Applying for authorisation of a SoHO preparation

Before a SoHO preparation is applied to a person, it must be authorised by the competent authority, which in Finland is Fimea.

Fimea's authorisation is also required where the SoHO is processed and immediately applied to the same person, for example in autologous use (a so-called bedside preparation), or within a relationship, for example in insemination treatment.

Fimea's authorisation is not required for a SoHO preparation used in a surgical procedure where SoHO is removed from the patient, prepared and immediately reapplied to the same patient in the surgical field during the procedure. A CE-marked medical device suitable for the intended purpose must be used. For example, authorisation is not required for the patient's own blood vessel used in coronary artery bypass surgery.

SoHO entities must submit applications for authorisation of SoHO preparations to Fimea's registry. Applications should primarily be submitted electronically. The application must include a cover letter, administrative information, information entered in the EU SoHO Platform, quality, non-clinical and clinical data, and a risk assessment. The application content is specified in greater detail in Article 39 of the SoHO Regulation. The extent of the documentation required depends on the risk level of the preparation, whether the preparation is described in a European Directorate for the Quality of Medicines & HealthCare (EDQM) monograph on SoHO, and whether it complies with that monograph. More detailed application instructions will be added to the website later in 2027.

SoHO entities must submit a separate application for authorisation for each SoHO preparation.

To be authorised, a SoHO preparation must be safe, of acceptable quality and effective. Fimea assesses this by reviewing the information on the quality of the preparation submitted by the applicant and, depending on the risk level of the preparation, the results of non-clinical and clinical studies conducted with the SoHO. On the basis of this information, an assessment report and a proposal for a decision are prepared for the SoHO preparation.

The conditions for authorising a SoHO preparation are that:

• the processing, characteristics, clinical indication and other information concerning the preparation have been duly reported;
• the preparation meets the manufacturing and quality requirements established by the EDQM for the preparation, or other applicable requirements;
• the preparation has a specific clinical indication;
• the benefits of the preparation in relation to its risks have been assessed, with scientific evidence and clinical data on the expected benefit and risk provided;
• a clinical-outcome monitoring plan has been presented if the risk associated with the preparation is more than negligible;
• a clinical study plan has been presented if the risk associated with the preparation is more than low;
• the use of the preparation has been compared with standard care if the risk associated with the preparation is more than moderate.

Fimea will request additional information from the applicant where necessary.

Fimea may authorise or reject the preparation.

Where the risk associated with the preparation is more than negligible, or its clinical effectiveness is not known, Fimea may grant a temporary authorisation to allow the clinical evidence required for authorisation to be generated.

Fimea may suspend or withdraw the authorisation of a SoHO preparation in accordance with the SoHO Regulation and national legislation.

The EU-level SoHO Coordination Board (SCB) will define application processing times by 2027 at the latest. These processing times will also be followed in Finland.

The processing time does not include time used for:

• a possible hearing of the applicant;
• requesting and submitting additional information;
• clinical-outcome monitoring;
• additional validation;
• producing additional information on quality and safety.

The processing time is paused during these stages (a so-called clock stop).

Fees will be laid down in greater detail 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 turn of 2026 and 2027.