One question we hear often: can a company with no pharmacist in its ownership structure open a pharmacy in Serbia at all? The answer depends on the form chosen. A pharmacy-health facility can. A private practice pharmacy cannot.
Opening a pharmacy in Serbia is governed by two key legal instruments: the Law on Healthcare and the Rulebook on Detailed Requirements for Performing Healthcare Activity. Before any registration application can be submitted, a permit from the Ministry of Health is required. The sequence of steps is not flexible.
This guide covers all conditions for opening a pharmacy in Serbia, explains the differences between the two organisational forms, and describes the registration procedure before the Serbian Business Registers Agency (SBRA).
(Ministry of Health of the Republic of Serbia)
Contents
- Two forms of pharmacy activity: comparison
- Ministry of Health permit
- Who can be the founder of a pharmacy
- Registering a branch
- Staff requirements
- Equipment requirements
- Premises requirements
- Required medication stock
- Registering the pharmacy and starting operations
- What products can a pharmacy sell
- Mandatory pharmacy signage and markings
- Penalties for legal violations
- Frequently asked questions
Two Forms of Pharmacy Activity: Comparison
A pharmacy in Serbia may be organised as a pharmacy-health facility or as a private practice pharmacy. The choice of form determines who may be the founder, how many staff are required, what premises and equipment must be in place, and whether branches are possible.
| Criterion | Pharmacy-health facility | Private practice pharmacy |
|---|---|---|
| Founder | Legal or natural person | Natural person (healthcare professional) |
| Founder qualifications | No healthcare qualification required | Unemployed or retired healthcare professional |
| Registration form | Healthcare institution (SBRA) | Sole proprietor (SBRA) |
| Branches | Yes | No |
| Staff | 2 graduate pharmacists + 1 pharmaceutical technician | 1 graduate pharmacist |
| Minimum premises | 45 m² | 30 m² |
| Medication stock | 10 days of operation | 5 days of operation |
Ministry of Health Permit
Without a permit from the Ministry of Health, it is not possible to initiate registration before the SBRA. This is the first mandatory step regardless of the chosen organisational form.
The Ministry of Health issues a permit after a pharmaceutical inspector determines that all prescribed conditions are met. The inspection is initiated by the submission of an application by the prospective founder. The inspector verifies staff, premises, equipment, and medication stocks on site. Only following a positive inspection finding does the Ministry issue the decision confirming compliance.
Who Can Be the Founder of a Pharmacy
A pharmacy-health facility may be publicly or privately owned. When privately owned, the founders may be both legal entities and natural persons, and they are not required to be healthcare professionals. This is the key distinction from a private practice pharmacy.
A private practice pharmacy may only be established by a natural person who is a healthcare professional and who is either unemployed or retired. An employed healthcare professional cannot be the founder of a private practice while their employment contract is in force.
For legal entities interested in entering the pharmaceutical sector, the only available form is the pharmacy-health facility. The general framework for establishing such an entity in Serbia is covered in our guide on company formation in Serbia, while the specifics of healthcare institution registration are governed by sector-specific legislation.
Registering a Branch
Since a private practice pharmacy is registered as a sole proprietorship, registering branches is not possible. A pharmacy-health facility, by contrast, may have branches.
Each branch of a pharmacy-health facility must independently meet the same conditions as the headquarters: at least one graduate pharmacist, one pharmaceutical technician with secondary vocational education, a minimum area of 30 m², and medication stocks sufficient for ten days of operation. The branch is registered in the Register of Healthcare Institutions and the Unified Register of Healthcare Subjects maintained by the SBRA, by submitting the appropriate registration application.
Staff Requirements
Staff requirements are stricter for a pharmacy-health facility than for a private practice pharmacy.
A pharmacy-health facility must have at least two graduate pharmacists and one pharmaceutical technician with secondary vocational education. For a private practice pharmacy, one graduate pharmacist is sufficient, and that individual is also the founder.
Those planning to open a private practice should verify that their current employment status satisfies the requirement of being unemployed or retired before submitting the application to the Ministry. For questions about employment status and labour law, see our article on employment contracts in Serbia.
Equipment Requirements
Equipment requirements differ between the two forms, but there is a shared baseline that applies to both.
For a private practice pharmacy, the prescribed equipment includes: porcelain, enamel, plastic, and glass measures, pharmacy spoons, syrup dissolution chambers, a refrigerator, a stove, professional literature, and other standard office and hygiene equipment. For a pharmacy-health facility, the applicable Rulebook requires a broader range of pharmaceutical equipment in addition to the above. The complete prescribed list is set out in the Rulebook.
Premises Requirements
For both forms, premises must satisfy general building conditions: sound, thermal, and hydro insulation, access to electrical and telephone networks, water supply, sewage, and heating. The temperature in the premises must remain between 18 and 25°C in accordance with the purpose of each room.
The minimum area for a pharmacy-health facility is 45 m². For a private practice pharmacy, the minimum is 30 m². The Rulebook also defines specific requirements regarding the layout and designated purpose of rooms within that total area.
