SoHO – overview of requirements for tissue and blood establishments 

The SoHO Regulation will replace existing blood and tissues and cells legislation from 7 August 2027.

What is a Substance of Human Origin (SoHO)?

SoHO means any substance collected from the human body, whether it contains cells or not and whether those cells are living or not. This includes SoHO preparations resulting from the processing of such substances.

Scope of SoHO – what is included?

  • SoHO intended for human application
  • SoHO donors
  • SoHO recipients
  • Offspring from medically assisted human reproduction
  • SoHO used to manufacture products regulated by other EU legislation and intended for human application, for example, medicinal products, ATMPs, IMPs, medical devices

SoHo activities included in the scope

SoHO activities that have a direct impact on the quality, safety or effectiveness of SoHO, as follows:

  • Collection
  • Processing
  • Quality Control
  • Storage
  • Release
  • Distribution
  • Import
  • Export 
  • Human application
  • Clinical outcome registration
  • SoHO donor registration
  • Donor history review and medical examination
  • Testing of SoHO donors or of persons from whom SoHO are collected for autologous or within relationship use

Scope of SoHO – what is not included?

  • Organs intended for transplantation as defined within Directive 2010/53/EU (the Organs Directive remains in place)
  • Breast milk when used exclusively for feeding one’s own child without any processing carried out by a SoHO entity

How does SoHO differ from previous legislation?

Establishments should be aware of the following key differences between SoHo and previous blood, tissues and cells (BTC) legislation. 

Registration of all entities  

The SoHO Regulation introduces the terms ‘SoHO entity’ and ‘SoHO establishment’. 

  • A SoHO entity means an entity legally established in the Union that carries out one or more SoHO activities.
  • A SoHO establishment means a SoHO entity that carries out any of the following SoHO activities: both processing and storage; release; import; export. 

All establishments are entities, but not all entities are establishments. All entities are required to register as a SoHO entity on the EU SoHO platform. This includes: 

  • testing laboratories involved in testing of SoHO donors or of persons from whom SoHO are collected for autologous or ‘within relationship’ use.
  • Sites which use SoHO and not previously covered under the BTC legislation, for example, hospitals/clinics/dentists which apply SoHO to patients (human application). 

Authorisations

There are three potential authorisations required by a SoHO establishment, depending on the activities undertaken:

  • SoHO establishment authorisation
  • SoHO importing establishment authorisation
  • SoHO preparation authorisation

New substances and activities included

The SoHO Regulation:

  • covers substances not previously addressed in previous legislation, for example, faecal microbiota (FMR); human breast milk; blood other than for transfusion; placenta capsules
  • applies to human application, which was out of scope of previous legislation
  • may require clinical outcome monitoring, depending on an establishment’s activities

Do previously authorised establishments remain authorised?

Establishments that were previously authorised will be deemed authorised under the new Regulation. Previously authorised tissue establishments published on the EU coding platform will be automatically transposed to the EU SoHO Platform by the European Commission. The HPRA will verify the information within the platform.

The HPRA will contact previously authorised establishments to: 

  • advise how to include information on the EU SoHO platform
  • advise of next steps in cases where they may no longer be considered establishments