Article 75 Confidentiality
1. 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. 2. 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. 3. 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. 4. 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. 5. 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: (a) the SoHO entity concerned is given the opportunity to comment on the information that the SoHO competent authority intends to publish or make otherwise publicly available, prior to its publication or release, taking into account the urgency of the situation; (b) the information or data which is published or made otherwise publicly available takes into account the comments expressed by the SoHO entity concerned or is published or released together with such comments; (c) the information or data concerned is made available in the interest of public health protection and is proportionate to the severity, extent and nature of the associated risk; (d) the information or data made publicly available does not unnecessarily undermine the protection of legal rights of the SoHO entity or any other natural or legal person; (e) the information or data made publicly available does not undermine the protection of court proceedings and legal advice. 6. 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.
Article 76 Data protection
1. 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. 2. 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: (a) to help to identify and evaluate risks associated with a particular SoHO donation or SoHO donor; (b) to process relevant information on clinical-outcome monitoring. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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.
Article 77 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. 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. 3. 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. 4. 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. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. 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.
Article 78 Urgency procedure
1. 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. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 77(6). In such case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
Article 79 Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Article 80 Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 7 August 2029, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
Article 81 Transitional provisions concerning establishments designated, authorised, accredited or licensed under Directives 2002/98/EC and 2004/23/EC
1. Blood establishments designated, authorised, accredited or licensed in accordance with Article 5(1) of Directive 2002/98/EC and tissue establishments designated, authorised, accredited or licensed in accordance with Article 6(1) of Directive 2004/23/EC before 7 August 2024 shall be deemed to be registered as SoHO entities and deemed to be authorised as SoHO establishments, in accordance with this Regulation and shall, as such, be subject to the relevant obligations provided for under this Regulation. 2. Tissue establishments that are designated, authorised, accredited or licensed as importing tissue establishments in accordance with Article 9(1) of Directive 2004/23/EC before 7 August 2024 shall be deemed to be authorised as importing SoHO establishments in accordance with this Regulation and shall, as such, be subject to the relevant obligations provided for under this Regulation. 3. For blood establishments referred to in paragraph 1 of this Article, SoHO competent authorities shall: (a) verify whether those establishments fall within the definition of a SoHO establishment as set out in Article 3, point (35); (b) submit to the EU SoHO Platform the information referred to in Article 35(3), points (a) and (d), and the information regarding the registration and authorisation status according to the verification referred to in point (a) of this paragraph. 4. For tissue establishments referred to in paragraphs 1 and 2 of this Article, the Commission shall: (a) verify whether those establishments fall within the definition of a SoHO establishment as set out in Article 3, point (35); (b) transfer to the EU SoHO Platform the relevant information from the EU Tissue Establishment Compendium of the EU Coding Platform laid down in Commission Directive 2006/86/EC ( 23 ) , including the information regarding the registration and authorisation status according to the verification referred to in point (a) of this paragraph; (c) inform the SoHO competent authorities of the establishments that do not fall within the definition of a SoHO establishment according to the verification referred to in point (a) of this paragraph. 5. SoHO competent authorities shall inform those establishments not falling within the definition of a SoHO establishment, according to the verification referred to in paragraph 3, point (a), and paragraph 4, point (a), and based on the information referred to in paragraph 4, point (c), that they are deemed to be registered as SoHO entities only and that they, as such, are subject to the obligations relevant for SoHO entities under this Regulation.
