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)

By way of derogation from paragraph 1, SoHO competent authorities may authorise imports of SoHO for immediate human application to a specific SoHO recipient, when requested by the SoHO entity responsible for that human application and when duly justified by the clinical circumstances on a case-by-case basis. SoHO competent authorities may also authorise imports of SoHO in emergency situations for immediate human application to SoHO recipients whose health would be seriously endangered without such an import of SoHO.

The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation by laying down specific criteria for the assessment of the applications in the course of the authorisation of importing SoHO establishments.

Where, in the case of risk to quality and safety of imported SoHO, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.

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.

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

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.

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:

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

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

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.

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

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:

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.

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).

The Commission may adopt implementing acts concerning technical elements of the procedures to be followed for inspections of SoHO establishments.

SoHO competent authorities may carry out, pursuant to Article 27(1), inspections of SoHO entities other than SoHO establishments, and of the third parties contracted, as necessary and proportionate to the risks associated with the SoHO and the SoHO activities registered for that SoHO entity, and to the SoHO entity’s past compliance records.

In the cases referred to in paragraph 1 of this Article, Article 27 shall apply, mutatis mutandis, to the inspection of SoHO entities other than SoHO establishments and of the third parties contracted.

At the request of one or more SoHO competent authorities, via their SoHO national authority to another SoHO national authority, inspections pursuant to Article 27(1) and Article 28(1) may be carried out with the participation of inspectors sent for that purpose by another Member State as a joint inspection.

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:

Where the SoHO competent authority receives a request for joint inspection of a SoHO entity, it may decline that request, in particular if:

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 SoHO competent authority leading the joint inspection shall be a SoHO competent authority of the Member State in which the joint inspection takes place and shall ensure that the joint inspection is carried out in accordance with the national legislation of that Member State.

Member States may set up joint inspection programmes to facilitate routine joint inspections. Member States may operate such programmes under a single written agreement as referred to in paragraph 4.

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

Inspectors shall possess a diploma, certificate or other evidence of formal qualifications in a relevant field, awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned.

Before inspectors take up their duties, SoHO competent authorities shall provide inspectors with a specific induction training. For the specific induction training, SoHO competent authorities shall take into account the relevant best practices documented and published by the SCB, as referred to in Article 69(1), point (d).

SoHO competent authorities shall ensure that the specific induction training includes at least the following:

SoHO competent authorities shall ensure that the specific induction training is complemented by specialised training for inspection of specific types of SoHO establishments and by continuous training, as appropriate. SoHO competent authorities shall make all reasonable efforts to ensure that inspectors participating in joint inspections have completed the relevant Union training referred to in Article 70(1) and are included in the list referred to in Article 70(5).

Inspectors may be assisted by technical experts provided that the SoHO competent authorities ensure that those experts comply with the relevant requirements of this Regulation.

SoHO competent authorities shall verify that SoHO entities that have activity data collection and reporting obligations pursuant to Article 41 submit to their SoHO competent authorities, via the EU SoHO Platform, an annual report with those activity data. The EU SoHO Platform shall allow for the compilation of the annual reports submitted by the SoHO entities and provide the SoHO competent authorities with an annual aggregated report with the activity data from their SoHO entities.

By way of derogation from paragraph 1 of this Article, Member States may decide that SoHO entities shall submit the activity data referred to in Article 41(1) to SoHO competent authorities through national or international registries, in cases where such registries collect activity data matching the data sets indicated on the EU SoHO Platform. In such case, the SoHO competent authorities shall submit those activity data in accordance with the implementing acts adopted pursuant to Article 41(3).

SoHO competent authorities shall ensure that the annual aggregated report of activity data for their SoHO entities is made publicly available in their Member States, including via the internet. The annual aggregated report of activity data may also be published on the EU SoHO Platform after review and approval by SoHO national authorities.

The Commission shall compile the annual aggregated reports from the SoHO competent authorities and prepare an annual Union SoHO activity report. After having shared that report with the SoHO national authorities for their review and approval, the Commission shall publish the annual Union SoHO activity report and make it available on the EU SoHO Platform.

