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Document 02024R1938-20240717
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance)
Consolidated text: Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance)
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance)
02024R1938 — EN — 17.07.2024 — 000.001
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REGULATION (EU) 2024/1938 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L 1938 17.7.2024, p. 1) |
Corrected by:
REGULATION (EU) 2024/1938 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 13 June 2024
on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation establishes measures that set high standards of quality and safety for all substances of human origin (SoHO) intended for human application and for activities related to those substances. It ensures a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction, including by strengthening the continuity of supply of critical SoHO.
Article 2
Scope
This Regulation applies to:
SoHO intended for human application and SoHO used to manufacture products regulated by other Union legislation, as referred to in paragraph 6, and intended for human application;
SoHO donors, SoHO recipients and offspring from medically assisted reproduction;
SoHO activities that have a direct impact on the quality, safety or effectiveness of SoHO, as follows:
SoHO donor registration;
SoHO donor history review and medical examination;
testing of SoHO donors or of persons from whom SoHO are collected for autologous or within-relationship use;
collection;
processing;
quality control;
storage;
release;
distribution;
import;
export;
human application;
clinical-outcome registration.
This Regulation does not apply to:
organs intended for transplantation within the meaning of Article 3, points (h) and (q), of Directive 2010/53/EU;
breast milk when used exclusively for feeding one’s own child, without any processing carried out by a SoHO entity.
In the case of SoHO intended for autologous use where:
SoHO are processed or stored before human application, this Regulation applies;
SoHO are neither processed nor stored before human application, this Regulation does not apply.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
‘substance of human origin’ or ‘SoHO’ means any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of such substance;
‘critical SoHO’ means a SoHO for which an insufficient supply will result in serious harm or risk of serious harm to recipients’ health or in a serious interruption in the manufacture of products regulated by other Union legislation, as referred to in Article 2(6), where an insufficient supply of such products will result in serious harm or risk of serious harm to human health;
‘reproductive SoHO’ means human sperm, oocytes, ovarian and testicular tissue intended to be used for the purpose of medically assisted reproduction or restoring endocrine function; for the purposes of this definition, embryos are considered reproductive SoHO even though they are not collected from the human body;
‘blood component’ means a constituent of blood, such as red blood cells, white blood cells, platelets and plasma, that can be separated from it;
‘SoHO donation’ means a process by which a person voluntarily and altruistically gives SoHO from their own body for persons in need, or authorises the use of such SoHO after their death; it includes the necessary medical formalities, examination and treatments and monitoring of the SoHO donor, irrespective of whether that donation is successful or not; it also includes, where applicable, the consent given by an authorised person in accordance with national legislation;
‘SoHO donor’ means a living or deceased SoHO donor;
‘living SoHO donor’ means a living person who has volunteered to a SoHO entity, or has been presented by a person granting consent on their behalf, in accordance with national legislation, with a view to making a donation of SoHO, for the purpose of use in a person other than themselves, and other than in situations of within-relationship use;
‘deceased SoHO donor’ means a deceased person who has been referred to a SoHO entity with a view to SoHO collection, and from whom consent had been granted in that respect or from whom SoHO collection is permitted, in accordance with national legislation;
‘SoHO recipient’ means the person to whom SoHO are applied or the human application of SoHO is envisaged, whether by allogeneic, autologous or within-relationship use;
‘recipient’ means a SoHO recipient or any person receiving a product manufactured from SoHO, regulated by other Union legislation, as referred to in Article 2(6);
‘consent’ means:
the permission given freely without coercion by a living SoHO donor or a SoHO recipient for an action affecting them to proceed;
the permission given freely without coercion by any person granting consent on behalf of a living SoHO donor or a SoHO recipient who has no capacity to consent, or the authorisation granted under national legislation, for an action to proceed in relation to the living SoHO donor or the SoHO recipient; or
the permission given freely without coercion by any person granting consent, or the authorisation granted under national legislation, for an action to proceed in the case of a deceased SoHO donor in accordance with national legislation;
‘allogeneic use’ means the human application of SoHO collected from a person other than the SoHO recipient;
‘autologous use’ means the human application of SoHO collected from a person to the same person;
‘within-relationship use’ means the use of reproductive SoHO for medically assisted reproduction between persons with an intimate physical relationship;
‘third-party donation’ means a donation of reproductive SoHO to be used for medically assisted reproduction in a SoHO recipient with whom the SoHO donor does not have an intimate physical relationship;
‘medically assisted reproduction’ means any laboratory or medical intervention, including any preparatory steps, that involves the handling of reproductive SoHO for the purpose of the facilitation of pregnancy or for preservation of fertility;
‘preservation of fertility’ means the process of saving or protecting a person’s reproductive SoHO intended to be used later in that person’s life;
‘offspring from medically assisted reproduction’ means children born following medically assisted reproduction;
‘human application’ means being inserted, implanted, injected, infused, transfused, transplanted, ingested, transferred, inseminated or otherwise added to the human body in order to create a biological interaction with that body;
‘SoHO donor recruitment’ means any activity aimed at informing persons about activities related to SoHO donation or at encouraging them to donate SoHO;
‘SoHO donor registration’ means recording in a registry, and transferring to other registries, where appropriate, information on a SoHO donor that is essential for identifying a match with a prospective SoHO recipient;
‘collection’ means a process by which SoHO are obtained from a person, including any preparatory steps, such as hormone treatment, needed to facilitate the process at, or under the supervision of, a SoHO entity;
‘processing’ means any operation involved in the handling of SoHO, including, but not limited to, washing, shaping, separation, decontamination, sterilisation, preservation and packaging, except for the preparatory handling of SoHO for immediate human application during a surgical intervention, without the SoHO being removed from the surgical field before they are applied;
‘quality control’ means performing a pre-defined test or set of tests or checks to confirm that pre-defined quality criteria are met;
‘storage’ means the maintenance of SoHO under appropriate controlled conditions;
‘release’ means a process through which it is verified that a SoHO meets defined quality and safety criteria and fulfils the conditions of any applicable authorisation, before distribution or export;
‘distribution’ means providing, within the Union, released SoHO:
intended for human application to a specific SoHO recipient in the same or in another SoHO entity;
intended for human application in general, without the prior identification of a specific SoHO recipient, in the same or in another SoHO entity;
intended for the manufacture of products regulated by other Union legislation, as referred to in Article 2(6), to a manufacturer of such products;
‘import’ means activities carried out to bring SoHO into the Union from a third country before their release;
‘third-country supplier’ means an organisation, located outside the Union, which is contracted to supply SoHO or to perform activities that might influence the quality and safety of the SoHO imported;
‘export’ means activities carried out to send SoHO from the Union to a third country;
‘clinical-outcome registration’ means the management of a clinical registry where information on the results from the implementation of a clinical-outcome monitoring plan are recorded, including transferring such information to other registries;
‘clinical-outcome monitoring plan’ means a programme for evaluating the safety and effectiveness of a SoHO preparation following human application;
‘SoHO entity’ means an entity legally established in the Union that carries out one or more of the SoHO activities referred to in Article 2(1), point (c);
‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to the supply of critical SoHO and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other SoHO entities or alternative substances or products for recipients;
‘SoHO establishment’ means a SoHO entity that carries out any of the following SoHO activities:
both processing and storage;
release;
import;
export;
‘responsible person’ means an appointed person in a SoHO entity who has the responsibility of ensuring compliance with this Regulation;
‘SoHO preparation’ means a type of SoHO that:
has been subjected to processing and, where relevant, one or more other SoHO activities referred to in Article 2(1), point (c);
has a specific clinical indication; and
is intended for human application to a SoHO recipient or is intended for distribution;
‘SoHO preparation authorisation’ means the formal approval by a SoHO competent authority of a SoHO preparation;
‘effectiveness of SoHO’ means the extent to which the human application of SoHO achieves the intended biological or clinical outcome in the SoHO recipient;
‘SoHO clinical study’ means an experimental evaluation of a SoHO preparation, with the objective of drawing conclusions regarding its safety and effectiveness;
‘SoHO compendium’ means a list kept up-to-date by the SoHO Coordination Board (SCB) of decisions, taken at Member State level, and opinions, issued by SoHO competent authorities and by the SCB, on the regulatory status of specific substances, products or activities, and published on the EU SoHO Platform;
‘vigilance’ means a set of organised surveillance and reporting procedures relating to adverse reactions and adverse events;
‘adverse reaction’ means any incident which could be reasonably associated with the quality or safety of SoHO, or their collection from a SoHO donor or human application to a SoHO recipient, that caused harm to a living SoHO donor, to a SoHO recipient or to offspring from medically assisted reproduction;
‘adverse event’ means any incident or error associated with SoHO activities that can affect the quality or safety of SoHO in such a way that implies a risk of harm to a living SoHO donor, to a SoHO recipient or to offspring from medically assisted reproduction;
‘serious adverse reaction’ or ‘SAR’ means an adverse reaction that results in any of the following:
death;
life-threatening, disabling or incapacitating condition, including transmission of a pathogen or of a toxic substance that might cause such condition;
transmission of a genetic disorder that:
in the case of medically assisted reproduction with third-party donation, resulted in pregnancy loss or might result in a life-threatening, disabling or incapacitating condition in the offspring from medically assisted reproduction; or
in the case of medically assisted reproduction in the context of within-relationship use, resulted in pregnancy loss or might result in a life-threatening, disabling or incapacitating condition in the offspring from medically assisted reproduction, due to a pre-implantation genetic test error;
hospitalisation or prolongation of hospitalisation;
the need for a major clinical intervention to prevent or reduce the effects of any of the results referred to in points (a) to (d);
prolonged sub-optimal health of a SoHO donor following single or multiple SoHO donations;
‘serious adverse event’ or ‘SAE’ means an adverse event that poses a risk of any of the following:
inappropriate SoHO distribution;
a defect posing a risk to SoHO recipients or SoHO donors is detected in one SoHO entity that would have implications for other SoHO recipients or SoHO donors because of shared practices, services, supplies or critical equipment;
loss of a quantity of SoHO that causes human applications to be postponed or cancelled;
loss of highly matched SoHO or SoHO for autologous use;
a mix-up of reproductive SoHO in such a way that an oocyte is fertilised with sperm from a person other than the intended person, or reproductive SoHO are applied to a SoHO recipient other than the intended SoHO recipient;
loss of the traceability of SoHO;
‘imputability’ means the likelihood that an adverse reaction, in a living SoHO donor, is associated with the collection process or that such a reaction, in a SoHO recipient or offspring from medically assisted reproduction, is associated with the human application of the SoHO;
‘seriousness’ means the degree of severity of an adverse reaction, involving harm to a living SoHO donor, a SoHO recipient or offspring from medically assisted reproduction or for public health in general, or the degree of severity of an adverse event involving a risk of such harm;
‘quality management system’ means a formalised system that documents the processes, procedures, and responsibilities to support achieving defined quality standards in a consistent manner;
‘delegated body’ means a legal body to which the SoHO competent authority has delegated certain SoHO supervisory activities in accordance with Article 9(1);
‘audit’ means a systematic and independent examination to determine whether activities and the related results of such activities comply with legislation and planned arrangements and whether such arrangements are applied effectively and are suitable to achieve the objectives;
‘inspection’ means a formal and objective control by a SoHO competent authority or delegated body to assess compliance with the requirements of this Regulation and other relevant Union or national legislation;
‘traceability’ means the ability to locate and identify SoHO from collection to human application, disposal or distribution for the manufacture of products regulated by other Union legislation, as referred to in Article 2(6);
‘Single European Code’ means the unique identifier applied to certain SoHO distributed in the Union;
‘EDQM SoHO monograph’ means a specification of the critical quality parameters of a particular SoHO preparation defined by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM);
‘compensation’ means making good of any losses or the reimbursement of expenses associated with SoHO donation;
‘financial neutrality of donation’ means that no financial gain or loss will be incurred by the SoHO donor as a result of the donation;
‘SoHO donor-base resilience’ means the capacity of the donation collection system to rely on a large number of SoHO donors for a given SoHO category;
‘European self-sufficiency’ means the Union’s degree of independence from third countries in relation to the collection, the distribution and any other SoHO activity, related to critical SoHO.
