Pursuant to the provisions of the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision), healthcare providers in the Republic of Serbia are:
- Healthcare institutions in public and private ownership;
- Higher education institutions in healthcare and other legal entities authorised by a special law to perform healthcare activities;
- Private practice;
- Healthcare professionals who perform healthcare activities in accordance with the law;
- Other higher education institutions, i.e. scientific-educational and scientific institutions, upon the opinion of the Ministry of Health, in accordance with the law.
A healthcare institution may be established with public or private funds, unless otherwise stipulated by the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision).
Under the conditions prescribed by the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision), a public healthcare institution is established by the Republic of Serbia, an autonomous province, or a local self-government unit while a legal or natural person establishes a private healthcare institution.
A healthcare institution may be established as:
- Primary health centre;
- Healthcare institution polyclinic;
- Pharmaceutical institution;
- Hospital (general or specialised);
- Health centre;
- Institute;
- Institute of Public Health;
- Clinic;
- Institute;
- Clinical-hospital centre;
- University clinical centre;
- Military healthcare institution or medical unit and institution within the Serbian Armed Forces, in accordance with a special law.
The legal provisions regulating business entities apply accordingly to the governing bodies, legal status changes, change of legal form, and cessation of existence of privately owned healthcare institutions.
A healthcare institution may also be established under public-private partnership regulations, unless otherwise stipulated by the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision).
Conditions for Establishing a Private Healthcare Institution
A healthcare institution may perform healthcare activities if it fulfils the conditions prescribed by the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision) and regulations adopted for the implementation of the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision), including having:
- The required type and number of healthcare professionals and associates with the appropriate higher or secondary education, who have passed the professional exam, hold the relevant licence for independent practice issued by the competent chamber, and, for performing certain activities and with the necessary specialisation or academic/teaching title, employed permanently;
- Prescribed diagnostic, therapeutic, and other equipment required to safely and modern perform the healthcare activities for which the institution is established;
- Prescribed premises for patient reception and accommodation, for performance of the diagnostic, therapeutic, and rehabilitation procedures, nursing care, as well as for storing medicines and medical supplies;
- Prescribed types and quantities of medicines and medical supplies necessary to carry out the healthcare activities for which the institution is established.
Two or more healthcare institutions may organise joint medical services for laboratory, X-ray, and other diagnostic procedures, as well as shared non-medical services for legal, economic-financial, technical, and other administrative tasks.
Detailed requirements regarding staffing, equipment, premises, and medicines that healthcare institutions or other forms of healthcare services must meet to be established and to carry out healthcare activities, or specific healthcare-related tasks, are prescribed by the Rulebook on Detailed Conditions for Performing Healthcare Activities in Healthcare Institutions and Other Forms of Healthcare Services (“Official Gazette of RS”, no. 43/2006, 112/2009, 50/2010, 79/2011, 10/2012 – amended rulebook, 119/2012 – amended rulebook, 22/2013, 16/2018, 18/2022, 20/2023, 87/2024, 21/2025, 29/2025, 75/2025 and 86/2025).
A healthcare institution that uses sources of ionising radiation must, in addition to general conditions prescribed by the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision), also meet other requirements set by laws governing protection from ionising radiation.
A healthcare institution may perform healthcare activities only once the Ministry of Health, by decision, confirms that all legal conditions for performing such activities have been met. For all other than pharmaceutical institutions, the decision is made by a healthcare inspector and is subject to appeal to the Minister of Health.
A healthcare institution may only perform the healthcare activities defined in the Ministry of Health’s decision confirming fulfilment of the prescribed requirements.
Exceptionally, by concluding a business-technical cooperation agreement with another healthcare institution or private practice, in accordance with the labour law and the law regulating the employment of public service employees, or by concluding a supplementary work contract with the healthcare professional, or in another manner prescribed by the labour law and the law regulating the employment of public service employees a healthcare institution may engage:
- a healthcare professional of a different speciality from another healthcare institution or private practice, if necessary, to ensure that a specific patient receives quality and safe healthcare through direct cooperation and consultation with the healthcare professional from that institution, as well as
- a healthcare professional licensed to perform methods and procedures of complementary medicine for additional diagnostics, treatment, and rehabilitation of a patient, within the scope of healthcare activities for which the institution is established.
It is prohibited for a healthcare professional of a different specialty to perform healthcare activities outside the scope of healthcare services defined in the Ministry of Health’s decision confirming the fulfilment of prescribed conditions for that healthcare institution, except in cases provided for by the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision).