SoHO competent authorities shall verify that SoHO entities have appropriate procedures in place to ensure traceability and coding of SoHO as referred to in Article 42.

SoHO competent authorities shall establish procedures for the unique identification of SoHO establishments that are to apply the Single European Code pursuant to Article 43. SoHO competent authorities shall ensure that such identification complies with the technical standards established for that coding system. For that purpose, SoHO competent authorities may use a SoHO establishment identification code generated by the EU SoHO Platform.

SoHO competent authorities shall be responsible for the supervision of vigilance associated with SoHO activities.

SoHO competent authorities shall provide guidance and templates for the submission of SAR or SAE notifications and investigation reports as referred to in Article 44. The guidance and templates provided shall take into account the best practices documented and published by the SCB as referred to in Article 69(1), point (d). SoHO competent authorities shall also establish procedures for the receipt of SAR or SAE notifications pursuant to Article 44.

Upon receipt of a SAR or SAE notification pursuant to Article 44(3), SoHO competent authorities shall:

Upon receipt of a SAR or SAE notification pursuant to Article 44(3), SoHO competent authorities may:

Upon receipt of a SAR or SAE investigation report, SoHO competent authorities shall:

SoHO competent authorities may carry out inspections, pursuant to Article 27 or 28, as appropriate, when the SAR or SAE notification or the investigation report received indicates, or gives reasonable grounds for suspecting, that requirements of this Regulation have not been complied with, or they may carry out inspections to verify an accurate implementation of the corrective and preventive actions planned, or when they consider that a particular serious adverse reaction or serious adverse event might constitute a public health threat.

Where a SAR or SAE notification concerns a risk to public health, SoHO competent authorities shall, without delay, communicate essential information to other SoHO competent authorities via the SoHO rapid alert procedure referred to in Article 34. SoHO competent authorities receiving that information shall in turn communicate it to the general public, where relevant.

Upon receipt of a SAR or SAE notification with implications for quality, safety or supply of a product manufactured from a SoHO and regulated by other Union legislation, as referred to in Article 2(6), SoHO competent authorities shall inform, without undue delay and via their SoHO national authority, the relevant authorities competent for that product, pursuant to Article 13(6).

Upon receipt of information regarding a serious incident within the meaning of Article 2, point (65), of Regulation (EU) 2017/745, or information regarding a serious adverse reaction within the meaning of Article 1, point (12), of Directive 2001/83/EC, associated with a product manufactured from or with SoHO, where that information indicates a possible association with the quality or safety of the SoHO used to manufacture that product, the SoHO competent authorities shall communicate without undue delay the information to the SoHO establishment that released the SoHO, to facilitate possible actions to prevent further distribution of the SoHO implicated in the serious incident or serious adverse reaction.

Upon receipt of information regarding a serious incident and field safety corrective action within the meaning of Article 2, points (65) and (68), of Regulation (EU) 2017/745, as well as within the meaning of Article 2, points (68) and (71), of Regulation (EU) 2017/746 of the European Parliament and of the Council ([^E0001]), the SoHO competent authorities receiving such information shall communicate it to the SoHO entities that may be using the medical device concerned when carrying out their SoHO activities. The SoHO competent authorities shall also submit that information to their SoHO national authority, provided that the incident falls within the definition of a serious adverse reaction as set out in Article 3, point (45), of this Regulation or the definition of a serious adverse event as set out in Article 3, point (46), of this Regulation.

SoHO competent authorities or Member States shall ensure that the procedures referred to in paragraphs 1 to 6 of this Article provide for an adequate interconnection between the SAR and SAE notifications pursuant to this Article and the reporting system established in accordance with Article 11 of Directive 2010/53/EU, for instance where a SAR or SAE notification relates to SoHO donations by SoHO donors that also donated organs.

SoHO competent authorities shall submit to their SoHO national authority an annual summary of the SAR and SAE notifications and the investigation reports of confirmed serious adverse reactions and serious adverse events. That summary shall, where necessary, include recommendations arising from an analysis of the serious adverse reactions and serious adverse events reported.