Article 4
More stringent Member State measures
CHAPTER II
MEMBER STATES’ SOHO COMPETENT AUTHORITIES
Article 5
Designation of SoHO competent authorities
Member States shall ensure that SoHO competent authorities:
have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined under national legislation;
have the necessary powers:
to properly perform the SoHO supervisory activities they have been made responsible for, including having access to the premises of, and documents and samples kept by, SoHO entities and any third parties contracted by a SoHO entity;
to order the immediate suspension or cessation of a SoHO activity that poses an immediate risk to SoHO donors, SoHO recipients, offspring from medically assisted reproduction or the general public;
have, or have access to, sufficient human and financial resources, operational capacity, and expertise, including technical expertise, to achieve the aims of, and fulfil their obligations under, this Regulation;
are subject to appropriate confidentiality obligations in order to comply with Article 75.
Member States shall submit to the EU SoHO Platform, and keep updated, information on:
the name and contact details of the SoHO national authority referred to in paragraph 4;
the names and contact details of any SoHO competent authority designated in accordance with paragraph 1, when such SoHO competent authority is different from the SoHO national authority referred to in paragraph 4.
Article 6
Independence and impartiality
Article 7
Transparency
SoHO competent authorities shall:
carry out the SoHO supervisory activities they have been made responsible for in a transparent manner, at least by complying with the publication requirements provided for in this Regulation; and
make any enforcement decision pursuant to Article 19(7), (8) and (9), Article 25(3), (4) and (5), or Article 27(8), point (h), and the reasons for it, accessible and clear to the public in cases where:
a SoHO entity does not comply with this Regulation; or
there is a serious risk to the safety of SoHO donors, recipients or offspring from medically assisted reproduction or to public health.
Article 8
General responsibilities and obligations of SoHO competent authorities
SoHO competent authorities shall be responsible, within their territory, for SoHO supervisory activities in order to verify the effective compliance by:
SoHO entities with the requirements set out in this Regulation; and
SoHO preparations with their corresponding authorisation.
SoHO competent authorities shall:
have, or have access to, a sufficient number of suitably qualified and experienced personnel, human and financial resources, operational capacity, and expertise, including technical expertise, to carry out the SoHO supervisory activities they have been made responsible for, efficiently and effectively;
have procedures in place to ensure compliance with the confidentiality obligations set out in Article 75;
ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;
have appropriate and properly maintained premises and equipment to ensure that the personnel can perform their SoHO supervisory activities safely, efficiently and effectively;
have a quality management system or standardised documented procedures in place for the SoHO supervisory activities they have been made responsible for that includes a plan for continuity of their activities in the case of crisis situations that impede the normal performance of their tasks;
develop and implement, or provide access to, training programmes to ensure that personnel performing SoHO supervisory activities receive, for their area of competence, appropriate training;
provide opportunities for their personnel to participate in the Union training referred to in Article 70 where such training is available and relevant.
Article 9
Delegation of certain SoHO supervisory activities to other bodies
The delegating SoHO competent authorities shall ensure that the written agreement referred to in paragraph 2 of this Article includes at least the following:
a precise description of the SoHO supervisory activities that the delegated body is expected to perform, and the conditions under which those activities are expected to be performed;
the condition that the delegated body participates in certification or other schemes at Union level, when available, to ensure the uniform application of principles of good practices required for their relevant sector;
a precise description of the arrangements ensuring an efficient and effective coordination between the delegating SoHO competent authority and the delegated body;
provisions on the fulfilment of the obligations set out in Articles 10 and 11;
provisions on its termination in the case of withdrawal of the delegation pursuant to Article 11.
Article 10
Obligations of the delegated bodies
Delegated bodies to which SoHO supervisory activities are delegated in accordance with Article 9 shall:
meet the obligations set out in Article 8(3);
inform the delegating SoHO competent authorities, on a regular basis and whenever those delegating SoHO competent authorities so request, of the outcome of the SoHO supervisory activities performed by them;
immediately inform the delegating SoHO competent authorities whenever the outcome of the delegated SoHO supervisory activities indicates non-compliance or points to the likelihood of non-compliance, unless specific written arrangements established between those delegating SoHO competent authorities and the delegated bodies provide otherwise; and
fully cooperate with the delegating SoHO competent authorities, including by providing access to their premises and documentation, including their information technology (IT) systems.
Article 11
Obligations of the delegating SoHO competent authorities
SoHO competent authorities that have delegated certain SoHO supervisory activities to delegated bodies in accordance with Article 9 shall:
regularly conduct audits of the delegated bodies;
fully or partly withdraw the delegation without delay, where necessary, and in particular in cases where:
there is evidence that the delegated bodies are failing to properly perform the SoHO supervisory activities delegated to them;
the delegated bodies have failed to take appropriate and timely action to remedy the shortcomings identified in the course of conducting SoHO supervisory activities; or
there is evidence that the independence or impartiality of the delegated bodies has been compromised.
The interval between the audits referred to in the first paragraph, point (a), of this Article shall be determined by the delegating SoHO competent authority, taking into account the participation of the delegated bodies in certification or other schemes referred to in Article 9(3), point (b), as well as the scope and the impact of the delegated SoHO supervisory activities on the quality and safety of SoHO.
Article 12
Communication and coordination between SoHO competent authorities
Article 13
Consultation and cooperation with authorities of other regulatory sectors
The SoHO competent authorities involved in the consultation referred to in paragraph 2 of this Article may also, via their SoHO national authority, indicate if they consider that there is a need for the SCB to consult, before issuing its opinion and in accordance with Article 69(1), point (c), with the relevant equivalent advisory bodies established under other relevant Union legislation referred to in Article 2(6).
The SoHO competent authorities involved in the consultation shall take into account the opinion issued by the SCB following such a request.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 14
Obligations as regards Commission controls
SoHO competent authorities and delegated bodies shall cooperate with the Commission in respect of the performance of the Commission controls referred to in Article 71. In particular, they shall:
take appropriate follow-up measures to remedy the shortcomings identified through those Commission controls;
provide the necessary technical assistance and the available documentation, upon justified request, as well as any other support that the Commission requests to enable it to perform controls efficiently and effectively, including facilitating access to all premises or any part thereof, and to documentation, including IT systems, of the SoHO competent authority or delegated body that is relevant for the execution of their duties.
Article 15
Transparency regarding fees for technical services required for making SoHO available
Member States may take appropriate measures which aim to ensure transparency in the fees in respect of technical services required for making SoHO available.
CHAPTER III
SOHO SUPERVISORY ACTIVITIES
Article 16
Register of SoHO entities
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 17
Registration of SoHO entities
SoHO competent authorities shall:
acknowledge receipt of the registration without undue delay;
request the SoHO entity to provide supplementary details on the information provided in accordance with Article 35(3), if needed;
provide instructions on the procedures to be followed to apply for an authorisation, where relevant;
where applicable, inform the SoHO entity of its status as a critical SoHO entity and of the related obligations pursuant to Articles 64 and 67;
inform the SoHO entity that its registration has been verified and published on the EU SoHO Platform.
