### (26) commission experts should be able to perform controls , including audits , in member states to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems. commission controls should also serve to investigate and collect information on enforcement practices or problems , emergencies and new developments in member states. official controls should be performed by personnel who are independent , free from any conflict of interest and in particular who are not in a situation which , directly or indirectly , could affect their ability to carry out their professional duties in an impartial manner. ### (26) commission experts should have the necessary medical experience and knowledge to be able to perform controls , including audits , in member states to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems. commission controls should also serve to investigate and collect information on enforcement practices or problems , emergencies and new developments in member states. official controls should be performed by personnel who are independent , free from any conflict of interest and in particular who are not in a situation which , directly or indirectly , could affect their ability to carry out their professional duties in an impartial manner.


### (27) since soho preparations are subjected to a series of soho activities prior to their release and distribution , competent authorities should assess and authorise soho preparations to verify that a high level of safety , quality and efficacy is achieved consistently by the application of that specific series of activities , performed in that specific manner. when sohos are prepared with newly developed and validated collection , testing or processing methods , consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. the extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that soho preparation and use. where a new or modified soho preparation poses negligible risks for recipients (or offspring in the case of medically assisted reproduction) , the vigilance reporting requirements provided for in this regulation should be adequate to demonstrate safety and quality. this should apply for well-established soho preparations that are introduced in a new soho entity but have been robustly demonstrated as safe and effective by their use in other entities. ### (27) since soho preparations are subjected to a series of soho activities prior to their release , distribution and issuing , competent authorities should assess and authorise soho preparations to verify that a high level of safety , quality and efficacy is achieved consistently by the application of that specific series of activities , performed in that specific manner. when sohos are prepared with newly developed and validated collection , testing or processing methods , consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. the extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that soho preparation and use. where a new or modified soho preparation poses negligible risks for recipients (or offspring in the case of medically assisted reproduction) , the vigilance reporting requirements provided for in this regulation should be adequate to demonstrate safety and quality. this should apply for well-established soho preparations that are introduced in a new soho entity but have been robustly demonstrated as safe and effective by their use in other entities.


### (28) with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation. ### (28) with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated , following the guidelines specified in this regulation. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation. if a conventional treatment or a control group is based on a medicinal product for human use , these studies shall be considered clinical trials that are covered by regulation 536/2014.


### (28) with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation. ### (28) with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for medium-term and long-term clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive medium-term and long-term clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with medium-term and long-term monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation.


### (29) in the interests of efficiency , it should be permitted to conduct clinical outcome studies using the established framework in the pharmaceutical sector for clinical trials , as set out in regulation (eu) no 536/2014 of the european parliament and of the council25 , when operators wish to do so. whilst applicants can choose to record the clinical data generated during the clinical outcome monitoring themselves , they should also be permitted to use existing clinical data registries as a means of such recording when those registries have been verified by the competent authority , or are certified by an external institution , in terms of the reliability of their data management procedures. ### (29) in the interests of efficiency , it should be permitted to conduct clinical outcome studies using the established framework in the pharmaceutical sector for clinical trials , as set out in regulation (eu) no 536/2014 of the european parliament and of the council25 , when operators wish to do so.


### (30) in order to facilitate innovation and reduce administrative burden , competent authorities should share with each other information on the authorisation of new soho preparations and the evidence used for such authorisations , including for the validation of certified medical devices used for soho collection , processing , storage or application to patients. such sharing could allow authorities to accept previous authorisations granted to other entities , including in other member states and to thus significantly reduce the requirements to generate evidence. ### (30) in order to facilitate innovation and reduce administrative burden , competent authorities should share with each other information on the authorisation of new soho preparations and the evidence used for such authorisations , through the eu soho platform , including for the validation of certified medical devices used for soho collection , processing , storage or application to patients. such sharing could allow authorities to accept previous authorisations granted to other entities , including in other member states and to thus significantly reduce the requirements to generate evidence. competent authorities should also share with each other information on clinical studies with soho , via the eu soho platform.


### (30) in order to facilitate innovation and reduce administrative burden , competent authorities should share with each other information on the authorisation of new soho preparations and the evidence used for such authorisations , including for the validation of certified medical devices used for soho collection , processing , storage or application to patients. such sharing could allow authorities to accept previous authorisations granted to other entities , including in other member states and to thus significantly reduce the requirements to generate evidence. ### (30) in order to facilitate innovation , identify the best solutions and preparations and reduce administrative burden , competent authorities should share with each other information on the authorisation of new soho preparations and the evidence used for such authorisations , including for the validation of certified medical devices used for soho collection , processing , storage or application to patients. such sharing could allow authorities to accept previous authorisations granted to other entities , including in other member states , to use these solutions and products for the benefit of recipients and to thus significantly reduce the requirements to generate evidence.


### (31) a broad range of public and private organisations influence the safety , quality and efficacy of sohos , even if they do not maintain banks of those sohos. many organisations carry out a single soho activity , such as collection or donor testing on behalf of one or many organisations that maintain banks of sohos. the soho entity concept includes this broad range of organisations , from donor registries to physicians that apply sohos to recipients or use soho processing devices at the recipient’s bedside. the registration of all such soho entities should ensure that competent authorities have a clear overview of the field and its scale and can take enforcement action when deemed necessary. a soho entity registration should refer to the legal entity , regardless of the number of physical sites associated with the entity. ### (31) a broad range of public and private organisations influence the safety , quality and efficacy of sohos , even if they do not maintain banks of those sohos. many organisations carry out a single soho activity , such as collection or donor testing on behalf of one or many organisations that maintain banks of sohos. the soho entity concept includes this broad range of organisations , from donor registries to physicians that apply sohos to recipients or use soho processing devices at the recipient’s bedside. the registration of all such soho entities in special directories should ensure that competent authorities have a clear overview of the field and its scale and can take enforcement action when deemed necessary. a soho entity registration should refer to the legal entity , regardless of the number of physical sites associated with the entity.


### (32) competent authorities should review the soho entities registered in their territory and ensure that those entities that carry out both processing and storage of sohos are inspected and authorised as soho establishments before starting those activities. a soho establishment authorisation should refer to the legal entity , even when one soho establishment has many physical sites. competent authorities should consider the impact on safety , quality and efficacy of the soho activities carried out at soho entities that do not meet the definition of a soho establishment and decide whether particular entities should be subject to establishment authorisations due to the risk or scale associated with their activities. similarly , soho entities that have a poor record in terms of compliance with reporting or other obligations might be suitable candidates for authorisation as soho establishments. ### (32) competent authorities should periodically review the soho entities registered in their territory and ensure that those entities that carry out both processing and storage of sohos are inspected and authorised as soho establishments before starting those activities. a soho establishment authorisation should refer to the legal entity , even when one soho establishment has many physical sites. competent authorities should consider the impact on safety , quality and efficacy of the soho activities carried out at soho entities that do not meet the definition of a soho establishment and decide whether particular entities should be subject to establishment authorisations due to the risk or scale associated with their activities. similarly , soho entities that have a poor record in terms of compliance with reporting or other obligations might be suitable candidates for authorisation as soho establishments.