SoHO national authorities shall submit an annual summary of confirmed SAR or SAE notifications and of the related investigation reports to the EU SoHO Platform before 30 June of the subsequent year and shall make an aggregated version of that summary publicly available in their Member State, including via the internet. SoHO national authorities shall include in the annual summary the numbers and types of SAR or SAE notifications reported to them that meet the thresholds of seriousness and imputability as set out in the best practices documented and published by the SCB, as referred to in Article 69(1), point (d).

The Commission shall aggregate the annual summaries of the SoHO national authorities, and prepare and publish an annual Union SoHO vigilance report, after having shared it with the SoHO national authorities for review and approval. That report shall include overall pattern analysis and recommendations.

The Commission may adopt implementing acts concerning the procedures to be followed for consultation and coordination between SoHO competent authorities and the ECDC concerning relevant SAR or SAE notifications and investigations.

SoHO competent authorities shall, upon receipt of a SAR or SAE notification or other information with implications for quality, safety or supply of SoHO in more than one Member State, inform their SoHO national authority, which shall in turn launch a SoHO rapid alert on the EU SoHO Platform.

SoHO national authorities shall launch a SoHO rapid alert in particular in the following circumstances:

The ECDC, with the support of its SoHO expert network, may also launch a SoHO rapid alert on the EU SoHO Platform when surveillance of communicable diseases indicates a new risk to the safety of SoHO. The ECDC may indicate in such a SoHO rapid alert that it has provided guidelines on the mitigation of risks associated with communicable disease outbreaks, in particular concerning the eligibility and testing of SoHO donors.

SoHO national authorities that receive a SoHO rapid alert shall communicate relevant information to SoHO competent authorities in their Member State and to the relevant SoHO entities without undue delay with a view to ensuring that risk mitigating actions can be taken promptly and that relevant information available among professionals in the SoHO sector can be shared with the SoHO competent authorities. SoHO national authorities may also supplement the information provided in the SoHO rapid alert with further information such as details of relevant risk mitigating actions taken in their Member State.

SoHO national authorities and the ECDC shall take into account the relevant best practices documented and published by the SCB, as referred to in Article 69(1), point (d), when launching and handling a SoHO rapid alert.

Entities shall register as a SoHO entity before commencing any of the SoHO activities referred to in Article 2(1), point (c).

SoHO activities shall only be carried out by persons who operate within a registered SoHO entity.

In order to register as a SoHO entity, the SoHO entity shall provide the following information:

SoHO entities shall declare, when registering, whether they need an authorisation pursuant to Article 19, 25 or 26. They shall also carry out a self-assessment of whether they meet the criteria for being a critical SoHO entity and communicate the result.

In Member States where the EU SoHO Platform is used for registration of SoHO entities, as referred to in Article 16(1), entities falling within the definition of a SoHO entity as set out in Article 3, point (33), shall register directly on the EU SoHO Platform in accordance with the instructions from their SoHO competent authorities.

SoHO entities shall register without undue delay changes to information registered pursuant to paragraph 3, points (a), (b) and (d) to (g). Where such changes indicate SoHO activities, including processing and storage, or release, or import or export of SoHO, those SoHO entities shall apply for an authorisation as SoHO establishment.

Where a registered SoHO entity partially or totally ceases to carry out its SoHO activities, it shall communicate this change on the register for SoHO entities without undue delay, indicating to which SoHO entity it will transfer SoHO for storage, and the data referred to in Article 42, where applicable.

Where the SoHO stored is intended for autologous or within-relationship use, or is a highly matched SoHO for a specific SoHO recipient, and the SoHO entity ceases SoHO activities affecting the storage or the possible use of such SoHO, it shall inform the persons from whom such SoHO were collected, and provide them with information about the new SoHO entity that will store such SoHO.

SoHO entities shall appoint a person responsible, within their entity, for ensuring that SoHO activities carried out by the SoHO entity comply with the requirements of this Regulation applicable to those SoHO activities.

The responsible person shall be in possession of 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 and shall have at least 2 years of experience in the relevant field.

