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1. Entities shall register as a SoHO entity before commencing any of the SoHO activities referred to in Article 2(1), point (c). Entities may request from a SoHO competent authority within their territory an opinion on whether the activities they are carrying out are subject to the registration requirements set out in this Chapter.

2. SoHO activities shall only be carried out by persons who operate within a registered SoHO entity.

3. In order to register as a SoHO entity, the SoHO entity shall provide the following information:

(a) name of the SoHO entity and all addresses where SoHO activities are performed by the SoHO entity;

(b) name and contact details of the responsible person as referred to in Article 36;

(c) acknowledgment from the SoHO entity that it may be inspected pursuant to Article 28 and that it will cooperate with the relevant SoHO competent authority in any matter relating to the conduct of SoHO supervisory activities in accordance with this Regulation;

(d) a list of the SoHO concerned and of the SoHO activities referred to in Article 2(1), point (c), that the SoHO entity carries out; where the SoHO entity carries out the SoHO activity referred to in Article 2(1), point (c)(iv), it shall also provide the name of the SoHO establishment responsible for the SoHO release prior to distribution;

(e) where applicable, a list of SoHO establishments for which the SoHO entity performs SoHO activities covered by an agreement;

(f) where applicable, details of any accreditation or certification received from an external body;

(g) where applicable, information regarding activities carried out and regulated under other Union legislation, as referred to in Article 13(1).

4. SoHO entities shall declare, when registering, whether they need an authorisation pursuant to Article 19, 25 or 26. They shall also carry out a self-assessment of whether they meet the criteria for being a critical SoHO entity and communicate the result.

5. In Member States where the EU SoHO Platform is used for registration of SoHO entities, as referred to in Article 16(1), entities falling within the definition of a SoHO entity as set out in Article 3, point (33), shall register directly on the EU SoHO Platform in accordance with the instructions from their SoHO competent authorities.

6. SoHO entities shall register without undue delay changes to information registered pursuant to paragraph 3, points (a), (b) and (d) to (g). Where such changes indicate SoHO activities, including processing and storage, or release, or import or export of SoHO, those SoHO entities shall apply for an authorisation as SoHO establishment.

7. Where a registered SoHO entity partially or totally ceases to carry out its SoHO activities, it shall communicate this change on the register for SoHO entities without undue delay, indicating to which SoHO entity it will transfer SoHO for storage, and the data referred to in Article 42, where applicable.

8. Where the SoHO stored is intended for autologous or within-relationship use, or is a highly matched SoHO for a specific SoHO recipient, and the SoHO entity ceases SoHO activities affecting the storage or the possible use of such SoHO, it shall inform the persons from whom such SoHO were collected, and provide them with information about the new SoHO entity that will store such SoHO.