### (33) with regards to standards concerning donor , recipient and offspring protection , this regulation should provide for a hierarchy of rules for their implementation. as risks and technologies change , this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this regulation. as part of that hierarchy , in the absence of union legislation describing particular procedures to be applied and followed to meet the standards set out in this regulation , following the guidelines of the european centre for disease prevention and control (ecdc) and the edqm should be considered as a means to demonstrate compliance with the standards laid down in this regulation to ensure high level of quality , safety and efficacy. soho entities should be permitted to follow other guidelines , provided that it has been demonstrated that those other guidelines achieve the same level of quality , safety and efficacy. in cases of detailed technical issues for which neither union legislation nor the ecdc and the edqm have defined a technical guideline or rule , operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified. ### (33) with regards to standards concerning donor , recipient and offspring protection , this regulation should provide for a hierarchy of rules for their implementation. as risks and technologies change , this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this regulation. as part of that hierarchy , in the absence of union legislation describing particular procedures to be applied and followed to meet the standards set out in this regulation , following the guidelines of the european centre for disease prevention and control (ecdc) and the edqm should be considered as a means to demonstrate compliance with the standards laid down in this regulation to ensure high level of quality , safety and efficacy. member states should be involved in both the drafting and voting of these guidelines and should follow a transparent process of consultation with other relevant eu authorities and stakeholders. soho entities should be permitted to follow other guidelines , provided that it has been demonstrated that those other guidelines are based on the most up-to-date scientific evidence and achieve the same level of quality , safety and efficacy. in cases of detailed technical issues for which neither union legislation nor the ecdc and the edqm have defined a technical guideline or rule , operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.


### (35) the edqm is a structural part of the council of europe working under the european pharmacopoeia partial agreement. the text of the convention on the elaboration of a european pharmacopoeia (ets no. 050) , accepted by council decision 94/358/ec26 , is considered to be the text of the european pharmacopoeia partial agreement. member states of the council of europe that have signed and ratified the european pharmacopoeia convention are the member states of the european pharmacopoeia partial agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement , including among others: the european pharmacopoeia commission , the european committee on organ transplantation (cd-p-to) , the european committee on blood transfusion (cd-p-ts) and the european committee on pharmaceuticals and pharmaceutical care (cd-p-ph). the european pharmacopoeia convention has been signed and ratified by the european union and all its member states , all of whom are represented in their intergovernmental bodies. in this context , the work of the edqm on developing and updating guidelines on safety and quality of blood , tissues and cells , should be considered an important contribution to the field of sohos in the union and should be reflected in this regulation. the guidelines address issues of quality and safety beyond the risks of communicable disease transmission , such as donor eligibility criteria for the prevention of the transmission of cancer and other non-communicablediseases and the assurance of safety and quality during collection , processing , storage and distribution. it should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this regulation. ### (35) the edqm is a structural part of the council of europe working under the european pharmacopoeia partial agreement. the text of the convention on the elaboration of a european pharmacopoeia (ets no. 050) , accepted by council decision 94/358/ec13 , is considered to be the text of the european pharmacopoeia partial agreement. member states of the council of europe that have signed and ratified the european pharmacopoeia convention are the member states of the european pharmacopoeia partial agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement , including among others: the european pharmacopoeia commission , the european committee on organ transplantation (cd-p-to) , the european committee on blood transfusion (cd-p-ts) and the european committee on pharmaceuticals and pharmaceutical care (cd-p-ph). the european pharmacopoeia convention has been signed and ratified by the european union and all its member states , all of whom are represented in their intergovernmental bodies. in this context , the work of the edqm on developing and updating guidelines on safety and quality of blood , tissues and cells , should be considered an important contribution to the field of sohos in the union and should be reflected in this regulation. the guidelines address issues of quality and safety beyond the risks of communicable disease transmission , such as donor eligibility criteria for the prevention of the transmission of cancer and other non- communicable diseases and the assurance of safety and quality during collection , processing , storage and distribution. it should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this regulation. a transparent and inclusive stakeholder consultation process shall be put in place for the development of the provisions and guidelines from the expert bodies. the consultation should include all key stakeholders: patients , consumers , health professionals , and industry representatives - both public and private.


### (35) the edqm is a structural part of the council of europe working under the european pharmacopoeia partial agreement. the text of the convention on the elaboration of a european pharmacopoeia (ets no. 050) , accepted by council decision 94/358/ec26 , is considered to be the text of the european pharmacopoeia partial agreement. member states of the council of europe that have signed and ratified the european pharmacopoeia convention are the member states of the european pharmacopoeia partial agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement , including among others: the european pharmacopoeia commission , the european committee on organ transplantation (cd-p-to) , the european committee on blood transfusion (cd-p-ts) and the european committee on pharmaceuticals and pharmaceutical care (cd-p-ph). the european pharmacopoeia convention has been signed and ratified by the european union and all its member states , all of whom are represented in their intergovernmental bodies. in this context , the work of the edqm on developing and updating guidelines on safety and quality of blood , tissues and cells , should be considered an important contribution to the field of sohos in the union and should be reflected in this regulation. the guidelines address issues of quality and safety beyond the risks of communicable disease transmission , such as donor eligibility criteria for the prevention of the transmission of cancer and other non-communicable diseases and the assurance of safety and quality during collection , processing , storage and distribution. it should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this regulation. ### (35) the edqm is a structural part of the council of europe working under the european pharmacopoeia partial agreement. the text of the convention on the elaboration of a european pharmacopoeia (ets no. 050) , accepted by council decision 94/358/ec26 , is considered to be the text of the european pharmacopoeia partial agreement. member states of the council of europe that have signed and ratified the european pharmacopoeia convention are the member states of the european pharmacopoeia partial agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement , including among others: the european pharmacopoeia commission , the european committee on organ transplantation (cd-p-to) , the european committee on blood transfusion (cd-p-ts) and the european committee on pharmaceuticals and pharmaceutical care (cd-p-ph). the european pharmacopoeia convention has been signed and ratified by the european union and all its member states , all of whom are represented in their intergovernmental bodies. in this context , the work of the edqm on developing and updating guidelines on safety and quality of blood , tissues and cells , should be considered an important contribution to the field of sohos in the union and should be reflected in this regulation. the guidelines address issues of quality and safety beyond the risks of communicable disease transmission , such as donor eligibility criteria for the prevention of the transmission of cancer and other non-communicable diseases and the assurance of safety and quality during collection , processing , storage and distribution. it should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this regulation. the development of the guidelines should include stakeholder consultations to ensure their suitability and transparency.member states should have an active role in the development of the guidelines , in cooperation with the edqm.


### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development. ### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states and the union should promote the donation of ethical sohos of high quality and safety , including plasma used as the starting material for manufacturing of plasma-derived medicinal products. these measures support european self-sufficiency , based on the broadest possible donor base , with a view to ensuring a more resilient supply system. member states and the union should also take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development.


### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development. ### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states and the union should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing the autonomy of the union , based on a wider donor base. member states and the union are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development.


### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development. ### (37) it is necessary and beneficial to all parties to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development.


### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos. ### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for tasks where access to necessary technical expertise in the field of sohos is required. in the latter case , european expert bodies such as the ecdc and the edqm and existing professional , scientific , experts and donor and recipient representative groups at union level in the field of sohos may also be invited.


### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos. ### (38) in order to promote a coherent and coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos.


### (39) some substances , products or activities have been subject to different legal frameworks with different requirements in the member states. this causes confusion among operators in the field , and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use sohos. the scb should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of sohos. the scb should keep a compendium of the opinions issued by the scb or the competent authorities and of decisions made at member state level , so that competent authorities considering the regulatory status under this regulation of a particular substance , product or activity may inform their decision-making process by referring to that compendium. the scb should also document agreed best practices to support a common union approach. it should also cooperate with similar union level bodies established in other union legislation with a view to facilitating coordinated and coherent application of this regulation between member states and across bordering legislative frameworks. these measures should promote a coherent cross-sectoral approach and facilitate soho innovation. ### (39) some substances , products or activities have been subject to different legal frameworks with different requirements in the member states. this causes confusion among operators in the field , and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use sohos. the scb should receive ongoing and constant relevant information on national decisions made on cases where questions were raised on the regulatory status of sohos. the scb should monitor these opinions in order to react quickly and in an informed manner to further requests for opinions from other member states , keep a compendium of the opinions issued by the scb or the competent authorities and of decisions made at member state level , so that competent authorities considering the regulatory status under this regulation of a particular substance , product or activity may inform their decision-making process by referring to that compendium. the scb should also document agreed best practices to support a common union approach. it should also cooperate with similar union level bodies established in other union legislation with a view to facilitating coordinated and coherent application of this regulation between member states and across bordering legislative frameworks. these measures should promote a coherent cross-sectoral approach and facilitate soho innovation.


### (39) some substances , products or activities have been subject to different legal frameworks with different requirements in the member states. this causes confusion among operators in the field , and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use sohos. the scb should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of sohos. the scb should keep a compendium of the opinions issued by the scb or the competent authorities and of decisions made at member state level , so that competent authorities considering the regulatory status under this regulation of a particular substance , product or activity may inform their decision-making process by referring to that compendium. the scb should also document agreed best practices to support a common union approach. it should also cooperate with similar union level bodies established in other union legislation with a view to facilitating coordinated and coherent application of this regulation between member states and across bordering legislative frameworks. these measures should promote a coherent cross-sectoral approach and facilitate soho innovation. ### (39) some substances , products or activities have been subject to different legal frameworks with different requirements in the member states. this causes confusion among operators in the field , and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use sohos. the scb should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of sohos. the scb should keep a compendium of the opinions issued by the scb , the classification advisory council or the competent authorities and of decisions made at member state level , so that competent authorities considering the regulatory status under this regulation of a particular substance , product or activity may inform their decision-making process by referring to that compendium. the scb should also document agreed best practices to support a common union approach. it should also cooperate with similar union level bodies established in other union legislation with a view to facilitating coordinated and coherent application of this regulation between member states and across bordering legislative frameworks. these measures should promote a coherent cross-sectoral approach and facilitate soho innovation.


### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. ### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities and better communication , collaboration , coordination and exchange of soho between member states. member states should preferably use this new platform in their exchanges to limit the administrative burden.


### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. ### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports and the centralisation of this data in order to apply the most viable solutions , as well as improved transparency of national reporting and supervisory activities.


### (43) as the eu soho platform requires the processing of personal data , it will be designed respecting the principles of data protection. any processing of personal data should be limited to achieving the objectives and obligations of this regulation. access to the eu soho platform should be limited to the extent necessary to carry out supervisory activities provided for in this regulation. ### (43) as the eu soho platform requires the processing of personal data , it will be designed respecting the principles of data protection. any processing of personal data should be limited to achieving the objectives and obligations of this regulation. access to the eu soho platform should be limited in time and with regard to the number of persons authorised to access these data and to the extent necessary to carry out supervisory activities provided for in this regulation.


### (44) this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and in particular human dignity , the integrity of the person , the protection of personal data , the freedom of art and science and to conduct business , non-discrimination , the right to health protection and access to health care , and the rights of the child. to achieve these aims , all supervisory and soho activities should always be carried out in a manner that fully respects those rights and principles. the right for dignity and integrity of donors , recipients and of offspring born from medically assisted reproduction should always be taken into account , amongst others , by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material , that donor eligibility criteria are based on scientific evidence , that the use of sohos in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices , that activities are conducted in a transparent manner that prioritises the safety of donors and recipients , and that allocation and equitable access to sohos are defined in a transparent manner , on the basis of an objective evaluation of medical needs. this regulation should therefore be applied accordingly. ### (44) this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and in particular human dignity , the prohibition of making the human body and its parts a source of economic gain , the integrity of the person , the protection of personal data , the freedom of art and science and to conduct business , non-discrimination , the right to health protection and access to health care , and the rights of the child. to achieve these aims , all supervisory and soho activities should always be carried out in a manner that fully respects those rights and principles. the right for dignity and integrity of donors , recipients and of offspring born from medically assisted reproduction should always be taken into account , amongst others , by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material , that donor eligibility criteria are based on scientific evidence , that the use of sohos in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices , that activities are conducted in a transparent manner that prioritises the safety of donors and recipients , and that allocation and equitable and non-discriminatory access to sohos are defined in a transparent manner , on the basis of an objective evaluation of medical needs. this regulation should therefore be applied accordingly.


