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)

The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation in cases where additional standards are needed in order to ensure the protection of SoHO donors.

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

SoHO entities shall not provide financial incentives or inducements to SoHO donors or any persons granting consent on their behalf.

Where Member States allow for the compensation of living SoHO donors, in accordance with the principle of voluntary and unpaid donation and based on transparent criteria, including through fixed allowances, or through non-financial forms of compensation, the conditions for such compensation shall be established in national legislation, including by setting an upper limit for compensation that shall endeavour to guarantee financial neutrality, consistent with the standards laid down in this Article. Member States may delegate the setting of conditions for such compensation to independent bodies that are established in accordance with national legislation. The setting of conditions for such compensation shall be based on criteria that take into account the practices documented by the SCB, as referred to in Article 69(1), point (g). SoHO donors may choose not to be compensated.

When Member States allow for the compensation of SoHO donors as referred to in paragraph 2, the conditions for such compensation applied by each Member State shall be made available to the SCB for sharing with the SoHO national authorities of the other Member States via the EU SoHO Platform and the information shall be updated without undue delay if it has been modified.

Member States shall ensure that any promotion and publicity activities in support of the donation of SoHO do not refer to compensation, without prejudice to the right of SoHO donors to be informed of their rights, in accordance with national law.

SoHO entities may compensate living SoHO donors as provided for by their Member States pursuant to paragraph 2. At the request of their SoHO competent authority, SoHO entities shall provide information in a transparent manner on the details of how they have implemented the conditions laid down in national legislation.

Member States shall ensure compliance with standards concerning voluntary and unpaid donation, equivalent to those laid down in this Article, also when SoHO are donated exclusively for use in research without any human application.

SoHO entities shall provide living SoHO donors or, where applicable, any persons granting consent on behalf of a SoHO donor, with all appropriate information relating to the SoHO donation process, in accordance with national legislation.

SoHO entities shall provide the information referred to in paragraph 1 before the consent to donate is granted. SoHO entities shall provide the information in an accurate and clear manner, using terms that are easily understood by the SoHO donors or, if applicable, any persons granting consent on their behalf. The information shall not be misleading, in particular as to the benefits of the donation for future recipients of the SoHO concerned.

In the case of living SoHO donors or, where applicable, persons granting consent on their behalf, SoHO entities shall provide information regarding:

In the case of deceased SoHO donors, SoHO entities shall provide any persons granting consent to collection on their behalf in accordance with national legislation, with the information referred to in paragraph 3, points (a), (b), (d) and (e).

When the Commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in Article 53 or 55, in order to ensure convergent and high levels of SoHO donor protection, the Commission may adopt implementing acts setting out particular procedures to be followed and applied to meet such standard, or element thereof.

On duly justified imperative grounds of urgency relating to a risk to SoHO donor health, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 79(3).

The implementing acts adopted in accordance with paragraphs 1 and 2 of this Article shall also apply to SoHO entities when they apply the standards concerning SoHO donor protection, or elements thereof, as referred to in Articles 53 and 55.

For those standards concerning SoHO donor protection, or elements thereof, for which no implementing act has been adopted, SoHO entities shall take into account:

In the cases referred to in paragraph 4, point (a), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the technical guidelines referred to in paragraph 4, point (a), of this Article.

In the cases referred to in paragraph 4, point (b), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the guidelines referred to in paragraph 4, point (b), of this Article.

In the cases referred to in paragraph 4, point (c), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall provide during inspection a justification to their SoHO competent authorities for each specific standard or element thereof, that the other guidelines are adequate to achieve the level of quality and safety set out in that standard. That justification may be based on a documented demonstration of equivalence with the technical guidelines published by the ECDC and by the EDQM referred to in paragraph 4, point (a), of this Article.

SoHO entities shall establish procedures that achieve high levels of quality and safety of SoHO. Such procedures shall ensure that benefits for SoHO recipients and offspring from medically assisted reproduction outweigh residual risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions that are potentially life-threatening, disabling or incapacitating and originate from a third-party donor, are not transmitted to SoHO recipients or offspring from medically assisted reproduction. Procedures to prevent the transmission of serious genetic conditions shall include genetic testing to the extent that national legislation allows for such testing.

