### 4. the commission may , by means of implementing acts , and following a substantiated request of the competent authority of a member state , grant time-limited derogations from the end dates or cut-off dates specified in annex v for a specified case where it is demonstrated in the request that no technically and economically feasible alternative is available for that particular application. the commission may include in those implementing acts reporting requirements , and may require submission of supporting evidence necessary for monitoring the use of the derogation , including evidence on amounts recovered for recycling or reclamation , results of leakage checks and amounts of unused halons in stocks. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2). ### 4. the commission may , by means of implementing acts , and following a substantiated request of the competent authority of a member state , grant time-limited derogations from the end dates or cut-off dates specified in annex v for a specified case where it is demonstrated in the request that no technically feasible alternative is available for that particular application. the commission may include in those implementing acts reporting requirements , and may require submission of supporting evidence necessary for monitoring the use of the derogation , including evidence on amounts recovered for recycling or reclamation , results of leakage checks and amounts of unused halons in stocks. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2).


### 1. the commission shall set up and ensure the operation of the electronic licensing system for ozone depleting substances listed in annex i and products and equipment containing those substances or whose functioning relies upon those substances ('the licensing system'). ### 1. the commission shall set up and ensure the operation of the electronic licensing system for ozone depleting substances listed in annex i and annex ii and products and equipment containing those substances or whose functioning relies upon those substances ('the licensing system').


### 1. ozone depleting substances listed in annex i contained in refrigeration , air-conditioning and heat pump equipment , equipment containing solvents or fire protection systems and fire extinguishers shall , during the maintenance or servicing of equipment or before the dismantling or disposal of equipment , be recovered for destruction , recycling or reclamation. ### 1. ozone depleting substances listed in annex i and annex ii contained in refrigeration , air-conditioning and heat pump equipment , equipment containing solvents or fire protection systems and fire extinguishers shall , during the maintenance or servicing of equipment or before the dismantling or disposal of equipment , be recovered for destruction , recycling or reclamation.


### 2. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of metal-faced panels that contain foams with ozone depleting substances listed in annex i are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein. ### 2. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of metal-faced panels that contain foams with ozone depleting substances listed in annex i and annex ii are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein.


### 3. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of foams in laminated boards installed in cavities or built-up structures that contain ozone depleting substances listed in annex i are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein. ### 3. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of foams in laminated boards installed in cavities or built-up structures that contain ozone depleting substances listed in annex i and annex ii are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein.


### 6. ozone depleting substances listed in annex i contained in products and equipment other than those mentioned in paragraphs 1 to 5 shall , if technically and economically feasible , be recovered for destruction , recycling or reclamation , or shall be destroyed without prior recovery. ### 6. ozone depleting substances listed in annex i and annex ii contained in products and equipment other than those mentioned in paragraphs 1 to 5 shall , if technically and economically feasible , be recovered for destruction , recycling or reclamation , or shall be destroyed without prior recovery.


### 9. member states shall promote the recovery , recycling , reclamation and destruction of ozone depleting substances listed in annex i and shall establish the minimum qualification requirements for the personnel involved. ### 9. member states shall promote the recovery , recycling , reclamation and destruction of ozone depleting substances listed in annex i and annex ii and shall establish the minimum qualification requirements for the personnel involved.


### 2. undertakings shall take all necessary precautions to prevent and minimise any unintentional release of ozone depleting substances listed in annex i during production , including inadvertently produced in the course of the manufacture of other chemicals , equipment manufacturing process , use , storage and transfer from one container or system to another or transport. ### 2. undertakings shall take all necessary precautions to prevent and minimise any unintentional release of ozone depleting substances listed in annex i and annex ii during production , including inadvertently produced in the course of the manufacture of other chemicals , equipment manufacturing process , use , storage and transfer from one container or system to another or transport.


### 3. undertakings operating equipment containing ozone depleting substances listed in annex i , shall ensure that any detected leakage is repaired without undue delay , without prejudice to the prohibition to use the ozone depleting substances. ### 3. undertakings operating equipment containing ozone depleting substances listed in annex i and annex ii , shall ensure that any detected leakage is repaired without undue delay , without prejudice to the prohibition to use the ozone depleting substances.