Article 18
SoHO preparation authorisation system
Article 19
Authorisation of SoHO preparations
Upon receipt of an application for a SoHO preparation authorisation, SoHO competent authorities shall:
acknowledge receipt of the application without undue delay;
assess the SoHO preparation pursuant to Article 20 and examine agreements between the applicant SoHO entity and any SoHO entity or third party contracted by that applicant SoHO entity to perform activities or relevant steps of the processing in relation to the SoHO preparation, where applicable;
request the applicant SoHO entity to provide supplementary information, if needed;
grant or refuse the approval for clinical-outcome monitoring plans, as appropriate, in accordance with Article 20(4), points (c) and (d), and indicate a time limit for the applicant SoHO entity to submit the results of the approved clinical-outcome monitoring;
on the basis of the assessment under point (b) of this paragraph, and of the results of the clinical-outcome monitoring referred to in point (d) of this paragraph, where applicable, grant or refuse the authorisation for the SoHO preparation and, indicate which conditions apply, if any.
SoHO competent authorities shall conclude the SoHO preparation authorisation steps referred to in paragraph 2 of this Article, within the time limit set out for the authorisation taking into account best practices documented and published by the SCB, as referred to in Article 69(1), point (d). Such time limit may be extended for:
the duration of the consultations referred to in Article 13(2) and (3);
the time needed to prepare and submit a response to a request for additional information to the SoHO entity;
the time needed to perform clinical-outcome monitoring; or
the time needed to perform additional validation or to generate additional quality and safety data as requested by the SoHO competent authority.
SoHO competent authorities shall specify a period of time for the investigation of the suspected non-compliance and for SoHO entities to rectify a confirmed non-compliance, during which the suspension will remain in place.
Where the procedures referred to in this Article have not been carried out, SoHO competent authorities may exceptionally authorise, at the request of the SoHO entity responsible for a planned human application of a SoHO preparation to a specific SoHO recipient within their territory, that human application provided that:
the specific SoHO recipient has no therapeutic alternative, the treatment cannot be postponed or the specific SoHO recipient’s prognosis is life-threatening;
the safety and effectiveness of the SoHO preparation can reasonably be assumed on the basis of the available clinical data; and
the SoHO recipient concerned is informed that the SoHO preparation concerned has not been authorised under this Regulation.
SoHO competent authorities may require that the SoHO entity concerned provide a summary of the clinical outcome in the specific case and shall inform the SoHO national authority of that exceptional authorisation without undue delay.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 20
Assessment of SoHO preparations
Where a SoHO preparation that is subject to an application for SoHO preparation authorisation pursuant to Article 19 has not been authorised in another SoHO entity, or where the SoHO competent authority chooses not to take a SoHO preparation authorisation in another Member State into account, the SoHO competent authority shall:
assess the adequacy of the information provided by the applicant SoHO entity pursuant to Article 39(2), point (b);
initiate the consultation provided for in Article 13, if, during the assessment of the information referred to in point (a) of this paragraph, questions arise as to whether the SoHO preparation falls, in part or fully, within the scope of this Regulation or other Union legislation, taking into account the activities performed for the SoHO preparation and the intended human application;
evaluate the benefit-risk assessment carried out by the applicant SoHO entity pursuant to Article 39(2), point (c), including the scientific evidence and clinical data provided regarding the expected benefit and risk;
in cases where the evidence provided in accordance with point (c) of this paragraph is not sufficient to provide certainty that the benefit outweighs the risk or where the risk is more than negligible, evaluate the plan to gather further evidence of safety and effectiveness through clinical-outcome monitoring, and the plan’s proportionality to the level of risk and expected benefit of the SoHO preparation in accordance with Article 21;
consult the SCB, pursuant to Article 69(1) on the evidence necessary and sufficient for the authorisation of a particular SoHO preparation where the best practices referred to in paragraph 7 of this Article are not sufficient;
assess, in the case of a clinical-outcome monitoring plan previously approved pursuant to Article 19(2), point (d), the results of the clinical-outcome monitoring upon its completion and submission of the results by the applicant.
Article 21
Clinical-outcome monitoring plans
The clinical-outcome monitoring plan shall include the following:
in cases of low risk, and an expected positive benefit-risk assessment, pro-active clinical follow-up of a pre-defined number of SoHO recipients;
in cases of moderate risk, and an expected positive benefit-risk assessment, in addition to point (a), a SoHO clinical study of a pre-defined number of SoHO recipients required to be able to assess pre-defined clinical end-points;
in cases of high risk, and an expected positive benefit-risk assessment, and in cases where the risk or the benefit are not evaluable due to a lack of scientific and clinical data or knowledge, in addition to point (a), a SoHO clinical study of a pre-defined number of SoHO recipients required to be able to assess pre-defined clinical endpoints with a comparison to standard therapy.
In the cases referred to in paragraph 3, points (b) and (c), SoHO competent authorities shall register each approved SoHO clinical study on the EU SoHO Platform, providing the following information:
the name and address of the SoHO entity carrying out the SoHO clinical study;
a description of the SoHO type and the intended clinical indication;
a summary of the processing methodology;
a summary of the study design;
the planned date of commencement and completion of the SoHO clinical study.
Article 22
Joint SoHO preparation assessments
The SoHO competent authorities participating in a joint SoHO preparation assessment shall conclude a written agreement prior to carrying out the joint SoHO preparation assessment. Such a written agreement shall specify at least the following:
the scope of the joint SoHO preparation assessment;
the roles of the participating SoHO preparation assessors during and following the joint SoHO preparation assessment;
the powers and responsibilities of each participating SoHO competent authority.
The SoHO competent authorities participating in the joint SoHO preparation assessment shall commit themselves in the agreement referred to in the first subparagraph to jointly accept the results of that assessment. That agreement shall be signed by all the participating SoHO competent authorities, including the respective SoHO national authorities.
Article 23
Specific requirements concerning SoHO preparation assessors
SoHO preparation assessors shall:
possess a diploma, certificate or other evidence of formal qualifications in the field of medical, pharmaceutical or life sciences, awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned;
have expertise in the processes being assessed or the human applications for which the SoHO preparations will be used.
Article 24
SoHO establishment authorisation system
SoHO competent authorities may decide that certain SoHO entities that do not fall within the definition of a SoHO establishment as set out in Article 3, point (35), also need to be authorised as SoHO establishments, in particular SoHO entities that:
have significant influence on the quality and safety of SoHO due to the scale, criticality or complexity of the SoHO activities they perform; or
carry out SoHO activities in connection with multiple SoHO establishments.
SoHO competent authorities shall inform the SoHO entity of such a decision and of the resulting obligation to comply with all provisions of this Regulation relating to SoHO establishments, including the submission of an application for SoHO establishment authorisation.
Article 25
Authorisation of SoHO establishments
Upon receipt of an application for a SoHO establishment authorisation, SoHO competent authorities shall:
acknowledge receipt of the application without undue delay;
assess the application;
examine agreements between the applicant SoHO establishment and any SoHO entities contracted by that SoHO establishment to perform SoHO activities;
request the applicant SoHO establishment to provide supplementary information, if needed;
carry out an on-site inspection of the applicant SoHO establishment pursuant to Article 27, and, where applicable, of SoHO entities or third parties contracted by the SoHO establishment pursuant to Article 28;
inform the applicant SoHO establishment, without undue delay, of the outcome of the assessment and inspections referred to in points (b), (c) and (e), and in point (d), where relevant;
grant or refuse the authorisation of the applicant SoHO establishment as a SoHO establishment, as appropriate, and indicate which SoHO and which SoHO activities for each SoHO are subject to the authorisation and which conditions apply, if any;
submit information regarding the authorisation granted in respect of the SoHO establishment, by amending the status of the SoHO entity to SoHO establishment on the EU SoHO Platform without undue delay;
assess and, as appropriate, authorise any significant changes made by the SoHO establishment to the information provided in the application and communicated to them pursuant to Article 46(2), and update that information on the EU SoHO Platform.
SoHO competent authorities shall specify a period of time for the investigation of a suspected non-compliance and for the SoHO establishment to rectify a confirmed non-compliance, during which the suspension will remain in place.
Article 26
Authorisation of importing SoHO establishments
Article 27
Inspections of SoHO establishments
SoHO competent authorities shall carry out the following inspections of SoHO establishments, as appropriate:
announced routine system inspections;
announced or unannounced inspections, in particular for the investigation of fraudulent or other illegal activities, or on the basis of information that indicates possible non-compliance with this Regulation;
announced or unannounced inspections targeted at a specific activity or topic as provided for in Article 20(6), Article 26(5), Article 29 and Article 33(6).
SoHO competent authorities shall carry out on-site inspections. However, exceptionally, SoHO competent authorities may conduct inspections, in full or in part, by virtual means, or by remote document review, provided that:
such inspection modes do not pose a risk to the quality and safety of SoHO;
such inspection modes do not prejudice the effectiveness of inspections;
protection of SoHO donors, SoHO recipients or offspring from medically assisted reproduction is respected; and
the maximum interval between two on-site inspections pursuant to paragraph 9 is not exceeded.
In cases where the SoHO establishments follow:
the technical guidelines published by the ECDC and by the EDQM referred to in Article 56(4), point (a), and Article 59(4), point (a), as applicable, the inspectors shall consider the standards set out in this Regulation to be met, insofar as they are addressed by such guidelines;
other guidelines as referred to in Article 56(4), point (b), and Article 59(4), point (b), adopted by the Member State in accordance with paragraph 7 of this Article, the inspectors shall consider the standards set out in this Regulation to be met, insofar as they are addressed by such guidelines;
guidelines other than those referred to in point (a) or (b) of this paragraph, or other technical methods that are not addressed in guidelines, applied in specific circumstances, as referred to in Article 56(4), point (c), and Article 59(4), point (c), the inspectors shall evaluate the steps taken by the SoHO establishments to ensure the adequacy of such guidelines or technical methods, and their compliance with the standards set out in this Regulation; for that evaluation, the SoHO establishments shall provide the inspectors with all the necessary information, pursuant to Article 56(7) and Article 59(7).