SoHO entities shall inform their SoHO competent authority of the name and contact details of the responsible person. Where the responsible person is permanently or temporarily replaced, SoHO entities shall without undue delay inform their SoHO competent authorities of the name and contact details of the new responsible person and the date on which the responsibility of that person is assumed.

The responsible person may fulfil the role of releasing officer, as referred to in Article 49, or the role of physician, as referred to in Article 50, provided that that person is in possession of the required qualifications or experience as laid down in those Articles.

SoHO entities shall establish, maintain and update a quality management system that is appropriate, taking into account their SoHO activities and that achieves a high level of quality of SoHO.

SoHO entities shall design the quality management system in a way that ensures that SoHO activities are carried out in a consistent manner, by personnel that have documented and periodically assessed competence to perform the tasks allocated to them and that SoHO activities are carried out in facilities that are designed and maintained in a manner that prevents SoHO contamination, or cross-contamination between SoHO, or loss of traceability. In that respect, SoHO entities shall take into account the technical guidelines for quality management published by the EDQM, together with the EDQM good practice guidelines, as indicated on the EU SoHO Platform. Alternative approaches to the design of the quality management system may be applied where SoHO entities can demonstrate to their SoHO competent authorities that they achieve an equivalent level of quality.

SoHO entities shall put in place procedures and specifications covering, where applicable to their SoHO activities, the following:

SoHO entities shall review the quality management system at regular intervals to verify its effectiveness and introduce corrective and preventive actions, if deemed necessary.

The Commission may adopt implementing acts regarding selected elements and specifications of the quality management system in order to ensure uniform quality management.

SoHO entities shall not release or, in the context of autologous or within-relationship use, shall not prepare and immediately apply to a SoHO recipient, SoHO preparations without prior SoHO preparation authorisation, other than in the context of the implementation of an approved clinical-outcome monitoring plan as part of a SoHO preparation authorisation.

SoHO entities may request an opinion from their SoHO competent authorities on the applicability of the authorisation requirements in this Regulation to their SoHO activities prior to submitting an application for a SoHO preparation authorisation.

SoHO entities may request from their SoHO competent authorities a derogation from the requirement for a SoHO preparation authorisation in health emergency situations referred to in Article 65, or for a specific SoHO recipient when justified by the clinical circumstances as referred to in Article 19(11).

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

Applications for SoHO preparation authorisation shall include the following:

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.

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.

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.

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.

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.

Where SoHO entities carry out, in the context of approved clinical-outcome monitoring plans, SoHO clinical studies as referred to in Article 21(3), points (b) and (c), with SoHO preparations that are not yet authorised, the SoHO entities shall comply with the requirements set out in this Regulation and in particular with the standards laid down in Chapters VI and VII.

Before commencing a SoHO clinical study for the risk level referred to in Article 21(3), point (c), SoHO entities shall:

When applying SoHO to SoHO recipients in the context of a SoHO clinical study, SoHO entities shall ensure that the intended SoHO recipients, or persons granting consent on their behalf, are informed that the SoHO preparation concerned has not yet been authorised in accordance with this Regulation and that the SoHO preparation is being applied in the context of a SoHO clinical study that forms part of the authorisation process for that SoHO preparation.

The person responsible for the SoHO clinical study shall be adequately qualified and trained.

In the course of a SoHO clinical study, SoHO entities shall comply with the vigilance and reporting requirements set out in Article 44.

SoHO entities shall collect and report data relating to any of the following SoHO activities:

The data collected pursuant to paragraph 1 shall comprise the data set indicated on the EU SoHO Platform.

The Commission shall adopt implementing acts laying down technical procedures for setting and updating the list of data sets to be reported to ensure uniformity and compatibility and comparability of the annual activity data reports, and for extraction, submission and publication of activity data.

SoHO entities shall submit to the EU SoHO Platform an annual report of the data collected pursuant to this Article before 30 June of the subsequent year.

