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1. Member States shall ensure that their SoHO national authority has appropriate mechanisms in place to communicate with the competent authorities for organs designated under Directive 2010/53/EU and any competent authorities designated under other Union legislation referred to in Article 2(6) of this Regulation within the Member State concerned.

2. In all cases where questions arise as to the regulatory status of a substance, product or activity, the SoHO competent authorities shall, in addition to the obligation set out in Article 12(2), consult, via the SoHO national authority, with the competent authorities referred to in paragraph 1 of this Article, as appropriate, with a view to reaching a decision on the regulatory status of that substance, product or activity. In such cases, the SoHO competent authorities involved in the consultation shall also consult the SoHO compendium, and consider any relevant regulatory status decision and take into account any relevant opinion included therein.

3. In the course of the consultation referred to in paragraph 2, the SoHO competent authorities involved in such consultation may also, via their SoHO national authority, submit a request to the SCB for an opinion on the regulatory status of the substance, product or activity under this Regulation. The SoHO competent authorities shall do so in all cases where the consultation referred to in paragraph 2 has not lead to a decision on the regulatory status of such a substance, product or activity in the Member State concerned. The SoHO competent authorities involved in the consultation referred to in paragraph 2 of this Article may also, via their SoHO national authority, indicate if they consider that there is a need for the SCB to consult, before issuing its opinion and in accordance with Article 69(1), point (c), with the relevant equivalent advisory bodies established under other relevant Union legislation referred to in Article 2(6). The SoHO competent authorities involved in the consultation shall take into account the opinion issued by the SCB following such a request.

4. When a consultation referred to in paragraph 2 and, where relevant, paragraph 3 of this Article leads to a regulatory status decision, the SoHO competent authorities shall, via their SoHO national authority, inform the SCB of the decision taken in the Member State concerned with a view to the publication thereof by the SCB in the SoHO compendium, pursuant to Article 69(1), point (e). The SoHO competent authorities shall include a description of the reasons for the decision, and where the decision taken differs from the SCB opinion, provide a justification.

5. The Commission shall, upon a duly substantiated request from a Member State following the consultation referred to in paragraph 2 of this Article, or may on its own initiative, by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, where such a determination is needed to avoid risks to the safety of SoHO donors, recipients or offspring from medically assisted reproduction, or risks of a compromised access of recipients to safe and effective treatment. Such a request from a Member State shall be considered duly substantiated where questions arise in respect of the regulatory status of a substance, product or activity under this Regulation, in particular where such questions cannot be resolved at Member State level, or in consultations conducted in accordance with Article 69(1), point (c), between the SCB and the advisory bodies established under other relevant Union legislation referred to in Article 2(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

6. In the case of SoHO referred to in Article 2(6) or (8), the SoHO competent authorities shall cooperate with the competent authorities responsible for the supervisory activities under other relevant Union legislation referred to in Article 2(6), with a view to ensuring coherent oversight. During that process, the SoHO competent authorities may seek, via their SoHO national authority, the assistance and advice of the SCB concerning, inter alia, good cooperation practices that ensure coherent oversight when the regulatory status of SoHO changes.

7. The consultation and cooperation referred to in paragraphs 2, 3 and 6 may also be initiated on the basis of a request from a SoHO entity for an opinion.

8. Where a SoHO competent authority takes an enforcement decision concerning a SoHO entity that performs SoHO activities and activities regulated by other Union legislation and overseen by competent authorities as referred to in paragraph 1, the SoHO competent authority shall, without undue delay, via the SoHO national authority, inform the relevant competent authority designated under that other Union legislation of its decision.