Inspectors shall carry out one or more of the following activities:
inspect premises;
evaluate and verify compliance of the procedures and the SoHO activities performed with the requirements of this Regulation;
examine any documents or other records relating to the requirements of this Regulation;
where applicable, evaluate the design and implementation of the quality management system in place pursuant to Article 37;
evaluate compliance with the vigilance and the traceability systems;
take samples for analysis, copies of documents, and photographs or videos, if required;
evaluate the SoHO entity emergency plan in place in accordance with Article 67, where applicable;
order or propose to the SoHO competent authority, the suspension or cessation of any procedure or activity or impose other measures, where necessary and proportionate to the risk detected; in such case, the inspector shall take all the necessary steps without undue delay.
Following the inspection referred to in Article 25(2), point (e), SoHO competent authorities shall carry out periodic inspections pursuant to paragraph 2, point (a), of this Article, so that the interval between two on-site inspections shall not exceed, in any event, 4 years. The frequency of inspections shall take account of:
identified risks associated with the type of SoHO that are subject to the SoHO establishment authorisation and the SoHO activities carried out;
the SoHO establishments’ past record as regards the outcome of previous inspections and their compliance with this Regulation;
the certification or accreditation by international bodies, where relevant;
the reliability and effectiveness of the quality management system referred to in Article 37.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 28
Inspections of SoHO entities, other than SoHO establishments, and of third parties
Article 29
Joint inspections
With the prior consent of the SoHO national authority, the SoHO competent authority receiving a request for a joint inspection shall make all reasonable efforts to accept such a request, taking into account its available resources, in cases where:
the SoHO entity to be inspected performs SoHO activities in more than one Member State, that have impact in the requesting Member State;
the SoHO competent authorities of the requesting Member State require specialist technical expertise of another Member State for that inspection;
the SoHO competent authorities of the Member State receiving the request agree that there are other reasonable grounds for conducting a joint inspection.
Where the SoHO competent authority receives a request for joint inspection of a SoHO entity, it may decline that request, in particular if:
there has been a joint inspection in that SoHO entity within the previous year; or
a joint inspection of that SoHO entity is already being planned.
The SoHO competent authorities participating in a joint inspection shall conclude a written agreement prior to carrying out the joint inspection. Such a written agreement shall specify at least the following:
the scope and objective of the joint inspection;
the roles of the participating inspectors during and following the inspection, including the designation of the SoHO competent authority leading the inspection;
the powers and responsibilities of each participating SoHO competent authorities.
The SoHO competent authorities participating in the joint inspection shall commit themselves in the agreement referred to in the first subparagraph to jointly accept the results of that inspection. That agreement shall be signed by all the participating SoHO competent authorities, including the respective SoHO national authorities.
The SoHO competent authority supervising the SoHO entity to be inspected through a joint inspection shall inform that SoHO entity in advance about the joint inspection and its nature, unless there are reasonable and duly justified grounds to suspect that such prior communication would compromise the effectiveness of the joint inspection.
Article 30
Specific requirements concerning inspectors
In exceptional cases, SoHO competent authorities may consider that a person’s considerable and relevant experience exempts that person from the requirements set out in the first subparagraph.
SoHO competent authorities shall ensure that the specific induction training includes at least the following:
the inspection techniques and procedures to be followed, including practical exercises;
an overview of relevant Union and national inspection guidance, where applicable, and the best practices documented and published by the SCB, as referred to in Article 69(1), point (d);
an overview of the authorisation systems in the Member State concerned;
the legal framework applicable to the performance of SoHO supervisory activities;
an overview of the technical aspects concerning SoHO activities;
SoHO technical guidelines as referred to in Articles 56 and 59;
an overview of the organisation and functioning of national regulatory authorities in the field of SoHO and related fields;
an overview of the national healthcare system and SoHO organisational structures in the Member State concerned.
Article 31
Extraction, submission and publication of activity data
Article 32
Traceability
Article 33
Vigilance
Upon receipt of a SAR or SAE notification pursuant to Article 44(3), SoHO competent authorities shall:
verify that the notification includes the information referred to in Article 44(3);
respond to the submitting SoHO entity if additional documentation or corrections are required.
Upon receipt of a SAR or SAE notification pursuant to Article 44(3), SoHO competent authorities may:
provide advice on the investigation planned by the SoHO entity;
request advice from the SCB pursuant to Article 69(1).
Where the SAR notification concerns a transmission of a communicable disease that is rare, or unexpected for that SoHO type, SoHO national authorities shall inform the ECDC. In such cases, the SoHO national authority shall take into account any advice or information provided by the ECDC or its SoHO expert network.
Upon receipt of a SAR or SAE investigation report, SoHO competent authorities shall:
verify that the investigation report includes the information required pursuant to Article 44(7);
assess the results of the investigation and of the corrective and preventive actions described;
request additional documentation from the submitting SoHO entity, if required;
inform the submitting SoHO entity of the conclusion of the assessment, if corrections are required.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 34
SoHO rapid alerts
SoHO national authorities shall launch a SoHO rapid alert in particular in the following circumstances:
a risk to the quality or safety of SoHO has been identified concerning SoHO that have been distributed from their Member State to at least one other Member State;
an outbreak of a communicable disease has occurred in their Member State and they have put in place SoHO donor deferral or testing measures to mitigate the risks of transmission by SoHO;
a defect or serious supply interruption has occurred concerning equipment, devices, materials or reagents that are critical for the collection, processing, storage or distribution of SoHO and that might be used in other Member States;
other information is available to the SoHO national authorities that could reasonably be considered useful in other Member States to reduce risks to the quality or safety of SoHO and where the launch of a SoHO rapid alert is proportionate and necessary.
CHAPTER IV
GENERAL OBLIGATIONS ON SOHO ENTITIES
Article 35
SoHO entity registration
Entities may request from a SoHO competent authority within their territory an opinion on whether the activities they are carrying out are subject to the registration requirements set out in this Chapter.
In order to register as a SoHO entity, the SoHO entity shall provide the following information:
name of the SoHO entity and all addresses where SoHO activities are performed by the SoHO entity;
name and contact details of the responsible person as referred to in Article 36;
acknowledgment from the SoHO entity that it may be inspected pursuant to Article 28 and that it will cooperate with the relevant SoHO competent authority in any matter relating to the conduct of SoHO supervisory activities in accordance with this Regulation;
a list of the SoHO concerned and of the SoHO activities referred to in Article 2(1), point (c), that the SoHO entity carries out; where the SoHO entity carries out the SoHO activity referred to in Article 2(1), point (c)(iv), it shall also provide the name of the SoHO establishment responsible for the SoHO release prior to distribution;
where applicable, a list of SoHO establishments for which the SoHO entity performs SoHO activities covered by an agreement;
where applicable, details of any accreditation or certification received from an external body;
where applicable, information regarding activities carried out and regulated under other Union legislation, as referred to in Article 13(1).
Article 36
Responsible person
Article 37
Quality management system
SoHO entities shall put in place procedures and specifications covering, where applicable to their SoHO activities, the following:
documentation of roles, responsibilities of personnel and organisation;
selection, training and competence assessment of personnel;
the procurement qualification, validation and monitoring of premises, materials and equipment, including IT systems;
other documentation relevant for the quality management system put in place;
quality control, and monitoring of key performance indicators of SoHO activities;
quarantine and release;
withdrawal of SoHO from the inventory of released SoHO and recalls;
internal audits;
management of contracted third parties;
management of cases where procedures have not been followed or specifications have not been met;
complaints;
management of traceability and vigilance, pursuant to Articles 42, 43 and 44;
continuity planning.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 38
SoHO preparation authorisation
Article 39
Application for SoHO preparation authorisation
Applications for SoHO preparation authorisation shall include the following:
the name and contact details of the applicant SoHO entity responsible for the SoHO preparation authorisation;
details of the SoHO activities performed for that SoHO preparation and including at least:
a description of the SoHO used for the SoHO preparation;
a list of the specific SoHO donor eligibility criteria, including SoHO donor tests specific for the SoHO preparation;
a summary of SoHO collection procedures and any specific quality control tests and checks carried out on the collected SoHO prior to processing;
a description of the steps of the processing applied, including details of relevant materials and equipment used, environmental conditions and the process parameters and controls at each step;
a description of equipment, reagents and materials coming into direct contact with the SoHO during processing and their certification status in accordance with Regulation (EU) 2017/745, where applicable, and, in the case of the use of in-house developed equipment, reagents or materials, evidence of the validation of their quality;
any specific conditions and time limits for storage and transport, including validation of those conditions and limits;
a specification of the SoHO preparation, including quality control and release parameters;
data resulting from process validation and equipment qualification;
details of any SoHO entities or third parties contracted to perform activities or relevant steps of the processing applied to the SoHO preparation;
the clinical indications for which the SoHO preparation is to be applied and the clinical data justifying this indication;
where relevant, non-clinical data on the effectiveness and toxicity of the SoHO preparation;
the results of a benefit-risk assessment conducted in respect of the combination of SoHO activities performed for the SoHO preparation, together with the intended clinical indication for which the application for SoHO preparation authorisation is submitted, taking into account:
whether the SoHO preparation is described in, and aligned with, an EDQM SoHO monograph included in the technical guidelines referred to in Article 59(4), point (a), or a specification included in the other guidelines referred to in Article 59(4), point (b) or (c);
whether the SoHO preparation meets the quality criteria defined in a monograph or specification as referred to in point (i) of this point and whether it is intended to be used for the indication and with the mode of human application to which that monograph or specification refers, where such details are provided in that monograph, or whether it meets the requirements set out in the other guidelines referred to in Article 59(4), point (b);
information regarding previous use and authorisation of the SoHO preparation or a comparable SoHO preparation in other SoHO entities, as available on the EU SoHO Platform;
where applicable, clinical functionality evidence generated as part of conformity assessment procedures, in accordance with Regulation (EU) 2017/745, of a certified medical device that is critical to the specific processing for the SoHO preparation, in cases where the applicant SoHO entity has access to such data;
documentation of a standardised process of identification, quantification and evaluation of any risks to SoHO donors, SoHO recipients or the offspring from medically assisted reproduction arising from the chain of activities performed for the SoHO preparation and taking into account the technical guidelines published by the EDQM for the performance of such risk assessments, as referred to in Article 56(4), point (a), and Article 59(4), point (a);
in cases where the indicated risk is greater than negligible, or the expected clinical effectiveness is unknown, a proposed plan for clinical-outcome monitoring for the purpose of providing further evidence, where necessary, for the SoHO preparation authorisation, in line with the results of the benefit-risk assessment and pursuant to point (c);
an indication of the data which is to be regarded as proprietary and which is to be accompanied, where appropriate, by a verifiable justification.
