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5. The representative of the Commission shall co-chair the meetings of the SCB together with a representative of the SoHO national authority of a Member State, elected by and from among the representatives of the Member States in the SCB, and in accordance with the rules of procedure of the SCB.

6. The Commission shall provide the secretariat for the SCB in accordance with Article 72.

7. The SCB shall deliberate by seeking to achieve consensus as far as possible. If consensus cannot be achieved, the SCB shall deliberate and adopt an opinion or other positions by, at least, a majority of two thirds of the votes of all the Member States. The representative of the Commission co-chairing the SCB shall not take part in votes of the SCB. Each Member State shall have one vote.

9. The Commission may, by means of implementing acts, adopt the necessary measures for the management of the SCB. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

1. The SoHO Coordination Board (SCB) is hereby established in order to promote coordination between Member States concerning the implementation of this Regulation and of the delegated and implementing acts adopted pursuant thereto, and to support them in that coordination, as well as to facilitate cooperation with stakeholders in that regard.

2. Each Member State shall appoint two permanent members and two alternates representing the SoHO national authority and, where the Member State chooses so, the Ministry of Health or other relevant authorities. The SoHO national authority may nominate members from other SoHO competent authorities. Those members shall ensure that the views and suggestions they express are endorsed by the SoHO national authority. The SCB may invite experts and observers to attend its meetings, and may cooperate with other external experts, as appropriate. The SCB may also invite, where relevant, other Union institutions, bodies, offices and agencies. In such cases, they shall have observer status.

3. Member States shall submit the names and affiliation of their nominated members and alternates, together with the corresponding declaration of interests for any member and alternate, stating the absence of any financial or other interest, to the Commission. The Commission shall make publicly available on the EU SoHO Platform the membership list indicating the name, the institution of origin and the declaration of interests of each nominated member and alternate.

4. The Commission shall make the rules of procedures of the SCB, the agenda and the summary minutes of each meeting, as well as the best practices documented and published by the SCB, as referred to in Article 74(3), point (d), of this Regulation, publicly available on the EU SoHO Platform, provided that such publication does not undermine the protection of any public or private interest, as referred to in Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council ().

8. When establishing the SCB, the Commission shall put forward the rules of procedure of the SCB which shall be approved by the SCB within the first semester of its functioning. The rules of procedure shall, in particular, lay down procedures for the following:

(a) scheduling of meetings;

(b) election of the SoHO national authority co-chairing the meetings of the SCB and the duration of this mandate;

(c) deliberation and voting, as well as timeframes for issuing opinions, taking into account the complexity of the file, the available evidence or other relevant factors;

(d) adoption of opinions or other positions, including in cases of urgency;

(e) submission of requests for advice to the SCB, and for other communications to the SCB;

(f) consultation with advisory bodies established under other relevant Union legislation;

(g) delegation of tasks to working groups, including on vigilance, inspection, and traceability, and on the applicability of this Regulation;

(h) delegation of ad-hoc tasks to SCB members or technical experts to explore, and report to the SCB on, specific technical topics, as required;

(i) invitation of experts to take part in the work of the SCB working groups and to contribute to ad-hoc tasks, on the basis of their personal experience and expertise or on behalf of recognised Union level or global professional associations;

(j) invitation of individuals, organisations, or public entities in the capacity of observers;

(k) declarations regarding conflict of interests of SCB members, alternates, observers and invited experts;

(l) establishment of working groups, including their composition and rules of procedure, and the delegation of ad-hoc tasks.