Regulation (EU) 2024/1938 CHAPTER IX — SOHO COORDINATION BOARD

Article 68–Article 69 · 2 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

SoHO Coordination Board

Article 68

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 ( 21 ) . 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. 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. 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).

Tasks of the SoHO Coordination Board

Article 69

1. The SCB shall assist SoHO competent authorities regarding the coordinated implementation of this Regulation and of the implementing and delegated acts adopted pursuant to it, by: (a) preparing opinions, at the request of SoHO competent authorities, submitted via their SoHO national authority, in accordance with Article 13(3), first subparagraph, on the regulatory status under this Regulation of a substance, product or activity and including such opinions in the SoHO compendium; (b) drawing up, by 7 August 2025, a list of the existing substances, products or activities for which an opinion on the regulatory status under this Regulation is not available but 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 treatments, making it publicly available on the EU SoHO Platform, and subsequently updating that list at its discretion; (c) initiating at Union level, when preparing the opinions referred to in point (a) of this paragraph, a consultation with equivalent advisory bodies established under other relevant Union legislation in accordance with Article 13(3), second subparagraph, and including in the SoHO compendium the opinions concerning the Union legislation to be applied in cases where there is agreement with the equivalent advisory bodies; (d) documenting and publishing best practices on the implementation of SoHO supervisory activities on the EU SoHO Platform; (e) recording information notified in accordance with Article 13(4), and including such information in the SoHO compendium; (f) setting indicative criteria for ‘critical SoHO’ and for ‘critical SoHO entity’, providing and updating a list of what is considered a ‘critical SoHO’ by Member States, and making such information available to the SoHO national authorities on the EU SoHO Platform; (g) documenting practices followed by Member States to establish the conditions for compensation as referred to in Article 54(2); (h) providing assistance and advice for the cooperation between SoHO competent authorities and other competent authorities, with a view to ensuring coherent oversight where the regulatory status of SoHO changes, as provided for in Article 13(6); (i) providing advice on the minimum evidence necessary for the authorisation of a particular SoHO preparation, as referred to in Article 20(4), point (e); (j) liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards within their respective areas of expertise, as well as with the European Medicines Agency on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2001/83/EC, to support the harmonised implementation of standards and technical guidelines; (k) collaborating for the effective organisation of joint inspections and joint SoHO preparation assessment involving more than one Member State; (l) providing advice to the Commission on the functional specifications of the EU SoHO Platform; (m) in cooperation with the Commission, and, where appropriate, with the Advisory Committee on public health emergencies established pursuant to Article 24 of Regulation (EU) 2022/2371, supporting a coordinated approach to ensure the implementation of the national SoHO emergency plans in cases where an emergency affects more than one Member State or in the case of emergencies with an effect beyond the Union, in accordance with Article 63(7) of this Regulation; (n) providing assistance in other matters related to the coordination or the implementation of this Regulation. 2. The Commission may adopt implementing acts setting out criteria and procedures for the consultation of advisory bodies established under other relevant Union legislation in relation to the performance of the SCB tasks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

Back to Regulation (EU) 2024/1938 — full text

Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Regulation (EU) 2024/1938, full textChapter navigation and full text, so you can read this section in contextEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview