SoHO Regulation- Scope and Key Changes from Previous Legislation

Scope of SoHO Regulation- What is covered?

The following areas are within the scope of the SoHO Regulation:

• 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 e.g. medicinal products, ATMPs, IMPs, medical devices
• SoHO activities that have a direct impact on the quality, safety or effectiveness of SoHO.
• Human application (not in scope of blood, tissues and cells legislation) 

SoHO activities included in scope

SoHO activities that have a direct impact on the quality, safety or effectiveness of SoHO. The following activities are regarded as SoHO activities by the Regulation:

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

Scope of SoHO Regulation- What is not covered?

• 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 the SoHO Regulation differ from the previous legislation?

SoHO Entities and Establishments

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 of the SoHO activities, referenced above under ‘what is covered under the SoHO Regulation scope’.

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 also 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 blood, and tissue and cells 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 

The SoHO Regulation includes substances that were not previously addressed in the Blood and Tissues and Cells Directives. e.g. Faecal microbiota (FMT); human breast milk; blood other than for transfusion; placenta capsules. 

Do previously authorised blood and tissue 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 tissue or blood establishments and advise of next steps in cases where they may no longer be considered establishments.