### the checks shall be carried out following a risk-based approach , which takes into consideration , in particular , the history of compliance of undertakings , the risk of non-compliance of a specific product with this regulation , and any other relevant information received from the commission , national customs authorities , market surveillance authorities , environmental authorities and other authorities with inspection functions or from competent authorities of third countries. ### the checks shall cover at least 10% of the relevant undertakings each year and be carried out following a risk-based approach , which takes into consideration , in particular , the history of compliance of undertakings , the risk of non-compliance of a specific product with this regulation , and any other relevant information received from the commission , national customs authorities , market surveillance authorities , environmental authorities and other authorities with inspection functions or from competent authorities of third countries.


### in cases of unlawful production , import , export , placing on the market , or use of ozone depleting substances listed in annex i or of products and equipment containing those substances or whose functioning relies upon those substances , member states shall envisage maximum administrative fines of at least five times the market value of the concerned substances or products and equipment concerned. in case of a repeated infringement within a five-year period , the member states shall envisage maximum administrative fines of at least eight times the market value of the concerned substances or products and equipment concerned. ### in cases of unlawful production , import , export , placing on the market , or use of ozone depleting substances listed in annex i or of products and equipment containing those substances or whose functioning relies upon those substances , member states shall envisage maximum administrative fines of at least ten times the market value of the concerned substances or products and equipment concerned. in case of a repeated infringement within a three-year period , the member states shall envisage maximum administrative fines of at least fifteen times the market value of the concerned substances or products and equipment concerned.


### in cases of infringements of article 21(1) , the potential impact on the climate shall be reflected by taking into account the carbon price in the determination of an administrative fine. ### in cases of infringements of article 21(1) , the potential impact on the climate shall be reflected in the determination of an administrative fine.


### 2. the power to adopt delegated acts referred to in article 7(4) , article 8(7) , article 9(3) , article 16(13) , article 18 , article 19(2) , article 20(8) , article 22 , article 23(3) and article 24(4) shall be conferred on the commission for an indeterminate period of time [from the date of application of the regulation] ### 2. the power to adopt delegated acts referred to in article 6 (1b) and (1d) , article 7(4) , article 8(7) , article 9(3) , article 15(1a) , article 16(13) , article 18 , article 19(2) , article 20(8) , article 22 , article 23(3) and article 24(4) shall be conferred on the commission for an indeterminate period of time [from the date of application of the regulation]


### 3. the delegation of power referred to in article 7(4) , article 8(7) , article 9(3) , article 16(13) , article 18 , article 19(2) , article 20(8) , article 22 , article 23(3) and article 24(4) may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force. ### 3. the delegation of power referred to in article 6 (1b) and (1d) , article 7(4) , article 8(7) , article 9(3) , article 15(1a) , article 16(13) , article 18 , article 19(2) , article 20(8) , article 22 , article 23(3) and article 24(4) may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force.


### 6. a delegated act adopted pursuant to article 7(4) , article 8(7) , article 9(3) , article 16(13) , article 18 , article 19(2) , article 20(8) , article 22 , article 23(3) and article 24(4) shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object. that period shall be extended by two months at the initiative of the european parliament or of the council. ### 6. a delegated act adopted pursuant to article 6 (1b) and (1d) , article 7(4) , article 8(7) , article 9(3) , article 15(a) , article 16(13) , article 18 , article 19(2) , article 20(8) , article 22 , article 23(3) and article 24(4) shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object. that period shall be extended by two months at the initiative of the european parliament or of the council.


### by 1 january 2033 , the commission shall publish a report on the implementation of this regulation. ### by 1 january 2028 , and every two years thereafter , the commission shall publish a report on the implementation and effectiveness of this regulation.


### critical uses of halons ### critical uses of halons


### proposal for a regulation of the european parliament and of the council on reporting of environmental data from industrial installations and establishing an industrial emissions portal (text with eea relevance) ### proposal for a regulation of the european parliament and of the council on reporting of environmental data from industrial activities and establishing an industrial pollution prevention tracker portal (text with eea relevance)


### (7) in line with the conclusions of the commission’s second report on implementation of regulation (ec) no 166/2006 , the commission , supported by the european environment agency (‘the agency’) , developed in june 2021 an industrial emissions portal (‘the portal’)38 to replace the european pollutant release and transfer register and therefore improve synergies with reporting under directive 2010/75/eu. ### (7) in line with the conclusions of the commission’s second report on implementation of regulation (ec) no 166/2006 , the commission , supported by the european environment agency (‘the agency’) , developed in june 2021 an industrial pollution prevention tracker portal (‘the portal’)38 to replace the european pollutant release and transfer register and therefore improve synergies with reporting under directive 2010/75/eu.


