### 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 to develop the use of electronic product information for all medicines in the eu; points to the urgent need to move forward with the creation of a european health data space to improve the scope and added value of clinical studies and research , thereby facilitating the digital transformation of our health systems.


### 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 and further regulatory flexibilities to other emergency medicines and innovative medicinal products for underserved areas; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu and allow electronic patients information instead of paper insert;


### 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 in close cooperation with the ema to consider extending the application of rolling reviews to other emergency medicines , while safeguarding high level of safety , quality and effectiveness; further calls on the commission to work with the ema to further accelerate the use of electronic product information for all medicines in the eu;


### 18. calls on the commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the ema to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years; ### 18. calls on the commission to assess how the conditional marketing authorisation approach has been used by regulators and industry to speed up the availability of innovative medicines to patients , with a view to making better use of conditional marketing authorisation in the future; reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the ema to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine;


### 18. calls on the commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the ema to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years; ### 18. calls on the commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation , based on robust clinical data; calls on the ema to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years , where sufficient data are available;


### 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; recognises the multiple drivers of shortages and therefore the importance of ensuring the involvement of manufacturers and other supply chain stakeholders to prevent and manage medicines’ shortages; calls on the commission to build on existing systems such as the european medicines verification system (emvs) , to develop a 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 and all supply chain stakeholders to provide early and transparent information on the demand of medicines , parallel trade activities , export bans and unexpected manufacturing or quality problems , while ensuring that reporting burdens do not increase , become ineffective or unjustified; stresses that confidentiality should be safeguarded; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; calls for systematic regulatory 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 develop an early warning system for drug shortages , based on the improved collection of digital information linked to telematics and digital shortages reporting , and greater public-private collaboration , 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 conduct a structured dialogue with relevant actors 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;


### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , and contribute to an effective response in the event of a health emergency; ### 21. calls on the commission to facilitate agreements between the ema and non-eu regulatory agencies on preventing emergencies and coordinating responses to them , while adhering to the high eu standards for personal data protection; encourages the commission to work with world trade organization members to facilitate trade in health products , increase resilience in global supply chains through stable access to raw materials , and to ensure the creation of minimum necessary stocks for both raw materials and medical equipment , and contribute to an effective response in the event of a health emergency;


### 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 to 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 a quality and environmental sustainable 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 , also to facilitate medicines movement to mitigate shortages if they occur; calls on the commission to take into account existing and self-regulated initiatives as models in future eu initiatives on pharmaceuticals in the environment , as well as to be 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 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 e-leaflets would be an effective way to reduce packaging; acknowledges steps taken already by the pharmaceutical industry to adopt and strengthen green practices , including 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 the production chain , including 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 specifically aimed at reducing packaging and the size of containers to ensure they are not larger or more intricately layered than necessary , thus helping to reduce price and waste , 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 seek a better enabling environment for innovation through stronger protection of intellectual property in the eu and in foreign markets; encourages 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 value innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu; highlights the importance of removing trade barriers and red tape in third countries , and ensuring fair access to international markets for companies operating in 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 european pharmaceutical industry , including smes , with a level playing field and a regulatory framework , facilitating trade agreements that prize manufacturing and technological know-how competitiveness , 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 robust and clear regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu;


### 24. reiterates its commitment to continue working with the commission and the world health organization to standardise effective , safe and sustainable regulatory frameworks for medicinal products; ### 24. reiterates its commitment to continue working with the commission and the world health organization and the international council for harmonisation to standardise effective , safe and sustainable regulatory frameworks for medicinal products;


### 2. notes the key role of the eea in delivering quality data on the state of the environment , which becomes increasingly important in light of the huge challenges that the union faces in tackling the climate and biodiversity crisis and finding answers through the european green deal; welcomes that the eea's opinion is being heard throughout the institutions of the union and recommends that the scientific committee of the eea play a key role in advising the commission; ### 2. notes the key role of the eea in delivering quality data on the state of the environment , which becomes increasingly important in light of the huge challenges that the union faces in tackling climate change and biodiversity loss; welcomes that the eea's opinion is being heard throughout the institutions of the union and recommends that the scientific committee of the eea play a key role in advising the commission;


