Critical substances of human origin (SoHO)

In Finland, the following have been identified as critical SoHOs:

• Red blood cells
• Platelets
• Plasma
• Whole blood products

The critical status of SoHOs is assessed in cooperation with the Ministry of Social Affairs and Health, in consultation with the entities. The list of critical SoHOs will be reviewed at a later date, and it may be updated as necessary.

Critical SoHO entity means a SoHO entity that carries out activities contributing to the supply of critical SoHO and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other SoHO entities or alternative substances or products for recipients.

The SCB has approved EU-level criteria for critical SoHO entities (Criteria for Critical SoHO and Critical SoHO Entities (circabc.europa.eu)).

SoHO entities shall carry out a self-assessment of whether they meet the criteria for being a critical SoHO entity upon registration. Fimea then reviews and confirms the outcome of the self-assessment.

The self-assessment should be carried out by professionals responsible for the entity's activities, who understand how their actions impact the system at local, regional, national, or EU levels.

Critical SoHO entities are subject to the same obligations as other SoHO entities, as well as the following obligations:

• Critical SoHO supply sufficiency (Art. 62 of the SoHO Regulation*): Critical SoHO entities shall establish appropriate mechanisms for the continuous monitoring of their stocks of critical SoHO, determine the acceptable stock and alert levels, and shall be able, in the event of shortages or upon request, to communicate such information to Fimea.
• Supply alerts for critical SoHOs (Art. 64 of the SoHO Regulation*): Critical SoHO entities must be able to detect significant supply interruptions of critical SoHOs at an early stage and send a SoHO supply alert to Fimea without undue delay. The supply alert shall indicate the underlying reasons, the expected impact on recipients and any mitigating actions taken.
• SoHO entity emergency plans (Art. 67 of the SoHO Regulation*): Critical SoHO entities shall draw up an emergency plan setting out measures to be applied without undue delay when the demand or the supply situation for critical SoHO presents, or is likely to present, a serious risk to human health. Risk-based preparedness includes, for instance, identifying risk scenarios, planning backup arrangements and response measures for different stages of the process, drawing up cooperation models with other entities, and testing and updating the emergency plan.

* EU 2024/1938 (pdf, EUR-Lex/Official Journal)