### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; ### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , nanomedicines , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the creation of a data monitoring committee exclusively for emergency clinical trials to ensure the human dignity of patients involved in research and to avoid duplication of emergency trials; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; calls on the commission to establish continuous dialogue between ecdc , ema , and vaccines developers;


### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu; ### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines and evaluate how further regulatory flexibilities , including for gmo medicinal products , could contribute to a more efficient authorisation system; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu , including a shift towards electronic labelling and package leaflets;


### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu; ### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema , the industry and all relevant stakeholders accelerate the development and adoption of electronic product information for all medicines in the eu by defining timelines and harmonised standards within a common european interoperable information exchange network;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to explore an early warning system for drug shortages based on existing structures , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of all relevant supply chain stakeholders to provide early and transparent information on relevant factors , including but not limited to the availability of medicines , demand for medicines , parallell trade activities and market distortions without undue regulatory burden; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies and create an emergency preparedness plan to fast track an increase in the production capacity so that it is sufficient to fulfil union needs for the medicinal products in times of crisis and unexpected demand;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; calls on the commission for measures of flexibility to mitigate shortages when they occur;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to take steps in this direction leading to the strengthening of cooperation between member states , in order to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information exchange network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. supports the commission in its efforts to achieve a public disclosure , in accordance to good clinical practices , through a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community , with the aim of protecting the dignity of human beings involved in clinical trials and to address weaknesses in the global medicines manufacturing and supply chain;


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; emphasises that actions such as dual sourcing and safety stocks mitigate upcoming risks , increase resilience and the security of supply;


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address the root causes of shortages of medicines and the weaknesses in the global medicines manufacturing and supply chain;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. stresses the need for an environmentally-friendly and climate-neutral pharmaceutical industry throughout the life cycle of the medicinal product and ensure that no action taken jeopardises access to safe and effective pharmaceutical treatments for human patients; calls on the commission to develop with industry global manufacturing frameworks for environmental protection in medicines manufacturing; urges the commission to ensure quality and environmental sustainability framework for active pharmaceutical ingredients imported from third countries; calls on the commission to address the problem of domestic pharmaceutical waste , with incentives to optimise packaging , as well as to facilitate medicines movement to mitigate shortages if they occur; call on the commission to take into account existing and self-regulated initiatives as models in future eu initiatives on pharmaceuticals in the environment , which shall be proportionate and based on scientific evidence;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to identify a system of incentives and funding for companies to ensure the achievements of such objectives; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , highlighting the correlation between packaging and the prescribed treatment , and to bring medical prescriptions into line with real therapeutic needs;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain , particularly outside the eu; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; notes that the creation of electronic systems of information and identification of packaging would be an effective way to reduce it; acknowledges steps taken already by the pharmaceutical industry like , for example , the eco-pharmaco-stewardship initiative;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout especially the part of the production chain located outside the eu; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs;


### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu; ### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework promoting the highest standards on quality and safety at international level , facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu;


### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu; ### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to preserve the pharmaceutical sector as a strategic pillar of the eu;


### 5. notes that 209 of the 224 authorised posts were occupied on 31 december 2020; ### 5. notes that 209 of the 224 authorised posts were occupied on 31 december 2020; considers that , in order to properly perform the tasks on the union’s path to climate neutrality , this number should grow in subsequent years;


### 7. notes that the agency , with regard to senior management positions , reports that 23 (76 ,6 %) positions are occupied by men and 7 (23 ,33 %) by women; notes that the agency reports , for the management board , a gender balance distribution of 14 men (37 ,8 %) and 23 women (62 ,2 %) and , for staff overall , 266 men (46 ,7 %) and 306 women (53 ,3 %); ### 7. notes with concern that the agency reports again gender imbalance for 2020 , with regard to senior management positions as 23 (76 ,6 %) positions are occupied by men and 7 (23 ,33 %) by women; with regard to the management board , with 14 men (37 ,8%) and 23 women (62 ,2 %) and , with regard to staff overall with 266 men (46 ,7 %) and 306 women (53 ,3 %); asks the agency to ensure gender balance at the senior management level in the future; asks the commission and the member states to take into account the importance of ensuring gender balance when nominating their members to the agency’s management board;