In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of communicable disease transmission from SoHO donors to SoHO recipients by combining at least the following measures:

In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of non-communicable disease transmission, when they are relevant to the SoHO concerned, including the transmission of serious genetic conditions and cancer, from SoHO donors to the SoHO recipients or to offspring from medically assisted reproduction by combining at least the following measures:

In the procedures referred to in paragraph 1, SoHO entities shall take measures to mitigate the risks of communicable or non-communicable disease transmission to the SoHO recipients resulting from cross-contamination between SoHO during collection, processing, storage and distribution. Such measures shall ensure that physical contact between SoHO from different SoHO donors, as well as SoHO collected from different persons for future autologous or within-relationship use, is avoided or, in cases where pooling of SoHO is necessary for the effectiveness or feasibility of the SoHO preparation, such contact is limited to a justifiable level.

In the procedures referred to in paragraph 1, SoHO entities shall mitigate risks arising from microbial contamination of SoHO from the environment, the personnel, the equipment and the materials coming into contact with SoHO during collection, processing, storage or distribution. SoHO entities shall mitigate such risks by combining at least the following measures:

In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks that any reagents and solutions added to SoHO or coming into contact with SoHO during collection, processing, storage and distribution might be transferred to SoHO recipients and have a harmful effect on their health, by combining at least the following measures:

In the procedures referred to in paragraph 1 of this Article, SoHO entities shall mitigate the risks that inherent properties of SoHO, necessary for clinical effectiveness, might be changed by any SoHO activity performed, in a manner that renders the SoHO ineffective or less effective when applied to SoHO recipients, by combining at least the following measures:

In the procedures referred to in paragraph 1 of this Article, SoHO entities shall mitigate the risks that SoHO cause an unexpected immune reaction in SoHO recipients by combining at least the following measures:

In the procedures referred to in paragraph 1, SoHO entities shall mitigate any other avoidable risk to the health, including where related to the protection of dignity, in accordance with national law, of SoHO recipients or of offspring from medically assisted reproduction arising from SoHO applied and not addressed in paragraphs 2 to 8, by applying procedures that SoHO entities have validated as safely and effectively mitigating the risk concerned or that are demonstrated by published scientific evidence as mitigating the risk.

SoHO entities that distribute reproductive SoHO from third-party donation shall comply with rules established in national legislation regarding the limits to the number of offspring from medically assisted reproduction or of human applications with reproductive SoHO from a single SoHO donor, where applicable. SoHO entities shall monitor compliance with such rules via registries for reproductive SoHO donors, in accordance with the national legislation. Without prejudice to such rules, when reproductive SoHO are distributed to another Member State, the distributing SoHO entity shall respect the limits imposed by the receiving Member State. This Article shall not affect Member States’ rules concerning limits on the cross-border distribution of reproductive SoHO.

When carrying out SoHO activities, SoHO entities shall, to the extent possible, make use of technologies that reduce the risk of human error.

SoHO entities shall not:

For the measures referred to in paragraphs 2 and 3, SoHO entities shall verify the eligibility of a SoHO donor by means of:

SoHO entities shall document the results of SoHO donor eligibility verification as referred to in paragraphs 2 and 3, and shall communicate and clearly explain the results of SoHO donor eligibility verification to SoHO donors or, where relevant, any persons granting consent on their behalf, in accordance with national legislation.

SoHO entities applying SoHO to SoHO recipients shall obtain their consent or, where relevant, that of any person granting consent on their behalf, in accordance with national legislation, for the human application of SoHO.

The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation in cases where additional standards are deemed necessary to ensure the protection of SoHO recipients or offspring from medically assisted reproduction from risks associated with SoHO.

Where, in the case of risk to SoHO recipients and offspring from medically assisted reproduction arising from inadequate levels of quality and safety of SoHO, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.

When the Commission deems it necessary to establish binding rules on the implementation of a particular standard, or elements thereof, referred to in Article 58, in order to ensure convergent and high levels of protection of SoHO recipients and offspring from medically assisted reproduction, the Commission may adopt implementing acts setting out particular procedures to be applied to meet such standard or element thereof.

On duly justified imperative grounds of urgency relating to a risk to the health of the SoHO recipient or of the offspring from medically assisted reproduction, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 79(3).

The implementing acts adopted in accordance with paragraphs 1 and 2 of this Article shall also apply to SoHO entities when they apply the standards, or elements thereof, concerning protection of SoHO recipients and offspring from medically assisted reproduction as referred to in Article 58.