### (8) the portal should provide the public with free-of-charge and online access to a further integrated and coherent dataset on key environmental pressures generated by industrial installations since such data constitute a cost-effective tool for drawing comparisons and taking decisions in environmental matters , encouraging better environmental performance , tracking trends , demonstrating progress in pollution reduction , benchmarking installations , monitoring compliance with relevant international agreements , setting priorities and evaluating progress achieved through union and national environmental policies and programmes. ### (8) the portal should provide the public with free-of-charge and online access to a further integrated and coherent dataset on key environmental pressures generated by industrial installations since such data constitute a cost-effective tool for drawing comparisons and taking decisions in environmental matters , encouraging better environmental performance , tracking trends , demonstrating progress in pollution reduction , benchmarking installations , monitoring compliance with relevant international agreements , setting priorities and evaluating progress achieved through union and national environmental policies and programmes. therefore , the portal should facilitate public participation in environmental decision-making and contribute to the prevention and reduction of pollution of the environment.


### (9) the portal should present the data it contains in aggregated and non-aggregated forms to permit users to undertake targeted searches. ### (9) the portal should present the data it contains in aggregated and non-aggregated forms to permit users to undertake targeted searches and downloads of query-based datasets.


### (12) in order to monitor the environmental performance of industrial installations , the data to be included in the portal should cover , above quantitative thresholds , releases to the environment of certain pollutants , off-site transfers of waste water containing these pollutants and off-site transfers of waste. ### (12) in order to monitor the environmental performance of industrial installations , the data to be included in the portal should cover , when occurring , releases to the environment of certain pollutants , off-site transfers of waste water containing these pollutants and off-site transfers of waste.


### (13) the portal should also include data on the use of water , energy and raw materials by the concerned installations to allow monitoring of progress towards a circular , highly resource-efficient economy ### (13) the portal should also include data on the use of water , energy and raw materials by the concerned installations and its compliance and permitting information to allow and enhance public access to information and monitoring of progress towards a circular , highly resource-efficient economy.


### (15) operators of installations should also report information concerning the production volume , number of employees and operating hours of the concerned installation as well as information on accidents that have led to releases , in order to enable the contextualisation of reported data on pollutant releases and off-site transfers of waste and waste water. ### (15) operators of installations should also report information concerning the production volume , number of employees and operating hours of the concerned installation as well as information on dangerous events or accidents that have led to releases or endagered the wellbeing of employees of the installation , in order to enable the contextualisation of reported data on pollutant releases and off-site transfers of waste and waste water and to improve work safety.


### (17) for the purpose of legal certainty , operators of installations should be required to enter a nil return when releases and off-site transfers of waste and of waste water from their installations are below reporting thresholds. ### deleted


### (18) to improve the quality of reported data and to ensure their comparability , it is appropriate to harmonise quantification methods to be used by operators when reporting releases , off-site transfers of waste , off-site transfers of waste water and resource use. operators should therefore be required to use , as a priority , measurement as the most accurate quantification method and , if not practicable , calculation , whereas estimation should only be used as a last resort. ### (18) to improve the quality of reported data and to ensure their comparability , it is appropriate to harmonise quantification methods to be used by operators when reporting releases , off-site transfers of waste , off-site transfers of waste water and resource use. operators should therefore be required to use , as a priority , measurement as the most accurate quantification method and , if not practicable , calculation.


### (21) given the importance for the union citizens of quick access to environmental information , it is essential that member states and the commission make data publicly available as fast as technically feasible. to that end , whereas the precise reporting deadline is to be established in an implementing act , it should be no later than 11 months after the end of the reporting year. ### (21) given the importance for the union citizens of quick access to environmental information , it is essential that member states and the commission make data publicly available as fast as technically feasible , not exceeding 1 month after the information has been generated. to that end , whereas the precise reporting deadline is to be established in an implementing act , it should be no later than 11 months after the end of the reporting year.


### (31) in order to ensure effective implementation of this regulation , member states should lay down rules on penalties applicable to its infringements and should ensure that they are implemented. ### (31) in order to ensure effective implementation of this regulation , member states should lay down rules on effective penalties applicable to its infringements with minimum conditions and should ensure that they are implemented in a way that ensures complience with this regulation. the commission should bianually assess the rules set by the member states and , where appropriate , issue recommendations for further improvements. member states should address the commission’s recommendations.