By way of derogation from paragraph 4 of this Article, where Member States require SoHO entities to report activity data as referred to in Article 31(2), the SoHO entities shall submit their annual report of activity data to the indicated registries before 30 June of the subsequent year.

SoHO entities shall implement a traceability system, in order to unambiguously link each SoHO donor or the person from whom SoHO are collected for autologous or within-relationship use, to their SoHO and to all the documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO at any point.

The traceability system referred to in paragraph 1 of this Article shall be able to:

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:

SoHO entities shall include the codes referred to in paragraph 3, on the labels applied to the SoHO, prior to its distribution, or on the documents accompanying the distributed SoHO, where it can be guaranteed that such documents will not be separated from the SoHO or will be kept digitally linked to the SoHO concerned.

SoHO entities shall use a labelling system that meets the labelling requirements set out in the relevant technical guidelines referred to in Article 56(4) and Article 59(4).

SoHO entities shall keep the data necessary to ensure traceability, appropriately safeguarded and accessible to the SoHO competent authority, for a minimum of 30 years from the SoHO distribution date or, where applicable, from the date of disposal or export. They may store the data in electronic form. Where a SoHO entity ceases its activity, the traceability data shall be transferred to a contracted SoHO entity for the remaining part of the traceability period, after informing the SoHO competent authority.

The Commission shall adopt implementing acts concerning the minimum SoHO donor and SoHO recipient data to be kept to ensure traceability.

SoHO entities shall apply a Single European Code to SoHO distributed for human application. In cases where SoHO are transferred for further processing in another SoHO entity or released for manufacture of products regulated by other Union legislation, as referred to in Article 2(6), or exported to third countries, SoHO entities shall, at least, apply the elements of the Single European Code that allow for the identification of the donation. The Single European Code shall also appear on the primary packaging of the SoHO concerned or on a label attached thereto, or on the documents referring to that SoHO where it can be ensured that such documents accompany the SoHO concerned.

Paragraph 1 of this Article shall not apply to:

The Commission shall adopt implementing acts concerning the format of the Single European Code and the requirements related to its application to SoHO entities and to SoHO at the point of distribution.

SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse reactions and adverse events, including those detected during clinical-outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 39.

SoHO entities shall make all reasonable efforts to encourage prospective parents of children born from third-party donation to communicate information concerning serious genetic conditions as soon as they emerge in the children, to the SoHO entity where they were treated. The SoHO entity shall communicate, without undue delay, that information to the SoHO establishment that released the reproductive SoHO for human application with a view to investigating the suspected serious adverse reaction and preventing further distribution of SoHO from the implicated SoHO donor, in accordance with national legislation on the storage and use of reproductive SoHO.

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:

SoHO entities other than SoHO establishments shall communicate adverse reactions or adverse events to the SoHO establishment for which they carry out SoHO activities on the basis of an agreement or to the SoHO establishment that distributed the SoHO to them, as appropriate. In such cases, the SoHO establishments which receive the communication shall be responsible for the investigation and shall report to their SoHO competent authorities when the adverse reaction or adverse event concerned is deemed to be a serious adverse reaction or serious adverse event.

Upon receipt of information regarding a serious incident and field safety corrective action within the meaning of Regulation (EU) 2017/745 or (EU) 2017/746, concerning a medical device or in vitro diagnostic medical device that is used by a SoHO entity, the SoHO entity receiving such information shall communicate it to its SoHO competent authority.

SoHO entities shall have in place a procedure to accurately, efficiently and verifiably withdraw from distribution or use those SoHO affected, or suspected to be affected, by serious adverse reactions or serious adverse events, as referred to in paragraph 3, as appropriate. In the case of reproductive SoHO, such procedure shall be in accordance with national legislation.

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:

SoHO entities shall communicate information concerning a serious adverse reaction or serious adverse event to other SoHO entities engaged in the collection, processing, testing, storage and distribution of SoHO collected from the same SoHO donor, or otherwise possibly affected. They shall only communicate information necessary and appropriate in order to facilitate traceability and ensure quality and safety of SoHO in such cases, and shall, in particular, limit the information to details necessary to take risk mitigating actions. A risk assessment of the seriousness and likelihood of recurrence shall be included in the communication. SoHO entities shall, where relevant, also communicate such information to organ procurement organisations in cases where the SoHO donor who is implicated in the serious adverse reaction or serious adverse event has also donated organs or to manufacturers in cases where SoHO collected from that SoHO donor have been distributed to manufacture products regulated by other Union legislation, as referred to in Article 2(6).

