Eurlexa

Article 1Subject matterThis 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 2Scope1.This Regulation applies to:(a)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;(b)SoHO donors, SoHO recipients and offspring from medically assisted reproduction;(c)SoHO activities that have a direct impact on the quality, safety or effectiveness of SoHO, as follows:(i)SoHO donor registration;(ii)SoHO donor history review and medical examination;(iii)testing of SoHO donors or of persons from whom SoHO are collected for autologous or within-relationship use;(iv)collection;(v)processing;(vi)quality control;(vii)storage;(viii)release;(ix)distribution;(x)import;(xi)export;(xii)human application;(xiii)clinical-outcome registration.2.This Regulation does not apply to:(a)organs intended for transplantation within the meaning of Article 3, points (h) and (q), of Directive 2010/53/EU;(b)breast milk when used exclusively for feeding one’s own child, without any processing carried out by a SoHO entity.3.This Regulation shall be without prejudice to national legislation which establishes rules relating to aspects of SoHO other than their quality and safety and other than the safety of SoHO donors.4.By way of derogation from paragraph 1 of this Article, the provisions of this Regulation concerning the publication or communication of information, in particular the obligations in that respect set out in Article 4(2), Article 7, Article 19(3), Articles 29, 31, 41, 63, 64 and 67 and Article 81(3), point (b), shall not apply when such publication or communication might imply a risk to national security and defence.5.In the case of SoHO intended for autologous use where:(a)SoHO are processed or stored before human application, this Regulation applies;(b)SoHO are neither processed nor stored before human application, this Regulation does not apply.6.In the case of SoHO collected for the purposes of manufacturing medical devices, regulated by Regulation (EU) 2017/745, medicinal products, regulated by Directive 2001/83/EC, advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or investigational medicinal products, regulated by Regulation (EU) No 536/2014, the provisions of this Regulation applicable to the SoHO activities referred to in paragraph 1, points (c)(i) to (iv) and (viii), of this Article apply. Insofar as the SoHO activities referred to in paragraph 1, points (c)(vii), (ix), (x) and (xi), of this Article are carried out on SoHO up to and including their distribution to a manufacturer regulated by other Union legislation, as referred to in this paragraph, this Regulation also applies.7.By way of derogation from paragraph 6, where SoHO are used to manufacture products regulated by other Union legislation and those products are exclusively for therapeutic use on the person from whom the SoHO were collected, the provisions of this Regulation relating to the SoHO activities referred to in paragraph 1, points (c)(iii) and (iv), apply.8.Where non-viable SoHO or their derivatives, within the meaning of Article 2, points (16) and (17), of Regulation (EU) 2017/745, incorporate, as an integral part, a medical device, and where the action of the non-viable SoHO or their derivatives is principal to that of the medical device, this Regulation applies to the non-viable SoHO or their derivatives and the final combination shall be subject to this Regulation. Where the action of the non-viable SoHO or their derivatives is ancillary to that of the medical device, this Regulation applies to all SoHO activities to which the non-viable SoHO or their derivatives are subjected up to and including their distribution for integration into the medical device, and the final combination shall be subject to Regulation (EU) 2017/745.