### this regulation implements the unece protocol on pollutant release and transfer registers (‘the protocol’) by laying down rules on the collection and reporting of environmental data on industrial installations and establishes an industrial emissions portal (‘portal’) at union level in the form of an online database giving access to such data. ### this regulation implements the unece protocol on pollutant release and transfer registers (‘the protocol’) by laying down rules on the collection and reporting of environmental data on industrial activities and establishes an industrial pollution prevention tracker portal (‘portal’) at union level in the form of an online database giving access to such data. the portal shall enhance public access to information that would also facilitate public participation in environmental decision-making and contribute to the prevention and reduction of pollution of the environment notably through benchmarking and compliance promotion on industrial activities. it also contributes to enhancing work safety of industrial activities.


### 2. the portal shall include links to the following: ### 2. the portal shall integrate performance data and other pollution prevention information of the following:


### 1. the commission shall make the portal publicly accessible , presenting the data in both aggregated and non-aggregated forms with a view to enabling searches by: ### 1. the commission , assisted by the agency , shall present data in both aggregated and non-aggregated forms with a view to enabling searches and downloads of query-based datasets by:


### 2. the portal shall be designed for maximum ease of public access to allow the data , under normal operating conditions , to be continuously and readily accessible on the internet. its design shall take into account the possibility of its future expansion and shall include all data reported for previous reporting years , up to at least the previous ten reporting years. ### 2. the portal shall be established with a view to satisfy at least the following purposes:


### reporting by operators to competent authorities ### reporting by operators to the portal


### releases to air , water and land of any pollutant specified in annex ii for which the applicable threshold value specified in annex ii is exceeded; ### releases to air , water and land of any pollutant specified in annex ii , when occurring;


### off-site transfers of hazardous waste exceeding 2 tonnes per year or of non-hazardous waste exceeding 2 000 tonnes per year , for any operations of recovery or disposal with the exception of the disposal operations of land treatment and deep injection disposal operations , as specified in annex i to directive 2008/98/ec , indicating with ‘r’ or ‘d’ respectively whether the waste is destined for recovery or disposal and , for transboundary movements of hazardous waste , the name and address of the recoverer or the disposer of the waste and the actual recovery or disposal site. waste which is subject to land treatment or deep injection disposal operations shall be reported as a release to land only by the operator of the installation from which the waste originates; ### off-site transfers of hazardous waste exceeding 1 tonne per year or of non-hazardous waste exceeding 1 000 tonnes per year , for any operations of recovery or disposal , indicating with ‘r’ or ‘d’ respectively whether the waste is destined for recovery or disposal , the name and address of the recoverer or the disposer of the waste and the actual recovery or disposal site and the eu waste code(s). waste which is subject to land treatment or deep injection disposal operations shall be reported as a release to land only by the operator of the installation from which the waste originates;


### information allowing contextualisation of the data reported under points (a) to (d) , including production volume , number of employees , number of operating hours , and information on accidents that have led to releases; ### information allowing contextualisation of the data reported under points (a) to (d) , of the portal including production volume , information generated pursuant to directive 2010/75/eu , notably pursuant to its article 14 and article 24 , number of employees , number of operating hours , and information on dangerous events or accidents that have lead to releases or endagered the wellbeing of employees of the installation;


### 2. where the releases referred to in paragraph 1 , point (a) , or off-site transfers of pollutants referred to in paragraph 1 , point (c) , do not exceed the applicable threshold values specified in annex ii , or where off-site transfers of waste do not exceed the thresholds set out in paragraph 1 , point (b) , the operator of the installation concerned shall declare , in its report , that releases or off-site transfers are below those values or thresholds. ### deleted


### 3. operators shall obtain the data referred to in paragraph 1 by means of measurement. where measurement is not practicable , operators shall use calculation. where neither measurement nor calculation is practicable , operators may obtain the data by estimation. ### 3. operators shall obtain the data referred to in paragraph 1 by means of measurements , minimal calibration frequencies for monitoring devices and measurement uncertainty levels shall be aligned to state-of-the-art. when measurement uncertainty is applied , the level of the uncertainty level subtrated and an url to the latest calibration report must be provided. where measurement is not practicable , operators may use calculation which is considered as scientifically reliable. where neither measurement nor calculation is practicable , operators may obtain the data by estimation.


