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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).

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 2027 ◄ 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 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.