### 3. notes that in 2020 , the eea's total budget was eur 63 229 066 (a 21 ,5% increase on 2019 although still below the 2018 figure) , of which eur 41 972 000 (representing an increase of 5 ,6 % compared to 2019) came from the general budget of the union; notes that the eea is expected to play a key role (monitoring , reporting and validating) in supporting the european green deal actions and the 8th general union environment action programme1 ; insists therefore that the staff budget for the eea should be increased to meet these obligations; notes that any future cuts will negatively impact the functioning of the eea and the delivery of the european green deal; ### 3. notes that in 2020 , the eea's total budget was eur 63 229 066 (a 21 ,5% increase on 2019 although still below the 2018 figure) , of which eur 41 972 000 (representing an increase of 5 ,6 % compared to 2019) came from the general budget of the union; notes that the eea is expected to play a key role (monitoring , reporting and validating) in supporting the european green deal actions and the 8th general union environment action programme1 ; insists therefore that the staff budget for the eea should be increased to meet these obligations; notes that any future cuts could conceivably have a negative impact on the functioning of the eea;


### 6. recalls that , in 2020 , the eea provided assessments and briefings on topics such as biowaste management and treatment , biodegradable plastics , the emerging challenges of waste management in europe , and how europe will be affected by key climate hazards such as droughts , floods , forest fires and sea level rise during the 21st century and beyond; ### 6. recalls that , in 2020 , the eea provided assessments and briefings on topics such as biowaste management and treatment , biodegradable plastics , the emerging challenges of waste management in europe , air quality and noise pollution , and how europe will be affected by key climate hazards such as droughts , floods , forest fires and sea level rise during the 21st century and beyond;


### 8. notes the gender balance within the agency’s senior management members , with 5 out of 8 (62 ,50 %) being men; notes the gender balance within the agency’s management board , with 16 out of 30 (53 ,34 %) being men; notes the gender balance within the agency’s overall staff , with 111 out of 203 (54 ,68 %) being women; ### 8. notes the gender balance within the agency’s senior management members , with 5 out of 8 (62 ,50 %) being men; notes the gender balance within the agency’s management board , with 16 out of 30 (53 ,34 %) being men; notes the gender balance within the agency’s overall staff , with 111 out of 203 (54 ,68 %) being women; points out , however , that , in the recruitment of new staff and in connection with promotions , the agency should bear in mind that candidates’ skills , knowledge and experience are the most important factors; points out that the need for a geographical balance among staff members should also be borne in mind;


### 5. stresses the need to ensure that the agency is able to fulfil its mandate in the long term; calls , in this regard , for the lack of predictability of the agency’s budget income to be addressed; notes the declining trend in fee income and believes that a new stable financing model should be developed and introduced without unnecessary delays; ### 5. stresses the need to ensure that the agency is able to fulfil its mandate in the long term; calls , in this regard , for the lack of predictability of the agency’s budget income to be addressed; notes the declining trend in fee income and believes that a new stable financing model should be developed and introduced without delay;


### 6. underlines the necessity of ensuring adequate staffing reflecting the needs of the european green deal and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular; ### 6. underlines the necessity of ensuring adequate staffing reflecting , in particular , the needs of the chemicals strategy for sustainability , the circular economy action plan , the delivery of a toxic-free environment , a zero-pollution ambition and the eighth environmental action programme.


### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages cooperation among the union agencies where and when possible; ### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding to strengthen exchanges of information , better mutual understanding and , where appropriate , joint projects; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages cooperation among the union agencies where and when possible;


### (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 mapping consumption for human medicines and preventing medicines shortages , and of the substance , product , organisation and referential (spor) master management for human medicines and the eudamed it platform for medical devices. that work should also be facilitated by , where appropriate , emerging digital technologies such as computational models and simulations for clinical trials , as well as data from the eu space programme such as the galileo geolocation services , and copernicus earth observation data.


### (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 including use of the european medicines verification system (set up in the context of the falsified medicines fmd) data for mapping consumption for human medicines and preventing medicines shortages , and of the substance , product , organisation and referential (spor) master management1 for human medicines and the eudamed it platform for medical devices.


### monitor and report on shortages of medicinal products for human use and medical devices; ### monitor and report to prevent 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 recognised by the european commission in accordance with article 23(1) of regulation (eu) 2020/[…]17 and the agency will define upfront the actual criteria to capture the drivers of such and emergency in article 3;


### ‘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/[…] and the agency will define upfront the actual criteria to capture the drivers of such an emergency in article 3.


