A SHORT GUIDE TO OPENING A PHARMACY

08
Jul 2020

Contact: Kristina Vuljaj

Contact: Olivera Nećak

medicine on the table

The COVID-19 pandemics, the keyword for the year 2020, has caused some major changes in almost every commercial activity across the world. Even though the long-term consequences to the economy are yet to be seen, pharmacies, as the foundation of the primary healthcare protection, have stood out as the facilities whose necessity came to the forefront. The lines in front of pharmacies and high demand for medication, supplements, basic hygiene products, disinfectants and other medicines have shown that the demand for these facilities is surging.

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.

Pharmacies can take two forms: a pharmacy – health facility and a private practice pharmacy. Choosing between these two will depend on the staff, premises, and equipment. What one should also keep in mind is that a private practice pharmacy is established in the form of an entrepreneur.

We have made an overview of the basic differences between these two forms of performing pharmaceutical activities in the table below, while they will be explained in more detail in the following 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 + 1 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

The first thing you should have in mind is that you need to obtain the permit of the Ministry of Health before establishing and registering the pharmacy in the appropriate registry.

The Ministry of Health issues a permit for the establishment of a pharmacy only after it determines that the founder has met all the requirements for performing the pharmaceutical activities. The pharmaceutical inspector checks whether these requirements are met, after the submission of the request by the potential founder.

To get acquainted with the requirements for the establishment of a pharmacy, we will look at each of them in more detail.

THE FOUNDER

Pharmacy facilities can be public or private ownership. When they are privately owned, they can be established by legal and natural persons. The founder himself does not have to meet special conditions, i.e. he does not have to be a medical worker. This is a great advantage to the private practice pharmacy, which can be established exclusively by natural persons that are medical workers (unemployed or retired).

A BRANCH

Given that the private practice pharmacy is registered as an entrepreneur, there is no possibility of opening a branch. In contrast, a pharmacy facility may have a branch, which must also meet the requirements in terms of the staff, equipment, premises and required quantities of provided medication, as well as the seat of the pharmacy, with some difference – the pharmacy branch must have one bachelor pharmacist and one pharmaceutical technician, space area of 30 m2, etc. In terms of equipment, the branch must also have medication in the range and quantity enough for ten days of work.

A branch is registered by submitting the appropriate application to the commercial court.

plants on the table

STAFF

The requirements for the establishment of a pharmacy facility in terms of staff are set stricter than the ones for opening a private practice pharmacy. Namely, a pharmacy facility must have at least two graduate pharmacists and one pharmaceutical technician. On the other hand, for the establishment of a private practice pharmacy, only one graduate pharmacist is required.

EQUIPMENT

The equipment for a pharmacy facility is much more extensive and the requirements are set higher than those for a private practice pharmacy. In addition to the standard office and hygienic equipment, a private practice pharmacy needs to have, among other things: porcelain, enamel, plastic and glass beakers, pharmacy spoons, syrup dissolving chamber, refrigerator, professional literature, etc., while in the pharmacy facility, according to the Rulebook, it is necessary to have a wider range of equipment, in addition to the above-listed one.

PREMISES

little bottles

Both the pharmacy facility and the private practice pharmacy are required to meet certain general requirements regarding the building, such as sound, thermal and hydro insulation, access to the electricity and a telephone network, water supply, sewerage and a heating system. The temperature, depending on the purpose of the room should be 18-25°C. The Rulebook also prescribes special requirements regarding the size of the premises. Thus, a pharmacy facility must have a room of 45 m2, while a private practice pharmacy may have 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.

In addition to these, 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 the decision confirming the fulfilment of all requirements is issued, the procedure for the establishment and registration of a pharmacy is initiated before the appropriate registry.

The private practice pharmacy is entered in the register of business entities kept by the Business Registers Agency, in the form of an entrepreneur. The BRA will establish it within 3-5 days from the submission of the registration application.

The Registry of the pharmacy facilities (for now) is kept by commercial courts, and from October 11, 2020, this registry will also be kept by BRA. The procedure for establishing a pharmacy facility is more complex since it is necessary to enclose appropriate legal acts such as the founding act and the statute as the accompanying documentation. The Commercial Court shall register the pharmacy within approximately 10 days from the date of submission of the application.

WHAT CAN PHARMACIES SELL BESIDES MEDICATION?

question mark and pills

You have probably noticed that in many pharmacies you can find products that are not medicaments. The interesting thing is that a special act of the ministry regulates exactly what products the pharmacies can sell. This means that the pharmacy cannot have anything in its offer.

The range of products that can be found in pharmacies is wide in practice, which many pharmacy founders and members of the pharmaceutical chamber consider a problem. They argue that this type of expansion of the offer in the service distracts the employed experts, whose task is not only to sell the medicine but at least to advise the patient, give instructions and help the patient.

DISTINCTIVE CHARACTERISTICS OF PHARMACIES

The pharmacy must put out the inscription “Pharmacy”, as well as the information about its form – a pharmacy facility or a private practice pharmacy, and display the first and the last name of the responsible pharmacist in a visible place. On the other hand, the pharmacy can display the logo, if it has one, and it must also display the pharmacy sign, i.e. one of the following symbols: a glass with a snake, a scale, a mortar and pestle, a white or a green cross.

Also, did you know that it is forbidden to display items and advertisements that include gifts or lowering the prices of medicines and medical devices when advertising pharmaceutical activities? However, a very vague requirement must be met, i.e. if the gift or the price lowering isn’t in accordance with the ethical code and reputation of the pharmaceutical profession and the Ethics code of pharmacists. Furthermore, the advertisement of a medical device must not contain the name of the pharmacy where the medical device can be purchased.

It is also forbidden to encourage customers to buy medicines and medical devices by rewarding them or by using other market approaches, which can result in unnecessary or excessive use.

Many of these have probably surprised you since you can think of examples where these provisions do not seem to be respected.

PENALTIES FOR VIOLATIONS AND PERFORMING ILLEGAL ACTIVITIES

The Law on Healthcare prescribes severe fines in case of non-compliance with the law. They are prescribed in many situations, and here are just a few: if the pharmacy performs the activity and does not meet the requirements, does not state the business name, performs healthcare activities not compliant with the decision of the Ministry, does not provide professional training of medical workers and medical associates, enables the performance of healthcare activities by a medical worker who does not meet the requirements. Penalties are imposed on the pharmacy itself, but they can also be imposed on the responsible person that performs the pharmaceutical activity, as well as on the medical worker himself.

There have been initiatives for the adoption of a new law that will regulate exclusively the performance of pharmaceutical activities. The draft was made in 2017, and it was withdrawn the same year, leaving many pharmacists dissatisfied. Although the existing law is not comprehensive and does not regulate many issues of importance, such as the conditions of market competition in this area, this is not an obstacle to start a pharmacy and successfully develop your business.

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