SoHO establishments shall not carry out any of the SoHO activities that would qualify them as a SoHO establishment as defined in Article 3, point (35), without prior SoHO establishment authorisation. This shall apply regardless of whether all SoHO activities are carried out by the SoHO establishment itself or whether one or more are contracted to another SoHO entity.

In cases where SoHO establishments contract other SoHO entities to perform a part or all of certain SoHO activities, the SoHO establishments shall ensure that those contracted SoHO entities carry out those contracted SoHO activities in compliance with this Regulation. Such contracted SoHO entities may be audited by the contracting SoHO establishment or inspected by the SoHO competent authority, in particular in cases where the contracted SoHO entity has not been accredited, certified or authorised, as part of a national programme, for the specific contracted SoHO activities.

The requirement to obtain a SoHO establishment authorisation shall be without prejudice to more stringent measures adopted by a Member State in accordance with Article 4 and directly affecting the SoHO activities carried out in the SoHO establishment or contracted SoHO entities concerned pursuant to paragraph 2 of this Article.

SoHO entities shall submit the application for authorisation as SoHO establishment to the SoHO competent authorities of their territories.

The applicant SoHO establishment shall provide the name and contact details of the responsible person as referred to in Article 36.

Significant changes for the purposes of paragraph 2 means changes relating to the types of SoHO concerned, to the types of SoHO activities carried out, to the use of new premises or to the modification of premises having an impact on the conditions under which SoHO activities are carried out.

SoHO establishments shall also, without undue delay, inform their SoHO competent authorities of any changes of an administrative nature, related to the SoHO establishment authorisation, including a permanent or temporary replacement of the responsible person.

The legal entity that holds the SoHO establishment authorisation shall be based in the Member State where the SoHO establishment is authorised.

SoHO establishments shall not import SoHO without a prior importing SoHO establishment authorisation.

In the case of import of human plasma that is intended to be used for the manufacture of medicinal products regulated by other Union legislation and which is included in a plasma master file (PMF) as referred to in Directive 2001/83/EC, paragraph 1 of this Article shall not apply as the importers are to be authorised by other Union legislation. In those cases, the importers shall be registered as SoHO entities.

SoHO entities responsible for human application to a specific SoHO recipient may submit a request to their SoHO competent authorities for a derogation from the requirement for an importing SoHO establishment authorisation in the circumstances referred to in Article 26(6).

The Commission shall adopt delegated acts in accordance with Article 77 to supplement this Regulation by laying down obligations and procedures for importing SoHO establishments regarding the import of SoHO in order to verify equivalent standards of quality, safety and effectiveness of such imports.

Article 46 shall apply mutatis mutandis to the applications for importing SoHO establishment authorisations.

Prior to applying for an importing SoHO establishment authorisation, SoHO establishments shall put in place written agreements with one or more third-country suppliers. Such agreements shall include the elements set out in paragraph 3, point (b).

The applicant SoHO establishment shall provide:

The importing SoHO establishment shall be responsible for the physical reception and visual examination and verification of imported SoHO prior to their release. The importing SoHO establishment shall verify coherence between the SoHO received and the associated documentation and conduct an examination of the integrity of packaging, labelling and transport conditions, taking into account the relevant standards and technical guidelines as referred to in Articles 57, 58 and 59.

The releasing officer of an importing SoHO establishment shall release imported SoHO for distribution only after that officer has verified compliance with the quality, safety and effectiveness requirements specified in the agreement referred to in paragraph 3, point (b), and when the physical and documentation controls referred to in paragraph 4 are satisfactory.