### (44) this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and in particular human dignity , the integrity of the person , the protection of personal data , the freedom of art and science and to conduct business , non-discrimination , the right to health protection and access to health care , and the rights of the child. to achieve these aims , all supervisory and soho activities should always be carried out in a manner that fully respects those rights and principles. the right for dignity and integrity of donors , recipients and of offspring born from medically assisted reproduction should always be taken into account , amongst others , by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material , that donor eligibility criteria are based on scientific evidence , that the use of sohos in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices , that activities are conducted in a transparent manner that prioritises the safety of donors and recipients , and that allocation and equitable access to sohos are defined in a transparent manner , on the basis of an objective evaluation of medical needs. this regulation should therefore be applied accordingly. ### (44) this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and in particular human dignity , the integrity of the person , the protection of personal data , the freedom of art and science and to conduct business , non-discrimination , the right to health protection and access to health care , and the rights of the child. to achieve these aims , all supervisory and soho activities should always be carried out in a manner that fully respects those rights and principles. the right for dignity and integrity of donors , recipients and of offspring born from medically assisted reproduction should always be taken into account , amongst others , by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material , that donor eligibility criteria are based on scientific evidence and criteria of compatibility between donors and recipients , that the use of sohos in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices , that activities are conducted in a transparent manner that prioritises the safety of donors and recipients , and that allocation and equitable access to sohos are defined in a transparent manner , on the basis of an objective evaluation of medical needs. this regulation should therefore be applied accordingly.


### (45) sohos , by definition , relate to persons , and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this regulation , especially provisions relating to vigilance and communication between competent authorities. this regulation should provide a legal basis under article 6 and , where relevant , fulfil the conditions under article 9(2) , point (i) , of regulation (eu) 2016/679 for processing of such personal data. with respect to personal data processed by the commission , this regulation should provide a legal basis under article 5 and , where relevant , fulfil the conditions under article 10(2) , point (i) , of regulation (eu) 2018/1725. data on safety and efficacy of new soho preparations in recipients should also be shared , with appropriate protective measures , to allow aggregation at union level for more robust evidence gathering on the clinical efficacy of soho preparations. for all data processing , such processing should be necessary and appropriate with a view to ensuring compliance with this regulation in order to protect human health. data on donors , recipients and offspring should hence be limited to the minimum necessary and pseudonymised. donors , recipients and offspring should be informed of the processing of their personal data in line with the requirements of regulations (eu) 2016/679 and (eu) 2018/1725 , and in particular as provided for under this regulation , including the possibility of exceptional cases where circumstances require such processing. ### (45) sohos , by definition , relate to persons , and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this regulation , especially provisions relating to vigilance and communication between competent authorities. this regulation should provide a legal basis under article 6 and , where relevant , fulfil the conditions under article 9(2) , point (i) , of regulation (eu) 2016/679 for processing of such personal data. with respect to personal data processed by the commission , this regulation should provide a legal basis under article 5 and , where relevant , fulfil the conditions under article 10(2) , point (i) , of regulation (eu) 2018/1725. data on safety and efficacy of new soho preparations in recipients should also be shared , with appropriate protective measures and , where possible , anonymised , to allow aggregation at union level for more robust evidence gathering on the clinical efficacy of soho preparations. for all data processing , such processing should be necessary and appropriate with a view to ensuring compliance with this regulation in order to protect human health. data on donors , recipients and offspring should hence be limited to the minimum necessary and pseudonymised , or anonymised , as appropiate in each case. donors , recipients and offspring should be informed of the processing of their personal data in line with the requirements of regulations (eu) 2016/679 and (eu) 2018/1725 , and in particular as provided for under this regulation , including the possibility of exceptional cases where circumstances require such processing.


### (46) in order to enable better access to health data in the interests of public health , member states should entrust competent authorities as data controllers within the meaning of regulation (eu) 2016/679 with powers to take decisions on the access to and re-use of such data. ### (46) in order to enable better access to health data in the interests of public health , member states should entrust competent authorities as data controllers within the meaning of regulation (eu) 2016/679 with powers to take decisions on the access to and re-use of such data , specifying the period for which they are to be retained and how they are to be accessed or the number of persons having access and for how long.


### (47) the exchange of sohos between member states is necessary for ensuring optimal patient access and sufficiency of supply , particularly in the case of local crises or shortages. for certain sohos that need to be matched between the donor and the recipient , such exchanges are essential to allow patients to receive the treatment they need. in this context , the objective of this regulation , namely to ensure quality and safety of sohos and a high level of protection of donors , needs to be achieved at union level , by establishing high standards of quality and safety for sohos , based on a common set of requirements that are implemented in a consistent manner across the union. thus , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union. in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective. ### (47) the exchange of sohos between member states is necessary for ensuring optimal patient access and sufficiency of supply , particularly in the case of local crises or shortages. for certain sohos that need to be matched between the donor and the recipient , such exchanges are essential to allow patients to receive the treatment they need. this regulation will increase coordination between member states and facilitate the cross-border exchange of soho.


### (47) the exchange of sohos between member states is necessary for ensuring optimal patient access and sufficiency of supply , particularly in the case of local crises or shortages. for certain sohos that need to be matched between the donor and the recipient , such exchanges are essential to allow patients to receive the treatment they need. in this context , the objective of this regulation , namely to ensure quality and safety of sohos and a high level of protection of donors , needs to be achieved at union level , by establishing high standards of quality and safety for sohos , based on a common set of requirements that are implemented in a consistent manner across the union. thus , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union. in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective. ### (47) the exchange of sohos between member states is necessary for ensuring optimal patient access and sufficiency of supply , particularly in the case of local crises or shortages , using a database to trace the availability thereof in various member states. for certain sohos that need to be matched between the donor and the recipient , such exchanges are essential to allow patients to receive the treatment they need in the optimal timeframe to achieve the desired results. in this context , the objective of this regulation , namely to ensure quality and safety of sohos and a high level of protection of donors , needs to be achieved at union level , by establishing high standards of quality and safety for sohos , based on a common set of requirements that are implemented in a consistent manner across the union. thus , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union. in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective.


### this regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘sohos’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection , in particular for soho donors , soho recipients and offspring from medically assisted reproduction. this regulation is without prejudice to national legislation which establishes rules relating to aspects of sohos other than their quality and safety and the safety of soho donors. ### this regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘sohos’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection , in particular for soho donors , soho recipients and offspring from medically assisted reproduction , and for enhanced coordination between member states to improve the availability and accessibility of soho across the union. this regulation is without prejudice to national legislation which establishes rules relating to aspects of sohos other than their quality and safety and the safety of soho donors , recipients and offspring of medically assisted reproduction.


