New regulation on substances of human origin

Substances of Human Origin (SoHO) refers to substances collected from the human body or produced by processing a substance of human origin (excluding organs). In addition to blood, tissues and cells, SoHO also include faecal microbiota and human breast milk.

The SoHO Regulation applies, among others, to the following SoHO activities: 
(i) SoHO donor registration; 
(ii) evaluation of SoHO donors; 
(iii) testing of SoHO donors; 
(iv) collection of SoHO; 
(v) processing of SoHO; 
(vi) quality control of SoHO; 
(vii) storage of SoHO; 
(ix) distribution of SoHO; 
x) import of SoHO; 
xi) export of SoHO; 
(xii) human application of SoHO.

Thus, a large number of healthcare actors in the private and public sectors, such as clinical laboratories, health clinics, hospitals, surgical, intensive care and inpatient wards, fertility treatment clinics, stem cell transplantation units, and banks for blood, tissues, cells, faecal microbiota and breast milk fall within the scope of the regulation.

A SoHO entity, is a entity legally established in the Union that carries out one or more of the SoHO activities referred to in Article 2(1)(c) of the SoHO Regulation (such as donor registration, donor evaluation, donor testing, collection, processing, quality control, storage, release, distribution, import, export, human application). SoHO entities are subject to the obligations laid down for SoHO entities in the SoHO Regulation. 

An establishment processing SoHO, a so-called SoHO establishment, is a SoHO entity that both processes and stores SoHO, releases SoHO, imports SoHO into the EU or exports SoHO from the EU. In addition to the obligations laid down for SoHO entities in the SoHO Regulation, SoHO establishments are subject to the general obligations applying to SoHO establishments set out in Chapter V.

For more information, see the website of the European Commission. In addition, Fimea updates the website on Substances of human origin as soon as new information on the topic becomes available and organises discussion events for operators.

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