### 14. notes that the agency made a smooth transition to large-scale teleworking for staff , continuing collaboration with external stakeholders and moving the operation of all of the agency’s bodies online following the outbreak of the pandemic; notes that , according to the agency’s report , the rapid transition to large-scale , long-term teleworking resulted in significant additional efforts for the agency’s security unit , not least because not all the agency’s contractors were prepared for the large-scale teleworking and related arrangements had to be put in place , with high priority; calls on the agency to carefully evaluate the arrangements in place , including from a cyber-security perspective , and related risks for business continuity; ### 14. notes that the agency made a smooth transition to large-scale teleworking for staff , continuing collaboration with external stakeholders and moving the operation of all of the agency’s bodies online following the outbreak of the pandemic; notes that , according to the agency’s report , the rapid transition to large-scale , long-term teleworking resulted in significant additional efforts for the agency’s security unit , not least because not all the agency’s contractors were prepared for the large-scale teleworking and related arrangements had to be put in place , with high priority; calls on the agency to carefully evaluate the arrangements in place , including from the perspective of cyber-security , of related risks for business continuity , as well as of the right to disconnect , while respecting the balance between professional and private life;


### (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 unprecedent 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 in a harmonised way between authorities , industry and other stakeholders of the pharmaceuticals supply chain. the union needs to give a higher priority to health , to have health systems ready to provide state of the art care , and to be prepared to cope with epidemics and other unforeseeable health threats in line with the international 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 , 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 in a coordinated way between public authorities , industry and other entities of the pharmaceuticals' manufacturing , distribution and provision chains. a two-way dialogue between authorities and all the industry stakeholders is key and should be ensured to prevent and better manage medicines shortage. 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 , by strengthening its capacity and improving cooperation and coordination between the eu member states , 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 and by the lack of cooperation and coordination between the latter.


### (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 unprecedend 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 in a harmonised way between authorities , industry and other stakeholders of the pharmaceuticals supply chain. europe needs to give a higher priority to health not with standing the competences of the member states in the area of healthcare , to have health systems ready to provide state of the art care , and to be prepared to cope with epidemics and other unforeseeable health threats in line with the international health regulations. 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.


### (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) disruptions to 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 , uncertainty related to their supply and demand in the context of the covid-19 pandemic , and the lack of production in europe of certain essential medicinal products or chemical active ingredients 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. ### (3) the covid-19 pandemic has exacerbated the already existing difficulty 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 , also due to the lack of implementation of sustainable economic , regulatory and industrial policy reforms needed.


### (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. ### (does not affect english version.)


### (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 existing problem of shortages for certain medicinal products considered as essential and critical in addressing the pandemic , and has highlighted the union’s dependence on third countries such as india or china , particularly in terms of the production of chemical active ingredients , the lack of coordination and cooperation between member states , the structural limitations in the union’s ability to rapidly and effectively react to such challenges during public health crises , and the need to support and strengthen the union’s industrial fabric through appropriate policies.


### (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 ability to rapidly and effectively react to such challenges during public health crises and the need for a more active and extended involvement of the european institutions addressing the health of the european citizens.


### (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 already existing 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 , also due to the lack of implementation of sustainable economic , regulatory and industrial policy reforms needed


### (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 stock shortages. 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 and the necessary coordination within the union.


### (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 personal protective equipments and 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.


### (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 or bans amongst member states and other national protective measures , such as inappropriate stockpiling , 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 or suitable ppe such as masks , gloves and protective clothing. it is therefore important to address the question of shortages , reinforce and formalise monitoring of critical medicinal products and medical devices , and improve coordination within the union.


### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. ### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers or other entities in the pharmaceutical supply chain and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.


### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. ### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers , other entities of the pharmaceutical supply chain and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.


### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. ### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers , other stakeholders of the pharmaceutical supply chain and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.


