacy of medicinal products with the potential to address public health emergencies. both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. as regards article 114 tfeu , this regulation establishes a framework for the monitoring and reporting on shortages of medicinal products and medical devices during public health crises. as regards article 168(4)(c) tfeu , this regulation provides for a strengthened union framework ensuring the quality and safety of medicinal products and medical devices. ### (11) this regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices , with a high level of human health protection being fundamental in those aims. moreover , this regulation aims to ensure the quality , safety and efficacy of medicinal products with the potential to address public health emergencies. both objectives are being pursued simultaneously , but quality , safety and efficacy of medical products should be a paramount priority. as regards article 114 tfeu , this regulation establishes a framework for the monitoring and reporting on shortages of medicinal products and medical devices during public health crises. as regards article 168(4)(c) tfeu , this regulation provides for a strengthened union framework ensuring the quality and safety of medicinal products and medical devices.


### (12) in order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the union , the procedures and the respective roles and obligations of different concerned entities involved should be clarified. the framework should build on the ad hoc solutions identified so far in the response to the covid-19 pandemic. ### (12) in order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the union , the procedures and the respective roles and obligations of different concerned entities involved should be clarified. the framework should build on the ad hoc solutions identified so far in the response to the covid-19 pandemic , while remaining flexible enough to tackle any future health crisis in the most efficient way to the benefit of public health and patients.


### (12) in order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the union , the procedures and the respective roles and obligations of different concerned entities involved should be clarified. the framework should build on the ad hoc solutions identified so far in the response to the covid-19 pandemic. ### (12) in order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the union , the procedures and the respective roles and obligations of different concerned entities involved should be clarified. the framework should build on the ad hoc solutions identified so far in the response to the covid-19 pandemic and on experiences and examples in other countries.


### (13) a harmonised system of monitoring of shortages of medicinal products and medical devices should be established , which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events , which may have a serious impact on public health. that system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. in order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices , the agency should be able to ask and obtain information and data from the concerned marketing authorisation holders , manufacturers and member states through designated points of contact. ### (13) a harmonised system of monitoring of shortages of medicinal products and medical devices should be established , which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events , which may have a serious impact on public health. that system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to mitigate public health emergencies. in order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices , the agency should be able to ask and obtain information and data from the concerned marketing authorisation holders , manufacturers , wholesalers and member states through designated points of contact. the agency should also establish a system for the exchange of information on the availability of medicines and medical devices with healthcare professionals , in particular medical doctors and community and hospital pharmacists , consumers and patients facilitated through national medicines agencies.


### (13) a harmonised system of monitoring of shortages of medicinal products and medical devices should be established , which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events , which may have a serious impact on public health. that system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. in order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices , the agency should be able to ask and obtain information and data from the concerned marketing authorisation holders , manufacturers and member states through designated points of contact. ### (13) a harmonised system of monitoring of shortages of medicinal products and medical devices should be established , which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events , which may have a serious impact on public health. that system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to mitigate public health emergencies. in order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices , the agency should be able to ask and obtain information and data from the concerned marketing authorisation holders , manufacturers , wholesalers and member states through designated points of contact.


### (15) with respect to medicinal products , an executive steering group should be established within the agency to ensure a robust response to major events and to coordinate urgent actions within the union in relation to the management of issues relating to the supply of medicinal products. the steering group should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality , safety , and efficacy of medicinal products and ensure a high level of human health protection. ### (15) with respect to medicinal products , an executive steering group should be established within the agency to ensure a robust response to major events and to coordinate urgent actions within the union in relation to the management of issues relating to the supply of medicinal products. the steering group should establish single european lists of critical medicinal products in consultation with the industry and healthcare professionals , to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality , safety , and efficacy of medicinal products and ensure a high level of human health protection.


### (15) with respect to medicinal products , an executive steering group should be established within the agency to ensure a robust response to major events and to coordinate urgent actions within the union in relation to the management of issues relating to the supply of medicinal products. the steering group should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality , safety , and efficacy of medicinal products and ensure a high level of human health protection. ### (15) with respect to medicinal products , an executive steering group should be established within the agency to ensure a robust response to major events and to coordinate urgent actions within the union in relation to the management of issues relating to the supply of medicinal products. the steering group should establish a general list of critical medicinal products applicable to any major event or public health emergency , such as those related to emergency care , surgical operations and intensive medical care. this list would serve as the basis for more specific lists of critical medicinal products , applicable in specific health crises to ensure monitoring of those products. the steering group should be able to provide advice on the necessary action to take to safeguard the quality , safety , and efficacy of medicinal products and ensure a high level of human health protection.


### (17) in order to ensure that safe , high quality , and efficacious medicinal products , which have the potential to address public health emergencies , can be developed and made available within the union as soon as possible during public health emergencies , an emergency task force should be established within the agency to provide advice on such medicinal products. the emergency task force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols , to those organisations involved in their development , such as marketing authorisation holders , clinical trial sponsors , public health bodies , and academia , irrespective of their exact role in the development of such medicinal products. ### (17) in order to ensure that safe , high quality , and efficacious medicinal products , which have the potential to address public health emergencies , can be developed , if necessary , and made available within the union as soon as possible during public health emergencies , an emergency task force should be established within the agency to provide advice on such medicinal products. the emergency task force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols , to those organisations involved in their development , such as marketing authorisation holders , clinical trial sponsors , public health bodies , and academia , irrespective of their exact role in the development of such medicinal products.


### (18) the work of the emergency task force should be separate from the work of the scientific committees of the agency and should be carried out without prejudice to the scientific assessments of those committees. the emergency task force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. the committee for medicinal products for human use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation. ### (18) the work of the emergency task force should be separate from the work of the scientific committees of the agency and should be carried out without prejudice to the scientific assessments of those committees. the emergency task force should provide recommendations with regard to the use of medicinal products in the fight to overcome the public health crisis. the committee for medicinal products for human use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation.


### (19) the establishment of the emergency task force should build on the support provided by the agency during the covid-19 pandemic , notably as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review i.e. on an on-going basis , of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies. ### (19) the establishment of the emergency task force should build on the support provided by the agency during the covid-19 pandemic , notably as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review i.e. on an on-going basis , of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies while guaranteeing a high level of human health protection.


### (20) individual research entities may agree together , or with another party , to act as a sponsor in order to prepare one harmonised union-wide clinical trial protocol , yet experience during the covid-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the union , while interacting with multiple member states. it is therefore appropriate for the agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or , where applicable , to define respective responsibilities as co-sponsors in accordance with article 72 of regulation (eu) 536/2014. such an approach would strengthen the research environment in the union , and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. a union sponsor could benefit from union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development , application , submission , and running of the trial. this may be particularly valuable for trials established by union or international public health or research organisations. ### (20) individual research entities may agree together , or with another party , to act as a sponsor in order to prepare one harmonised union-wide clinical trial protocol , yet experience during the covid-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the union , while interacting with multiple member states. it is therefore appropriate for the agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or , where applicable , to define respective responsibilities as co-sponsors in accordance with article 72 of regulation (eu) 536/2014 and coordinate the development of clinical trial protocols. the emergency task force should define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials , so that they can meet the criteria for effective public health interventions. such an approach would strengthen the research environment in the union , and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. a union sponsor could benefit from union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development , application , submission , and running of the trial. this may be particularly valuable for trials established by union or international public health or research organisations.


### (20) individual research entities may agree together , or with another party , to act as a sponsor in order to prepare one harmonised union-wide clinical trial protocol , yet experience during the covid-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the union , while interacting with multiple member states. it is therefore appropriate for the agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or , where applicable , to define respective responsibilities as co-sponsors in accordance with article 72 of regulation (eu) 536/2014. such an approach would strengthen the research environment in the union , and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. a union sponsor could benefit from union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development , application , submission , and running of the trial. this may be particularly valuable for trials established by union or international public health or research organisations. ### (20) individual research entities may agree together , or with another party , to act as a sponsor in order to prepare one harmonised union-wide clinical trial protocol , yet experience during the covid-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the union , while interacting with multiple member states. it is therefore appropriate for the agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or , where applicable , to define respective responsibilities as co-sponsors in accordance with article 72 of regulation (eu) 536/2014 and coordinate the development of clinical trial protocols. such an approach would strengthen the research environment in the union , and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. a union sponsor could benefit from union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development , application , submission , and running of the trial. this may be particularly valuable for trials established by union or international public health or research organisations or other non-commercial entities.