### 2. in cases of autologous use of sohos where: ### 2. in cases of autologous use of sohos , excluding cases where the processing involves a substantial modification or where its application is non-homologous , where:


### (1) ‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the body; ### (1) ‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the body. it consists of a liquid part , plasma , and a solid consisting of red blood cells , leucocytes and platelets;


### (5) ‘substance of human origin’ (soho) means any substance collected from the human body in whatever manner , whether it contains cells or not and whether those cells are living or not. for the purposes of this regulation , soho does not include organs in the sense of article 3 , point (h) , of directive 2010/53/eu; ### (5) ‘substance of human origin’ (soho) means any substance collected from the human body in whatever manner , whether it contains cells or not and whether those cells are living or not. for the purposes of this regulation , soho does not include organs in the sense of article 3 , point (h) , of directive 2010/53/eu , but does include substances which can be extracted from them;


### (6) ‘human application’ means inserted , implanted , injected , infused , transfused , transplanted , ingested , transferred (as in transfer to the uterus or fallopian tube of a woman) , inseminated or otherwise added to the human body in order to create a biological , mechanical or physiological interaction with that body; ### (6) ‘human application’ means inserted , implanted , injected , infused , transfused , transplanted , ingested , transferred (as in transfer to the uterus of a woman) , inseminated or otherwise added to the human body in order to create a biological , mechanical or physiological interaction with that body;


### (7) ‘soho activity’ means an action , or series of actions , that has a direct impact on the safety , quality or efficacy of sohos , as listed in article 2(1); ### (7) ‘soho activity’ means an action , or series of actions , that has a direct impact on the safety , quality , efficacy or functionality of sohos , as listed in article 2(1);


### (8) ‘soho donor’ means any person who has presented themselves to a soho entity with a view to making a donation of sohos , whether that donation is successful or not; ### (8) ‘soho donor’ means any person who has presented themselves to a soho entity with a view to making a donation of sohos , or a deceased person who has authorised , or on his/her behalf a family member or authorised person , the donation of parts of his/her body after death , whether that donation is successful or not;


### (8) ‘soho donor’ means any person who has presented themselves to a soho entity with a view to making a donation of sohos , whether that donation is successful or not; ### (8) ‘soho donor’ means any person who has presented themselves voluntarily to a soho entity with a view to making a donation of sohos , whether that donation is successful or not;


### (10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm , in vitro fertilisation or any other laboratory or medical intervention that promotes conception; ### (10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm , in vitro fertilisation or any other laboratory or medical intervention that promotes conception and uses sohos for the preservation of fertility through collection and storage of soho substances for subsequent human application;


### (11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction; ### (11) ‘offspring from medically assisted reproduction’ means children that are born following medically assisted reproduction;


### meets a pre-defined specification; and ### meets a pre-defined specification;


### is intended for application to a recipient for a specific clinical indication or is intended for distribution for manufacture of a product regulated by other union legislation , or as the starting and raw material thereof; ### is intended for application to a recipient for a specific and homologous clinical indication or is intended for distribution for manufacture of a product regulated by other union legislation , or as the starting and raw material thereof; and


### (13) ‘donor recruitment’ means any activity aimed at encouraging persons to become soho donors; ### (13) ‘donor recruitment’ means any information and communication activity aimed at encouraging persons to become soho donors;


### (13) ‘donor recruitment’ means any activity aimed at encouraging persons to become soho donors; ### (13) ‘donor recruitment’ means any activity aimed at informing and encouraging persons to become soho donors;


### (15) ‘processing’ means any operation involved in the handling of sohos , including washing , shaping , separation , fertilisation , decontamination , sterilisation , preservation and packaging; ### (15) ‘processing’ means any operation involved in the handling of sohos , including washing , shaping , separation , fertilisation , decontamination , sterilisation , preservation and packaging. it does not include activities involving a substantial modification of sohos that would make it a medicinal product or an advanced therapy;


### (16) ‘quality control’ means several tests or checks to confirm that a soho activity or soho preparation meets pre-defined quality criteria; ### (16) ‘quality control’ means several tests or checks , based on common criteria , to confirm that a soho activity or soho preparation meets pre-defined quality criteria;


### (16) ‘quality control’ means several tests or checks to confirm that a soho activity or soho preparation meets pre-defined quality criteria; ### (16) ‘quality control’ means defined tests or checks to confirm that a soho activity or soho preparation meets pre-defined quality criteria;


### (17) ‘storage’ means the maintenance of sohos under appropriate controlled conditions until distribution; ### (17) ‘storage’ means the maintenance of sohos under appropriate controlled conditions until distribution or issuing;


### (18) ‘release’ means a process through which it is verified that a soho or a soho preparation meets defined safety and quality criteria and the conditions of any applicable authorisation before distribution; ### (18) ‘release’ means a process through which it is verified that a soho or a soho preparation meets defined safety and quality criteria and the conditions of any applicable authorisation before distribution , issuing , export or human application;


### (20) ‘import’ means activities carried out to bring sohos or soho preparations into the union from a third country , including the organisation of such activities and physical verification of coherence with associated documentation , the appropriateness of transport conditions , the integrity of packaging and the adequacy of labelling before release; ### (20) ‘import’ means activities carried out to bring sohos or soho preparations into the union from a third country , including the organisation of such activities and physical verification of coherence with associated documentation and of the quality of the preparations , in accordance with eu standards , the appropriateness of transport conditions , the integrity of packaging and the adequacy of labelling before release;


### (21) ‘export’ means distribution of sohos or soho preparations to third countries; ### (21) ‘export’ means distribution of sohos or soho preparations to third countries outside the union;


### (22) ‘clinical outcome monitoring’ means evaluation of the health of a soho recipient for the purpose of monitoring the results of a soho preparation application , maintaining care and demonstrating safety and efficacy; ### (22) ‘clinical outcome monitoring’ means evaluation of the health of a soho recipient for the purpose of monitoring the results of a soho preparation application , maintaining care and demonstrating safety and efficacy or functionality;


### (23) ‘autologous use’ means collection of soho from one individual for subequent application to the same individual , with or without further soho activities between collection and application; ### (23) ‘autologous use’ means collection of soho from one individual for subequent application to the same individual;


### (24) ‘soho entity’ means an organisation legally established in the union that carries out one or more of the soho activities set out in article 2(1); ### (24) ‘soho entity’ means an organisation legally established in the union and accredited that carries out one or more of the soho activities set out in article 2(1);


