Is Stem Cell Therapy Legal in Serbia: 2025

Yes, stem cell therapy is legal in Serbia

Stem cell therapy is governed primarily by the:

Law on Human Cells and Tissues (Zakon o ljudskim ćelijama i tkivima, Official Gazette of RS No. 57/2018 and 111/2021)

This law lays out the rules for everything that happens to stem cells and tissues, including:

Where they come from – How they’re donated and collected

How they’re handled – Testing, processing, storing, and transporting them safely

How they’re used – In treatments that are supervised by licensed doctors, including both your own stem cells (autologous) and donor stem cells (allogeneic)

Who can do it – Only clinics and labs that are officially licensed and regularly inspected

In short: if a clinic is offering stem cell therapy, it must follow this law at every step. From cell donation to treatment.

Quote from Article 1 (paraphrased):
The law ensures the quality and safety of human cells and tissues intended for use in the treatment of humans.
Quote from Article 4
This law applies to hematopoietic stem cells from bone marrow, peripheral blood, and umbilical cord blood, for autologous or allogeneic transplantation.
Official source:Law on Human Cells and Tissues – Official Gazette RS 57/2018, 111/2021 (in Serbian)

Key Conditions

Stem cell therapy is only legal if:

Performed by licensed clinics or hospitals
Cells are obtained from or processed by authorized tissue establishments
The procedure follows medical, ethical, and safety standards set by the Ministry of Health

While Serbia has laws regulating stem cell therapy, enforcement is inconsistent. Especially in the private sector. Some clinics operate in legal gray areas, especially those targeting international patients. By offering therapies that fall outside these strict requirements, often without formal approval.

If you’re looking at prices for Stem Cell Therapy, our article on costs in different countries might be useful for you!

Who Regulates Stem Cell Therapy in Serbia?

Ministry of Health of the Republic of Serbia
Directorate for Biomedicine (Uprava za biomedicinu)
ALIMS (Agency for Medicines and Medical Devices of Serbia. if therapy qualifies as ATMP)

What Clinics Can Offer Stem Cell Treatments in Serbia

Only certified, government authorized clinics and institutions are legally permitted to offer stem cell therapy in Serbia. These clinics must undergo a formal approval process and meet rigorous criteria defined by the Law on Human Cells and Tissues (Official Gazette RS No. 57/2018 and 111/2021).

Certifications and Conditions Stem Cell Clinics in Serbia Must Meet

To legally offer stem cell therapy, a clinic must obtain the following:

Approval as a Health Institution for Cell and Tissue Use
- The clinic must be a registered healthcare institution (e.g. hospital, specialized clinic) authorized to perform cell and tissue transplantation.
- This requires:
  – Qualified medical staff trained specifically in stem cell and tissue transplantation
  – Proper lab and clinical facilities to safely process and deliver stem cells
  – Strong internal quality systems to ensure every procedure meets medical and legal standards
- Legal Basis: Article 11–13, Law on Human Cells and Tissues, RS No. 57/2018
License as a “Tissue Establishment” (Tkivna ustanova)
- If a clinic processes, grows, stores, or distributes stem cells, like culturing them to increase the dose, it must be officially registered as a “tissue establishment.”
- To qualify, it needs:
  – GMP-grade clean rooms (like those used in pharmaceutical labs)
  – Strict biosafety protocols to prevent contamination
  – Systems to trace every cell sample from donor to patient
  – And it must be listed in the National Registry of Tissue Establishments, run by Serbia’s Directorate for Biomedicine
- In short: no clinic can legally grow or distribute stem cells unless it meets serious medical manufacturing standards and is approved by the Ministry of Health.
- Legal Basis: Articles 17–22, Law on Human Cells and Tissues, RS No. 57/2018 Article 26 defines the Registry
Ethical Approval (If Research or Experimental Treatment is Involved)
- Clinics must also obtain approval from a national ethics committee for any treatment involving:
  – Non standard therapeutic use
  – Clinical trials or investigational protocols
Supervision and Inspection Readiness
- The clinic must accept:
  – Inspections by the Directorate for Biomedicine
  – Data reporting requirements (e.g. adverse events, patient follow-ups)
- Legal Basis: Articles 47–53, Law on Human Cells and Tissues

What’s Not Allowed in Serbia regarding Stem Cell Treatments

Aesthetic/cosmetic clinics without formal medical accreditation cannot legally offer stem cell therapy.
Clinics cannot legally operate without Ministry of Health authorization, even if they import cells from abroad or partner with foreign labs.
Private wellness centers often bypass these requirements and are not recognized as legitimate providers under Serbian law.