### ‘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 and the agency will define upfront the actual criteria to capture the drivers of such an emergency in article 3.


### ‘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 for 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 or veterinary use or a medical device does not meet patient need for that medicinal product or medical device at national level 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 or veterinary use or a medical device does not meet demand for that medicinal product or medical device for patient need , no matter the cause;


### ‘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 and who , as part of that product’s development , is seeking to generate scientific data with regard to the product's quality , safety and efficacy;


### ‘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 and one authorised senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields.


### 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 to attend its meetings. the chair shall ensure that a broad spectrum of opinions is taken into account. the chair shall ensure that the stakeholders in the medicines supply chain can give an informed opinion about the situation in the various member states concerned;


### 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 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 to attend its meetings. ### 3. the medicines steering group shall be chaired by the agency. the chair should invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. the chair shall ensure that a broad spectrum of opinions is taken into account. the chair shall ensure that the stakeholders in the medicines supply chain can give an informed opinion about the situation in the various member states concerned;


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


### 4. the medicines steering group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists , sets of information , and recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. ### 4. the medicines steering group shall establish its rules of procedure including the clarified mention of its competences , procedures relating to the working party referred to the paragraph 5 and on the adoption of lists , sets of information , and recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency.


### 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 and it shall be capable of establishing the necessary preventive mechanisms that are necessary.


### 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 and it should be capable of establishing the necessary preventive mechanisms that are necessary.


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


### following the recognition of a public health emergency or a request for assistance referred to in article 4(3) , the medicines steering group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety , quality , and efficacy of the medicinal products concerned. ### following the express recognition of a public health emergency or a request for assistance referred to in article 4(3) , the medicines steering group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety , quality , and efficacy of the medicinal products concerned.


### following the recognition of a public health emergency or a request for assistance referred to in article 4(3) , the medicines steering group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety , quality , and efficacy of the medicinal products concerned. ### following the express recognition of a public health emergency or a request for assistance referred to in article 4(3) , the medicines steering group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety , quality , and efficacy of the medicinal products concerned. the information evaluated shall become public in due time.


### 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 726/2004.18 ### 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 726/2004.18this advice shall be made public , together with all the relevant information based on which the advice was compiled. if certain information can't be made available to the public , in order to respect confidentiality , the public health , commercial interests , grounds derived from article 30 of this regulation , or the public order , it is mentioned. the medicines steering group shall strive for the greatest transparency possible.


### 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 consultation with marketing authorisation holders , 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.


### 3. the medicines steering group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. ### 3. the medicines steering group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party and the pharmaceutical operators concerned thereof.


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


### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### on the basis of the critical medicines lists , the establishment of a two way communication line with industry via the industry single point of contacts (ispoc)and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation.


### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand with demand being based on actual patient need at the member state level , as perarticle 2(f) , of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation.


### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### on the basis of the critical medicines lists , the establishment of a two way communication line with industry via the industry single point of contacts (ispoc) and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. aspart of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu)2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation.


### 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 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 , member states , the pharmaceutical industry 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 report on a systematic , structured , and timely basis 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 , member states and the pharmaceutical industry 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.


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


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


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


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems , by implementing and building on existing regulatory infrastructure (eu telematics). this system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the agency and the national competent authorities , as well as a two way communication between the agency and marketing authorisation holders. in case of public health emergency , aggregated information should be collected by the agency from national competent authority shortages reporting systems in a harmonised and consolidated way , based on harmonised data fields across member states. the agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (ispoc) , if this information has not been provided yet to the member states.


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems; by implementing and building on existing regulatory infrastructure (eu telematics). this system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the agency and the national competent authorities , as well as a two way communication between the agency and marketing authorisation holders. in case of public health emergency , aggregated information should be collected by the agency from national competent authority shortages reporting systems in a harmonised and consolidated way , based on harmonised data fields across member states. the agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (ispoc) , if this information has not been provided yet to the member states.


