The COVID-19 pandemic, which dominated throughout the year 2020, has brought about significant changes globally, affecting almost every sector of the economy worldwide. The profound impact of the pandemic is evident in the economy, with pharmacies emerging as key institutions in ensuring primary healthcare. Long queues outside pharmacies and increased demand for supplements, medications, basic hygiene products, and disinfectants highlight the significant need for these institutions that provide vital resources.
The general requirements for performing pharmaceutical healthcare activities are regulated by the Law on Healthcare, while more detailed provisions can be found in the Rulebook on Detailed Requirements for Performing Healthcare Activity in Health Facilities and Other Forms.
A pharmacy can exist in two forms: as a pharmacy – a pharmacy – health facility or as a private practice pharmacy. The choice between these forms depends on personnel, space, and equipment. It is also important to note that a private practice is registered as a sole proprietorship.
In the table below, we have outlined the basic differences between these two forms of pharmacy practice, while detailed explanations will be provided in the text.
| PHARMACY – HEALTH FACILITY | PRIVATE PRACTICE PHARMACY | |
| FOUNDER | Natural or legal person | Natural person |
| BRANCH |  |
 |
| FOUNDER’S QUALIFICATIONS | |
Unemployed medical worker or a retired medical worker |
| STAFF | 2 Bachelors of Pharmacy + Pharmaceutical technician | 1 Bachelor of Pharmacy |
| EQUIPMENT | More necessary equipment | Less necessary equipment |
| PREMISES | Bigger space | Smaller space |
| THE AMOUNT OF PROVIDED MEDICATION | In the range and quantity enough for ten days of work | In the range and quantity enough for five days of work |
PERMIT OF THE MINISTRY OF HEALTH
Before establishing a pharmacy and registering it in the appropriate registry, the first thing to keep in mind is that you must obtain permission from the relevant Ministry of Health.
The Ministry of Health issues a permit for the establishment of a pharmacy after determining that the founder has fulfilled all prescribed conditions for the operation of a pharmacy-health facility or private practice pharmacy. Compliance with these conditions is verified by a pharmaceutical inspector after the submission of the application by the potential founder of the pharmacy.
To become more familiar with the prescribed conditions for establishing a pharmacy-health facility or private practice pharmacy, we will now address each of these conditions in detail.
THE FOUNDER
Pharmacy-health facilities can be either publicly or privately owned. When privately owned, the founders can be both legal entities and individuals and are not required to meet specific conditions, meaning they do not have to be healthcare professionals. This is a significant advantage compared to private practice pharmacies, which can only be established by individuals who are healthcare professionals (unemployed or retirees).
A BRANCH
Since the pharmacy practice is organized as a sole proprietorship, it is not possible to register branches. In contrast, a pharmacy-health facility can have branches. Branches of pharmacy-health facilities must also meet requirements regarding personnel, equipment, premises, and the necessary quantity of medications, as well as the headquarters of the pharmacy-health facility. A branch of a pharmacy-health facility must have at least one graduate pharmacist, one pharmaceutical technician with secondary vocational education, an area of at least 30 m², etc. Regarding equipment, the branch must have medications in stock in quantities 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 Business Registers Agency (BRA), by submitting the appropriate registration application. Before the establishment of this register, healthcare institutions were registered in commercial courts.
STAFF
The requirements for establishing a pharmacy-health facility regarding personnel are stricter than those for opening a private practice pharmacy. A pharmacy-health facility must have at least two graduate pharmacists and one pharmaceutical technician with secondary vocational education. On the other hand, for the establishment of a private practice pharmacy, it is sufficient to have only one graduate pharmacist.
EQUIPMENT
The equipment for pharmacy-health facilities is much more extensive, and the requirements are higher compared to those for private practice pharmacies. In addition to standard office and hygiene equipment, the following equipment is needed for a private practice pharmacy: porcelain, enamel, plastic, and glass measures, pharmacy spoons, syrup dissolution chambers, refrigerator, stove, professional literature, etc. For pharmacy-health facilities, according to the applicable Regulations on the detailed conditions for conducting this activity, in addition to the above, it is necessary to have a broader range of pharmacy equipment.
