Registration of SoHO Entities

An entity must register as a SoHO entity if it performs one or more of the following activities involving substances of human origin (SoHO):

• registration of SoHO donors
• assessment of the suitability of SoHO donors (including review of medical history and medical examinations)
• testing of SoHO donors, or individuals from whom SoHO are collected for autologous or partner donation use (including infectious disease testing) 
• collection of SoHO 
• quality control (testing) of SoHO 
• processing of SoHO without storage 
• storage of SoHO without processing 
• distribution of SoHO 
• application of SoHO to a human recipient 
• registration of clinical outcomes.

If you are unsure whether your activities fall within the definition of a SoHO entity or a SoHO establishment, you may contact Fimea before registering at [email protected]  

An entity must apply for a SoHO establishment authorisation if it performs any of the following activities: 

• both processing and storage of SoHO 
• release of SoHO 
• import of SoHO from outside the European Union 
• export of SoHO outside the European Union.

New SoHO establishments falling within the scope of the Regulation will be registered as part of the authorisation procedure from 7 August 2027 onwards. Guidance on applying for authorisation will be published separately in spring 2027.

An organisation may have several SoHO-related activities or operating sites. The organisation should assess which activities and sites together constitute an appropriate SoHO entity for registration purposes. A SoHO entity must designate a single responsible person and operate under a common quality system.

Examples of SoHO entities include:

• public and private hospitals, clinics and other healthcare units where substances of human origin are applied to humans;
• laboratories that perform donor infectious disease testing or microbiological or other quality control testing of SoHO preparations;
• blood centres that store and distribute blood components;
• hospital pharmacies that process autologous SoHO preparations but do not release them for use or store them.

Before submitting a registration notification, please ensure that the following requirements have been addressed:

• The entity carries out at least one activity within the scope of the SoHO Regulation.
• The applicable registration procedure has been identified: whether the entity is a SoHO entity or a SoHO establishment requiring authorisation. 
• The general obligations applicable to entities handling substances of human origin, as set out in Chapter IV of the SoHO Regulation, have been taken into account. 
• A responsible person has been designated for the entity who meets the qualification and experience requirements laid down in Article 36 of the SoHO Regulation. 
• The information required for registration has been compiled in accordance with Article 35 of the SoHO Regulation. 
• The organisation has assessed whether its activities meet the criteria for a critical SoHO entity. Further information on critical substances of human origin is available on Fimea’s website: Critical Substances of Human Origin.

Registration will be carried out using a dedicated form, which will be published on these pages by 1 January 2027. The registration notification must include, among other things, the following information:

• the name of the SoHO entity; 
• the administrative contact details of the SoHO entity, including an email address, telephone number and postal address; 
• details of the responsible person; 
• details of the operating sites; 
• the substances of human origin handled by the entity; 
• the SoHO activities carried out by the entity; 
• an assessment of the significance of the entity’s activities for the availability of critical substances of human origin.

The contact email address published on the EU SoHO Platform must not be a personal email address belonging to an individual.

1. Complete Fimea’s registration form. Instructions for completing the form are provided with the form.
2. Submit the completed form to Fimea in accordance with the instructions.
3. Fimea will process the notification and record the information in the national register.
4. Fimea will transmit the information required under the SoHO Regulation to the EU electronic SoHO Platform.
5. Fimea will notify the operator once the registration has been processed and the information has been published on the EU SoHO Platform.

Fimea may request additional information during the processing of the registration, if necessary.

The processing time for the registration of a SoHO entity by Fimea is up to 60 days. The processing period does not include any time required for requesting and submitting additional information.

Registration is free of charge if the registration notification is submitted to Fimea before 7 August 2027. Registration notifications submitted after that date will be subject to a fee. Fees will be laid down in a Decree of the Ministry of Social Affairs and Health on fees charged for services provided by the Finnish Medicines Agency. The decree will enter into force at the beginning of 2027.
 

A SoHO entity must keep its registration information up to date and notify Fimea of any changes affecting the registered information without undue delay.

Examples of changes that must be reported:

• a change of the responsible person; 
• a change in the name or contact details of the SoHO entity; 
• the commencement of operations at a new operating site;
• the relocation of an operating site to new premises; 
• the closure of an operating site; 
• changes to or expansion of SoHO activities; 
• changes to the categories of substances of human origin handled by the entity; 
• the suspension or cessation of activities.

If a change in activities may result in the SoHO entity becoming a SoHO establishment requiring authorisation, the entity must contact Fimea before commencing the modified activities.