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems by implementing and building on existing regulatory infrastructure (eu telematics). this system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the agency and the national competent authorities , as well as a two way communication between the agency and marketing authorisation holders. in case of public health emergency , aggregated information should be collected by the ema from national competent authority shortages reporting systems in a harmonised and consolidated way , based on harmonised data fields across member states. the agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (ispoc) , if this information has not been provided yet to the member states;


### develop streamlined electronic monitoring and reporting systems; ### develop a streamlined electronic monitoring and reporting systems; accessible by member state authorities and marketing authorization holders;


### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004; ### update the article 57(1)(l) of regulation 726/2004 data base by including the industry single point of contacts (ispoc) , this database should be digital , regularly updated , and compliant with the standards of the international organization for standardization (iso) for the identification of medicinal products (idmp);


### establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the union , through the database provided for in article 57(1)(l) of regulation 726/2004; ### update the article 57(1)(l) of regulation 726/2004 data base by including the industry single point of contacts (ispoc) , this database should be digital , regularly updated , and compliant with the standards of the international organization for standardization (iso) for the identification of medicinal products (idmp)1a;


### establish and maintain for the duration of the public health emergency or major event , a sub-network of single points of contact from marketing authorisation holders based on the medicinal products included on the critical medicines lists; ### establish and maintain for the duration of the public health emergency or major event , a sub-network of single points of contact from marketing authorisation holders from the contacts established under article 9(1) point (e) , and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public , based on the medicinal products included on the critical medicines lists;


### 3. the information referred to in point (b) of paragraph 2 shall include at least: ### 3. the information referred to in point (b) of paragraph 2 (as determined in article 9(1) (c) and article 11 (a) shall not include any information available to the agency via collection of information submitted by industry to the national competent authority shortages systems in a harmonised and consolidated way by means of common data fields for each member state. the system at the agency shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process by industry via industry single points of contact (ispoc).


### 3. the information referred to in point (b) of paragraph 2 shall include at least: ### 3. the information referred to in point (b) of paragraph 2 (as determined in article 9(1)(c) and article 11 shall not include any information available to the agency via collection of information submitted by industry to the national competent authority shortages systems in a harmonised and consolidated way by means of common data fields for each member state. the system at the agency will be interoperable with the national shortages reporting to prevent any duplication of the reporting process by industry via industry single points of contact (ispoc).


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency. they shall submit the information through the points of contact designated in accordance with article 9(2) and using the reporting methods and system established pursuant to article 9(1). they shall provide updates where necessary. ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency , if the information is not available via the interoperable system connected with the national shortages reporting systems established in article 9(1) (c).


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency. they shall submit the information through the points of contact designated in accordance with article 9(2) and using the reporting methods and system established pursuant to article 9(1). they shall provide updates where necessary. ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency , if the information is not available via the interoperable system connected with the national shortages reporting systems established in article 9 (1) (c).


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency. they shall submit the information through the points of contact designated in accordance with article 9(2) and using the reporting methods and system established pursuant to article 9(1). they shall provide updates where necessary. ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency , if the information is not available via the interoperable system connected with the national shortages reporting systems established in the article 9(1)(c).


### 2. marketing authorisation holders of medicinal products authorised in the union shall , within 6 months from the date of application of this regulation , provide the information required pursuant to article 9(1)(e) in the form of an electronic submission in the database referred to in article 57(1)(l) of regulation (ec) no 726/2004. those marketing authorisation holders shall update their submission wherever necessary. ### 2. marketing authorisation holders of medicinal products authorised in the union shall , within 12-24 months from the date of application of this regulation , provide the information required pursuant to article 9(1)(e) in the form of an electronic submission in the database referred to in article 57(1)(l) of regulation (ec) no 726/2004 and compliant with the standards of the international organization for standardization (iso) for the identification of medicinal products (idmp). those marketing authorisation holders shall update their submission wherever necessary.


### 2. marketing authorisation holders of medicinal products authorised in the union shall , within 6 months from the date of application of this regulation , provide the information required pursuant to article 9(1)(e) in the form of an electronic submission in the database referred to in article 57(1)(l) of regulation (ec) no 726/2004. those marketing authorisation holders shall update their submission wherever necessary. ### 2. marketing authorisation holders of medicinal products authorised in the union shall , within 12-24 from the date of application of this regulation , provide the information required pursuant to article 9(1)(e) in the form of an electronic submission in the database referred to in article 57(1)(l) of regulation (ec) no 726/2004 and compliant with the standards of the international organization for standardization (iso) for the identification of medicinal products (idmp)5. those marketing authorisation holders shall update their submission wherever necessary.


