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1. Member States shall designate the SoHO competent authority or authorities to which they confer responsibility for SoHO supervisory activities. The SoHO competent authority or authorities designated shall be independent from any SoHO entity.

2. A Member State may confer responsibilities for SoHO supervisory activities to more than one SoHO competent authority, at national, regional or local level.

3. Member States shall ensure that SoHO competent authorities:

(a) have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined under national legislation;

(b) have the necessary powers:

(i) to properly perform the SoHO supervisory activities they have been made responsible for, including having access to the premises of, and documents and samples kept by, SoHO entities and any third parties contracted by a SoHO entity;

(ii) to order the immediate suspension or cessation of a SoHO activity that poses an immediate risk to SoHO donors, SoHO recipients, offspring from medically assisted reproduction or the general public;

(c) have, or have access to, sufficient human and financial resources, operational capacity, and expertise, including technical expertise, to achieve the aims of, and fulfil their obligations under, this Regulation;

(d) are subject to appropriate confidentiality obligations in order to comply with Article 75.

4. When a Member State designates only one SoHO competent authority in accordance with paragraph 1 of this Article, that SoHO competent authority shall also be considered as the SoHO national authority. When a Member State designates more than one SoHO competent authority in accordance with that paragraph, it shall designate a single SoHO national authority among them, in accordance with national law. The SoHO national authority shall be responsible for the tasks referred to in Article 8(2). The designation of a single SoHO national authority shall not prevent the Member State from assigning certain tasks to other SoHO competent authorities, in particular the management of SoHO rapid alerts, in order to ensure an efficient and agile communication when serious adverse reactions or serious adverse events involve more than one Member State.

5. Member States shall submit to the EU SoHO Platform, and keep updated, information on:

(a) the name and contact details of the SoHO national authority referred to in paragraph 4;

(b) the names and contact details of any SoHO competent authority designated in accordance with paragraph 1, when such SoHO competent authority is different from the SoHO national authority referred to in paragraph 4.