For those standards, or elements thereof, concerning protection of SoHO recipients and offspring from medically assisted reproduction for which no implementing act has been adopted, SoHO entities shall take into account:

In the cases referred to in paragraph 4, point (a), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the technical guidelines referred to in paragraph 4, point (a), of this Article.

In the cases referred to in paragraph 4, point (b), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the technical guidelines referred to in paragraph 4, point (b), of this Article.

In the cases referred to in paragraph 4, point (c), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall provide during inspection a justification to their SoHO competent authorities, for each specific standard, or element thereof, that the other guidelines are adequate to achieve the level of quality and safety set out in that standard. That justification may be based on a documented demonstration of equivalence with the technical guidelines published by the ECDC and by the EDQM referred to in paragraph 4, point (a), of this Article.

The physician referred to in Article 50 may authorise a releasing officer in a SoHO establishment referred to in Article 49, to release a certain SoHO preparation for distribution and for human application to an intended SoHO recipient even in cases where that SoHO preparation does not meet all of the relevant standards referred to in Articles 58 and 59, or does not fully comply with its SoHO preparation authorisation, or has been imported under the derogation referred to in Article 26(6), provided that the potential benefit for the SoHO recipient outweighs the risks and that no alternative is available. The exceptional release condition shall be explicitly indicated on the label or in the documentation accompanying the released SoHO preparation.

Exceptional release referred to in paragraph 1 of this Article shall be authorised in the case of release for distribution, on the basis of a documented request from the physician treating the intended SoHO recipient, where such a request includes a confirmation of full knowledge of, and agreement to, any deviation from this Regulation. The physician referred to in Article 50 shall document the agreement together with a benefit-risk assessment. In such circumstances, the intended SoHO recipient, or person granting consent on their behalf, shall be informed of the exceptional release and shall be required to give consent in accordance with national legislation prior to the human application of SoHO.

Exceptional release, as referred to in paragraph 1, may also be authorised in the case of release for export, on the basis of a documented request from a treating physician, or from a regulatory authority, in a third country, where such a request includes a confirmation of full knowledge of, and agreement to, any deviation from this Regulation.

Exceptional release, as referred to in paragraph 1 of this Article, may also be authorised in the case of certain SoHO to be used for the manufacture of a product regulated by other Union legislation and intended for a specific recipient, in cases where the SoHO preparation does not meet all of the relevant standards and guidelines referred to in Article 58 or 59 and on the basis of a documented request from the manufacturer, where such a request includes a confirmation of full knowledge of, and agreement to, any deviation from this Regulation.

Member States shall, within their territories and in collaboration with SoHO national authorities, SoHO competent authorities and SoHO entities, each within their respective competence, consider all reasonable efforts for achieving a sufficient, adequate and resilient supply of critical SoHO with a view to appropriately meet recipients’ needs, and to contribute to European self-sufficiency.

Member States shall make all reasonable efforts to:

Critical SoHO entities shall establish appropriate mechanisms for the continuous monitoring of their stocks of critical SoHO and shall be able, in the event of shortages or upon request, to communicate such information to their SoHO competent authorities.

In cases where the availability of critical SoHO depends on commercial interests, each Member State shall seek that the critical SoHO entities, within the limit of their responsibilities, provide an appropriate and continuous supply of critical SoHO for recipients in their territory.

Member States, in collaboration with SoHO national authorities, shall draw up national SoHO emergency plans setting out measures to be applied without undue delay when the demand or the supply situation for critical SoHO presents, or is likely to present, a serious risk to human health.

In developing national SoHO emergency plans, Member States shall ensure cooperation and consultation, as appropriate, with their health surveillance bodies, military medical services, civil protection services and other services routinely involved in emergency responses. Member States shall implement national SoHO emergency plans in coordination with other response actions at national or Union level, if adopted, and, where relevant, in a manner consistent with the national prevention, preparedness and response plans developed in accordance with Article 6 of Regulation (EU) 2022/2371 and with Directive (EU) 2022/2557 of the European Parliament and of the Council ([^E0002]).

Member States shall draw up the plans referred to in paragraph 1 of this Article, setting out the following elements:

Member States shall take into account the guidance of the ECDC, for emergencies related to epidemiological outbreaks, and the guidelines published by the EDQM, for emergency planning in general.

Member States shall involve relevant stakeholders in the elaboration of their national SoHO emergency plans, in particular by cooperating with their critical SoHO entities, as well as with the EDQM and the ECDC. Member States shall review at least every 4 years such plans in order to take into account changes in the designation of critical SoHO entities, the organisation of SoHO competent authorities and the experience gained from implementing the plans and simulation exercises.