### 3. each member state shall make available to the public its data , reported in accordance with article 5 and , where available , article 7(1) , in a continuous manner , free of charge and without restricting access to registered users. ### 3. each member state shall make available to the public its data , reported in accordance with article 5 and , where available , article 7(1) , in a continuous manner , free of charge and without restricting access.


### 1. member states shall lay down the rules on penalties applicable to infringements of national measures adopted pursuant to this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive. member states shall without delay notify the commission of those rules and of those measures and shall notify it without delay of any subsequent amendment affecting them. ### 1. member states shall lay down the rules on penalties applicable to infringements of national measures adopted pursuant to this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive. member states shall without delay notify the commission of those rules and of those measures and shall notify it without delay of any subsequent amendment affecting them.


### 2. the penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person who has committed the infringement. the level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the infringement of the economic benefits derived from that infringement. the level of the fines shall be gradually increased for repeated infringements. ### 2. the penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person who has committed the infringement. the level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the infringement of the economic direct and indirect benefits derived from that infringement.


### the population or the environment affected by the infringement , bearing in mind the impact on the objective of achieving a high level of protection of human health and the environment. ### the population or the environment that was directly or indirectly affected by the infringement , bearing in mind the impact on the objective of achieving a high level of protection of human health and the environment , in accordance to the one health approach.


### — having regard to the intergovernmental panel on climate change (ipcc) special report on global warming of 1.5° c , its sixth assessment report (ar6) and its synthesis report thereon , ### — having regard to the special report of the intergovernmental panel on climate change (ipcc) on global warming of 1.5 °c , its sixth assessment report (ar6) and its synthesis report thereon , its special report on climate change and land , and its special report on the ocean and cryosphere in a changing climate;


### — having regard to the world meteorological organisation (wmo) report on the state of the global climate in 2020 of april 2021 , ### — having regard to the world meteorological organisation (wmo) report of april 2021 on the state of the global climate in 2020 , and of may 2022 on the state of the global climate in 2021;


### a. whereas health is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , alongside investment and research; ### a. whereas health is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , alongside investment and research; whereas patients should be involved in every aspect of the medicine regulatory lifecycle;


### a. whereas health is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , alongside investment and research; ### a. whereas health is fundamental to the well-being of all and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , and investment and research should be patient-centred;


### b. whereas covid-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the eu’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats , more european integration is necessary; whereas a european health union , which contributes to an increasingly social union , is key in this process; ### b. whereas covid-19 has had a huge impact on people’s health , physical and mental , and on the economy; whereas it has highlighted both the eu’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats , a certain level of european integration is necessary;


### c. whereas the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality; ### c. whereas the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality; whereas the strategy offers the opportunity to restore balance in the pharmaceutical sector between public and private interests in order to fulfil the union’s primary mission in the pharmaceutical sector , which is to ensure patients’ access to affordable medicines that bring additional therapeutic benefits;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality and affordable medicines , are essential for making progress in the prevention and treatment of diseases and for improving the quality of healthcare given to patients;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that public investment in research into and the development of innovative medicines and treatments , as well as ensuring access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases;


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of many patients with chronic diseases – including those with rare diseases , paediatric cancers and neurodegenerative diseases , or to deal with antimicrobial resistance (amr);


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that public investment in research has not been sufficient to meet the therapeutic needs of patients , particularly patients with rare diseases , paediatric cancers and neurodegenerative diseases , or to deal with antimicrobial resistance (amr);


### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; ### 4. calls on the commission to promote public health driven research and the development of new medicines for unmet therapeutic needs , such as in the field of rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options at affordable prices and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases;


### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess new criteria for national pricing , such as whether a product is ‘made in europe’ , whether the eu invested in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population; ### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess new criteria for national pricing , such as whether a product is ‘made in europe’ , whether any type of public funding was used in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population and the wider patient community; stresses the need to promote discussion as well on what constitutes a socially acceptable profit margin for pharmaceutical products; calls for the timely development by the commission and member states of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; calls on the commission and the national competition authorities to monitor unfair practices in order to protect consumers from artificially inflated drug prices;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system so it contributes to innovation and medicine affordability , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition and the timely entry to market of generics and biosimilars;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions;


### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; ### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to broadly increasing patient access to treatments as well as to the budgetary sustainability of healthcare systems by providing more treatment options and potentially by helping reduce medicine shortages and by generating cost savings while maintaining equal quality of care , freeing up resources also for the development of new treatments; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; keeping the patient always informed and at the centre of all decision-making;


### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; ### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; calls for the removal of barriers to the production and distribution of generic medicines; calls on member states to increase public production of generic and biosimilar medicines;


### 7. calls on the commission to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently; ### 7. calls on the commission to facilitate joint procurement and make it standard practice and apply most economically advantageous tender (meat) criteria more stringently , in order to help push the price of medicines down; draws attention , in that connection , to the new zealand pharmac experiment or the kiwi model;


### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with european medicines agency (ema) times , in order to ensure rapid and equal access to medicines for everyone in the eu; ### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; calls on the commission to tackle the problem of diverging market launches of medicines by linking the centralised marketing authorisation to a commitment on the part of pharmaceutical companies , i.e. , once authorised , medicinal products have to be launched in all eu countries in a timely manner and pharmaceutical companies should not be allowed to subsequently withdraw these products from particular markets for commercial reasons;


### 8. regrets the excessive influence of industry interest groups , which is detrimental to public-health , patient and consumer associations and to trade unions. ### 8. calls on the commission to guarantee total transparency and democratic scrutiny of decisions , procedures and choices in this area; condemns the excessive influence of industry interest groups , which is exerted to the detriment of associations representing patients , consumers and health professionals , experts in clinical trials , public-health associations and trade unions representing workers in the industry; calls for transparent governance arrangements and decision-making procedures independent of the pharmaceutical industry to be established for all authorities , public agencies and joint undertakings in the health sector;


### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; ### deleted


### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; ### 9. highlights the problems related to public-private partnerships for national health systems in funding research into and the production of innovative medicines , such as concentration of research and development in profitable medicinal areas; underscores how this model has contributed to the neglect of rare diseases in particular;


### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; ### 9. highlights the role of public-private partnerships in funding research into and the production of innovative medicines; calls on the commission to ensure that the european partnership for health innovation is driven by public interest considerations and to maximise public return on public investment;


### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; ### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially , but not limited to , emergency medicines and unmet therapeutic needs; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of covid-19 vaccines;


### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; ### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; draws attention to the fact that national pricing policies in some member states use different price levels to reduce expenditure on national health budgets by encouraging the links in the supply chain to buy medicines intended for patients in other member states , thereby causing the secondary unavailability of those medicines for the patients for whom they were originally intended;


### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; ### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to stabilise and balance national drug pricing systems; strongly believes that the pricing of medicines should not be left to fluctuations in the market;


### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; ### 11. is concerned that the affordability of medicines remains a challenge for patients and national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems;


### supporting a competitive and innovative eu pharmaceutical industry ### supporting an eu pharmaceutical industry that meets peoples' needs


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. insists that a focus on competitiveness for the eu pharmaceutical industry is contrary to meeting patients’ needs; points out that the industry needs to be regulated to ensure patients' needs are met; believes that the industry can provide an essential public good by providing medicines to people in need rather than profits to patent-holders; recalls the contribution to global public health from the act of avoiding the intellectual properly system , such as with the development of the highly-successful polio vaccine;


### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the eu; ### deleted


### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; ### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative for the prevention , diagnosis , treatment and post-treatment of all diseases are potentially hazardous and should therefore be used only with great care and in accordance with the precautionary principle; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness of these innovations;


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


### 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. 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; ### 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; stresses that electronic product information should complement , but not replace , the package information leaflet;


### 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 dependence on 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 , and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


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


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; stresses the need to discuss key health policies directly with representatives of patient organisations , health service providers , industry , regulators and other key stakeholders , on the basis of the high-level forum format , which has proven successful in coordinating joint action against covid-19;


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


### 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; 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; calls on the commission to promote the use of trips flexibilities to improve access to medicines and to support that member states can import medicines produced under a compulsory license by reversing their opt-out of article 31bis of the trips agreement;


### 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; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; welcomes the intention to revise the pharmaceuticals legislation; 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; commends the commission's intention to consider advertising , marketing and prescription of pharmaceuticals having negative environmental impact; calls on the commission to include an era that assesses the impact of pharmaceutical substances , their degradation products and metabolites on the quality of surface and ground water bodies , including drinking water resources , in the risk-benefit analysis; urges the commission to speed up the catch-up procedure for era of pharmaceuticals authorised before 2006;


