The SoHO Coordination Board (SCB) is a body that supports a coordinated application of the SoHO Regulation (Regulation (EU) 2024/1938) within Member States (MS).
The SCB:
- is composed of two members per Member State, nominated based on their role and expertise in their SoHO competent authorities and two alternates
- is co-chaired by the Commission and the Member States. The Commission also provides the SCB with a secretariat. Observers and experts can be invited to participate in the SCB's activities
- responsibilities include:
- documenting best practices for supervisory activities and compensation conditions
- establishing indicative criteria for critical SoHO and critical SoHO entities
- supporting joint oversight activities such as inspections and preparation assessments
- plays a role in coordinating responses during emergencies and supports the Commission in defining the specifications for the EU SoHO Platform.
The EU SoHO Platform is an online tool under development that enables SoHO entities, SoHO competent authorities, Member States and the Commission to process information, data and documents concerning SoHO and SoHO activities.
Furthermore, the SCB advises on whether the SoHO Regulation applies and facilitates exchanges on good practices with expert bodies like the ECDC, EDQM, and EMA. It also engages with advisory bodies under other legislative frameworks.
Records of advice given by the SCB on regulatory status and national decisions related to regulatory status will be stored in a compendium hosted on the EU SoHO platform.
Article 68(3) of Regulation (EU) 2024/1938 specifies that 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.
In addition, Art 68(4) indicates that the Commission shall make the:
- rules of procedures of the SCB
- agenda and the summary minutes of each meeting
- best practices are documented and published by the SCB.
As referred 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 in Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and the Council. Until the EU SoHO Platform becomes available, this information will be provided in the subsections below.
Members of the SCB
The members of SCB are designated by the Member States in accordance with Article 68(2) of Regulation (EU) 2024/1938, following a request from the Commission. Observers from EEA countries are designated following a similar procedure.
Rules of procedure
Terms of reference
Terms of reference of the working groups of the SCB on:
- registration of entities and authorisation of establishments
- authorisation and assessment of SoHO preparations
- inspections
- vigilance and traceability
- supply
- regulatory questions.
