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)

Type Regulation

Publication 2024-07-17

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 89

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

The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

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.

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.

CHAPTER XIII TRANSITIONAL PROVISIONS

Article 81

Transitional provisions concerning establishments designated, authorised, accredited or licensed under Directives 2002/98/EC and 2004/23/EC

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 2027 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.

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 2027 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.

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.

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 ([^E0005]), 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.

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

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 2027 shall be deemed to be authorised as the corresponding SoHO preparations in accordance with this Regulation.

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 2027, 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.

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.

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 2027 shall be allowed to continue such activities until 8 August 2028 , 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;

(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 2027.

Article 84

Status of SoHO in storage or distributed before the application of this Regulation

SoHO already in storage before 7 August 2027 shall not be subject to the relevant obligations provided for under this Regulation, provided that those SoHO are released and distributed before 8 August 2029, 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.

SoHO which have been distributed before 7 August 2027 and kept under appropriate control conditions until that date shall not be subject to the relevant obligations provided for under this Regulation.

SoHO already in storage before 7 August 2027, 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.

CHAPTER XIV FINAL PROVISIONS

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 2032, 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

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.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

[^E0001]: () Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

[^E0002]: () Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of critical entities and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164).

[^E0003]: () Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

[^E0004]: () Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, p. 1).

[^E0005]: () Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p. 32).

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