Article 40
SoHO clinical studies
Before commencing a SoHO clinical study for the risk level referred to in Article 21(3), point (c), SoHO entities shall:
apply for a favourable opinion from a relevant ethics committee and shall communicate such an opinion to their SoHO competent authority; such an opinion shall address the ethical, legal and methodological aspects of the SoHO clinical study in order to determine the capacity of the study, as designed, to draw robust conclusions;
await approval by the SoHO competent authority of the clinical-outcome monitoring plan, as referred to in Article 19(2), point (d), and Article 21.
Article 41
Activity data collection and reporting
SoHO entities shall collect and report data relating to any of the following SoHO activities:
SoHO donor registration;
collection;
distribution;
import;
export;
human application.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 42
Traceability and coding
Importing SoHO establishments shall ensure an equivalent level of traceability with regard to imported SoHO.
The traceability system referred to in paragraph 1 of this Article shall be able to:
identify the SoHO donor or the person from whom SoHO are collected for autologous or within-relationship use and the SoHO establishment releasing the SoHO;
identify the SoHO recipient at the SoHO entity applying the SoHO to the SoHO recipient, or the manufacturer of products regulated by other Union legislation, as referred to in Article 2(6);
locate and identify all relevant data relating to the quality and safety of the SoHO and any materials or equipment that have come into contact with those SoHO that might pose a risk to their quality or safety.
SoHO entities distributing SoHO shall apply a code that contains the information required by the traceability system referred to in paragraph 1 of this Article. SoHO entities shall ensure that the code generated:
is unique within the Union;
is machine-readable, unless the size or storage conditions mean that a machine-readable code cannot be applied;
does not reveal the identity of the SoHO donor or the person from whom SoHO are collected in the case of autologous use;
complies with technical rules for the Single European Code referred to in Article 43, where applicable as indicated in that Article.
The first subparagraph shall not apply in the context of autologous or within-relationship use of SoHO collected in the same SoHO entity where they are applied.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 43
European coding system
Paragraph 1 of this Article shall not apply to:
reproductive SoHO for within-relationship use;
blood or blood components for transfusion or for the manufacture of medicinal products;
SoHO applied to a SoHO recipient without being stored;
SoHO imported into the Union by way of derogation and authorised directly by SoHO competent authorities pursuant to Article 26(6);
SoHO that are imported to or collected in the same SoHO entity where they are applied.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 44
Vigilance and reporting
In cases where SoHO entities detect or suspect that an adverse reaction or adverse event falls within the definition of a serious adverse reaction as set out in Article 3, point (45), or the definition of a serious adverse event as set out in Article 3, point (46), they shall submit a notification to their SoHO competent authorities without undue delay and shall include the following information:
a description of the suspected serious adverse reaction or serious adverse event;
a preliminary assessment of the level of imputability, where applicable;
details of any immediate steps taken to limit harm, where applicable;
a preliminary assessment of the seriousness of the consequences of the suspected serious adverse reaction or serious adverse event.
SoHO entities other than those referred to in the first subparagraph shall investigate and report serious adverse reactions or serious adverse events directly to their SoHO competent authorities.
SoHO entities shall conduct an investigation of each serious adverse reaction or serious adverse event detected by, or communicated to, them in accordance with paragraph 4. On completion of that investigation, SoHO entities shall provide an investigation report to their SoHO competent authorities. The SoHO entities shall include in the report:
a full description of the investigation of the serious adverse reaction or serious adverse event and the final assessment of the imputability of the serious adverse reaction to the collection process or to the human application of the SoHO, where applicable;
the final assessment of the seriousness of the harm to a SoHO donor, a SoHO recipient or the offspring from medically assisted reproduction or for public health in general, including a risk assessment of the likelihood of recurrence, where relevant;
a description of the corrective or preventive actions that have been taken to limit any harm or to prevent recurrence.
CHAPTER V
GENERAL OBLIGATIONS ON SOHO ESTABLISHMENTS
Article 45
SoHO establishment authorisation
In the case of a decision on the need for a SoHO establishment authorisation under Article 24(4), the SoHO entity shall not carry out the SoHO activity requiring SoHO establishment authorisation as communicated by the SoHO competent authority, without prior SoHO establishment authorisation.
Article 46
Application for SoHO establishment authorisation
The SoHO establishment shall not make any significant changes with regard to the SoHO or the SoHO activities subject to the authorisation without the prior written authorisation of the SoHO competent authority.
Article 47
Importing SoHO establishment authorisation
Article 48
Application for importing SoHO establishment authorisation
The applicant SoHO establishment shall provide:
documentation of the accreditation, designation, authorisation or licence granted by a competent authority or authorities to the third-country supplier for carrying out the activities related to the SoHO to be imported;
a written agreement as referred to in paragraph 2 that shall include, at least:
details of the third-country supplier contracted;
the requirements to be met to ensure the equivalence of the quality, safety and effectiveness of the SoHO to be imported;
the right of the SoHO competent authorities to inspect the activities, including the facilities, of any third-country supplier or entity sub-contracted by that supplier, contracted by the importing SoHO establishment;
documentation describing the imported SoHO and demonstrating that the procedures the third-country suppliers have in place will ensure that the imported SoHO will be equivalent, in terms of quality, safety and effectiveness, to SoHO authorised in accordance with this Regulation.
In the case of national or international donor registries that are authorised as importing SoHO establishments, the physical and documentation controls referred to in paragraph 5 may be delegated to the SoHO entity that receives the imported SoHO for human application and the release step may be completed remotely.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 49
Releasing officer
The responsibility for releasing SoHO may be delegated to an alternate in the event of short-term absence of the releasing officer, provided that the alternate meets the requirements set out in paragraph 2.
Article 50
Physician
Each SoHO establishment shall appoint a physician who carries out their tasks in the same Member State and who shall at least fulfil the following conditions and have the following qualifications:
possession of formal qualification as a physician; and
at least 2 years’ practical experience in the relevant field.
The physician referred to in paragraph 1 shall be responsible for at least the following tasks:
development, review and approval of procedures for establishing and applying SoHO donor eligibility criteria, procedures for SoHO collection and criteria for the allocation of SoHO;
supervision of the implementation of procedures referred to in point (a) when they are carried out by SoHO entities contracted by the SoHO establishment;
the clinical aspects of investigation of suspected adverse reactions in SoHO donors, SoHO recipients and offspring from medically assisted reproduction from the perspective of the SoHO establishment;
design and supervision, in collaboration with treating physicians, of clinical-outcome monitoring plans to generate evidence required to support applications for SoHO preparation authorisations pursuant to Article 39;
other tasks of relevance to the health of SoHO donors, SoHO recipients and offspring from medically assisted reproduction in relation to SoHO collected or supplied by the SoHO establishment.
Article 51
Export
CHAPTER VI
SOHO DONOR PROTECTION
Article 52
Objectives regarding SoHO donor protection
Article 53
Standards concerning SoHO donor protection
Where SoHO are collected from SoHO donors, regardless of whether or not the SoHO donor is related to the intended recipient, SoHO entities shall:
meet all applicable consent or authorisation requirements in force in the Member State concerned;
provide SoHO donors or, where applicable, any persons granting consent on their behalf, in accordance with national legislation, with:
the information referred to in Article 55 in a way that is adequate in view of their capacity to understand it;
the contact details of the SoHO entity responsible for collection from which they can request further information, if needed;
safeguard the rights of the living SoHO donor to physical and mental integrity, to non-discrimination, to privacy and to the protection of the personal data, including health data concerning them, in accordance with Regulation (EU) 2016/679;
ensure that SoHO donation is voluntary and unpaid, pursuant to Article 54;
verify the eligibility of the living SoHO donor on the basis of a donor health evaluation that aims to identify, with a view to minimising, any risk that the SoHO collection might pose to the SoHO donor’s health;
document the results of the living SoHO donor health evaluation;
communicate and clearly explain the results of the living SoHO donor health evaluation to the living SoHO donor or, where applicable, any persons granting consent on their behalf, in accordance with national legislation;
identify and minimise any risks to the health of the living SoHO donor during the SoHO collection procedure, including exposure to reagents or solutions that might be harmful to health;
in cases where SoHO can be donated repeatedly, and frequent donation might negatively influence the living SoHO donor’s health, verify, by means of registries, as referred to in paragraph 3 of this Article, that living SoHO donors are not donating more frequently than indicated as safe in technical guidelines referred to in Article 56(4) and monitor relevant health indicators to evaluate whether their health is not compromised;
in cases where SoHO donation implies a significant risk to a living SoHO donor, develop and implement a plan for monitoring the SoHO donor’s health after donation as referred to in paragraph 4;
in the case of an unrelated SoHO donation, refrain from revealing the SoHO donor’s identity to the recipient or to the offspring from medically assisted reproduction, apart from in circumstances where such information exchange is permitted in the Member State concerned.