Founding Act of a healthcare institution
The founder of a healthcare institution shall adopt a Founding Act, which must include:
- The name and registered seat, or full name and place of residence of the founder;
- The name and registered seat of the healthcare institution;
- The activity (scope of services) of the healthcare institution;
- The amount of funds for establishing and starting the work of the healthcare institution, as well as the method of securing those funds;
- The rights and obligations of the founder in relation to the activity for which the healthcare institution is established;
- The mutual rights and obligations of the healthcare institution and the founder;
- The governing bodies of the healthcare institution at the time of establishment and their powers;
- The full name of the person who will, until the appointment of the director, perform the duties and exercise the powers of the director;
- The deadline for adopting the statute, appointing the director, and forming the governing bodies.
The signatures of the founders on the Founding Act of a privately owned healthcare institution must be notarised in accordance with the law.
The Founding Act of a healthcare institution must be registered and published on the website of the Serbian Business Registers Agency (SBRA).
Statute of the Healthcare Institution
Every healthcare institution must have a statute regulating its activities, internal organisation, management, operations, criteria for appointing and dismissing the director and deputy director, and other matters relevant to the institution’s functioning.
The founder adopts the statute of a private healthcare institution.
The statute of the healthcare institution must be registered and published on the SBRA website.
Termination of Healthcare Institutions
A healthcare institution may be dissolved, merged with another, or split into multiple institutions, in accordance with the law.
Provisions regulating the legal status of business entities also apply to the termination of healthcare institutions.
Prohibition of Performing Healthcare Activities or Specific Healthcare Tasks within a Healthcare Institution
The Ministry of Health shall issue a decision prohibiting the performance of healthcare activities, or the performance of specific healthcare tasks within a healthcare institution, if:
- The institution does not meet the prescribed conditions regarding staff, equipment, premises, medicines, and medical supplies;
- It performs healthcare activities that are not defined in the decision confirming the fulfilment of prescribed conditions for performing healthcare activities;
- A measure of prohibition is proposed as a result of professional work quality assessment;
- It displays the name or marks the healthcare institution contrary to the decision confirming the fulfilment of prescribed conditions;
- It advertises the performance of professional medical procedures and methods of healthcare services contrary to the Ministry’s decision referred to in Article 33, paragraph 2 of the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision), or in violation of the Law on Healthcare (“Official Gazette of RS”, no. 25/2019, 92/2023 – authentic interpretation, and 29/2025 – Constitutional Court decision).or the law regulating advertising;
- It performs activities contrary to the law.
Based on the above findings, a healthcare inspector shall issue a decision prohibiting the performance of healthcare activities, or the performance of specific healthcare tasks within healthcare activities in the healthcare institution—except in pharmaceutical institutions—until the identified irregularities are remedied, in accordance with the law. An appeal may be submitted to the Minister of Health against the healthcare inspector’s decision.
A healthcare institution may, following a confirmatory inspection, and based on a decision by the healthcare inspector confirming the lawfulness of its operations, commence its activities if, within the time period prescribed by law or stipulated in the inspector’s decision, it eliminates the reasons that led to the prohibition of performing healthcare activities or specific healthcare tasks within healthcare activities.
Register of Healthcare Institutions and Unified Database of Healthcare Entities
The Register of Healthcare Institutions and the Unified Database of Healthcare Entities are maintained by the Serbian Business Registers Agency (SBRA).
Healthcare institutions, whether in public or private ownership, shall be registered in the Register of Healthcare Institutions in accordance with the law.
The Register of Healthcare Institutions is an electronic, central, public database of registered healthcare institutions that perform healthcare activities based on a decision by a healthcare or pharmaceutical inspector confirming that the prescribed conditions for performing such activities have been met, in accordance with the law.
The Unified Register of Entities in the Healthcare Sector comprises consolidated data on healthcare institutions and private practices operating within the territory of the Republic of Serbia.
Based on the decision confirming fulfilment of the prescribed conditions for performing healthcare activities, a healthcare institution and its organisational unit located outside its registered seat shall be entered into the Register of Healthcare Institutions, which is maintained by the Serbian Business Registers Agency (SBRA), in accordance with the law.
A healthcare institution acquires legal entity status and may commence operations on the day it is entered into the Register of Healthcare Institutions maintained by the SBRA.
An organisational unit located outside the registered seat of the healthcare institution may also commence operations on the day it is entered into the Register of Healthcare Institutions, in accordance with this law and the regulations adopted for its implementation.
The Rulebook on the Content of the Register of Healthcare Institutions and the Documentation Required for Registration (“Official Gazette of RS”, no. 80/2019) regulates the detailed content of the Register maintained by the Business Registers Agency of the Republic of Serbia, the content and format of the registration application, and the documentation required for registration.
Last update: 20. 1. 2026.
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