### (27) ‘adverse occurrence’ means any incident that caused harm to a living soho donor , harm to a soho recipient or to offspring from medically assisted reproduction or that implied a risk of such harm; ### (27) ‘adverse occurrence’ means any incident associated with the donation or human application of soho that caused harm to a living soho donor , harm to a soho recipient or to offspring from medically assisted reproduction or that implied a risk of such harm;


### (29) ‘soho rapid alert’ means a communication regarding a sao , a communicable disease outbreak or other information that might be of relevance to the safety and quality of sohos in more than one member state and is to be transmitted rapidly between competent authorities and the commission to facilitate the implementation of mitigating measures; ### (29) ‘soho rapid alert’ means a communication regarding an adverse ocurrence or other information that might be of relevance to the safety and quality of sohos in more than one member state and is to be transmitted rapidly between competent authorities and the commission to facilitate the implementation of preventive or mitigating measures;


### (31) ‘eu soho platform’ means the digital platform established by the commission to exchange information concerning soho activities; ### (31) ‘eu soho platform’ means the digital platform established and managed by the commission for the exchange of information concerning soho activities at union level , between competent authorities , the commission , soho entities and other relevant entities , and to facilitate coordination and cross-border cooperation , between member states , on soho;


### (31) ‘eu soho platform’ means the digital platform established by the commission to exchange information concerning soho activities; ### (31) ‘eu soho platform’ means the digital platform established by the commission to exchange information concerning soho activities and which is accessible in all the official eu languages;


### (33) ‘the compendium’ means a list kept up-to-date by the soho coordination board of decisions , taken at member state level , and opinions , issued by competent authorities and by the scb , on the regulatory status of specific substances , products or activities and published on the eu soho platform; ### (33) ‘the compendium of soho’ means a list kept up-to-date by the soho coordination board of decisions , taken at member state level , and opinions , issued by competent authorities and by the scb and the classification advisory council , on the regulatory status of specific substances , products or activities and published on the eu soho platform;


### (38) ‘union training’ means activities for the personnel of competent authorities and , where appropriate , for personnel of delegated bodies performing soho supervisory activities; ### (38) ‘union training’ means training activities for the personnel of competent authorities and , where appropriate , for personnel of delegated bodies performing soho supervisory activities;


### (41) ‘critical soho’ means a soho for which an insufficient supply will result in serious harm or risk of harm to patients; ### (41) ‘critical soho’ means a soho for which an insufficient supply will result in serious harm or risk of harm to recipients;


### (42) ‘critical soho entity’ means a soho entity that carries out activities contributing to the supply of critical sohos and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for patients; ### (42) ‘critical soho entity’ means a soho entity that carries out activities contributing to the supply of critical sohos and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for recipients;


### (45) ‘technical guidelines’ means a description of a series of methodological procedures and parameters that , if followed , achieve a level of quality and safety of a soho activity or a soho preparation that is considered to be acceptable as a means to comply with regulatory standards; ### (45) ‘technical guidelines’ means a description of a series of methodological procedures and parameters , updated in accordance with the latest scientific evidence , that , if followed , achieve a level of quality and safety of a soho activity or a soho preparation that is considered to be acceptable as a means to comply with regulatory standards;


### (47) ‘traceability’ means the ability to locate and identify sohos during any step from collection through processing and storage to distribution or disposal , including the ability to: ### (47) ‘traceability’ means the ability to locate and identify sohos during any step from collection through processing and storage , distribution or issuing , to human application or disposal , including the ability to:


### (51) ‘imputability’ means the likelihood that a serious adverse occurrence , in a soho donor , is related to the donation process or , in a recipient , to the application of the sohos; ### (51) ‘imputability’ means the likelihood that an adverse occurrence , in a soho donor , is related to the collection process or , in a recipient , to the application of the sohos;


### (61) ‘reproductive cells’ means all cells intended to be used for the purpose of medically assisted reproduction; ### (61) ‘soho for reproduction’ means all cells intended to be used for the purpose of medically assisted reproduction and embryos resulting from fertilisation;


### (62) ‘third party donation’ means a donation of reproductive cells by a person to a person or a couple with whom the donor does not have an intimate physical relationship; ### (62) ‘third party donation’ means a donation of soho for reproduction by a person to a recipient or a couple with whom the donor does not have an intimate physical relationship;


### (63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction from two persons with an intimate physical relationship , where one person supplies their own oocytes and the other person supplies their own sperm; ### (63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction between two persons with an intimate physical relationship , where one person supplies their own oocytes and the other person supplies their own sperm. such gametes shall under no circumstances be applied to third parties;


### (64) ‘compensation’ means making good of any losses associated with donation; ### (64) ‘compensation’ means making good of any quantifiable losses associated with donation , without any net gain or loss;


### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation on condition that those national measures are compatible with union law , and are proportionate to the risk to human health. ### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation on condition that those national measures are compatible with union law. in particular , member states may introduce requirements for donations , including the prohibition or restriction of imports of soho , to ensure a high level of health protection and to achieve the objective defined in article 54 , provided that the conditions of the treaties are met. such measures shall not hinder coordination between member states or european autonomy.


### have sufficient resources , operational capacity , and expertise to achieve the aims of , and fulfil their obligations under , this regulation; ### have sufficient human and material resources , as well as operational capacity , and expertise to achieve the aims of , and fulfil their obligations under , this regulation;


### 2. competent authorities shall ensure that their personnel have no direct or indirect economic , financial or personal interest that might be considered prejudicial to their independence and , in particular , that they are not in a situation that may , directly or indirectly , affect the impartiality of their professional conduct. ### 2. competent authorities shall ensure that their personnel have no direct or indirect economic , financial or personal interest that might be considered prejudicial to their independence and , in particular , that they are not in a situation of incompatibility that may , directly or indirectly , affect the impartiality of their professional conduct.


### 1. without prejudice to article 75 , competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a soho entity has failed to comply with an obligation under this regulation and where such failure causes or may cause a serious risk to human health. ### 1. without prejudice to article 75 , competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a soho entity has failed to comply with an obligation under this regulation and where such failure causes or may cause a serious risk to human health. they shall also be transparent about the criteria used for the assessment and authorisation of soho preparations and soho entities.


### 1. competent authorities shall be responsible for the soho supervisory activities referred to in chapter iii in order to verify the effective compliance of soho entities in their territory with the requirements set out in this regulation. ### 1. competent authorities shall be responsible for the soho supervisory activities referred to in chapter iii in order to verify the effective compliance of soho entities and soho preparations authorised in their territory with the requirements set out in this regulation.