### (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. requirements could be defined in close cooperation between authorities , industry and relevant entities of the pharmaceutical supply chain.


### (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 and better coordinate the rules on monitoring of shortages of medicinal products and medical devices , and , through increased support for research and innovation , 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.


### (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 , based on common data fields , of monitoring of shortages of medicinal products , personal protective equipment and medical devices should be established , which will facilitate appropriate access for relevant national and union authorities on markets situations for 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 telematics 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 , as well as to avoid duplications of the information submitted , the system should be interoperable with the national shortages reporting system , the agency should be able to ask and obtain additional any information and data – not already in the system - from the concerned marketing authorisation holders , manufacturers and member states who should all have the obligation to provide complete information and data through designated points of contact (ispoc and spoc).


### (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 european union of health digitalized and interoperable early-warning system 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 access information and data from the concerned marketing authorisation holders , manufacturers , relevant entities of the pharmaceuticals' supply chain and member states' national agencies , directly via the uploaded information at national level available in the european union of health early-warning , interoperable and digitalized system , avoiding duplications of reporting requirements at different levels.


### (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 , based on common data fields , of monitoring of shortages of medicinal products , personal protective equipments and medical devices should be established , which will facilitate appropriate access for relevant national and eu authorities on markets situations for 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 telematic 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 , as well as to avoid duplications of the information submitted , the agency should be able to ask and obtain additional information and data , not already in the system , from the concerned marketing authorisation holders , manufacturers and member states who all have the obligation to provide complete information and data 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 a european list of essential and critical medicinal products , in cooperation with all stakeholders , 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 as well as adequate supplies. priorities should be established for the different types of medicinal product by drawing a distinction in particular between ‘medicinal products of major therapeutic interest’ (mitms) , i.e. medicines for which an interruption of treatment is likely to jeopardise the vital prognosis of patients in the short or medium term or significantly diminishes the patient’s chances with regard to the progressive potential of the disease , or for which there are no suitable therapeutic alternatives available in sufficient quantity , and ‘medicinal products of health and strategic importance’ (misss) , for which the interruption of treatment causes an immediate threat to the patient’s life.


### (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 lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice and recommendations 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. the steering group should take into account and integrate in its works the outcomes of the ongoing discussions in the context of the european commission structured dialogue on manufacturing and supply chain among institutions , national authorities and stakeholders , in order to achieve the best results in preventing and responding to shortage of medicines.


### (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 single pan-european lists of critical medicinal products , in close cooperation with industry , 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 during public health emergencies and major events. such a list should take into account and integrate the outcomes of the ongoing discussions in the context of the ec structured dialogue on manufacturing and supply chain among institutions , national authorities and stakeholders , in order to avoid duplications of work and contradicting results


### (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 shall establish list of critical medicinal products , in close cooperation with industry , 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 during public health emergencies and major events.


### (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 is committed to overcome the divergencies among the individual regulatory frameworks , placing itself as guarantee and protection for eu citizens. the 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 ongoing basis , of emerging evidence to allow a more efficient assessment of medical products including vaccines during public health emergencies.


### (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 use of the european medicines verification system (set up in the context of the falsified medicines fmd) data for preventing medicines shortages in an epidemiological crisis by enabling national regulators to assess the availability of products versus what has been consumed or parallel exported in their market , as well as the substance , product , organisation and referential (spor) master management for human medicines and the eudamed it platform for medical devices.


### (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 the use of the european medicines verification system (set up in the context of the falsified medicines fmd) data for preventing medicines shortages in an epidemiological crisis by enabling national regulators to assess the availability of products versus what has been consumed or parallel exported in their market , as well as the substance , product , organisation and referential (spor) master management1a for human medicines and the eudamed it platform for medical devices.


### (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 interoperable infrastructure , taking advantage of all the potential of the supercomputing , the artificial intelligence and the big data science to develop predicting models and take better and more timely-effective decisions , without compromising the privacy rights.


### (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 shall allow as well the definition of programs and data collection systems relating to outcomes , results , adverse and undesiderable events usable for all developers.