### (21) with respect to medical devices , an executive steering group on medical devices should be established to coordinate urgent actions within the union in relation to the management of supply and demand issues of medical devices , and to establish a list of critical devices in the case of a public health emergency. ### (21) with respect to medical devices , an executive steering group on medical devices should be established to coordinate urgent actions within the union in relation to the management of supply and demand issues of medical devices , and to establish a list of critical devices for the most probable cases of public health emergencies.


### (24) given the agency’s long-standing and proven record of expertise in the field of medicinal products and considering the agency’s experience from working with a multitude of groups of experts , it is appropriate to establish the appropriate structures within the agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the agency with a mandate to host the expert panels on medical devices. this would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. those structures would in no way change the regulatory system or the decision-making procedures in the area of medical devices already in place in the union , which should remain clearly distinct from the one for medicinal products. ### (24) given the agency’s long-standing and proven record of expertise in the field of medicinal products and considering the agency’s experience from working with a multitude of groups of experts , it is appropriate to establish the appropriate structures within the agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the agency with a mandate to host the expert panels on medical devices. in this regard , all national and , eventually , union entities engaged in stockpiling of medical devices , should report their stocks to the agency. this would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. those structures would in no way change the regulatory system or the decision-making procedures in the area of medical devices already in place in the union , which should remain clearly distinct from the one for medicinal products.


### (24) given the agency’s long-standing and proven record of expertise in the field of medicinal products and considering the agency’s experience from working with a multitude of groups of experts , it is appropriate to establish the appropriate structures within the agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the agency with a mandate to host the expert panels on medical devices. this would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. those structures would in no way change the regulatory system or the decision-making procedures in the area of medical devices already in place in the union , which should remain clearly distinct from the one for medicinal products. ### (24) given the agency’s long-standing and proven record of expertise in the field of medicinal products and considering the agency’s experience from working with a multitude of groups of experts , it is appropriate to establish the appropriate structures within the agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the agency with a mandate to host the expert panels on medical devices. in this regard , all national and , eventually , union entities that are engaged in stockpiling of medical devices , should report their stocks to the agency. this would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. those structures would in no way change the regulatory system or the decision-making procedures in the area of medical devices already in place in the union , which should remain clearly distinct from the one for medicinal products.


### (25) in order to facilitate the work and the exchange of information under this regulation , provision should be made for the establishment and management of it infrastructures and synergies with other existing it systems or systems under development , including the eudamed it platform for medical devices. that work should also be facilitated by , where appropriate , emerging digital technologies such as computational models and simulations for clinical trials , as well as data from the eu space programme such as the galileo geolocation services , and copernicus earth observation data. ### (25) in order to facilitate the work and the exchange of information under this regulation , provision should be made for the establishment and management of it infrastructures and synergies with other existing it systems or systems under development , including spor data management for human medicines and the eudamed it platform for medical devices. that work should also be facilitated by , where appropriate , emerging digital technologies such as computational models and simulations for clinical trials , as well as data from the eu space programme such as the galileo geolocation services , and copernicus earth observation data.


### (26) rapid access and exchange of health data , including real world data i.e. health data generated outside of clinical studies , is essential to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure. ### (26) rapid access and exchange of health data , including real world data i.e. health data generated outside of clinical studies , is essential to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure. it is of utmost importance to ensure that health data is used in full respect to the provisions of the gdpr on personal data protection.