Member States shall present a summary of their national SoHO emergency plans, and major reviews of those plans, within the SCB.

The SCB, in cooperation with the Commission, shall support a coordinated approach to ensure the implementation of the national SoHO emergency plans in cases where an emergency affects more than one Member States or in the case of emergencies with an effect beyond the Union, to communicate and collaborate with relevant international organisations and authorities.

Critical SoHO entities shall, without undue delay, send a SoHO supply alert to their SoHO competent authorities in the event of significant shortages of supply of critical SoHO, indicating the underlying reasons, the expected impact on recipients and any mitigating actions taken, including in relation to possible alternative supply channels if appropriate.

SoHO competent authorities that receive a SoHO supply alert referred to in paragraph 1 of this Article shall:

The SoHO national authorities shall submit, without undue delay, to the EU SoHO Platform the SoHO supply alert received in cases where the supply interruption might affect other Member States and may do so where such interruption might be addressed through cooperation, including through exchange of SoHO, between Member States as referred to in Article 63(3), point (e).

By way of derogation from Article 19, SoHO competent authorities may permit, at the request of a SoHO entity as referred to in Article 38(3) and duly justified by a health emergency situation, the distribution, or preparation for immediate human application, of SoHO preparations within their territory even if the procedures referred to in Article 19 have not been carried out, provided that:

SoHO competent authorities shall:

The SoHO national authority shall inform the Commission and the other Member States via the EU SoHO Platform of any decision to permit the distribution, or preparation for immediate human application, of SoHO preparations in accordance with paragraph 1.

In cases where such SoHO preparations might be distributed to other Member States, the SoHO national authority of the receiving Member State shall confirm the validity of the permission within its territory before the distribution takes place.

Insofar as necessary to ensure supply of critical SoHO, Member States may allow for derogations from certain standards and obligations set out in this Regulation when large scale life-threatening situations in the context of man-made or natural disasters, in particular in the context of armed conflicts, pose a risk to human life, and such derogations are the only measure available to mitigate the risk. Derogations shall not be granted from the provisions of this Regulation that concern voluntary and unpaid donation and SoHO donor consent. The derogations shall be applied in a manner that ensures the protection of SoHO donors and SoHO recipients to the maximum extent possible in the circumstances of the crisis.

Member States granting such derogations shall inform the other Member States and the Commission without undue delay and provide reasons for the measures taken.

The SoHO Coordination Board (SCB) is hereby established in order to promote coordination between Member States concerning the implementation of this Regulation and of the delegated and implementing acts adopted pursuant thereto, and to support them in that coordination, as well as to facilitate cooperation with stakeholders in that regard.

Each Member State shall appoint two permanent members and two alternates representing the SoHO national authority and, where the Member State chooses so, the Ministry of Health or other relevant authorities.

Member States shall submit the names and affiliation of their nominated members and alternates, together with the corresponding declaration of interests for any member and alternate, stating the absence of any financial or other interest, to the Commission. The Commission shall make publicly available on the EU SoHO Platform the membership list indicating the name, the institution of origin and the declaration of interests of each nominated member and alternate.

The Commission shall make the rules of procedures of the SCB, the agenda and the summary minutes of each meeting, as well as the best practices documented and published by the SCB, as referred to in Article 74(3), point (d), of this Regulation, publicly available on the EU SoHO Platform, provided that such publication does not undermine the protection of any public or private interest, as referred to in Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council ([^E0003]).

The representative of the Commission shall co-chair the meetings of the SCB together with a representative of the SoHO national authority of a Member State, elected by and from among the representatives of the Member States in the SCB, and in accordance with the rules of procedure of the SCB.

The Commission shall provide the secretariat for the SCB in accordance with Article 72.

The SCB shall deliberate by seeking to achieve consensus as far as possible. If consensus cannot be achieved, the SCB shall deliberate and adopt an opinion or other positions by, at least, a majority of two thirds of the votes of all the Member States. The representative of the Commission co-chairing the SCB shall not take part in votes of the SCB. Each Member State shall have one vote.

When establishing the SCB, the Commission shall put forward the rules of procedure of the SCB which shall be approved by the SCB within the first semester of its functioning. The rules of procedure shall, in particular, lay down procedures for the following:

The Commission may, by means of implementing acts, adopt the necessary measures for the management of the SCB.