### procedures to ensure the independence , impartiality , effectiveness , quality , suitability for purpose and consistency of their soho supervisory activities; ### procedures to ensure the independence , impartiality , transparency , effectiveness , quality , suitability for purpose and consistency of their soho supervisory activities;


### appropriate and properly maintained facilities and equipment to ensure that personnel can perform their soho supervisory activities efficiently and effectively; ### appropriate and properly maintained facilities and equipment to ensure that personnel can perform their soho supervisory activities efficiently , safely and effectively;


### 1. in all cases where questions arise as to the regulatory status of a substance , product or activity , competent authorities shall consult with authorities established in other relevant union legislation referred to in article 2(3) , as relevant. in such cases , competent authorities shall also consult the compendium referred to article 3 point (33). ### 1. in all cases where questions arise as to the regulatory status of a substance , product or activity , competent authorities shall consult with the classification advisory council , defined in article 67(a) in such cases , competent authorities shall also consult the compendium referred to article 3 point (33).


### in the course of the consultation referred to in paragraph 1 , the competent authorities may also submit a request to the scb for its opinion on the regulatory status of the substance , product or activity under this regulation and shall do so in all cases where the competent authorities , after the consultations referred to in paragraph 1 , are not in a position to take a decision in that respect. ### deleted


### the competent authorities may also indicate that they consider there is a need that the scb consults , in accordance with article 68(1) , point (b) , with the equivalent advisory bodies established in other relevant union legislation referred to in article 2(3). ### deleted


### 3. the competent authorities shall inform the scb of the subsequent decision taken in their member state , following the consultations referred to in paragraph 1 of this article , regarding the regulatory status of the substance , product or activity concerned under this regulation and on any consensus reached as a result of those consultations for publication in the compendium by the scb. ### 3. the competent authorities shall inform the classification advisory council of the subsequent decision taken in their member state , following the consultations referred to in paragraph 1 of this article , regarding the regulatory status of the substance , product or activity concerned under this regulation and on any consensus reached as a result of those consultations for publication in the compendium by the scb. to the extent possible , member states shall accept the opinion of the classification advisory council. otherwise , they shall inform the classification advisory council as soon as possible of the decision taken and its justification.


### the commission may , upon a duly substantiated request of a member state following the consultation referred to in paragraph 1 , or on its own initiative , by means of implementing acts , determine the regulatory status of a substance , product or activity under this regulation , in case questions arise in that respect , notably when these questions cannot be resolved at the member state level , or in discussions between the scb and the advisory bodies established in other relevant union legislation , in accordance with article 68(1) , point (b). ### the commission may , upon a duly substantiated request of a member state or the classification advisory council , following the consultation referred to in paragraph 1 , by means of implementing acts , determine the regulatory status of a substance , product or activity under this regulation , in case questions arise in that respect , notably when these questions cannot be resolved at the member state level , or in discussions in the classification advisory council. this decision shall be based on the most up-to-date scientific evidence.


### 5. for sohos that are intended to be subsequently used to manufacture products under other union legislation , or as the starting and raw material thereof , as referred to in article 2(3) , or sohos that are intended to be combined with medical devices , as referred to in article 2(4) , the competent authority shall cooperate with the authorities responsible for the supervisory activities under the relevant union legislation , with a view to ensuring coherent oversight. during the process , the competent authorities may seek the assistance of the scb. ### deleted


### 6. the consultation and cooperation referred to in paragraphs 1 , 2 and 5 may also be initiated on the basis of a request for advice from a soho entity , as referred to in article 40. ### 6. the consultation referred to in paragraph 1 may also be initiated on the basis of a request for advice from a soho entity , as referred to in article 40.


### the commission may , by means of implementing acts , lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant union legislation referred to in article 2(3). ### the commission may , by means of implementing acts , lay down rules concerning procedures for consultation referred to in paragraph 1.


### participate in training in the subject matter and on the obligations of competent authorities resulting from this regulation , as referred to in paragraph 3. ### participate regularly in training at national or european level in the subject matter and on the obligations of competent authorities resulting from this regulation , as referred to in paragraph 3 so as to be up to date with any changes or updates to the provisions of the regulation.


### 3. competent authorities , in cooperation with delegated bodies as necessary , shall develop and implement training programmes for the purpose of ensuring that personnel performing soho supervisory activities receive the training referred to in paragraph 2 , points (b) , (c) and (d). competent authorities shall maintain records of the training undertaken by their personnel. competent authorities shall provide opportunities for their personnel to participate in the union training referred to in article 69 where such union training is available and appropriate. ### 3. competent authorities , in cooperation with delegated bodies as necessary , shall develop and implement training programmes at national level for the purpose of ensuring that personnel performing soho supervisory activities receive the training referred to in paragraph 2 , points (b) , (c) and (d). competent authorities shall maintain records of the training undertaken by their personnel. competent authorities shall provide opportunities for their personnel to participate in the union training referred to in article 69 where such union training is available and appropriate.


### 3. soho preparation authorisations shall be valid throughout the union for the period defined in the terms of the authorisation , when such a time period has been defined , or until a competent authority has suspended or withdrawn the authorisation. where a member state has adopted a more stringent measure , in accordance with article 4 , which relates to a specific soho preparation , that member state may decline to recognise the validity of the soho preparation authorisation of another member state pending verification that the more stringent measure has been met. ### 3. soho preparation authorisations shall be valid throughout the union for the period defined in the terms of the authorisation , when such a time period has been defined , or until a competent authority has suspended or withdrawn the authorisation. where a member state has adopted a more stringent measure , in accordance with article 4 , which relates to a specific soho preparation , that member state may decline to recognise the validity of the soho preparation authorisation of another member state pending verification that the more stringent measure has been met. this information shall be notified , without undue delay , in the eu soho platform.


### 1. competent authorities shall have procedures in place to allow that applications for the authorisation of soho preparations are submitted in accordance with article 41. they shall provide guidelines and templates for the submission of applications for soho preparation authorisation. when developing these guidelines and templates , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). competent authorities may establish simplified procedures for applications concerning modifications to previously authorised soho preparations. ### 1. competent authorities shall have procedures in place to allow that applications for the authorisation of soho preparations are submitted in accordance with article 41. they shall provide guidelines and templates for the submission of applications for soho preparation authorisation. when developing these guidelines and templates , competent authorities shall follow the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). competent authorities may establish simplified procedures for applications concerning modifications to previously authorised soho preparations.