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


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


### 1. observes that the european chemicals agency ('the agency') is the driving force among regulatory authorities in implementing the union's chemicals legislation for the benefit of human health and the environment , as well as for innovation and competitiveness; notes that the agency provides information on chemicals , helps companies comply with legislation and promotes the safe use of chemicals; ### 1. observes that the european chemicals agency ('the agency') is the driving force among regulatory authorities in implementing the union's chemicals legislation for the benefit of human health and the environment , as well as for innovation and competitiveness; notes that the agency provides information on chemicals , helps companies comply with legislation and promotes the safe use of chemicals; underlines that regulation (ec) no 1907/2006 of the european parliament and of the council1a ("reach regulation") specifies that this should be done in a way that ensures that animal testing is only ever a last resort and that the use of non-animal methods is promoted;


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


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


### (18) the work of the emergency task force should be separate from the work of the scientific committees of the agency and should be carried out without prejudice to the scientific assessments of those committees. the emergency task force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. the committee for medicinal products for human use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation. ### (18) while guaranteeing the independence of any subsequent evaluations , the work of the emergency task force should be separate from the work of the scientific committees of the agency and should be carried out without prejudice to the scientific assessments of those committees. the emergency task force should provide recommendations driven only by science and public-health needs and not by other interests , with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. the committee for medicinal products for human use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation.


### (19) the establishment of the emergency task force should build on the support provided by the agency during the covid-19 pandemic , notably as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review i.e. on an on-going basis , of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies. ### (19) the establishment of the emergency task force should build on the support provided by the agency during the covid-19 pandemic , notably as regards scientific advice on clinical trials design and product development , the transparency of related activities , including the rapid publishing clinical data for the products in question , as well as the ‘rolling’ review i.e. on an on-going basis , of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies.


### (26) rapid access and exchange of health data , including real world data i.e. health data generated outside of clinical studies , is essential to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure. ### (26) rapid access and exchange of health data , including when generated with appropriate quality criteria , real world data i.e. health data generated outside of clinical studies , can be essential as supportive evidence or signal-eliciting evidence to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure.


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


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


### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission , and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the steering group shall also include a representative of the patients’ and consumers’ working party and a representative of the healthcare professionals’ working party.


### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the declarations of interests of all experts shall be made public and all necessary restrictions shall apply where conflicts of interest occur.


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


### 3. the medicines steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. ### 3. the medicines steering group shall be chaired by the agency. the chair may decide to hear third parties , including marketing authorisation holders , developers of medicinal products , clinical trial experts , public-health advocacy groups , sectoral trade unions , consumer and patient organisations , as well as healthcare professionals.


### 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 and minutes of the steering group as well as the rules of procedure and recommendations shall be made available to the public via the ema web-portal.


### 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. after being established , these rules shall be made publicly available.


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


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


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


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


### sales and market share data; ### production , sales and market share data;


### mitigation plans including production and supply capacity; ### prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients , potential alternative production sites , minimum stock levels , etc;


### mitigation plans including production and supply capacity; ### mitigation plans including location-specific manufacturing , production and supply capacity;


### 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. 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 whenever necessary or upon request.


### 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 might contain information of a commercially confidential nature , they shall identify the relevant parts , clarify the reasons for such an indication and offer sufficient , actual and specific evidence of harm stemming from disclosure. the agency shall assess the merits of each request , considering the benefits for public health of disclosure and act accordingly.


### 5. where marketing authorisation holders for medicinal products included on the critical medicines lists 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. ### 5. where marketing authorisation holders for medicinal products included on the critical medicines lists 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. in the absence of notification of essential information , the agency , the commission and member states should enact sanctions , e.g. financial penalties , extending compulsory license or removing intellectual property rights to allow that other actors can minimise the shortage.


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


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group , and ensure adequate consultation with the patients’ and consumers’ working party and the healthcare professionals’ working party.


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work and the data used and its sources based on which the recommendations of the medicines steering group are taken. proceedings and recommendations , including dissenting views , shall be documented and made publicly available.


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


### providing scientific recommendations with regard to the use of any medicinal product , which may have the potential to address public health emergencies , in accordance with article 16; ### providing , by making publicly available , scientific recommendations with regard to the use of any medicinal product , which may have the potential to address public health emergencies , in accordance with article 16;


### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency. ### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , including a representative of the patients’ and consumers’ working party and a representative of the healthcare professionals’ working party , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014 .21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency.


### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency. ### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency. members of the emergency task force , including external experts , shall not have financial or other interests in the health industry which could affect their independence and impartiality. they shall undertake to act in the public interest and in an independent manner , and shall make an annual declaration of their financial interests which shall be published. members of the emergency task force shall declare , at each meeting , any potential conflict of interest with respect to the items on the agenda. in the event of such a conflict of interest , the concerned member shall withdraw from the meeting.


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


### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , and interest groups representing patients and healthcare professionals to attend its meetings. ### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties to attend its meetings , and decide to hear third parties , including marketing authorisation holders , developers of medicinal products , clinical trial experts , public health advocacy groups , sectoral trade unions , consumer and patient organisations , as well as healthcare professionals.


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


### 2. in preparation of the review , the emergency task force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force may also , where available , make use of observational studies of health data generated outside of clinical studies taking into account their reliability. ### 2. in preparation of the review , the emergency task force may request all relevant information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force shall use the results of comparative randomized controlled trials when available , but , if not , may also , when necessary , make use of real world data including pragmatic trials as in “close to everyday practice” taking into account their reliability as supportive evidence or signal-eliciting evidence.


### 7. the agency shall publish the opinions adopted pursuant to paragraph 4 including any updates on its web-portal. ### 7. the agency shall publish the recommendations provided pursuant to paragraph3 and opinions adopted pursuant to paragraph 4 including any updates on its web-portal


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force , and ensure adequate consultation with the patients’ and consumers’ working party and the healthcare professionals’ working party.


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work and the data and sources used in the decision-making process of the emergency task force.


### develop and maintain electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies; ### develop and maintain electronic tools for the submission of information and data , including electronic health data generated outside the scope of interventional clinical studies;


### as part of its regulatory tasks , make use of digital infrastructures or tools , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies , and the exchange of such data between member states , the agency , and other union bodies; ### as part of its regulatory tasks , make use of digital infrastructures or tools , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of interventional clinical studies , and the exchange of such data between the member states , the agency , and the other union bodies.


### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the steering group shall also include a representative the patients’ and consumers’ working party and a representative of the healthcare professionals’ working party.


### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the declarations of interests of all experts must be made public and all necessary restrictions shall apply where conflicts of interest occur.


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


### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings. ### 3. the medical devices steering group shall be chaired by the agency. the chair may decide to hear third parties , including developers and producers of medical devices , public-health advocacy groups , sectoral trade unions , consumer and patient organisations , as well as healthcare professionals.


### specify the procedures for establishing the public health emergency critical devices list; ### specify the procedures for establishing the public health emergency critical devices list , ensuring adequate consultation with consumers , patients and healthcare professionals and a high level of transparency;


### mitigation plans including production and supply capacity; ### mitigation plans including production and supply capacity; these plans shall contain preventative measures that help ensure the continued supply of critical medical devices;


### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list; ### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list while at the same time ensuring both patient and product safety;


### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746; ### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746 while at the same time ensuring both patient and product safety;


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group and ensure adequate consultation with the patients’ and consumers’ working party and the healthcare professionals’ working party.


### commercially confidential information and trade secrets of a natural or legal person , including intellectual property rights; ### commercially confidential information and trade secrets of a natural or legal person , including intellectual property rights , unless there is an overriding public interest in disclosure;


### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. ### 5. the commission , the agency , and the member states may exchange commercially confidential information and , where necessary to protect public health , anonymised and aggregated personal and sensitive personal data , with regulatory authorities of the third countries with which they have concluded bilateral or multilateral confidentiality arrangements.


### (22) this regulation also provides the agency with a role to support the expert panels on medical devices designated under commission implementing decision (eu) 2019/139612 to provide independent scientific and technical assistance to the member states , the commission , the medical device coordination group (mdcg) , notified bodies and manufacturers. ### (22) this regulation also provides the agency with a role to support the expert panels on medical devices designated under commission implementing decision (eu) 2019/139612 to provide independent scientific and technical assistance to the member states , the commission , the medical device coordination group (mdcg) , notified bodies and manufacturers , while upholding maximum transparency as a condition for fostering trust and confidence in the eu regulatory system.


### 4. the composition of the emergency task force shall be approved by the management board of the agency. the executive director of the agency or their representative and representatives of the commission shall be entitled to attend all meetings. ### 4. the composition of the emergency task force shall be approved by the management board of the agency and made publicly available. the executive director of the agency or their representative and representatives of the commission shall be entitled to attend all meetings.