### (27) during a public health emergency or in relation to a major event , the agency should ensure cooperation with the european centre for disease prevention and control and other union agencies as appropriate. such cooperation should include data sharing , including data on epidemiological forecasting , regular communication at an executive level , and invitations to representatives of the european centre for disease prevention and control and other union agencies to attend meetings of the emergency task force , the medicines steering group , and the medical devices steering group , as appropriate. ### (27) during a public health emergency or in relation to a major event , the agency should ensure cooperation with the european centre for disease prevention and control and other union agencies as appropriate. such cooperation should include data sharing , including data on epidemiological forecasting , regular communication at an executive level , and invitations to representatives of the european centre for disease prevention and control and other union agencies to attend meetings of the emergency task force , the medicines steering group , and the medical devices steering group , as appropriate. this cooperation should also include strategic discussions with relevant entities of the union in a position to boost the research and development of appropriate solutions and technologies to mitigate the effects of the public health emergency or major event , or prevent future similar public health emergencies or major events , such as the proposed european health emergency preparedness and response authority (hera).


### (29) in order to ensure that sufficient resources are available for the work provided for under this regulation , expenditure of the agency should be covered by the contribution from the union to the agency’s revenue. ### (29) in order to ensure that sufficient resources , including appropriate staffing and adequate expertise , are available for the work provided for under this regulation , expenditure of the agency should be covered by the contribution from the union to the agency’s revenue.


### monitor and report on shortages of medicinal products for human use and medical devices; ### prevent , monitor and report on shortages of medicinal products for human use and medical devices;


### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device; ### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet the anticipated demand for that medicinal product or medical device , no matter the cause;


### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device; ### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet patients' demand plus appropriate buffer stock for that medicinal product or medical device at national level;


### ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one member state. such an event concerns a deadly threat or otherwise serious threat to health of biological , chemical , environmental or other origin or incident that can affect the supply or quality , safety , and efficacy of medicinal products. such an event may lead to shortages of medicinal products in more than one member state and necessitates urgent coordination at union level in order to ensure a high level of human health protection. ### ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in one or more member states. such an event concerns a deadly threat or otherwise serious threat to health of biological , chemical , environmental or other origin or incident that can affect the supply and availability or quality , safety , and efficacy of medicinal products. such an event may lead to shortages of medicinal products and/or medical devices in one or more member state and necessitates urgent coordination at union level in order to ensure a high level of human health protection.


### 1. the executive steering group on shortages and safety of medicinal products (‘the medicines steering group’) is hereby established as part of the agency. it shall meet either in person or remotely , in preparation for or during a public health emergency or following a request for assistance referred to in article 4(3). the agency shall provide its secretariat. ### 1. the executive steering group on shortages and safety of medicinal products (‘the medicines steering group’) is hereby established as part of the agency. it shall meet either in person or remotely. meetings may be scheduled in preparation for or during a public health emergency or following a request for assistance referred to in article 4(3) or to deal with a shortage that has been declared by at least one member state. the agency shall provide its secretariat.


### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission , one senior representative per member state , a representative of the patients' and consumers' working party (pcwp) and a representative of the healthcare professionals' working party (hcpwp). each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the list of members of the steering group shall be made public on the ema web-portal.


### 3. the medicines steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. ### 3. the medicines steering group shall be chaired by the agency. all members of the medicines steering group may propose to the chair to invite third parties , including representatives of medicinal product interest groups , in particular healthcare professionals , patients , consumers and marketing authorisation holders to attend its meetings when their contribution may inform the discussions of the steering group.


### 3. the medicines steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. ### 3. the medicines steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders , representatives of healthcare professionals , patients and consumers to attend its meetings.


### 3. the medicines steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. ### 3. the medicines steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders , representatives of patients , consumers and healthcare professionals to attend its meetings. to avoid market distortions , the medicines steering group shall ensure that data is evenly shared within or withheld from all marketing authorisation holders.


### 4. the medicines steering group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists , sets of information , and recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. ### 4. the medicines steering group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists , sets of information , and recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. agendas and minutes of the steering group as well as the rules of procedure and recommendations shall be made available to the public via the ema web-portal.