Article 82 Transitional provisions concerning SoHO preparations
1. The preparations resulting from tissue and cell preparation processes designated, authorised, accredited or licensed in accordance with Article 6(2) of Directive 2004/23/EC before 7 August 2024 shall be deemed to be authorised as the corresponding SoHO preparations in accordance with this Regulation. 2. Blood components that were verified by SoHO competent authorities as complying with applicable quality and safety requirements for blood components in accordance with Article 5(3) and Article 23 of Directive 2002/98/EC or with the blood component monographs included in the edition of the Guide to the preparation, use and quality assurance of blood components of the EDQM indicated on the EU SoHO Platform on 7 August 2024, or that were otherwise designated, authorised, accredited or licensed under national legislation before that date, shall be deemed to be authorised as the corresponding SoHO preparations in accordance with this Regulation. 3. SoHO competent authorities shall submit the information about the SoHO preparations referred to in paragraphs 1 and 2 to the EU SoHO Platform, and link those SoHO preparations, deemed to be authorised pursuant to those paragraphs, to the respective SoHO entities. 4. The Commission may adopt implementing acts in order to establish uniform procedures for ensuring that SoHO preparations deemed to be authorised pursuant to paragraphs 1 and 2 are fully documented in line with the requirements for SoHO preparation authorisation in this Regulation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Article 83 Transitional provisions concerning SoHO not addressed explicitly in Directive 2002/98/EC or 2004/23/EC
Entities carrying out one or more of the SoHO activities referred to in Article 2(1), points (c)(i), (iv) to (ix) and (xii), of this Regulation, in respect of SoHO not addressed explicitly in Directive 2002/98/EC or 2004/23/EC, before 7 August 2024 shall be allowed to continue such activities until 8 August 2025, without applying this Regulation, except for the following requirements: (a) registration as SoHO entities pursuant to Article 35 of this Regulation; (b) application for any and all relevant SoHO preparation authorisations, where required pursuant to Article 38 of this Regulation; (c) application for a SoHO establishment authorisation, where required pursuant to Article 45 of this Regulation; (d) compliance with the standards referred to in Chapters VI and VII of this Regulation for the SoHO activities carried out during the transition phase. Such SoHO entities shall comply with the requirements referred to in the first paragraph, points (b) and (c), by 8 November 2024.
Article 84 Status of SoHO in storage or distributed before the application of this Regulation
1. SoHO already in storage before 7 August 2024 shall not be subject to the relevant obligations provided for under this Regulation, provided that those SoHO are released and distributed before 8 August 2026, under the condition that those SoHO were fully compliant with the applicable Union legislation and national law in force at the time when those SoHO were collected. 2. SoHO which have been distributed before 7 August 2024 and kept under appropriate control conditions until that date shall not be subject to the relevant obligations provided for under this Regulation. 3. SoHO already in storage before 7 August 2024, and not distributed as referred to in paragraph 1 of this Article, and for which no alternative SoHO are available, in particular because the SoHO are autologous, intended for within-relationship use or highly matched for a specific SoHO recipient, shall only be subject to Article 61. Those SoHO shall be subject to that Article from that date.
Article 85 Repeals
Directives 2002/98/EC and 2004/23/EC are repealed with effect from 7 August 2027.
Article 86 Evaluation
The Commission shall, by 8 August 2029, assess the application of this Regulation, produce an evaluation report on the progress towards achievement of the objectives of this Regulation and present its main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. The evaluation report shall include an assessment of the implementation of Article 54. For the purpose of the evaluation report, the Commission shall use aggregated and anonymised data and information gathered from SoHO competent authorities and from data and information submitted to the EU SoHO Platform. Member States shall provide the Commission with additional information as necessary and proportionate for the preparation of the evaluation report, including information on the conditions for compensation of SoHO donors pursuant to Article 54. The evaluation report shall, where appropriate, be accompanied by a legislative proposal to amend this Regulation.
Article 87 Entry into force and application
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . Unless otherwise provided for in paragraph 2, it shall apply from 7 August 2027. 2. The Commission is empowered to adopt the delegated acts referred to in Article 47(4), and the implementing acts referred to in Article 41(3), Article 42(7), Article 43(3), Article 48(7) and Article 74(4) from 6 August 2024. Article 68 and Article 69(1), point (b), shall apply from 7 August 2024. Article 80, Article 81(3), (4) and (5) and Article 82(3) shall apply from 7 August 2028.