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.
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).
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.
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