### (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 – which should provide forecasts in a timely manner to relevant actor of the pharmaceutical supply chain - 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. regular two-way communication and exchange of information between regulators , industry and pertinent stakeholders of the pharmaceutical supply chain shall also be guaranteed to kick off prompt debates about estimated potential drug shortages in the market by way of sharing expected supply constraints which authorities become aware of via the notification process , allowing better coordination , interactions and proper response when required


### (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 – which should provide forecasts in a timely manner to relevant actor of the pharmaceutical supply chain - 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. regular two-way communication and exchange of information between regulators , industry and pertinent stakeholders of the pharmaceutical supply chain shall also be guaranteed to kick off prompt debates about estimated potential drug shortages in the market by way of sharing expected supply constraints which authorities become aware of via the notification process , allowing better coordination , interactions and proper response when required;


### prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices; ### prevent , prepare for , manage and coordinate at european level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;


### prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices; ### prepare for , coordinate and manage at european level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;


### prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices; ### prepare for and manage the impact of major events in order to limit urgently that impact on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;


### prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices; ### prepare and manage (at a pan-european level) the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;


### monitor and report on shortages of medicinal products for human use and medical devices; ### monitor and report on shortages of medicinal products for human use and medical devices , and adopt all adequate and necessary measures to ensure that shortages of essential medicinal products can be avoided and patients have access to safe medicinal products and treatments at accessible prices;


### 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;


### ‘public health emergency’ means a public health emergency at union level recognised by the european commission in accordance with article 23(1) of regulation (eu) 2020/[…]17; ### ‘public health emergency’ means a public health emergency at union level declared by the european commission in accordance with article 23(1) of regulation (eu) 2020/[…]17;


### ‘public health emergency’ means a public health emergency at union level recognised by the european commission in accordance with article 23(1) of regulation (eu) 2020/[…]17 ; ### ‘public health emergency’ means a public health emergency at union level recognised by the european commission in accordance with article 23(1) of regulation (eu) 2020/[…]17 ;arising from a threat of human , animal , plant , food or environmental origin having a health dimension which requires urgent action by authorities.


### ‘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 for that medicinal product or medical device at national level for a period of more than two weeks;


### ‘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 patient and healthcare actors’ needs;


### ‘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 needs of patients or healthcare professionals;


### ‘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 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 patient and healthcare actor’s needs at national level for a period of more than two weeks.


### ‘developer’ means any legal or natural person seeking to generate scientific data with regard to the quality , safety and efficacy of a medicinal product as part of that product’s development; ### ‘developer’ means any legal or natural person holding intellectual property rights for a medicinal product who is seeking to generate scientific data with regard to the quality , safety and efficacy of that medicinal product as part of the product’s development;


### ‘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 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 demand , quality , safety , and efficacy of medicinal products. such an event may lead to shortages of critical 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 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 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 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 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 demand and/or supply , or quality , safety , and efficacy of medicinal products. such an event may lead to shortages of critical 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.


### 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 , a representative of the patients' organizations , a representative of the healthcare professionals' organizations 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. the list of the members of the steering group shall be transparent and made public on the ema web-portal.


### 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 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. the steering group shall also include a representative the patients’ and consumers’ working party and a representative of the healthcare professionals’ working party.


### 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 , marketing authorisation holders or any other entity in the relevant pharmaceutical supply chain , healthcare professionals and patients’ associations , to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.


### 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. on a regular basis , the chair shall invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. in the event of an actual or imminent major event , the chair shall invite relevant entities from the pharmaceutical supply chain 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 , marketing authorisation holders , representatives of healthcare professionals , and of patients 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 shall invite third parties , including representatives of medicinal product interest groups , marketing authorisation holders and other representatives of the pharmaceutical supply chain to attend its meetings and actively participate in the dialog with the authorities.


### 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.


### 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 , via the industry single point of contact (ispoc) , and other stakeholders in the medicines supply chain as well as interest groups representing patients and healthcare professionals , to attend its meetings.


