Can Healthcare Institutions in Serbia Perform Stem Cell Treatments?

Our office has received the following questions regarding the performance of stem cell treatments in healthcare institutions in Serbia:

  1. Can a healthcare institution in Serbia (and in what prescribed form of healthcare institution) perform stem cell treatments?
  2. Is an additional permit required for this, aside from the usual consent from the health inspection?
  3. Specifically, the treatments in question are:
    • Autologous cell products from adipose tissue,
    • Autologous cell products from bone marrow,
    • PRP method.

Legal Basis and AK STATT’s Position

According to the provisions of the Law on Healthcare (“Official Gazette of RS”, No. 25/19, 92/23 – authentic interpretation), healthcare activities in Serbia must be based on scientific evidence, safe, effective, and efficient, in line with professional standards, adopted guidelines of good practice, treatment protocols, and principles of professional ethics. Healthcare institutions and private practices are obliged to apply scientifically proven, verified, and safe healthcare technologies in the prevention, diagnosis, treatment, healthcare, and rehabilitation of the sick and injured.

Definition of Healthcare Technologies

Healthcare technologies encompass all methods and procedures that can be used to improve human health, including safe, quality, and effective medicines, medical devices, medical software, medical procedures, and conditions for their application. A new healthcare technology is defined as one that is being introduced for the first time for use in Serbia or at a certain level of healthcare.

Procedure for Introducing New Healthcare Technologies

The assessment of healthcare technologies involves comparing new technologies with existing ones (“gold standard”) based on clinical effectiveness, safety, economic analyses, and other relevant factors. This assessment is conducted according to the Rulebook on Closer Conditions and Manner of Performing Healthcare Technology Assessment (“Official Gazette of RS”, No. 97/20), which stipulates that a healthcare institution can apply new technology if it has trained staff, appropriate space, equipment, medicines, and medical devices, with the approval of the Ministry of Health.

Specific Procedures

  1. Autologous Cell Products from Adipose Tissue and Autologous Cell Products from Bone Marrow: These methods can be considered new healthcare technologies and require an additional permit from the Ministry of Health.
  2. PRP Method: This technique is listed as a procedure in the field of aesthetic “anti-age” medicine and can be performed in institutions registered for surgical branches of medicine or dental medicine, but still requires an additional permit for new healthcare technology.

AK STATT’s Position

According to our opinion, in line with the Law on Healthcare and relevant regulations, healthcare institutions in Serbia can perform stem cell treatments if they:

  • Have trained staff and appropriate space, equipment, medicines, and medical devices.
  • Obtain approval from the Ministry of Health for the use of new healthcare technology.

Thus, in addition to the usual consent from the health inspection, an additional permit is required for the application of new healthcare technologies, including treatments with autologous cell products from adipose tissue, bone marrow, and the PRP method.


Healthcare institutions in Serbia can perform stem cell treatments if they meet certain conditions and obtain the necessary permits from the Ministry of Health. These procedures must comply with scientifically proven methods and safety standards, ensuring the safety and effectiveness of the treatments.

For more information and legal advice regarding the application of new healthcare technologies, contact AK STATT. Our team of experts is ready to provide comprehensive legal support.

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