### 1. the agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency. ### 1. the agency shall continuously monitor any event that has the potential to lead to a major event or a public health emergency. in this regard , the agency shall cooperate closely with the european centre for disease prevention and control (ecdc) and other union agencies , where relevant.


### 1. the agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency. ### 1. the agency shall continuously monitor any event that has the potential to lead to a major event or a public health emergency. in this regard , the agency shall cooperate closely with the european centre for disease prevention and control or other union agencies , where relevant.


### 2. to facilitate the monitoring task referred to in paragraph 1 , the national competent authorities , through the single points of contact referred to in article 3(5) , shall , based on the reporting criteria specified by the agency pursuant to article 9(1)(b) , report to the agency on any event , including a shortage of a medicinal product in a given member state , that is likely to lead to a major event or a public health emergency. where a national competent authority informs the agency of a shortage of a medicinal product in a given member state , it shall provide the agency with any information received from the marketing authorisation holder pursuant to article 23a of directive 2001/83/ec. based on a report of an event from a national competent authority and in order to understand the impact of the event in other member states , the agency may request information from the national competent authorities , through the working party referred to in article 3(5). ### 2. to facilitate the monitoring task referred to in paragraph 1 , the national competent authorities , through the single points of contact referred to in article 3(5) , shall , based on the reporting criteria specified by the agency pursuant to article 9(1)(b) , report without delay to the agency on any event , including a shortage of a medicinal product in a given member state , that is likely to lead to a major event or a public health emergency. where a national competent authority informs the agency of a shortage of a medicinal product in a given member state , it shall provide the agency with any information received from the marketing authorisation holder pursuant to article 23a of directive 2001/83/ec. based on a report of an event from a national competent authority and in order to understand the impact of the event in other member states , the agency may request information from the national competent authorities , through the working party referred to in article 3(5).


### 2. to facilitate the monitoring task referred to in paragraph 1 , the national competent authorities , through the single points of contact referred to in article 3(5) , shall , based on the reporting criteria specified by the agency pursuant to article 9(1)(b) , report to the agency on any event , including a shortage of a medicinal product in a given member state , that is likely to lead to a major event or a public health emergency. where a national competent authority informs the agency of a shortage of a medicinal product in a given member state , it shall provide the agency with any information received from the marketing authorisation holder pursuant to article 23a of directive 2001/83/ec. based on a report of an event from a national competent authority and in order to understand the impact of the event in other member states , the agency may request information from the national competent authorities , through the working party referred to in article 3(5). ### 2. to facilitate the monitoring task referred to in paragraph 1 , the national competent authorities , through the single points of contact referred to in article 3(5) , shall , based on the reporting criteria specified by the agency pursuant to article 9(1)(b) , report to the agency on any event , including a shortage of a medicinal product in a given member state , that has the potential to lead to a major event or a public health emergency. where a national competent authority informs the agency of a shortage of a medicinal product in a given member state , it shall provide the agency with any information received from the marketing authorisation holder pursuant to article 23a of directive 2001/83/ec. based on a report of an event from a national competent authority and in order to understand the impact of the event in other member states , the agency may request information from the national competent authorities , through the working party referred to in article 3(5).


### 3. where the agency considers that an actual or imminent major event needs to be addressed , it shall inform the commission and the member states thereof. the commission , on its own initiative or following a request from one or more member states , or the executive director of the agency may request the assistance of the medicines steering group to address the major event. ### 3. where the agency considers that an actual or imminent major event needs to be addressed , it shall inform the commission and the member states thereof. the commission shall then request the assistance of the medicines steering group to address the major event.


### 1. following a request for assistance referred to in article 4(3) and after consultation of its working party , the medicines steering group shall adopt a list of medicinal products authorised in accordance with directive 2001/83/ec or regulation (ec) no 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). the list shall be updated whenever necessary until the major event has been sufficiently addressed. ### 1. following a request for assistance referred to in article 4(3) and after consultation of its working party , the medicines steering group shall adopt a list of medicinal products authorised in accordance with directive 2001/83/ec or regulation (ec) no 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). the list shall be updated whenever necessary until the major event has been sufficiently addressed and it is confirmed that the assistance of the medicines steering group is no longer needed as per article 4(4).


