How Do The Procedures For Starting A Pharmacy In A City, Town And Countryside Differ In 2023?

The requirements for a pharmacy depend on the area where it is located (city, town or countryside). Today we will share our experience of providing assistance in starting a pharmacy in Ukraine.

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General requirements to open a pharmacy and example of requirements for a pharmacy in the city

Regular premises for a pharmacy.

Ideal option is an isolated non-residential premise with a separate exit, which is located on the ground floor.

Acceptable option is a non-residential premise without separate exit, which is located on the ground floor in a public building.

A pharmacy shall not be located in educational institutions and residential halls.

Exception to the rule: if a pharmacy is located in a healthcare facility, it may be located on any floor and is not required to have a separate exit.

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Minimum area. The total area of the city pharmacy must be at least 50 square meters. The sales area shall be at least 18 square meters, the storage area (a so-called storage room) shall be at least 10 square meters and the area of the staff room - at least 8 square meters. There are no area requirements to the other rooms.

If there is a public entrance vestibule, its area is not taken into account in the area of the pharmacy.

Layout of rooms:

• The storage room shall be located so that visitors do not have access to it. It shall not be a walk-through room;
• The service and amenity rooms (staff room, dressing room, utility rooms) must not be connected to the production areas. You may not find such a direct requirement in the licensing regulations, but visitors shall have no access to the service and amenity rooms.

Accessibility for customers with reduced mobility.

Even a premise with a perfect location and a total area may fail to meet the licensing requirements. It’s worth remembering that there is now also a requirement to ensure persons with reduced mobility can access the pharmacy. More specifically, a pharmacy shall have a wheelchair ramp that complies with the current building regulations.

If your wheelchair ramp does not meet the requirements or you don’t have any at all, follow the following algorithm of actions:

First, make sure that the building does not belong to the architectural monuments of the city.

1. If not - you can install a new wheelchair ramp in accordance with the building and licensing regulations.
2. If it turns out that the building is an architectural monument, it is better to look for another premises, as you can not just install the ramp. Even recently, the way out was to install a call button, but with the adoption of new state building regulations, since April 2019 pharmacies have been actually prohibited from using call buttons, because they are not considered an element ensuring the accessibility to the building.

Practical legal advices to start a pharmacy in the city

Extra entrance to the pharmacy. Although according to the licensing requirements, a pharmacy shall have an extra service entrance, the requirements to its location are described rather sparingly. There have been cases when the State Service of Ukraine on Medicines and Drugs Control simply recommended to close it.

Life hacks to find the premises. With the lifting of the moratorium on inspections in 2019, the number of pharmacies that have had their license revoked is increasing. Practice shows that most of them rented their premises. Therefore, if you browse “rent a premise for a pharmacy”, there is every chance to find not only ready, but also fully furnished premises. Opening a pharmacy in the premises where there used to be a pharmacy is almost a 100% key to success.

Attention! Even when renting or buying a premise where there was already a pharmacy, you should pay attention to the accessibility conditions for people with disabilities. The previous pharmacy may have been licensed and operated at a time when a call button was acceptable. Today, you shall install a wheelchair ramp. During the pre-licensing inspection, you will be asked for an expert opinion on whether the ramp complies with the state building standards. You should therefore order it in advance.

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How to open a pharmacy in a small town?

It’s a mistake to think that the requirements for pharmacies in a small town are something average between city and village pharmacies, or that the requirements are simplified. In fact, the only difference between requirements for cities and small towns is the pharmacy total area: for the city - at least 50 square meters, and for the village - 40 square meters.

However, the requirements are really simplified for the staff of the pharmacy in a small town: the director and authorized person can be a bachelor with a “Pharmacy” specialty, even without work experience.

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What are the requirements for starting a pharmacy in the village (rural area)?

Selecting premises.

Of course, if you find a premise that meets the requirements for a pharmacy in the city, it will fully meet the licensing requirements. If not, then the main requirement - non-residential permanent structure. It can be a separate building or a built-in/attached isolated room with a separate exit.

In our practice there was a case when a pharmacist built a pharmacy right in his yard (of course, before applying for a license this construction was legalized and obtained a room data sheet).

A pharmacy may be also opened in public buildings (except for educational institutions).

The requirement for the total area and areas of the main rooms are reduced in comparison to a pharmacy in the city:

• The total area shall be at least thirty square meters;
• The sales area shall have only ten square meters;
• The storage room shall have six square meters.

Attention: The pharmacy in the village is not required to have a sewerage system and a water closet. Or the water closet may be outside the pharmacy - out in the open. But in this case, you do not need to specify the water closet in the documents when applying for a license.

If you want to make sure that your premises fully comply with the licencing requirements, or if you need help getting a Pharmacy Licence, call us!