PREMISES
For the establishment of both pharmacy-health facilities and private practice pharmacies, certain general conditions regarding the building structure must be met, such as sound, thermal, and hydro insulation, access to electrical and telephone networks, water supply, sewage, and heating. According to regulations, the temperature in the premises should range between 18 and 25°C, depending on their purpose. The regulations also define specific requirements regarding the size of the premises. For the establishment of a pharmacy-health facility, the minimum area of the premises must be 45 m2, while for a private practice pharmacy, this area is reduced to 30 m2.
THE AMOUNT OF OFFERED MEDICATION
When it comes to the required amount of the offered medication, the pharmacy facility must have medication in the range and the quantity enough for ten days of work, while the private practice pharmacy must have medication in the range and the quantity enough for five days of work.
Apart from the abovementioned, more requirements are prescribed for the pharmacy facility that organizes the galenic laboratory and the pharmacoinformatic unit, as a special organizational unit.
REGISTERING THE PHARMACY AND STARTING WORK
After obtaining the decision from the relevant ministry confirming compliance with all conditions, the procedure for establishing a pharmacy begins before the appropriate registry. Private practice pharmacies are registered in the Register of Business Entities at the Serbian Business Registers Agency (SBRA) as sole proprietors. The SBRA establishes a private practice pharmacy within 3-5 working days from the submission of the registration application.
On the other hand, the registry of pharmacy-health facilities is also maintained by the SBRA. The procedure for establishing a pharmacy-health facility is more complex as it requires additional documentation such as the founding act and statute. The decision of the competent ministry, the founding act, and the statute of the pharmacy-health facility are published on the SBRA website, and the deadline for deciding on the submitted registration application is also 3-5 working days.
WHAT CAN PHARMACIES SELL BESIDES MEDICATION?
You might have noticed that many pharmacies offer various products besides medical preparations and drugs. It’s important to note that by a special act of the relevant ministry, it’s regulated which specific products can be found in a pharmacy, ensuring that only appropriate products are offered. The range of products available in pharmacies can be diverse, which can pose a challenge for pharmacy owners and members of the pharmaceutical chamber.
Their arguments often emphasize that such expansion of the product range may distract pharmacists from their core responsibilities, including providing advice, giving instructions, and assisting patients.
DISTINCTIVE CHARACTERISTICS OF PHARMACIES
A pharmacy is obligated to display the sign “Pharmacy” and clearly indicate whether it is a pharmaceutical facility or a private pharmacy. Additionally, the name and surname of the responsible pharmacist should be prominently displayed. The pharmacy may use its logo, but it must also prominently feature a pharmacy symbol, such as a mortar and pestle, scales, or a green or white cross.
Interestingly, displaying items or advertisements that encourage gifts or price reductions on medicines and medical supplies is prohibited unless it complies with the dignity and reputation of the pharmaceutical profession and the Ethical Code of Pharmacists of Serbia. Moreover, advertising medical products to the general public must not mention the name of the pharmacy where the product can be purchased.
Furthermore, incentivizing or employing other marketing approaches to encourage the purchase of medicines and medical supplies is prohibited to avoid unnecessary and excessive usage. These provisions may come as a surprise to many, and you might now be thinking of numerous everyday examples where these provisions appear to be disregarded.
PENALTIES FOR VIOLATIONS AND PERFORMING ILLEGAL ACTIVITIES
The Law on Health Protection prescribes stringent monetary fines for violations of legal provisions. Fines are imposed in various situations, including failure to meet the conditions for conducting activities, lack of displayed name or business name, contravening ministry decisions, lack of professional development for healthcare workers, or allowing the performance of healthcare activities by unqualified personnel. Fines can be imposed on the pharmacy institution or practice itself, the responsible individual conducting the activity, as well as the healthcare worker involved.
There have been initiatives to enact a new law specifically addressing pharmacy activities. Although a draft of the law has existed since 2017, it has not been adopted, causing dissatisfaction within the pharmacy community. Despite the current law not covering all aspects of pharmacy operation, including market competition conditions, this does not deter interested parties from venturing into pharmacy establishment and successfully developing their business.
