Chapter IV, Article 39 · Regulation (EU) 2024/1938

Contents

Article 39Application for SoHO preparation authorisation#

1.SoHO entities shall submit applications for SoHO preparation authorisation to the SoHO competent authority in their territory.

2.Applications for SoHO preparation authorisation shall include the following:

(a)the name and contact details of the applicant SoHO entity responsible for the SoHO preparation authorisation;

(b)details of the SoHO activities performed for that SoHO preparation and including at least:

(i)a description of the SoHO used for the SoHO preparation;

(ii)a list of the specific SoHO donor eligibility criteria, including SoHO donor tests specific for the SoHO preparation;

(iii)a summary of SoHO collection procedures and any specific quality control tests and checks carried out on the collected SoHO prior to processing;

(iv)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;

(v)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;

(vi)any specific conditions and time limits for storage and transport, including validation of those conditions and limits;

(vii)a specification of the SoHO preparation, including quality control and release parameters;

(viii)data resulting from process validation and equipment qualification;

(ix)details of any SoHO entities or third parties contracted to perform activities or relevant steps of the processing applied to the SoHO preparation;

(x)the clinical indications for which the SoHO preparation is to be applied and the clinical data justifying this indication;

(xi)where relevant, non-clinical data on the effectiveness and toxicity of the SoHO preparation;

(c)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:

(i)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);

(ii)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);

(iii)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;

(iv)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;

(v)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);

(d)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);

(e)an indication of the data which is to be regarded as proprietary and which is to be accompanied, where appropriate, by a verifiable justification.

3.If the application for SoHO preparation authorisation includes clinical-outcome registration, in accordance with Article 20(5), the applicant shall provide details of the clinical registry to the SoHO competent authority and request approval for its use.

4.Where applicable, in accordance with Article 20(4), point (d), and Article 21, SoHO entities shall prepare and distribute the SoHO preparation concerned solely for the implementation and within the limitations, of a clinical-outcome monitoring plan that has been approved by the SoHO competent authority, pursuant to Article 19(2), point (d), and submit the results and their analysis to their SoHO competent authority in accordance with the time limit set in the approval.

5.The applicant SoHO entity remains responsible for collecting the clinical-outcome monitoring data and shall be in a position to make those data available upon request from the SoHO competent authority.

6.SoHO entities shall not make any significant change as to the steps of the processing applied or the activities performed for an authorised SoHO preparation, without the prior written SoHO preparation authorisation from the SoHO competent authorities. Significant changes for which an application for an updated SoHO preparation authorisation shall be required shall be those having an impact on the intended clinical indication or on the quality, safety or effectiveness of the SoHO preparation.

7.The SoHO entity authorised for the SoHO preparation shall be based in the Member State where the application for the SoHO preparation authorisation is submitted.

Defined terms · 58

Show every defined term

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;
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;
allogeneic use
means the human application of SoHO collected from a person other than the SoHO recipient;
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;
autologous use
means the human application of SoHO collected from a person to the same person;
blood component
means a constituent of blood, such as red blood cells, white blood cells, platelets and plasma, that can be separated from it;
clinical-outcome monitoring plan
means a programme for evaluating the safety and effectiveness of a SoHO preparation following human application;
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;
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;
compensation
means making good of any losses or the reimbursement of expenses associated with SoHO donation;
consent
means:
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;
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;
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;
delegated body
means a legal body to which the SoHO competent authority has delegated certain SoHO supervisory activities in accordance with Article 9(1);
distribution
means providing, within the Union, released SoHO:
effectiveness of SoHO
means the extent to which the human application of SoHO achieves the intended biological or clinical outcome in the SoHO recipient;
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.
export
means activities carried out to send SoHO from the Union to a third country;
financial neutrality of donation
means that no financial gain or loss will be incurred by the SoHO donor as a result of the donation;
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;
import
means activities carried out to bring SoHO into the Union from a third country before their release;
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;
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;
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;
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;
offspring from medically assisted reproduction
means children born following medically assisted reproduction;
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;
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;
quality management system
means a formalised system that documents the processes, procedures, and responsibilities to support achieving defined quality standards in a consistent manner;
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);
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;
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;
responsible person
means an appointed person in a SoHO entity who has the responsibility of ensuring compliance with this Regulation;
SAE
means an adverse event that poses a risk of any of the following:
SAR
means an adverse reaction that results in any of the following:
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;
Single European Code
means the unique identifier applied to certain SoHO distributed in the Union;
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;
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;
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;
SoHO donor
means a living or deceased SoHO donor;
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;
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;
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);
SoHO establishment
means a SoHO entity that carries out any of the following SoHO activities:
SoHO preparation
means a type of SoHO that:
SoHO preparation authorisation
means the formal approval by a SoHO competent authority of a SoHO preparation;
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;
storage
means the maintenance of SoHO under appropriate controlled conditions;
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;
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;
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);
vigilance
means a set of organised surveillance and reporting procedures relating to adverse reactions and adverse events;
within-relationship use
means the use of reproductive SoHO for medically assisted reproduction between persons with an intimate physical relationship;