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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 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.

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 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.

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 (), 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.