### 2. immediately following the recognition of a public health emergency and after consultation of its working party , the medicines steering group shall adopt a list of medicinal products authorised in accordance with directive 2001/83/ec or regulation (ec) no 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). the list shall be updated whenever necessary until the termination of the recognition of the public health emergency. ### 2. immediately following the recognition of a public health emergency and after consultation of its working party , the industry and representatives of health professionals , the medicines steering group shall adopt a list of medicinal products authorised in accordance with directive 2001/83/ec or regulation (ec) no 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). the list shall be updated whenever necessary until the termination of the recognition of the public health emergency.


### 3. the medicines steering group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. ### 3. the medicines steering group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. union or national entities that are engaged in stockpiling of medicinal products shall be informed accordingly.


### 3. the medicines steering group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. ### 3. the medicines steering group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. union or national entities that are engaged in stockpiling of medicinal products should be informed accordingly.


### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### on the basis of the single european critical medicines lists and the information and data provided in accordance with articles 10 and 11 , , and the database established in accordance with article 12a once fully operational , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation , as well as with the european centre for disease prevention and control. the medicines steering group shall also guarantee an open communication and close cooperation with the industry , relevant entities of the pharmaceutical supply chain , and representatives of healthcare professionals , patients and consumers with a view to enable early notification or identification of potential or actual shortages of critical medicines.


### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. monitoring shall be conducted during health crises as well as before , after and outside these crises in order to identify potential shortages before they can affect health and lives of eu citizens. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation.


### 2. where requested by the commission or the sub-network referred to in article 9(2) , the medicines steering group shall provide aggregated data and forecasts of demand to substantiate its findings. in that regard , the medicines steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medicinal product needs , and with the executive steering group on shortages of medical devices referred to in article 19 where medicinal products included on the critical medicines lists are administered with a medical device. ### 2. where requested by the commission or the sub-network referred to in article 9(2) , the medicines steering group shall provide aggregated data and forecasts of demand to substantiate its findings. in that regard , the medicines steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medicinal product needs , and with the executive steering group on shortages of medical devices referred to in article 19 where medicinal products included on the critical medicines lists are administered with a medical device. the aggregated data and forecasts of demand shall also be made available to industry and other entities of the pharmaceutical supply chain , where relevant , with the view to better prevent or mitigate potential or actual shortages.


### 2. where requested by the commission or the sub-network referred to in article 9(2) , the medicines steering group shall provide aggregated data and forecasts of demand to substantiate its findings. in that regard , the medicines steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medicinal product needs , and with the executive steering group on shortages of medical devices referred to in article 19 where medicinal products included on the critical medicines lists are administered with a medical device. ### 2. where requested by the commission or the sub-network referred to in article 9(2) , the medicines steering group shall provide aggregated data and forecasts of demand to substantiate its findings. in that regard , the medicines steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medicinal product needs , and with the executive steering group on shortages of medical devices referred to in article 19 where medicinal products included on the critical medicines lists are administered with a medical device. it shall share its findings and conclusions with union and national entities engaged with stockpiling of medicinal products and medical devices.


### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies. ### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities , including healthcare professionals , consumers and patients , to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies.


### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies. ### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities , including healthcare professionals and patients , to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies.


### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies. ### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities , including healthcare professionals , to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies.


### 4. the medicines steering group may , on its own initiative or upon request from the commission , provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events. ### 4. the medicines steering group may , on its own initiative or upon request from the commission , provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities , including healthcare professionals , to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events.


### 5. the medicines steering group may upon request from the commission coordinate measures , where relevant , between the national competent authorities , the marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency. ### 5. the medicines steering group may upon request from the commission coordinate measures , where relevant , between the national competent authorities , the marketing authorisation holders and other entities , including healthcare professionals , to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.