### 3. marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the agency. ### deleted


### 3. marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the agency. ### 3. marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the agency after consultation and agreement with industry on a case by case scenario.


### 4. where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature , they shall identify the relevant parts and clarify the reasons for such an indication. the agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure. ### 4. where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature , they shall identify the relevant parts and clarify the reasons for such an indication. it should be determined upfront what information is commercially confident , based on this the agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure.


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states shall , by the deadline set by the agency: ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states shall , by the deadline set by the agency , where relevant , following the creation of a harmonized pan-european interoperable and digital national competent authorities (ncas) shortages reporting system based on common data fields (a) submit the set of information requested by the agency in chapter 2 article 9 (4) including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1);


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states shall , by the deadline set by the agency: ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , member states shall , by the deadline set by the agency , where relevant , following the creation of a harmonized pan-european interoperable and digital national competent authorities (ncas) shortages reporting system based on common data fields;


### submit the set of information requested by the agency including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1); ### submit the set of available information to member states requested by the agency including estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1);


### submit the set of information requested by the agency including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1); ### submit the set of information requested by the agency in chapter 2 article 9(4) including available and estimated data on volume of demand , through its designated point of contact and using the reporting methods and system established pursuant to article 9(1);


### 2. where necessary to fulfil their reporting obligations set out in paragraph 1 , member states , with the support of the agency , shall gather information and data on stock levels from wholesale distributors and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists. ### deleted


### take into account any recommendations and guidelines and comply with any measures taken at union-level pursuant to article 12; ### acknowledge any recommendations and guidelines and comply with any measures taken at union-level pursuant to article 12;


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


### inform the medicines steering group of any measures taken and report on the results; ### inform the medicines steering group and industry (via the trade associations) of any measures taken and report on the results;


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


### 6. the emergency task force shall establish its rules of procedure including rules on the adoption of recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. ### 6. the emergency task force shall establish its rules of procedure including rules on the adoption of recommendations. the rules of procedure shall enter into force after receiving a favourable opinion from the commission and the management board of the agency. the agenda and minutes of the task force shall be made public through the agency's online portal.


### 3. the emergency task force shall establish procedures for the request and submission of the set of information and data required , including information on the member state or states where an application for authorisation of a clinical trial is submitted or is intended to be submitted. ### 3. the emergency task force shall establish procedures for the request and submission of the set of information and data required , in cooperation with the member states where an application for authorisation of a clinical trial is submitted or is intended to be submitted in accordance with article 4 of the regulation 536/2014 on clinical trials on medicinal products for human use.


### 3. the emergency task force shall establish procedures for the request and submission of the set of information and data required , including information on the member state or states where an application for authorisation of a clinical trial is submitted or is intended to be submitted. ### 3. the emergency task force shall establish and update procedures for the request and submission of the set of information and data required , in cooperation with the member states where an application for authorisation of a clinical trial is submitted or is intended to be submitted in accordance with article 4 of the regulation 536/2014on clinical trials on medicinal products for human use. these procedures shall become public.


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


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


### 5. the medical devices steering group shall be supported in its work by a working party comprised of single points of contact from national competent authorities for medical devices established in accordance with article 23(1). ### 5. the medical devices steering group may be supported in its work by a working party comprised of single points of contact from national competent authorities for medical devices established in accordance with article 23(1).


### 2. the medical devices steering group shall adopt a set of information necessary to monitor the supply and demand of medical devices included on the public health emergency critical devices list and inform its working party thereof. ### 2. the medical devices steering group shall adopt a set of information necessary to only monitor data for the long-term safety assessment of medical devices included on the public health emergency critical devices list.


### 3. the agency shall publish the public health emergency critical devices list and any updates to that list on its web-portal. ### 3. the agency shall publish on an accessible way , the public health emergency critical devices list and any updates to that list on its web-portal.


### 1. on the basis of the public health emergency critical devices list and the information and data provided in accordance with articles 24 and 25 , the medical devices steering group shall monitor supply and demand of medical devices included on that list with a view to identifying any potential or actual shortages of those medical devices. as part of that monitoring , the medical devices steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]22 and the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### 1. on the basis of the public health emergency critical devices list and the information and data provided in accordance with articles 24 and 25 , the medical devices steering group shall update the medical devices included on the list compiled by the medical device coordination group (mdcg) with a view to identifying any potential or actual shortages of those medical devices. as part of that monitoring , the medical devices steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]22 and the advisory committee on public health emergencies established pursuant to article 24 of that regulation.