### 6. the medicines steering group shall be responsible for fulfilling the tasks referred to in article 4(4) and articles 5 to 8. ### 6. the medicines steering group shall be responsible for fulfilling the tasks referred to in article 4(3) , 4 (4) and articles 5 to 8.


### 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 is likely to lead to a major event or a public health emergency in coordination with the relevant national or regional authorities.


### 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 in the union or in third countries that is likely to lead to a major event or a public health emergency.


### 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) , upload in the harmonised pan-european interoperable and digitalized shortages reporting and notification system , 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 uploads the information of a shortage of a medicinal product in a given member state on the pan-european harmonized system , it shall provide the agency with any information received from the marketing authorization holder pursuant to article 23a of directive 2001/83/ec. the information uploaded in the pan-european system are directly accessible for the agency and national competent authorities and while avoiding duplications of reporting , it shall support a two-way communication between authorities and industry to provide the transparency needed to take actions to prevent and mitigate cross border shortages. 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 , in due time , in an interoperable and digitalized platform for reporting and notifying shortages , 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) pro-actively and with the shortest delay , 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).


### 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 , 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. where requested to do so by at least two member states or the executive director of the agency , the commission shall request the assistance of the steering group.


### 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.


### evaluation of information and the provision of advice on action in relation to the safety , quality , and efficacy of medicinal products related to public health emergencies and major events ### (does not affect english version.)


### the medicines steering group shall provide advice to the commission and member states on any appropriate action it believes should be taken at union level on the medicinal products concerned in accordance with the provisions of directive 2001/83/ec or regulation (ec) no 726/200418. ### the medicines steering group shall provide advice and recommendations to the commission and member states on any appropriate action it believes should be taken at union level on the medicinal products concerned in accordance with the provisions of directive 2001/83/ec or regulation (ec) no 726/200418.


### 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 , medicinal product interest groups and supply chain stakeholders , in time adequate to the major event , 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. ### 1. following a request for assistance referred to in article 4(3) and after consultation of its working party , the medicines steering group , in coordination with stakeholders in the sector , 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.


### 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 medicines steering group , in coordination with stakeholders in the sector , 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 and actions 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. the medicines steering group shall report the agency and the commission in due time on the monitoring and shall notify immediately on any major event or shortage in the supply.


### 4. the agency shall immediately publish the critical medicines lists and any updates to those lists on its web-portal referred to in article 26 of regulation (ec) no 726/2004. ### 4. member state representatives and the european commission shall on a confidential basis be granted access to the critical medicines lists and any updates to those lists via the web-portal referred to in article 26 of regulation (ec) no 726/2004.


### 1. for the duration of a public health emergency or following a request for assistance referred to in article 4(3) and until its closure , the medicines steering group shall regularly report the results of its monitoring to the commission and the sub-network referred to in article 9(2) , and , in particular , signal any potential or actual shortages of medicinal products included on the critical medicines lists. ### 1. for the duration of a public health emergency or following a request for assistance referred to in article 4(3) and until it is confirmed that its assistance is no longer needed under article 4(4) , the medicines steering group shall regularly report the results of its monitoring to the commission and the sub-network referred to in article 9(2) , and , in particular , signal any potential or actual shortages of medicinal products included on the critical medicines lists.


### 1. for the duration of a public health emergency or following a request for assistance referred to in article 4(3) and until its closure , the medicines steering group shall regularly report the results of its monitoring to the commission and the sub-network referred to in article 9(2) , and , in particular , signal any potential or actual shortages of medicinal products included on the critical medicines lists. ### 1. for the duration of a public health emergency or following a request for assistance referred to in article 4(3) and until its closure , the medicines steering group shall regularly report the results of its monitoring to the commission , the pharmaceutical industry , relevant other stake-holders of the pharmaceutical supply chain and the sub-network referred to in article 9(2) , and , in particular , signal any potential or actual shortages of medicinal products included on the critical medicines lists.


### 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 use data from its interoperable and digitalized platform for reporting and notifying shortages and 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.