Article 54
Standards concerning voluntary and unpaid nature of SoHO donations
Article 55
Standards concerning information to be provided prior to consent
In the case of living SoHO donors or, where applicable, persons granting consent on their behalf, SoHO entities shall provide information regarding:
the purpose and nature of the SoHO donation;
the intended use of the donated SoHO, specifically covering proven benefits for the future SoHO recipients and any possible research or commercial uses of SoHO, including the use to manufacture products regulated by other Union legislation, as referred to in Article 2(6), to which specific consent shall be granted;
the consequences and risks of the SoHO donation;
the obligation for consent, in accordance with national legislation, in order for SoHO collection to be carried out;
the right to revoke consent and any restrictions on that right after the collection;
the purpose of the tests that will be performed in the course of the SoHO donor health evaluation, in accordance with Article 53(2);
the right of the SoHO donor or, where applicable, the person granting consent on their behalf to receive the confirmed results of the tests when relevant for their health, in accordance with national legislation;
the recording and protection of SoHO donor’s personal data, including health data, and medical confidentiality, including any potential sharing of data in the interest of the SoHO donor health monitoring and of public health, as necessary and proportionate, in accordance with Article 76;
the possibility that the SoHO donor identity may be revealed to the offspring from medically assisted reproduction that is born as a result of their SoHO donation in cases where national legislation grants that right to such offspring;
other applicable safeguards to protect the SoHO donor.
Article 56
Implementation of the standards concerning SoHO donor protection
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
For those standards concerning SoHO donor protection, or elements thereof, for which no implementing act has been adopted, SoHO entities shall take into account:
the most recent technical guidelines, as indicated on the EU SoHO Platform, as follows:
published by the ECDC concerning the prevention of communicable disease transmission;
published by the EDQM concerning SoHO donor protection other than from transmission of communicable diseases;
other guidelines, adopted by Member States, as referred to in Article 27(6), point (b);
other guidelines or technical methods, applied in specific circumstances, as referred to in Article 27(6), point (c).
Where other technical methods are applied, SoHO entities shall perform a risk assessment to demonstrate that the technical methods applied achieve a high level of protection of SoHO donors, and they shall record the practice followed to establish such technical methods. They shall make the assessment and record available for review by their SoHO competent authorities during inspection or on specific request of the SoHO competent authorities.
CHAPTER VII
PROTECTION OF SOHO RECIPIENTS AND OFFSPRING FROM MEDICALLY ASSISTED REPRODUCTION
Article 57
Objectives regarding protection of SoHO recipients and offspring from medically assisted reproduction
SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO and their human application, within the scope of their competences. They shall do so by identifying and minimising or eliminating those risks.
Article 58
Standards concerning protection of SoHO recipients and offspring from medically assisted reproduction
In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of communicable disease transmission from SoHO donors to SoHO recipients by combining at least the following measures:
reviewing and evaluating SoHO donors’ current and past health, travel and relevant behavioural histories and, where relevant, their family history, to allow for the application of temporary or permanent deferrals of SoHO donors when risks cannot be minimised by SoHO donor testing;
testing of SoHO donors for communicable diseases in laboratories duly accredited, certified or authorised, by using certified and validated testing methods or, when not feasible, by using other methods validated by those laboratories;
when feasible, taking other measures that reduce or eliminate any potential communicable pathogens.
In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of non-communicable disease transmission, when they are relevant to the SoHO concerned, including the transmission of serious genetic conditions and cancer, from SoHO donors to the SoHO recipients or to offspring from medically assisted reproduction by combining at least the following measures:
reviewing the SoHO donors’ current and past health and, where relevant, their family history, to allow for the application of temporary or permanent deferral of SoHO donors that carry a risk of transmitting cancerous cells, serious genetic conditions or other non-communicable diseases that might be passed to a SoHO recipient by human application of SoHO;
where the transmission of serious genetic conditions is an identified risk, and in particular in the case of medically assisted reproduction with third-party donation, and insofar as national legislation allows for any of the following testing:
routinely testing SoHO donors for potentially life-threatening, disabling or incapacitating genetic conditions with a significant prevalence in the SoHO donor population; or
testing SoHO recipients to identify genetic risk for potentially life-threatening, disabling or incapacitating conditions, according to family history, combined with testing third party SoHO donors for such identified serious genetic conditions to ensure matching that will prevent such conditions occurring in the offspring from medically assisted reproduction.
In the procedures referred to in paragraph 1, SoHO entities shall mitigate risks arising from microbial contamination of SoHO from the environment, the personnel, the equipment and the materials coming into contact with SoHO during collection, processing, storage or distribution. SoHO entities shall mitigate such risks by combining at least the following measures:
specifying and verifying the hygiene procedures of the personnel of the SoHO entity in contact with the SoHO throughout the SoHO preparation chain;
specifying and verifying the cleanliness of collection areas, taking into account the degree of exposure of SoHO to the environment during collection, and of storage areas;
in cases where SoHO are exposed to the environment during processing, specifying, based on a structured and documented risk assessment for each SoHO preparation, validating and maintaining a defined air quality in processing areas;
specifying, procuring and decontaminating equipment and materials that come into contact with SoHO during collection, processing, storage or distribution, such that their sterility, where necessary, is ensured;
performing quality control testing of SoHO to detect microbial contamination and using methods of inactivation or elimination of microorganisms, where feasible and appropriate.
In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks that any reagents and solutions added to SoHO or coming into contact with SoHO during collection, processing, storage and distribution might be transferred to SoHO recipients and have a harmful effect on their health, by combining at least the following measures:
specifying such reagents and solutions prior to their purchase and use;
verifying any required certifications of such reagents and solutions;
demonstrating the removal of such reagents and solutions, when necessary, prior to distribution.
In the procedures referred to in paragraph 1 of this Article, SoHO entities shall mitigate the risks that inherent properties of SoHO, necessary for clinical effectiveness, might be changed by any SoHO activity performed, in a manner that renders the SoHO ineffective or less effective when applied to SoHO recipients, by combining at least the following measures:
conducting comprehensive process validation and equipment qualification as referred to in Article 39(2), point (b)(viii);
gathering evidence of effectiveness as referred to in Article 39(2), point (d), when needed.
In the procedures referred to in paragraph 1 of this Article, SoHO entities shall mitigate the risks that SoHO cause an unexpected immune reaction in SoHO recipients by combining at least the following measures:
adequately typing and matching of SoHO recipients to SoHO donors, when such matching is necessary;
putting in place procedures to reduce, when feasible, those elements of SoHO that stimulate an unintended immune response, as applicable;
correctly distributing and applying SoHO to the correct SoHO recipients pursuant to Article 42.
SoHO entities shall not:
apply SoHO preparations to SoHO recipients without proven benefit, except in the context of:
a clinical-outcome monitoring plan approved by their SoHO competent authority pursuant to Article 19(2), point (d);
an individual treatment attempt with respect to the treating physician’s therapeutic decision pursuant to Article 19(11); or
a health emergency situation pursuant to Article 65;
apply SoHO preparations to SoHO recipients unnecessarily; SoHO entities shall make optimal use of SoHO, taking into account therapeutic alternatives, and following the most up-to-date guidelines as referred to in Article 59;
advertise or promote particular SoHO to potential SoHO recipients, or to any persons granting consent on their behalf, or to healthcare professionals using information that is misleading, in particular, as to the potential use and benefits to SoHO recipients, or minimising the associated risks of the SoHO concerned;
distribute or apply allogeneic SoHO for purposes other than the prevention or treatment of a medical condition, including through reconstructive surgery, or for medically assisted reproduction.
For the measures referred to in paragraphs 2 and 3, SoHO entities shall verify the eligibility of a SoHO donor by means of:
an interview with the SoHO donor, in the case of donation from a living SoHO donor or, where applicable, with any persons granting consent on their behalf; or
in the case of collection of SoHO from deceased SoHO donors, an interview with a relevant person that is informed regarding the SoHO donor’s health and lifestyle history.
In the case of donation from a living SoHO donor, the interview referred to in the first subparagraph, point (a), of this paragraph may also include any part of the interview conducted as part of the evaluation referred to in Article 53(1), point (e). For living SoHO donors that donate repeatedly, the interviews referred to in the first subparagraph, point (a), of this paragraph may be limited to aspects that might have changed and may be replaced with questionnaires. Interviews shall be added in cases where responses provided in questionnaires indicate changes in relevant information. This shall be without prejudice to Article 53(1), points (d) and (e), and Article 53(2).
Where SoHO is collected from deceased SoHO donors, SoHO entities shall communicate and explain the results of the SoHO donor eligibility verification, in particular any condition identified in the deceased SoHO donor that might imply a risk for the health of the deceased SoHO donors’ relatives or close contacts, to the relevant persons, in accordance with national legislation.
SoHO entities shall inform the SoHO recipients or any person granting consent on their behalf, of, at least, the following:
the safeguards intended to protect the personal data, including health data, of the SoHO recipients and, where relevant, of the offspring from medically assisted reproduction;
the need for SoHO recipients to report back any unintended reactions following the human application of SoHO or any serious genetic conditions in offspring from medically assisted reproduction with third-party donation, as referred to in Article 44(2).
Article 59
Implementation of the standards concerning protection of SoHO recipients and offspring from medically assisted reproduction
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
For those standards, or elements thereof, concerning protection of SoHO recipients and offspring from medically assisted reproduction for which no implementing act has been adopted, SoHO entities shall take into account:
the most recent technical guidelines, as indicated on the EU SoHO Platform, as follows:
published by the ECDC concerning the prevention of communicable disease transmission;
published by the EDQM concerning protection of SoHO recipients and offspring from medically assisted reproduction other than from transmission of communicable disease;
other guidelines, adopted by Member States, as referred to in Article 27(6), point (b);
other guidelines or technical methods, applied in specific circumstances, as referred to in Article 27(6), point (c).