### specify the procedures for establishing the critical medicines lists; ### specify the procedures for establishing the critical medicines lists , , ensuring adequate consultation with healthcare professionals , consumers , patients a high level of transparency in decision-making;


### establish and maintain for the duration of the public health emergency or major event , a sub-network of single points of contact from marketing authorisation holders based on the medicinal products included on the critical medicines lists; ### establish and maintain for the duration of the public health emergency or major event , a sub-network of single points of contact from marketing authorisation holders and wholesalers based on the medicinal products included on the critical medicines lists;


### details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause; ### details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause as well as information on potential bottlenecks in the supply chain;


### mitigation plans including production and supply capacity; ### prevention and mitigation plans including but not limited to information on production and supply capacity , production sites of finished pharmaceutical products and active pharmaceutical ingredients and raw materials , potential alternative production sites , minimum stock levels;[pa1] such plans shall contain preventative measures that help ensure the continued supply of critical medicines , such as diversification of supply chains;


### mitigation plans including production and supply capacity; ### mitigation plans , including production and supply capacity , with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;


### information from the wholesale distributors and legal person entitled to supply the medicinal product to the public. ### deleted


### obligations on marketing authorisation holders ### obligations on marketing authorisation holders and other actors in the supply chain


### 3. marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the agency. ### 3. marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the agency. marketing authorisation holders failing to comply with their reporting obligations shall be subject to proportionate sanctions set by the commission in a delegated act.


### 4. where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature , they shall identify the relevant parts and clarify the reasons for such an indication. the agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure. ### 4. where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature , they shall identify the relevant parts and clarify the reasons for such an indication. the agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure , unless the information is in the public interest. marketing authorisation holders failing to comply with their reporting obligations shall be subject to sanctions to be determined by the commission.


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities , including healthcare professionals , to support them in their work and in the communication with patients;


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities , including healthcare professionals;


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups in a timely manner with regard to the work of the medicines steering group , and ensure adequate consultation with the patients’ and consumers’ working party (pcwp) and the healthcare professionals’ working party (hcpwp). the list of the members of the medicines steering group , the rules of procedure , agendas and minutes of the meetings and recommendations shall be published on the agency’s web-portal.


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform without delay the public and interest groups with regard to the work of the medicines steering group , and respond to disinformation as appropriate.


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups in a timely manner with regard to the work of the medicines steering group , including the recommendations , opinions and decisions made by the medicines steering group as well as agendas and minutes of the group’s meetings.


### 1. the emergency task force is hereby established as part of the agency. it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat. ### 1. the emergency task force is hereby established as part of the agency. it shall be convened in preparation for and during public health emergencies , either in person or remotely. the agency shall provide its secretariat.


### 1. the emergency task force is hereby established as part of the agency. it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat. ### 1. the emergency task force is hereby established as part of the agency. it shall be convened in preparation for or during public health emergencies , either in person or remotely. the agency shall provide its secretariat.


### reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the union for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency , in accordance with article 15; ### reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the union , in particular on large multi-centre trials , for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency , in accordance with article 15;


### reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the union for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency , in accordance with article 15; ### reviewing clinical trial protocols and providing advice and guidance to developers on clinical trials to be conducted in the union for medicinal products intended to treat , prevent , or diagnose the disease causing the public health emergency , in accordance with article 15;


### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency. ### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , namely representatives of the patients’ and consumers’ working party and the healthcare professionals’ working party , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency.


### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , and interest groups representing patients and healthcare professionals to attend its meetings. ### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , independent clinical trials experts and researchers , and interest groups representing patients and healthcare professionals to attend its meetings.


### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , and interest groups representing patients and healthcare professionals to attend its meetings. ### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , independent clinical trial experts and researchers , and interest groups representing patients and healthcare professionals to attend its meetings.


### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , and interest groups representing patients and healthcare professionals to attend its meetings. ### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , researchers , and interest groups representing patients and healthcare professionals to attend its meetings.


