Fig. 2: SoHO activities, SoHO entities and SoHO establishments as defined by the new EU SoHO Regulation (Regulation (EU) 2024/1938). | npj Biofilms and Microbiomes

Fig. 2: SoHO activities, SoHO entities and SoHO establishments as defined by the new EU SoHO Regulation (Regulation (EU) 2024/1938).

From: The regulatory framework for microbiome-based therapies: insights into European regulatory developments

Fig. 2

The SoHO Regulation will apply to SoHO activities that have a direct impact on the quality, safety or effectiveness of SoHO. These SoHO activities are mentioned in Fig. 2. The SoHO Regulation defines a SoHO entity as an organization legally established in the European Union and carrying out one or more SoHO activities. These SoHO entities must be registered. However, some specific SoHO activities have to be carried out by a SoHO establishment, which will be authorised by the competent authority. Only registered SoHOs entities and authorised SoHO establishments will be permitted to carry out SoHO activities and release SoHO preparations.

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