Where other technical methods are applied, SoHO entities shall perform a risk assessment to demonstrate that the technical methods applied achieve a high level of protection of SoHO donors, and record the practice followed to establish the technical methods. They shall make the assessment and record available for review by their SoHO competent authorities during inspection or on specific request of the SoHO competent authorities.
Article 60
SoHO release
A SoHO establishment that releases SoHO for distribution or export shall have a procedure in place, under the control of the releasing officer as referred to in Article 49, for SoHO release to ensure that the standards, or elements thereof, referred to in Articles 58 and 59 and their implementation, have been verified and documented prior to release and that all conditions included in any applicable authorisations granted in accordance with this Regulation have been complied with.
SoHO processed for autologous use or within-relationship use, without SoHO storage, shall not require release before human application. In such cases, the SoHO preparation authorisation shall include a specification of the quality control parameters to be monitored during the processing.
Article 61
Exceptional release
The SoHO establishment which releases the SoHO preparation for distribution, in coordination with the SoHO entity which applies that SoHO preparation, where applicable, shall establish a plan for monitoring the SoHO recipient’s health after human application. The plan shall provide for monitoring the risks associated with the exceptional SoHO release. The SoHO establishment, in coordination with that SoHO entity, shall set out a time period during which the monitoring shall continue.
CHAPTER VIII
SUPPLY CONTINUITY
Article 62
Critical SoHO supply sufficiency
Member States shall make all reasonable efforts to:
facilitate public participation in SoHO donation activities for critical SoHO, with a view to ensuring a broad SoHO donor-base and SoHO donor-base resilience built on the standards concerning voluntary and unpaid donation in accordance with Article 54;
ensure that SoHO donor recruitment and retention strategies are put in place for critical SoHO, including communication campaigns and education programmes;
carry out the activities as referred to in paragraph 1 of this Article through preparedness and response measures, with due regard to Article 54; and
ensure optimal use of critical SoHO, taking into account therapeutic alternatives.
Accordingly, Member States shall encourage the collection of SoHO with a strong public and non-profit sector involvement.
SoHO competent authorities shall, in turn, establish appropriate mechanisms to receive such information referred to in the first subparagraph and shall be able to get an overview of the availability of critical SoHO in their territories, when needed.
Article 63
National SoHO emergency plans
Member States shall draw up the plans referred to in paragraph 1 of this Article, setting out the following elements:
potential risks to the supply of critical SoHO;
the designation of critical SoHO entities and any other relevant third party to be involved in the supply of critical SoHO;
a consolidated national overview of critical SoHO entity emergency plans referred to in Article 67;
the powers and responsibilities of SoHO competent authorities in situations of emergency as referred to in paragraph 1 of this Article;
procedures for sharing information, where appropriate, via the EU SoHO Platform, as well as elements of information to be exchanged with the SoHO national authorities of the other Member States and with other parties concerned, as appropriate, including in cases of shortages of critical SoHO with cross-border impact;
preparedness and response measures for specific identified risks, in particular those concerning communicable disease outbreaks, war or terrorist attacks and environmental disasters;
a procedure for the assessment and authorisation, in the context of a health emergency situation and in accordance with Article 65, of requests from SoHO entities for derogations from the obligation to have a SoHO preparation authorisation pursuant to Article 38(1);
a mechanism to ensure that in a health emergency situation, critical SoHO are prioritised according to specific medical needs.
Article 64
Supply alerts for critical SoHO
Shortages shall be considered significant when:
the human application of critical SoHO or the distribution of critical SoHO for the manufacture of products regulated by other Union legislation, as referred to in Article 2(6), is cancelled or postponed, or there is a significant risk of being cancelled or postponed, due to unavailability; and
the situation referred to in point (a) poses a serious risk to human health.
SoHO competent authorities that receive a SoHO supply alert referred to in paragraph 1 of this Article shall:
communicate that SoHO supply alert to their SoHO national authority;
implement appropriate measures to mitigate the risks, to the extent possible; and
take into account the information received in accordance with paragraph 1 of this Article in the review of the national SoHO emergency plans referred to in Article 63.
Article 65
Derogation from the obligations to authorise SoHO preparations in health emergency situations
By way of derogation from Article 19, SoHO competent authorities may permit, at the request of a SoHO entity as referred to in Article 38(3) and duly justified by a health emergency situation, the distribution, or preparation for immediate human application, of SoHO preparations within their territory even if the procedures referred to in Article 19 have not been carried out, provided that:
the human application of those SoHO preparations is in the interest of public health;
the SoHO preparations have a level of quality and safety that is acceptable considering the requirements of this Regulation or the available data indicate a positive benefit-risk assessment; and
the SoHO preparation is for immediate human application to a defined group of SoHO recipients, who have no therapeutic alternative, the treatment cannot be postponed, the prognosis is life-threatening and the expected benefit outweighs the risks.
The intended SoHO recipients or, where applicable, persons granting consent on their behalf, shall be informed of the derogation and shall give their consent to the immediate human application of that SoHO preparation, in accordance with national legislation, prior to the human application itself.
SoHO competent authorities shall:
indicate the period of time for which the permission referred to in paragraph 1 is granted and if such SoHO preparations may be distributed to other Member States;
instruct the requesting SoHO entity to submit an application for a SoHO preparation authorisation pursuant to Article 39 and collect retrospectively data on the human application of the SoHO preparation during the health emergency situation;
inform the SoHO national authority of the permission referred to in paragraph 1, provided for the SoHO preparation concerned.
Article 66
Emergency derogations in man-made or natural disasters
Article 67
SoHO entity emergency plans
Each critical SoHO entity shall draw up a SoHO entity emergency plan that implements the national SoHO emergency plan as referred to in Article 63.
Member States may consider that the measures set out in this Chapter are at least equivalent to the obligations laid down in Directive (EU) 2022/2557.
CHAPTER IX
SOHO COORDINATION BOARD
Article 68
SoHO Coordination Board
The SoHO national authority may nominate members from other SoHO competent authorities. Those members shall ensure that the views and suggestions they express are endorsed by the SoHO national authority.
The SCB may invite experts and observers to attend its meetings, and may cooperate with other external experts, as appropriate. The SCB may also invite, where relevant, other Union institutions, bodies, offices and agencies. In such cases, they shall have observer status.
When establishing the SCB, the Commission shall put forward the rules of procedure of the SCB which shall be approved by the SCB within the first semester of its functioning. The rules of procedure shall, in particular, lay down procedures for the following:
scheduling of meetings;
election of the SoHO national authority co-chairing the meetings of the SCB and the duration of this mandate;
deliberation and voting, as well as timeframes for issuing opinions, taking into account the complexity of the file, the available evidence or other relevant factors;
adoption of opinions or other positions, including in cases of urgency;
submission of requests for advice to the SCB, and for other communications to the SCB;
consultation with advisory bodies established under other relevant Union legislation;
delegation of tasks to working groups, including on vigilance, inspection, and traceability, and on the applicability of this Regulation;
delegation of ad-hoc tasks to SCB members or technical experts to explore, and report to the SCB on, specific technical topics, as required;
invitation of experts to take part in the work of the SCB working groups and to contribute to ad-hoc tasks, on the basis of their personal experience and expertise or on behalf of recognised Union level or global professional associations;
invitation of individuals, organisations, or public entities in the capacity of observers;
declarations regarding conflict of interests of SCB members, alternates, observers and invited experts;
establishment of working groups, including their composition and rules of procedure, and the delegation of ad-hoc tasks.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 69
Tasks of the SoHO Coordination Board
The SCB shall assist SoHO competent authorities regarding the coordinated implementation of this Regulation and of the implementing and delegated acts adopted pursuant to it, by:
preparing opinions, at the request of SoHO competent authorities, submitted via their SoHO national authority, in accordance with Article 13(3), first subparagraph, on the regulatory status under this Regulation of a substance, product or activity and including such opinions in the SoHO compendium;
drawing up, by 7 August 2025, a list of the existing substances, products or activities for which an opinion on the regulatory status under this Regulation is not available but is needed to avoid risks to the safety of SoHO donors, recipients or offspring from medically assisted reproduction, or risks of a compromised access of recipients to safe and effective treatments, making it publicly available on the EU SoHO Platform, and subsequently updating that list at its discretion;
initiating at Union level, when preparing the opinions referred to in point (a) of this paragraph, a consultation with equivalent advisory bodies established under other relevant Union legislation in accordance with Article 13(3), second subparagraph, and including in the SoHO compendium the opinions concerning the Union legislation to be applied in cases where there is agreement with the equivalent advisory bodies;
documenting and publishing best practices on the implementation of SoHO supervisory activities on the EU SoHO Platform;
recording information notified in accordance with Article 13(4), and including such information in the SoHO compendium;
setting indicative criteria for ‘critical SoHO’ and for ‘critical SoHO entity’, providing and updating a list of what is considered a ‘critical SoHO’ by Member States, and making such information available to the SoHO national authorities on the EU SoHO Platform;
documenting practices followed by Member States to establish the conditions for compensation as referred to in Article 54(2);
providing assistance and advice for the cooperation between SoHO competent authorities and other competent authorities, with a view to ensuring coherent oversight where the regulatory status of SoHO changes, as provided for in Article 13(6);
providing advice on the minimum evidence necessary for the authorisation of a particular SoHO preparation, as referred to in Article 20(4), point (e);
liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards within their respective areas of expertise, as well as with the European Medicines Agency on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2001/83/EC, to support the harmonised implementation of standards and technical guidelines;
collaborating for the effective organisation of joint inspections and joint SoHO preparation assessment involving more than one Member State;
providing advice to the Commission on the functional specifications of the EU SoHO Platform;
in cooperation with the Commission, and, where appropriate, with the Advisory Committee on public health emergencies established pursuant to Article 24 of Regulation (EU) 2022/2371, supporting a coordinated approach to ensure the implementation of the national SoHO emergency plans in cases where an emergency affects more than one Member State or in the case of emergencies with an effect beyond the Union, in accordance with Article 63(7) of this Regulation;
providing assistance in other matters related to the coordination or the implementation of this Regulation.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
CHAPTER X
UNION ACTIVITIES
Article 70
Union training and exchange of SoHO competent authorities’ personnel
Article 71
Commission controls
The Commission shall perform controls to confirm whether Member States effectively apply the requirements relating to:
SoHO competent authorities and delegated bodies provided for in Chapter II;
the SoHO supervisory activities carried out by SoHO competent authorities and delegated bodies;
the notification and reporting requirements of this Regulation.