### 1. the assessment of a soho preparation , shall include a review of all soho activities that are performed for that soho preparation and that might influence the safety , quality and efficacy of the soho preparation. ### 1. the assessment of a soho preparation shall include a review of all soho activities that are performed for that soho preparation and that might influence the safety , quality and efficacy of the soho preparation , to make sure it maintains all the properties for being compatible with recipients.


### 5. when assessing the soho preparation pursuant to paragraph 4 , points (e) and (g) , competent authorities shall consider , in the cases where the applicant has proposed to record , and recorded , the results of the clinical outcome monitoring in an existing clinical registry , that this is an acceptable method , provided that those competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of data. ### 5. when assessing the soho preparation pursuant to paragraph 4 , points (e) and (g) , competent authorities shall verify that the clinical studies and their results have been correctly recorded in the eu soho platform.


### 5. competent authorities shall ensure that the specific induction training is complemented by specialised training for assessment of processing methods and technologies used for specific types of soho preparations and by continuous training , as appropriate , throughout the career of the assessors. competent authorities shall make all reasonable efforts to ensure that assessors that participate in joint assessments have completed the relevant union training referred to in article 69(1) and are included in the list referred to in article 69(5). ### 5. competent authorities shall ensure that the specific induction training is complemented by regular specialised training for assessment of processing methods and technologies used for specific types of soho preparations and by continuous training , as appropriate , throughout the career of the assessors to keep step with technical developments in the field. competent authorities shall make all reasonable efforts to ensure that assessors that participate in joint assessments have completed the relevant union training referred to in article 69(1) and are included in the list referred to in article 69(5).


### 9. by derogation from paragraph 1 , in case of emergency competent authorities may authorise imports of sohos for immediate application to a specific recipient when justified by the clinical circumstances on a case-by-case basis. ### 9. by derogation from paragraph 1 , in the exceptional situations described in article 21(a) or in case of emergency , as described in article 64 , competent authorities may authorise imports of sohos for immediate application to a specific recipient when justified by the clinical circumstances on a case-by-case basis.


### in exceptional cases , competent authorities may consider that a person’s considerable and relevant experience may exempt this person from the requirement set out in the first subparagraph. ### in exceptional cases , competent authorities may consider that a person’s considerable and relevant experience may exempt this person from the requirement set out in the first subparagraph. they shall also perform their duties impartially , transparently and free from conflicts of interest.


### 2. competent authorities shall provide inspectors with a specific induction training before inspectors take up their duties. for the specific induction training , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). ### 2. competent authorities shall provide inspectors with a specific induction training before inspectors take up their duties. for the specific induction training , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). the designation criteria shall be clear and transparent.


### 2. competent authorities shall establish procedures for the unique identification of soho establishments that are subject to the provisions on the single european code in article 46. competent authorities shall ensure that such identification complies with the technical standards defined for that coding system. for this purpose , competent authorities may use a soho establishment identification code generated by the eu soho platform. ### 2. competent authorities shall establish procedures for the unique identification of soho establishments that are subject to the provisions on the single european code in article 46. competent authorities shall ensure that such identification complies with the technical standards defined for that coding system. for this purpose , competent authorities may preferably use a soho establishment identification code generated by the eu soho platform.


### 2. the responsible person for release of sohos shall be in possession of a diploma , certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the member state concerned and shall have at least 2 years of experience in the relevant field. ### 2. the responsible person for release of sohos shall be in possession of a diploma , certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the member state concerned and shall have at least 2 years of experience in the relevant field. the soho entity shall ensure that the person responsible for the release of soho receives adequate and up-to-date training , appropriate to their job and responsibilities , including specific training on those sohos that require it.


### 3. soho entities may request to their competent authorities a derogation from the requirement for a soho preparation authorisation in the exceptional circumstances referred to in article 64. ### 3. soho entities may request to their competent authorities a derogation from the requirement for a soho preparation authorisation in the exceptional circumstances referred to in articles 21(a) 64.


### (ii) any specific soho collection procedures; ### (ii) any specific soho collection procedures with a view to maintaining all the properties to be compatible with recipients;


### 4. soho entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to article 21(2) , point (c) , and submit the results to their competent authorities. in conducting the clinical investigation study as referred to in paragraph 3 , points (b) and (c) , for the soho preparation concerned , the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of data. ### 4. soho entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to article 21(2) , point (c) , and submit the results to their competent authorities. in conducting the clinical investigation study as referred to in paragraph 3 , points (b) and (c) , for the soho preparation concerned , the applicant shall register that study and the results obtained in the soho eu platform in accordance with article 36 (a).


### 1. soho entities shall maintain a system for detecting , investigating and recording information concerning adverse occurrences , including adverse occurrences detected during clinical outcome monitoring as part of a soho preparation authorisation application as referred to in article 41. ### 1. soho entities shall maintain a system for detecting , investigating and recording information concerning adverse occurrences , including adverse occurrences detected during clinical outcome monitoring as part of a soho preparation authorisation application as referred to in article 41 or as part of a clinical study with soho , as referred to in article 41(a).


### 1. soho establishments shall not carry out any activities without prior soho establishment authorisation. this shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another soho entity. ### 1. soho establishments shall not carry out any soho activities without prior soho establishment authorisation. this shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another soho entity.


### 2. soho entities shall protect the health of living donors before , during and after the donation. ### 2. soho entities shall protect the physical and mental health of living donors before , during and after the donation.


### provide donors or their relatives or any persons granting authorisation on their behalf , in accordance with national legislation , with the information referred to in article 55 and in a way that is adequate in view of their capacity to understand it; ### provide donors or their relatives or any persons granting authorisation on their behalf , in accordance with national legislation , with the information referred to in article 55 and in a way that is adequate in view of their capacity to understand it , so that they can give free and informed consent;


### verify the eligibility of the donor on the basis of a donor health evaluation that aims to minimise any risk that the donation might pose to the donor’s health; ### verify the eligibility of the donor on the basis of a donor health evaluation , including mental health-related aspects that could be altered by the donation process , that aims to minimise any risk that the donation might pose to the donor’s health;


### 2. in the course of the donor health evaluations referred to in paragraph 1 , point (f) , soho entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of health and their health histories to assure the safety of the donation process for those donors. soho entities may perform laboratory tests as part of the donor health evaluations. they shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. the physician , as referred to in article 51 , shall approve the procedure and criteria for donor health evaluations. ### 2. in the course of the donor health evaluations referred to in paragraph 1 , point (f) , soho entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of physical and mental health and their health histories to assure the safety of the donation process for those donors. soho entities may perform laboratory tests as part of the donor health evaluations. they shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. the physician , as referred to in article 51 , shall approve the procedure and criteria for donor health evaluations.