Chapter III, Article 27 · Regulation (EU) 2024/1938

Contents

Article 27Inspections of SoHO establishments#

1.SoHO competent authorities of the Member States where SoHO establishments are located shall carry out inspections of those SoHO establishments, and, where applicable, of SoHO entities or third parties contracted by SoHO establishments.

10.Following each inspection, the SoHO competent authorities shall draw up a report on the findings of the inspection and provide it to the SoHO establishment concerned. Where the result of the inspection so requires, the SoHO competent authorities shall, as appropriate, set out any corrective or preventive action needed or shall request the SoHO establishment to respond with a proposal for such actions, with associated dates for completion.

11.For the purpose of inspections referred to in paragraph 1 of this Article, SoHO competent authorities shall take into account the relevant best practices on inspections documented and published by the SCB, as referred to in Article 69(1), point (d).

12.The Commission may adopt implementing acts concerning technical elements of the procedures to be followed for inspections of SoHO establishments.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

2.SoHO competent authorities shall carry out the following inspections of SoHO establishments, as appropriate:

(a)announced routine system inspections;

(b)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;

(c)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).

3.SoHO competent authorities that identify during inspections cases of non-compliance with this Regulation may include follow-up to those inspections, where necessary and proportionate, to verify that SoHO establishments have undertaken appropriate corrective and preventive actions.

4.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:

(a)such inspection modes do not pose a risk to the quality and safety of SoHO;

(b)such inspection modes do not prejudice the effectiveness of inspections;

(c)protection of SoHO donors, SoHO recipients or offspring from medically assisted reproduction is respected; and

(d)the maximum interval between two on-site inspections pursuant to paragraph 9 is not exceeded.

5.SoHO competent authorities shall ensure that inspections are carried out by inspectors who meet the requirements set out in Article 30.

6.The inspections shall include the verification that SoHO establishments comply with the standards, or elements thereof, set out in Chapters VI and VII.In cases where the SoHO establishments follow:

(a)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;

(b)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;

(c)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).

7.When adopting the guidelines referred to in paragraph 6, point (b), of this Article, the Member State shall, prior to the inspection, verify and document that those guidelines are adequate to achieve compliance with the standards set out in Chapters VI and VII and shall make those guidelines available on the EU SoHO Platform. Those guidelines shall be deemed to be adequate to achieve compliance with the standards of this Regulation where they have been established to be equivalent with the technical guidelines published by the ECDC and by the EDQM referred to in paragraph 6, point (a), of this Article.

8.Inspectors shall carry out one or more of the following activities:

(a)inspect premises;

(b)evaluate and verify compliance of the procedures and the SoHO activities performed with the requirements of this Regulation;

(c)examine any documents or other records relating to the requirements of this Regulation;

(d)where applicable, evaluate the design and implementation of the quality management system in place pursuant to Article 37;

(e)evaluate compliance with the vigilance and the traceability systems;

(f)take samples for analysis, copies of documents, and photographs or videos, if required;

(g)evaluate the SoHO entity emergency plan in place in accordance with Article 67, where applicable;

(h)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.

9.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:

(a)identified risks associated with the type of SoHO that are subject to the SoHO establishment authorisation and the SoHO activities carried out;

(b)the SoHO establishments’ past record as regards the outcome of previous inspections and their compliance with this Regulation;

(c)the certification or accreditation by international bodies, where relevant;

(d)the reliability and effectiveness of the quality management system referred to in Article 37.

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;