Following each control, the Commission shall:
prepare a draft report on the findings and, where appropriate, include recommendations addressing the shortcomings identified;
send a copy of the draft report referred to in point (a) to the SoHO national authority concerned for its comments;
take the comments referred to in point (b) into account in preparing the final report; and
make publicly available a summary of the final report on the EU SoHO Platform.
Article 72
Assistance by the Union
To facilitate the fulfilment of the requirements provided for in this Regulation, the Commission shall support implementation by:
providing secretariat and technical, scientific and logistic support to the SCB and its working groups;
funding Commission controls in Member States, including the costs of Member State experts assisting the Commission;
providing funding from the relevant Union programmes in support of public health to:
support collaborative work between SoHO competent authorities and organisations representing groups of SoHO entities and SoHO professionals with the aim of facilitating efficient and effective implementation of this Regulation, and in particular of collaborating on initiatives to achieve sufficiency of supply, including actions to promote donation and optimal use of critical SoHO, and on training activities referred to in Article 70(1) and programmes for the exchange of SoHO competent authorities’ personnel referred to in Article 70(4);
where applicable, support financially in accordance with the relevant Union programmes, the development and updating of technical guidelines with a view to contributing to the implementation of this Regulation, including through cooperation, as provided for in Union law, with the EDQM on the guidelines published by them;
facilitating the cooperation between the SCB and advisory bodies established by other Union legislation referred to in Article 2(6), in particular through the organisation of joint meetings on the experience acquired with the application of Article 69(1), point (c), and aiming for a common approach to the assessment of the regulatory status of substances, products and activities, taking into account the specificities and the scope of each legal framework;
establishing, managing and maintaining the EU SoHO Platform.
CHAPTER XI
EU SOHO PLATFORM
Article 73
Establishment, management and maintenance of the EU SoHO Platform
Article 74
General functionalities of the EU SoHO Platform
The EU SoHO Platform shall provide a secure channel for restricted exchange of information and data, in particular:
between Member States’ SoHO national authorities;
between two SoHO competent authorities within the Member State or between a SoHO competent authority and its SoHO national authority;
between SoHO national authorities and the Commission, in particular in relation to activity data concerning SoHO activities of SoHO entities, the summaries of notifications and investigation reports of confirmed serious adverse reaction or serious adverse event, SoHO rapid alerts and SoHO supply alerts;
between SoHO national authorities and the SCB;
between SoHO national authorities and the ECDC, in relation to SoHO rapid alerts related to communicable diseases, where applicable;
between SoHO entities and their respective SoHO competent authorities, when the SoHO competent authorities choose to use the EU SoHO Platform for such exchanges.
The EU SoHO Platform shall provide public access to information regarding:
the registration and authorisation status of SoHO entities and their identification code and the SoHO establishment identification code;
approved SoHO clinical studies and authorised SoHO preparations;
the annual Union SoHO activity report and annual Union SoHO vigilance report, in aggregated and anonymised formats, after their approval by SoHO national authorities;
relevant best practices documented and published by the SCB;
technical guidelines for quality management published by the EDQM;
technical guidelines concerning the prevention of communicable and non-communicable diseases published by the ECDC and the EDQM, and concerning protection of SoHO donors, SoHO recipients and offspring from medically assisted reproduction;
the name, the institution of origin and the declaration of interests of each SCB member and alternate;
the SoHO compendium;
the list of the existing substances, products or activities for which an opinion on the regulatory status under this Regulation is not available and is needed as referred to in Article 69(1), point (b);
the more stringent measures adopted by Member States in accordance with Article 4;
the rules of procedure of the SCB, the agenda and the summary minutes of each meeting, unless such publication undermines the protection of a public or private interest, as referred to in Article 4 of Regulation (EC) No 1049/2001;
the list of SoHO national authorities.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
CHAPTER XII
PROCEDURAL PROVISIONS
Article 75
Confidentiality
Without prejudice to national legislation on the publication of the outcome of SoHO supervisory activities, SoHO competent authorities may publish or make otherwise publicly available the outcome of SoHO supervisory activities regarding individual SoHO entities provided that the following conditions are met:
the SoHO entity concerned is given the opportunity to comment on the information that the SoHO competent authority intends to publish or make otherwise publicly available, prior to its publication or release, taking into account the urgency of the situation;
the information or data which is published or made otherwise publicly available takes into account the comments expressed by the SoHO entity concerned or is published or released together with such comments;
the information or data concerned is made available in the interest of public health protection and is proportionate to the severity, extent and nature of the associated risk;
the information or data made publicly available does not unnecessarily undermine the protection of legal rights of the SoHO entity or any other natural or legal person;
the information or data made publicly available does not undermine the protection of court proceedings and legal advice.
Article 76
Data protection
Personal data, including data concerning health, exchanged through the EU SoHO Platform and required for the application of Articles 73 and 74 shall, where necessary, be processed in the interest of public health and for the following purposes:
to help to identify and evaluate risks associated with a particular SoHO donation or SoHO donor;
to process relevant information on clinical-outcome monitoring.
Article 77
Exercise of the delegation
Article 78
Urgency procedure
Article 79
Committee procedure
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
Article 80
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 7 August 2029, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
CHAPTER XIII
TRANSITIONAL PROVISIONS
Article 81
Transitional provisions concerning establishments designated, authorised, accredited or licensed under Directives 2002/98/EC and 2004/23/EC
For blood establishments referred to in paragraph 1 of this Article, SoHO competent authorities shall:
verify whether those establishments fall within the definition of a SoHO establishment as set out in Article 3, point (35);
submit to the EU SoHO Platform the information referred to in Article 35(3), points (a) and (d), and the information regarding the registration and authorisation status according to the verification referred to in point (a) of this paragraph.
For tissue establishments referred to in paragraphs 1 and 2 of this Article, the Commission shall:
verify whether those establishments fall within the definition of a SoHO establishment as set out in Article 3, point (35);
transfer to the EU SoHO Platform the relevant information from the EU Tissue Establishment Compendium of the EU Coding Platform laid down in Commission Directive 2006/86/EC ( 5 ), including the information regarding the registration and authorisation status according to the verification referred to in point (a) of this paragraph;
inform the SoHO competent authorities of the establishments that do not fall within the definition of a SoHO establishment according to the verification referred to in point (a) of this paragraph.
Article 82
Transitional provisions concerning SoHO preparations
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 83
Transitional provisions concerning SoHO not addressed explicitly in Directive 2002/98/EC or 2004/23/EC
Entities carrying out one or more of the SoHO activities referred to in Article 2(1), points (c)(i), (iv) to (ix) and (xii), of this Regulation, in respect of SoHO not addressed explicitly in Directive 2002/98/EC or 2004/23/EC, ►C1 before 7 August 2027 ◄ shall be allowed to continue such activities ►C1 until 8 August 2028 ◄ , without applying this Regulation, except for the following requirements:
registration as SoHO entities pursuant to Article 35 of this Regulation;
application for any and all relevant SoHO preparation authorisations, where required pursuant to Article 38 of this Regulation;
application for a SoHO establishment authorisation, where required pursuant to Article 45 of this Regulation;
compliance with the standards referred to in Chapters VI and VII of this Regulation for the SoHO activities carried out during the transition phase.
Such SoHO entities shall comply with the requirements referred to in the first paragraph, points (b) and (c), ►C1 by 8 November 2027 ◄ .
Article 84
Status of SoHO in storage or distributed before the application of this Regulation
CHAPTER XIV
FINAL PROVISIONS
Article 85
Repeals
Directives 2002/98/EC and 2004/23/EC are repealed with effect from 7 August 2027.
Article 86
Evaluation
The Commission shall, ►C1 by 8 August 2032 ◄ , assess the application of this Regulation, produce an evaluation report on the progress towards achievement of the objectives of this Regulation and present its main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. The evaluation report shall include an assessment of the implementation of Article 54. For the purpose of the evaluation report, the Commission shall use aggregated and anonymised data and information gathered from SoHO competent authorities and from data and information submitted to the EU SoHO Platform. Member States shall provide the Commission with additional information as necessary and proportionate for the preparation of the evaluation report, including information on the conditions for compensation of SoHO donors pursuant to Article 54. The evaluation report shall, where appropriate, be accompanied by a legislative proposal to amend this Regulation.
Article 87
Entry into force and application
Unless otherwise provided for in paragraph 2, it shall apply from 7 August 2027.
Article 68 and Article 69(1), point (b), shall apply from 7 August 2024.
Article 80, Article 81(3), (4) and (5) and Article 82(3) shall apply from 7 August 2028.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
( ) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
( ) Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of critical entities and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164).
( ) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
( ) Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, p. 1).
( ) Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p. 32).