### 6. the emergency task force shall establish its rules of procedure including rules on the adoption of recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. ### 6. the emergency task force shall establish its rules of procedure including rules on the adoption of recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. the rules of procedure including rules on the adoption of recommendations , as well as the opinions meeting minutes and agendas should be made public on the agency web-portal.


### 1. during a public health emergency , the emergency task force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process. ### 1. during a public health emergency , the emergency task force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process based on targets referred to in article 15.(-1). when providing scientific advice , a balance shall always be maintained between necessary facilitation in a crisis situation and patients’ safety.


### 2. in preparation of the review , the emergency task force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force may also , where available , make use of observational studies of health data generated outside of clinical studies taking into account their reliability. ### 2. in preparation of the review , the emergency task force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force may also , where available , make use of observational studies of health data generated outside of clinical studies taking into account their reliability. the emergency task force shall liaise with medicine agencies of third countries for additional information and data exchange.


### 2. in preparation of the review , the emergency task force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force may also , where available , make use of observational studies of health data generated outside of clinical studies taking into account their reliability. ### 2. in preparation of the review , the emergency task force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force may also , where available , make use of observational studies of health data generated outside of clinical studies taking into account their reliability. the emergency task force should liaise with agencies of third countries that authorise medicinal products for additional information and data.


### 4. following receipt of the recommendation , the committee for medicinal products for human use shall adopt an opinion on the conditions for use , the conditions for distribution and the patients targeted. the opinion shall be updated where necessary. ### 4. following receipt of the recommendation , the committee for medicinal products for human use shall adopt an opinion on the conditions for use , the conditions for distribution and the patients targeted. the opinion shall be updated where necessary , and made public on the agency's web-portal.


### 6. in the preparation of its recommendations provided pursuant to paragraphs 3 , the emergency task force may consult the concerned member state and request it to provide any information and data , which informed the member state’s decision to make the medicinal product available for compassionate use. following such a request , the member state shall provide all of the requested information. ### 6. in the preparation of its recommendations provided pursuant to paragraphs 3 , the emergency task force may consult the concerned member state and request it to provide any information and data , which influenced the member state’s decision to make the medicinal product available for compassionate use. following such a request , the member state shall provide all of the requested information.


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force , and ensure adequate consultation with the patients’ and consumers’ working party and the healthcare professionals’ working party. the list of the members of the emergency task force , the rules of procedure , agendas and minutes of the meetings and recommendations shall be published on the agency’s web-portal.


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform without delay the public and relevant interest groups with regard to the work of the emergency task force , and respond to disinformation as appropriate.


### coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities. such coordination shall be conducted jointly with the european centre for disease prevention and control and notably through a new vaccine monitoring platform; ### coordinate independent utilisation , effectiveness and safety monitoring studies of medicinal products intended to treat , prevent or diagnose a disease using relevant data held by public authorities; for vaccines , such coordination shall be conducted jointly with the european centre for disease prevention and control and notably through a new vaccine monitoring platform;


### 1. the executive steering group on medical devices (‘the medical devices steering group’) is hereby established as part of the agency. it shall meet either in person or remotely , in preparation for or during a public health emergency. the agency shall provide its secretariat. ### 1. the executive steering group on medical devices (‘the medical devices steering group’) is hereby established as part of the agency. it shall meet either in person or remotely , in preparation for or during a public health emergency , or upon request of a member state affected by a shortage. the agency shall provide its secretariat.


### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission , one senior representative per member state , a representative of the patients' and consumers' working party (pcwp) and a representative of the healthcare professionals' working party (hcpwp). each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the list of members of the steering group shall be made public on the agency web-portal.


### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings. ### 3. the medical devices steering group shall be chaired by the agency. all members of the medicines steering group may propose to the chair to invite third parties , including representatives of medical device interest groups , in particular healthcare professionals , consumers and patients , to attend its meetings when their contribution may inform the discussions of the steering group.


### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings. ### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups , representatives of patients and healthcare professionals , to attend its meetings.


### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings. ### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups , healthcare professionals as well as representatives of patients and consumers to attend its meetings.