### 2. as part of the monitoring , the medical devices steering group may also make use of data from device registries and databanks where such data is available to the agency. in so doing , the medical devices steering group shall take into account the data generated pursuant to article 108 of regulation (eu) 2017/745 and article 101 of regulation (eu) 2017/746. ### deleted


### 3. as part of the reporting referred to in paragraphs 1 and 2 , the medical devices steering group may also provide recommendations on measures , which may be taken by the commission , member states , medical device manufacturers , notified bodies and other entities to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , where relevant , with the health security committee and the advisory committee on public health emergencies. ### deleted


### 4. the medical devices steering group may , on its own initiative or upon request from the commission , provide recommendations on measures which may be taken by the commission , member states , medical device manufacturers , notified bodies and other entities to ensure preparedness to deal with potential or actual shortages of medical devices caused by public health emergencies. ### deleted


### specify the procedures for establishing the public health emergency critical devices list; ### after consultation with all relevant stakeholders specify the procedures for establishing the public health emergency critical devices list;


### 4. where manufacturers of medical devices included on the public health emergency critical devices list and concerned notified bodies are in possession of any additional information , which provides evidence of a potential or actual shortage , they shall immediately provide such information to the agency. ### deleted


### 1. unless otherwise provided for in this regulation and without prejudice to regulation (ec) no 1049/200124 and existing national provisions and practices in the member states on confidentiality , all parties involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: ### 1. without prejudice to regulation (ec) no 1049/200124 and existing national provisions and practices in the member states on confidentiality , all parties involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:


### 2. where a developer engages in an accelerated scientific advice process , the emergency task force shall provide such advice free of charge at the latest 20 days following the submission to the agency of a complete set of requested information and data by the developer. the advice shall be endorsed by the committee for medicinal products for human use. ### 2. where a developer engages in an accelerated scientific advice process , the emergency task force shall provide such advice free of charge . the advice shall be endorsed by the committee for medicinal products for human use at the latest 20 days following the submission to the agency of a complete set of requested information and data by the developer.


### 2. notes that , owing to the global covid-19 pandemic , 2020 was an extremely challenging year for the ema , requiring a shift in its priorities and extreme agility and resilience to maintain the ema’s activities while supporting global efforts to combat the pandemic in a new and challenging environment; ### 2. notes that following its relocation in 2019 , the ema had planned to resume full-scale activities in 2020; however , the covid-19 outbreak forced a re-prioritisation of its operations to tackle the pandemic; stresses that 2020 was consequently an extremely challenging year for the ema , requiring extreme agility and resilience to maintain the ema’s activities while supporting global efforts to combat the pandemic in a new and challenging environment;


### 10. welcomes the proposal to extend the ema’s mandate but expresses concern that the addition of significant new tasks and its increasing workload over the years has not been accompanied by corresponding increases in the ema's staff and resources , and that such a shortage of staff puts the continuity of its operations under significant pressure; ### 10. welcomes the proposal to extend the ema’s mandate but expresses concern that the addition of significant new tasks and its increasing workload over the years has not been accompanied by corresponding increases in the ema's staff and resources , and that such a shortage of staff puts the continuity of its operations under significant pressure at an already critical time;


### 14. notes , in addition , that the court identified irregularities in a catering and restaurant services framework contract , including a failure to verify that the amounts invoiced were correct; ### 14. notes , with concern , that the court identified irregularities in a catering and restaurant services framework contract , including a failure to verify that the amounts invoiced were correct;


### 15. notes with satisfaction that the ema cooperates with other agencies , in particular with the european centre for disease prevention and control and with the european food safety authority , including on the european vaccination information portal and on antimicrobial resistance; ### 15. notes with satisfaction that the ema cooperates with other agencies , in particular with the european centre for disease prevention and control and with the european food safety authority , including on the european vaccination information portal , for monitoring vaccine safety and reporting side effects , as well as on antimicrobial consumption and resistance;


### (3) binding occupational exposure limit values are important component of the general arrangements for the protection of workers established by directive 2004/37/ec and must not be exceeded. limit values and other directly related provisions should be established for all those carcinogens or mutagens for which the available information , including scientific and technical data , make this possible. ### (3) binding occupational exposure limit values are an important component of the general arrangements for the protection of workers established by directive 2004/37/ec and must not be exceeded. limit values and other directly related provisions should be established for all those carcinogens or mutagens for which the available information , including scientific and technical data , make this possible.