The SCB shall assist SoHO competent authorities regarding the coordinated implementation of this Regulation and of the implementing and delegated acts adopted pursuant to it, by:

The Commission may adopt implementing acts setting out criteria and procedures for the consultation of advisory bodies established under other relevant Union legislation in relation to the performance of the SCB tasks.

The Commission shall, in cooperation with SoHO national authorities, organise Union training on the implementation of this Regulation.

The Commission may provide Union training to personnel of SoHO competent authorities of EEA Member States, of countries that are applicants or candidates for Union membership and to personnel of bodies to whom specific responsibilities for SoHO supervisory activities have been delegated. It may organise aspects of the training in collaboration with international organisations and regulators working in the field of SoHO.

SoHO competent authorities shall ensure that the knowledge and materials acquired through the Union training activities referred to in paragraph 1 of this Article are disseminated as necessary and appropriately used in the personnel training activities referred to in Article 8.

The Commission may support, in cooperation with the SoHO national authorities, the organisation of programmes for the exchange of SoHO competent authorities’ personnel between two or more Member States and for the temporary secondment of personnel from one Member State to the other as part of personnel training.

The Commission shall maintain a list of the SoHO competent authority personnel that have successfully completed the Union training referred to in paragraph 1 of this Article, with a view to facilitating joint activities, in particular those referred to in Articles 22, 29, and 71. The Commission shall make this list available to the SoHO national authorities.

The Commission shall perform controls to confirm whether Member States effectively apply the requirements relating to:

The Commission shall organise the controls referred to in paragraph 1 in cooperation with the SoHO national authorities, and shall carry them out in a manner that avoids unnecessary administrative burden.

When performing the controls referred to in paragraph 1 of this Article, the Commission shall consult the relevant best practices documented and published by the SCB, as referred to in Article 69(1), point (d), on SoHO supervisory activities.

The Commission, in carrying out the controls referred to in paragraph 1 of this Article, may be supported by experts from the SoHO competent authorities selected, whenever possible, from the list referred to in Article 70(5). Experts from the SoHO competent authorities shall be given the same rights of access as the Commission.

Following each control, the Commission shall:

To facilitate the fulfilment of the requirements provided for in this Regulation, the Commission shall support implementation by:

With regard to the support referred to in paragraph 1, point (a), the Commission shall, in particular, organise the meetings of the SCB and its working groups, the travel, reimbursement and special allowances for participants in those meetings.

Upon request from Member States, technical support may be provided, through the Technical Support Instrument established by Regulation (EU) 2021/240 of the European Parliament and of the Council ([^E0004]), for the reform of national or regional SoHO supply supervision, provided those reforms aim to achieve compliance with this Regulation.

In order to perform the activities referred to in paragraph 1 to the mutual benefit of the Commission and of the beneficiaries, relating to preparation, management, monitoring and controls, as well as to support expenditure, the Commission shall have recourse to the technical and administrative assistance it might need.

The Commission shall establish, manage and maintain a digital platform to facilitate efficient and effective exchange of information concerning SoHO activities in the Union, as provided for in this Regulation (the ‘EU SoHO Platform’).

The processing of personal data, including health data, by the SoHO entities, the SoHO competent authorities, the Member States and the Commission through the EU SoHO Platform shall only be carried out in cases where it is necessary for the performance of the tasks, the achievement of the objectives and the fulfilment of obligations as laid down in this Regulation. The processing of personal data, including health data, shall be carried out in accordance with the applicable Union data protection legislation.

The Commission shall provide instructions, materials and training on the correct use of the EU SoHO Platform for SoHO competent authorities via their SoHO national authority. The Commission shall, where appropriate and in cooperation with their SoHO national authority, provide instructions and training for SoHO entities on the correct use of the EU SoHO Platform. Those training materials shall be available on the EU SoHO Platform.

The EU SoHO Platform shall enable SoHO entities, SoHO competent authorities, Member States and the Commission to process information, data and documents concerning SoHO and SoHO activities, including the submission, retrieval, storage, management, handling, exchange, analysis, publication, tracking and deletion of such data and documents as provided for in this Regulation.