Summary: What Certification a Stem Cell Clinic in Serbia Needs

Requirement	Description
Registered Health Institution	Must be a formally licensed clinic or hospital in Serbia
Ministry of Health Authorization	Approval to conduct cell/tissue therapy under the 2018 law
Tissue Establishment License (if needed)	Required for any lab processing, storing, or growing cells
Ethical Approval (optional)	For experimental, non-standard, or clinical trial use
National Registry Entry	Must be listed in the Directorate for Biomedicine’s Registry

Can Stem Cell Centers grow & culture cells in a lab?

Yes. Clinics in Serbia are allowed to grow and culture stem cells for patient use. Including expanding cells to higher dosages, but only under strict regulatory conditions defined by national law.

Legal Basis

The Law on Human Cells and Tissues (Official Gazette RS No. 57/2018, 111/2021) regulates all forms of:

Processing, including: isolation, culture/expansion, modification, packaging, and preservation of human cells and tissues for therapeutic use.

Key Definition (Article 3, Paragraph 1, Line 14):

“Processing means any operation performed during the preparation, handling, preservation, and packaging of human cells or tissues intended for human application.”

This explicitly includes growing or expanding stem cells in a laboratory for use in patients.

Conditions for Culturing Cells in Serbia (e.g. High-Dose Therapies)

To legally culture or expand stem cells, a clinic must:

Be Authorized as a Tissue Establishment (Tkivna ustanova)
- The facility must be licensed by the Ministry of Health
- It must meet technical and biosafety standards similar to Good Manufacturing Practice (GMP):
  – Sterile labs
  – Quality control procedures
  – Validated protocols for cell expansion and safety
- Source: Articles 17–22, Law on Human Cells and Tissues
Have an Approved Clinical Use Protocol
- If the expanded cells are intended for standard medical treatment, the clinic must have:
  – A registered indication
  – Oversight by the Ministry or Directorate for Biomedicine
- If the expanded cells are part of experimental or investigational use, the clinic must also:
  – Obtain Ethics Committee approval
  – Possibly conduct the treatment under a clinical trial framework
Comply with Traceability and Safety Regulations
- Every batch of expanded cells must be traceable from donor to recipient
- Must undergo:
  – Contamination screening
  – Identity confirmation
  – Viability testing
- Clinics must report adverse events to the Directorate
- Source: Articles 35–47, Law on Human Cells and Tissues

Not Permitted

Clinics without a tissue establishment license cannot legally culture or grow cells
Cosmetic/aesthetic clinics offering unproven high-dose treatments without Ministry approval are operating outside the law
Clinics cannot import and culture foreign cells without Serbian regulatory oversight

What “High Dose” Means in Practice

There is no specific dosage limit stated in the law. However:
- Higher cell counts are permitted if the lab growing the cells follows validated expansion protocols and maintains:
  – Genetic stability
  – Potency
  – Safety across the culture process
Such procedures are considered Advanced Therapy and may require oversight by ALIMS (Serbia’s drug agency) if the final product behaves like a drug (e.g. manipulated cells with therapeutic claims).

Can Clinics in Serbia use Umbilical cord derived Stem Cells?

Yes, clinics in Serbia can use umbilical cord–derived stem cells on different people (allogeneic use), but only if the cells are sourced from a licensed tissue establishment.

The clinic also has to be authorized by the Ministry of Health, and the treatment follows all regulations under the Law on Human Cells and Tissues (Official Gazette RS No. 57/2018, 111/2021), including donor screening, informed consent, and clinical oversight.

What Stem Cell Treatments are Legal in Serbia?

Hematopoietic stem cell transplants (bone marrow, peripheral blood, umbilical cord)
Autologous stem cell treatments for:

Blood disorders (e.g. leukemia, lymphoma)
Certain autoimmune diseases (e.g. multiple sclerosis, systemic sclerosis)
Orthopedic use (e.g. osteoarthritis, cartilage repair – if clinically validated and approved)

What Stem Cell Treatments are Not allowed in Serbia

Unlicensed cosmetic or “anti-aging” stem cell injections
Stem cell therapies for unapproved conditions (e.g. autism, erectile dysfunction, neurological treatments) unless part of an approved clinical trial

However, enforcement in this space is lax. So clinics can offer stem cell treatments, but most aren’t officially regulated or licensed to do so. This shouldn’t put you off getting treatment in Serbia! But just be aware, we know it’s super confusing!

If you want to read the sources we used to create this article, check them out below:

Link