### (5) this directive strengthens the protection of workers’ health and safety at their workplace. new limit values should be set out in directive 2004/37/ec in the light of available information , including new scientific and technical data and should also be based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace. that information should , if possible , include data on residual risks to the health of workers , opinions of the committee for risk assessment (rac) of the european chemicals agency (echa) , as well as opinions of the advisory committee on safety and health at work (acsh). information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens. ### (5) this directive strengthens the protection of workers’ health and safety at their workplace. new limit values should be set out in directive 2004/37/ec in the light of available information , including new scientific and technical data and should also be based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the workplace , also differentiating and analysing impacts and available infrastructures in different regions and member states of the union. that information should , if possible , include data on residual risks to the health of workers , opinions of the committee for risk assessment (rac) of the european chemicals agency (echa) , as well as opinions of the advisory committee on safety and health at work (acsh). information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens.


### (7) it is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagens , including the possibility of uptake through the skin , in order to ensure the best possible level of protection. ### (7) it is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagens , including the possibility of uptake through the skin , in order to ensure the best possible level of protection. encourages the commission , in close cooperation with the member states and relevant authorities to continue their close cooperation with research centers , academia and other relevant stakeholders , to ensure the most up to date information available.


### (10) with regard to acrylonitrile , a limit value of 1 mg/m³ (0.45 ppm) and a short-term limit value of 4 mg/m³ (1.8 ppm) may be difficult to be complied with in the short term. a transitional period of four years after entry into force of this directive should be introduced from which these occupational exposure limit (oel) values shall apply. ### (10) with regard to acrylonitrile , a limit value of 1 mg/m³ (0.45 ppm) and a short-term limit value of 4 mg/m³ (1.8 ppm) may be difficult to be complied with in the short term. a transitional period of at least four years after entry into force of this directive should be introduced from which these occupational exposure limit (oel) values shall apply , allowing for full adaptation in all member states.


### (12) with regard to nickel compounds , limit values of 0.01 mg/m³ for the respirable fraction and 0.05 mg/m³ for the inhalable fraction may be difficult to be complied with in a number of sectors or processes , including specifically smelting , refineries and welding. furthermore , since identical risk management measures can be used both for chromium (vi) and nickel compounds , the transitional measures aiming to reduce the exposure to these two groups of carcinogens should be aligned. therefore , a transitional period until 17 january 2025 inclusive should be introduced during which a limit value of 0.1 mg/m³ for the inhalable fraction of the nickel compounds should apply. this transitional period would ensure alignment with the date of application of the oel for chromium (vi) compounds adopted in directive 2017/2398/eu48 . ### (12) with regard to nickel compounds , limit values of 0.01 mg/m³ for the respirable fraction and 0.05 mg/m³ for the inhalable fraction may be difficult to be complied with in a number of sectors or processes , including specifically mining , smelting , welding , casting , and refineries. furthermore , since identical risk management measures can be used both for chromium (vi) and nickel compounds , the transitional measures aiming to reduce the exposure to these two groups of carcinogens should be aligned. therefore , a transitional period until 17 january 2025 inclusive should be introduced during which a limit value of 0.1 mg/m³ for the inhalable fraction of the nickel compounds should apply. this transitional period would ensure alignment with the date of application of the oel for chromium (vi) compounds adopted in directive 2017/2398/eu48 .


### (13) benzene meets the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and is therefore carcinogen within the meaning of directive 2004/37/ec. benzene can also be absorbed through the skin. the limit value set out in annex iii to directive 2004/37/ec for benzene should be revised in the light of more recent scientific data and it is appropriate to keep the skin notation. the acsh , based on the rac opinion , agreed on the usefulness of the biomonitoring for benzene. this should be considered when developing guidance on the practical use of biomonitoring. ### (13) benzene meets the criteria for classification as carcinogenic (category 1a) in accordance with regulation (ec) no 1272/2008 and is therefore carcinogen within the meaning of directive 2004/37/ec. benzene can also be absorbed through the skin and has in particular been found to also be a cause of various types of leukemia. the limit value set out in annex iii to directive 2004/37/ec for benzene should be revised in the light of more recent scientific data and it is appropriate to keep the skin notation. the acsh , based on the rac opinion , agreed on the usefulness of the biomonitoring for benzene. this should be considered when developing guidance on the practical use of biomonitoring.