Required Medication Stock
A pharmacy-health facility must maintain medication stocks in the range and quantity sufficient for ten days of operation. A private practice pharmacy must have stocks sufficient for five days of operation. For pharmacy-health facilities that organise a galenic laboratory or a pharmacoinformatics unit, additional requirements apply beyond this baseline.
Registering the Pharmacy and Starting Operations
After obtaining the positive decision from the Ministry of Health, the registration procedure is initiated before the SBRA.
Private practice pharmacies are registered in the Register of Business Entities at the SBRA as sole proprietors. The SBRA decides within 3 to 5 working days of a complete application. The procedure is similar to the electronic registration of entrepreneurs in Serbia, with the addition of the Ministry's decision as supporting documentation.
The registry for pharmacy-health facilities is also maintained by the SBRA, but the procedure is more complex. In addition to the Ministry's decision, a Founding Act and statute are required. The Ministry's decision, the Founding Act, and the statute are published on the SBRA website. The decision period is the same as for private practice: 3 to 5 working days. All registration forms and documentation requirements are available on the SBRA website.
What Products Can a Pharmacy Sell
Beyond medicines and medical devices, a pharmacy may sell other products, but only those designated as permissible by a special act of the relevant ministry. The expansion of the product range is not left to the pharmacy's own discretion.
Within the profession, there is ongoing debate about whether a broader product range diverts pharmacists from their core advisory role towards patients. These professional concerns do not modify the applicable regulation, but they are relevant context for understanding the practical constraints that govern pharmacy operations.
Mandatory Pharmacy Signage and Markings
Every pharmacy is required to display the sign "Pharmacy" and clearly indicate whether it operates as a pharmacy-health facility or a private pharmacy. The name and surname of the responsible pharmacist must be prominently displayed.
A pharmacy may use its own logo, but must also display a pharmacy symbol: a mortar and pestle, scales, a chalice with a snake, or a green or white cross.
Displaying items or advertising messages that encourage gifts or price reductions on medicines and medical devices is prohibited unless this complies with the Ethical Code of Pharmacists of Serbia. Advertising a medical product to the general public must not mention the name of any pharmacy where it can be purchased. Incentivising or employing marketing approaches that encourage the purchase of medicines for unnecessary or excessive use is also prohibited.
Penalties for Legal Violations
The Law on Healthcare prescribes monetary fines for violations of its provisions. Fines are imposed in various situations: failure to meet operating conditions, absence of required signage, operating contrary to a Ministry decision, absence of professional development for healthcare workers, or permitting a person without the required qualifications to perform healthcare activities.
Fines may be imposed on the pharmacy institution or practice itself, on the responsible individual, and on the healthcare professional personally. For managing tax and regulatory compliance risk in pharmacy operations, we recommend seeking support from a corporate lawyer.
Frequently Asked Questions – Opening a Pharmacy in Serbia
Can a foreign person open a pharmacy in Serbia?
Yes. A foreign natural person or legal entity may be the founder of a pharmacy-health facility in Serbia. The foreign founder is not required to be a healthcare professional. For a private practice pharmacy, a foreign natural person must be a healthcare professional who is unemployed or retired. Before proceeding, foreign investors should review the general conditions for company formation in Serbia and consult a corporate lawyer regarding sector-specific requirements.
How long does it take to open a pharmacy in Serbia?
The total duration depends on two phases. The Ministry of Health phase (inspection and permit issuance) has no legally prescribed deadline and can take from several weeks to several months, depending on the completeness of documentation and inspector availability. The SBRA registration phase takes 3 to 5 working days from a complete application. Preparing premises, staffing, and equipment before the inspection is the key factor in reducing overall duration.
Can a pharmacy-health facility have multiple locations in Serbia?
Yes. A pharmacy-health facility may register branches. Each branch must independently meet staff requirements (at least one graduate pharmacist and one pharmaceutical technician), premises requirements (minimum 30 m²), and maintain medication stocks for ten days of operation. The branch is registered at the SBRA with a separate application. A private practice pharmacy cannot have branches as it is registered as a sole proprietor. For details on branch registration in Serbia, see our article on branch and representative office registration.
Can an employed pharmacist open a private practice pharmacy?
No. A private practice pharmacy may only be founded by an unemployed or retired healthcare professional. A pharmacist who is currently in employment does not satisfy the eligibility condition while that employment contract remains in force. For questions about employment status and termination options, see our overview of employment contracts in Serbia.
What are the costs of opening a pharmacy in Serbia?
Costs vary by form. For a private practice pharmacy, the SBRA registration fee is relatively low, but the costs of fitting out the premises and acquiring the initial medication stock for five days of operation must be factored in. For a pharmacy-health facility, in addition to registration fees, there are costs for drafting the Founding Act and statute, larger premises, and a more extensive equipment list. Current SBRA registration fees are available on the SBRA website.
