Introducing a dedicated website section for substances of human origin

We have opened a new section of the Fimea.fi website on substances of human origin (SoHO). The aim is to provide clear and up-to-date information and guidance for both operators in the field and the general public. The website section presents all regulations, guidelines, authorisation procedures and supervision practices related to substances of human origin. 

The aim of this addition is to ensure that both operators and the general public receive easy-to-understand and up-to-date information on the topic. Contents that have previously been under the Supervision heading on Fimea.fi have been transferred to the new section. The change of the content structure is based on the upcoming SoHO regulation. 

The new EU SoHO Regulation (EU 2024/1938) brings extensive changes to the regulation of substances of human origin in Finland. The regulation will significantly expand the definition of substances of human origin: moving forward, not only blood, tissues, and cells, but also substances like breast milk and faecal microbiota, as well as potential other substances included in the future, will be regulated as substances of human origin.

As a result of the reform, regulation will extend to a wider range of activities and operators, such as donors, laboratories and clinical use units. Fimea is expected to have up to a few hundred new operators under its supervision. In addition, the regulation will also bring about changes in the operation of existing establishments handling substances of human origin, and the number of SoHO establishments to be inspected may increase from 50 to more than 100.

Read more:
Substance of human origin