Article 3DefinitionsFor the purposes of this Regulation, the following definitions apply:(1)"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;(2)"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;(3)"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;(4)"blood component" means a constituent of blood, such as red blood cells, white blood cells, platelets and plasma, that can be separated from it;(5)"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;(6)"SoHO donor" means a living or deceased SoHO donor;(7)"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;(8)"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;(9)"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;(10)"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);(11)"consent" means:(a)the permission given freely without coercion by a living SoHO donor or a SoHO recipient for an action affecting them to proceed;(b)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(c)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;(12)"allogeneic use" means the human application of SoHO collected from a person other than the SoHO recipient;(13)"autologous use" means the human application of SoHO collected from a person to the same person;(14)"within-relationship use" means the use of reproductive SoHO for medically assisted reproduction between persons with an intimate physical relationship;(15)"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;(16)"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;(17)"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;(18)"offspring from medically assisted reproduction" means children born following medically assisted reproduction;(19)"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;(20)"SoHO donor recruitment" means any activity aimed at informing persons about activities related to SoHO donation or at encouraging them to donate SoHO;(21)"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;(22)"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;(23)"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;(24)"quality control" means performing a pre-defined test or set of tests or checks to confirm that pre-defined quality criteria are met;(25)"storage" means the maintenance of SoHO under appropriate controlled conditions;(26)"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;(27)"distribution" means providing, within the Union, released SoHO:(a)intended for human application to a specific SoHO recipient in the same or in another SoHO entity;(b)intended for human application in general, without the prior identification of a specific SoHO recipient, in the same or in another SoHO entity;(c)intended for the manufacture of products regulated by other Union legislation, as referred to in Article 2(6), to a manufacturer of such products;(28)"import" means activities carried out to bring SoHO into the Union from a third country before their release;(29)"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;(30)"export" means activities carried out to send SoHO from the Union to a third country;(31)"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;(32)"clinical-outcome monitoring plan" means a programme for evaluating the safety and effectiveness of a SoHO preparation following human application;(33)"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);(34)"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;(35)"SoHO establishment" means a SoHO entity that carries out any of the following SoHO activities:(a)both processing and storage;(b)release;(c)import;(d)export;(36)"responsible person" means an appointed person in a SoHO entity who has the responsibility of ensuring compliance with this Regulation;(37)"SoHO preparation" means a type of SoHO that:(a)has been subjected to processing and, where relevant, one or more other SoHO activities referred to in Article 2(1), point (c);(b)has a specific clinical indication; and(c)is intended for human application to a SoHO recipient or is intended for distribution;(38)"SoHO preparation authorisation" means the formal approval by a SoHO competent authority of a SoHO preparation;(39)"effectiveness of SoHO" means the extent to which the human application of SoHO achieves the intended biological or clinical outcome in the SoHO recipient;(40)"SoHO clinical study" means an experimental evaluation of a SoHO preparation, with the objective of drawing conclusions regarding its safety and effectiveness;(41)"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;(42)"vigilance" means a set of organised surveillance and reporting procedures relating to adverse reactions and adverse events;(43)"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;(44)"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;(45)"serious adverse reaction" or "SAR" means an adverse reaction that results in any of the following:(a)death;(b)life-threatening, disabling or incapacitating condition, including transmission of a pathogen or of a toxic substance that might cause such condition;(c)transmission of a genetic disorder that:(i)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(ii)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;(d)hospitalisation or prolongation of hospitalisation;(e)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);(f)prolonged sub-optimal health of a SoHO donor following single or multiple SoHO donations;(46)"serious adverse event" or "SAE" means an adverse event that poses a risk of any of the following:(a)inappropriate SoHO distribution;(b)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;(c)loss of a quantity of SoHO that causes human applications to be postponed or cancelled;(d)loss of highly matched SoHO or SoHO for autologous use;(e)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;(f)loss of the traceability of SoHO;(47)"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;(48)"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;(49)"quality management system" means a formalised system that documents the processes, procedures, and responsibilities to support achieving defined quality standards in a consistent manner;(50)"delegated body" means a legal body to which the SoHO competent authority has delegated certain SoHO supervisory activities in accordance with Article 9(1);(51)"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;(52)"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;(53)"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);(54)"Single European Code" means the unique identifier applied to certain SoHO distributed in the Union;(55)"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);(56)"compensation" means making good of any losses or the reimbursement of expenses associated with SoHO donation;(57)"financial neutrality of donation" means that no financial gain or loss will be incurred by the SoHO donor as a result of the donation;(58)"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;(59)"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 4More stringent Member State measures1.Member States may maintain or introduce within their territories national measures that are more stringent than those provided for in this Regulation on condition that those measures are compatible with Union law, and are proportionate to the risk to human health, including in light of relevant scientific knowledge.2.Member States shall make publicly available details of the more stringent measures adopted in accordance with paragraph 1 without undue delay, including via the internet. The SoHO national authority shall submit the details of any such more stringent measures to the EU SoHO Platform.

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)