An authorised importing SoHO establishment may delegate the physical reception, visual examination and verification referred to in paragraph 4 to the SoHO entity that will apply the SoHO to a SoHO recipient in cases where the import of SoHO is organised for a specific SoHO recipient.

The Commission shall adopt implementing acts specifying the information to be provided in an application for an importing SoHO establishment authorisation to ensure compatibility and comparability of such data.

In cases where a SoHO establishment releases SoHO, it shall appoint one or more releasing officers.

The releasing officer shall be in possession of 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 and shall have at least 2 years of experience in the relevant field.

The releasing officer may delegate the task of releasing SoHO as referred to in paragraph 1 to other persons who shall be qualified by training and experience to perform such a task. In such cases, those persons shall perform that task under the responsibility of the releasing officer who will always be responsible for the release.

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:

The physician referred to in paragraph 1 shall be responsible for at least the following tasks:

The physician may delegate the tasks referred to in paragraph 2 to other persons who shall be qualified by training and experience to perform such tasks. In such cases, those persons shall perform those tasks under the responsibility of the physician.

By way of derogation from paragraph 2 of this Article, where SoHO entities are authorised as SoHO establishments in accordance with Article 24(4), the physician shall be responsible for those tasks that are relevant to the SoHO activities performed by the SoHO entities and that have a direct influence on the health of SoHO donors, SoHO recipients and, where relevant, offspring from medically assisted reproduction.

SoHO establishments shall ensure that SoHO released for export comply with the requirements of this Regulation.

By way of derogation from paragraph 1 of this Article, SoHO that do not comply with all the relevant standards and guidelines referred to in Articles 58 and 59 may be released for export in the case of exceptional release pursuant to Article 61(3). Nevertheless, SoHO establishments shall even in those circumstances comply with the standards referred to in Chapter VI, as well as the obligations related to vigilance and traceability.

SoHO entities shall ensure respect for the dignity and integrity of SoHO donors.

SoHO entities shall ensure high levels of safety and protect the health of living SoHO donors from risks related to the SoHO donation, by identifying and minimising such risks before, during and after the SoHO collection.

SoHO competent authorities shall verify the compliance with this Chapter as well as with national legislation on consent and voluntary and unpaid donation.

Where SoHO are collected from SoHO donors, regardless of whether or not the SoHO donor is related to the intended recipient, SoHO entities shall:

In the course of the living SoHO donor health evaluations referred to in paragraph 1, point (e), of this Article, SoHO entities shall conduct interviews with the SoHO donors and gather information concerning the SoHO donors’ present and recent state of physical, and, where appropriate, mental health and their health histories to assure the safety of the SoHO donation process for those SoHO donors. SoHO entities may perform additional tests as part of the SoHO donor health evaluations. They shall perform such tests in cases where evaluations indicate that additional tests are necessary to establish the eligibility of those SoHO donors from the perspective of their own protection. The physician referred to in Article 50 shall approve the procedure and criteria for SoHO donor health evaluations.

SoHO entities that collect SoHO from living SoHO donors as referred to in paragraph 1, point (i), of this Article shall register such SoHO donors in a SoHO entity registry or, where available, in national or recognised international registries, to verify donation frequency. SoHO entity-level and national registries shall have the possibility of interconnectivity with other such registries. Where a SoHO entity-level registry or a national registry is used, and where the circumstances point to a risk that a SoHO donor is donating too frequently in more than one SoHO entity located in one or more Member States, SoHO entities shall verify whether this is the case by consulting with interconnected SoHO donor registries on a case-by-case basis. SoHO entities shall be in a position to demonstrate to their SoHO competent authorities, on request, that an appropriate procedure that mitigates such risk is in place. Such procedures shall take into account the technical guidelines referred to in Article 56(4).

SoHO entities that collect SoHO from living SoHO donors that are subjected to a surgical procedure in order to donate, or that are treated with prescribed medication to facilitate SoHO donation, shall ensure that the plan for monitoring the SoHO donor’s health after SoHO donation, as referred to in paragraph 1, point (j), is proportionate to the risks associated with the SoHO donation. SoHO entities shall include in the plan the time period during which the monitoring shall continue.