The EU SoHO Platform shall provide a secure channel for restricted exchange of information and data, in particular:

The EU SoHO Platform shall provide public access to information regarding:

By 7 August 2025, the Commission shall adopt implementing acts laying down technical specifications for the EU SoHO Platform, covering its management, maintenance, functions, including its minimal functionalities, the roles and responsibilities of each of the parties listed in paragraph 1, the retention periods for personal data and the technical and organisational measures to ensure the safety and security of personal data processed, including health data.

Unless otherwise provided for in this Regulation or in national legislation on confidentiality, and without prejudice to Regulation (EC) No 1049/2001, each party involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the effective implementation of this Regulation, in particular for the purpose of authorisations, inspections, investigations or Commission controls.

Information and data may be exchanged on a confidential basis between SoHO competent authorities and between SoHO national authorities and the Commission, and shall not be disclosed without the prior agreement of the SoHO competent authorities from whom that information originates.

Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and SoHO competent authorities with regard to the exchange of information and the dissemination of alerts, nor the obligations of persons to provide information under national criminal law.

The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements, as necessary and proportionate for the protection of human health.

Without prejudice to national legislation on the publication of the outcome of SoHO supervisory activities, SoHO competent authorities may publish or make otherwise publicly available the outcome of SoHO supervisory activities regarding individual SoHO entities provided that the following conditions are met:

Regarding information or data that is, by its nature, covered by professional secrecy and that is obtained by SoHO competent authorities in carrying out SoHO supervisory activities, SoHO competent authorities may only publish or make that information or data publicly available, without prejudice to national legislation, provided that the conditions laid down in paragraph 5, point (c), are met.

Personal data required for the application of Article 5(5), Article 9(4), Articles 33 and 34, Article 35(3), points (a) and (b), Article 36(3), Article 39(2), point (a), Article 46(2), Article 64 and Article 68(3) shall be collected for the purpose of identifying the relevant contact persons within the relevant SoHO entities, SoHO competent authorities or delegated bodies, and shall only be processed further for the purpose of ensuring the administration and transparency of the SoHO supervisory activities and SoHO activities concerned.

Personal data, including data concerning health, exchanged through the EU SoHO Platform and required for the application of Articles 73 and 74 shall, where necessary, be processed in the interest of public health and for the following purposes:

Personal data, including data concerning health, required for the application of Articles 33, 34, 39, 42 and 44, Article 53(1), points (e) and (f), Article 53(3), and Article 58(13), (14) and (15), shall only be processed for the purpose of ensuring quality and safety of SoHO and protecting the concerned SoHO donors, SoHO recipients and offspring from medically assisted reproduction. Those data shall be directly related to the performance of the supervisory activities and SoHO activities concerned and be limited to the extent necessary and proportionate for that purpose.

All information shall be processed by the Commission, Member States, SoHO competent authorities, including SoHO national authorities, delegated bodies, SoHO entities and any third party contracted by a SoHO entity, as applicable, in such a way that the personal data of the subjects remain protected in accordance with the applicable legislation on personal data protection. They shall, in particular, minimise the risk that subjects can be identified and shall limit the information processed to elements necessary and appropriate for carrying out their tasks and fulfilling their obligations under this Regulation.

The Commission, Member States, SoHO competent authorities, including SoHO national authorities, delegated bodies, SoHO entities and any third party contracted by a SoHO entity, shall implement appropriate technical and organisational measures to protect information and personal data processed, including health data, against unauthorised or unlawful access, disclosure, dissemination, alteration, destruction or accidental loss, in particular where the processing involves transmission over a network.

In relation to their responsibilities to process personal data to comply with the obligations of this Regulation, SoHO entities and SoHO competent authorities of the Member States shall be regarded as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679.

In relation to its responsibility to establish and manage the EU SoHO Platform, as referred to in Article 73 of this Regulation and the processing of personal data, including health data, that might result from that activity, the Commission shall be regarded as a controller as defined in Article 3, point (8), of Regulation (EU) 2018/1725.

For the purposes of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation by laying down the retention periods for personal data, including health data, as appropriate to their purpose and specific criteria that would allow identification of data relevant for public health protection as referred to in paragraph 2 of this Article.

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

The power to adopt delegated acts referred to in Article 26(7), Article 47(4), Article 53(5), Article 58(16) and Article 76(8) shall be conferred on the Commission for an indeterminate period of time from 6 August 2024.

The delegation of power referred to in Article 26(7), Article 47(4), Article 53(5), Article 58(16) and Article 76(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to Article 26(7), Article 47(4), Article 53(5), Article 58(16) or Article 76(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.