### (18) given that this directive concerns the protection of the health and safety of workers at their workplace , it should be transposed within two years of the date of its entry into force. ### (18) given that this directive concerns the protection of the health and safety of workers at their workplace , it should be transposed within four years of the date of its entry into force , allowing for another two years of transitional phase for all member states to adapt accordingly.


### 1. member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [two years] after the date of entry into force of this directive at the latest. they shall forthwith communicate to the commission the text of those provisions. ### 1. member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [four years] after the date of entry into force of this directive at the latest. they shall forthwith communicate to the commission the text of those provisions.


### 1. observes that the mission of the european centre for disease prevention and control (the 'centre') is to identify , assess and communicate current and emerging threats to human health from communicable diseases; emphasises that thecovid-19 outbreak and subsequent pandemic in 2020 was the most serious public health event that the centre has had to respond to since it became operational in 2005; ### 1. observes that the mission of the european centre for disease prevention and control (the 'centre') is to identify , assess and communicate current and emerging threats to human health from communicable diseases; emphasises that the covid-19 outbreak and subsequent pandemic in 2020 was the most serious public health event that the centre has had to respond to since it became operational in 2005 , and that supporting the union's response to covid-19 became its principal activity; notes , moreover , that the centre started operating at public health event (phe) level 2 , acute phase on 31 january 2020 and continued to operate in this phase for the remainder of the year;


### 2. highlights the 24 covid-19 related risk assessments carried out by the centre , the 159 covid-19 formal scientific requests from the commission and members of the european parliament , and the more than 100 formal scientific requests from member states; ### 2. highlights the 24 covid-19 related risk assessments carried out by the centre , the 159 covid-19 formal scientific requests from the commission and members of the european parliament , and the more than 100 formal scientific requests from member states; furthermore notes that the number of downloads of rapid risk assessments increased by 1086 percent when compared with 2019 figures;


### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’. ### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have specific concerns about the compatibility with environmental law of administrative acts with significant adverse effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states , which should be preceded by a close consultation on the matter with the member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’.


### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’. ### deleted


### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’. ### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’.


### (4) taking into account the provisions of article 9(3) of the aarhus convention , as well as concerns expressed by the aarhus convention compliance committee62 , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters in a way that is compatible with the fundamental principles of union law and with its system of judicial review. ### (4) taking into account the provisions of article 9(3) of the aarhus convention , as well as concerns expressed by the aarhus convention compliance committee62 , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters in a way that is compatible with the fundamental principles of union law and treaties , as well as with its system of judicial review.


### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope is the main obstacle for environmental non-governmental organisations seeking to have recourse to internal review under article 10 of that regulation also as regards administrative acts that have a wider scope. it is therefore necessary to broaden the scope of the internal review procedure laid down in that regulation to include non-legislative acts of a general scope. ### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope may be , in certain cases , an obstacle for environmental non-governmental organisations seeking to have recourse to internal review under article 10 of that regulation also as regards administrative acts that have a wider scope. where appropriate , it may therefore be justified to appropriately broaden the scope of the internal review procedure laid down in that regulation to include non-legislative acts of a general scope.


### (5) the limitation of the internal review provided for in regulation (ec) no 1367/2006 to administrative acts of individual scope is the main obstacle for environmental non-governmental organisations seeking to have recourse to internal review under article 10 of that regulation also as regards administrative acts that have a wider scope. it is therefore necessary to broaden the scope of the internal review procedure laid down in that regulation to include non-legislative acts of a general scope. ### deleted


### (6) the definition of an administrative act for the purposes of regulation (ec) no 1367/2006 should include non-legislative acts. however , a non legislative act might entail implementing measures at national level against which environmental non-governmental organisations can obtain judicial protection , including before the court of justice of the european union (cjeu) through a procedure for preliminary ruling under article 267 tfeu. therefore , it is appropriate to exclude from the scope of the internal review those provisions of such non-legislative acts for which union law requires implementing measures at national level. ### deleted