Head of Medical Law Practice
Specializes in medical, corporate, and migration law. Has extensive experience working with medical and pharmaceutical businesses, particularly in licensing, circulation of medicines, and comprehensive legal support of healthcare institutions, including corporate, tax, and employment matters, as well as market entry projects of foreign companies into Ukraine.
Case: Obtained a pharmacy license
Service: Pharmacy License
A client from the Ivano-Frankivsk region approached us. She owned a non-residential premises in her locality and planned to open her own pharmacy and develop a pharmaceutical business in the region.
Understanding that in order to obtain a license for the retail sale of medicinal products, the premises must fully comply with licensing requirements and undergo inspection by the licensing authority, the client decided to act strategically. To avoid mistakes and unnecessary costs for redoing repairs, she contacted our specialists at the planning stage to properly organize the premises from the start and prepare it for licensing.
Premises Analysis and Pharmacy Layout Planning
At first glance, the task seemed simple: the premises were already owned, and all that remained was renovation and preparation of documents for obtaining a retail pharmaceutical license. However, in practice, opening a pharmacy requires compliance with numerous licensing requirements related to layout, temperature control, accessibility, storage of medicines, and organization of pharmaceutical staff work.
As a first step, our lawyers and профиль specialists conducted an analysis of the premises intended for the pharmacy.
We assessed:
- the total area of the premises and the possibility of zoning. Currently, the requirements are: for cities — from 50 m², for settlements — from 30 m², for villages — from 11 m²;
- compliance of the future pharmacy with licensing requirements;
- the possibility of arranging the required functional zones.
Based on the analysis, the client received a detailed consultation on organizing the pharmacy premises, including:
- proper zoning according to functional purposes;
- area of each zone;
- requirements for internal pharmacy layout;
- placement of signage on the facade and information about the license holder and working hours at the entrance;
- placement of cabinets, refrigerators, and measuring devices to ensure proper temperature and humidity conditions;
- arrangement of staff premises with a minimum size of 8 m²;
- availability of a restroom with a sink;
- arrangement of a storage area for cleaning equipment and labeling requirements for such equipment;
- heating requirements;
- protection of workplaces from airborne infections, etc.
This allowed us to establish the correct architectural layout of the premises before renovation, ensuring compliance with licensing requirements.
Support During Pharmacy Renovation
A separate stage of our work involved supporting the client during renovation works.
We provided recommendations on arranging the key zones of the pharmacy:
- customer service area (dispensing medicines) — at least 18 m² in cities (from 11 m² in settlements, from 6 m² in villages);
- medicine storage area with proper temperature conditions — from 10 m²;
- staff premises;
- area for receiving and quality control of medicines.
We also helped incorporate an important modern legal requirement — accessibility for people with reduced mobility. In particular, we developed recommendations regarding barrier-free entrance, passage width, access to service areas, ramp requirements, etc.
As a result, the premises were immediately prepared in accordance with current licensing standards.
Preparation of Documents for Licensing
After the renovation was completed, our lawyers moved to the next stage — preparing documents for obtaining the pharmacy license.
We ensured:
- preparation of a full package of licensing documents;
- legal support for submitting documents to the State Service of Ukraine on Medicines and Drugs Control.
During document preparation, we took into account recent changes to licensing requirements approved by the Cabinet of Ministers of Ukraine, particularly regarding pharmacy operations, material and technical base, and rules for the sale of medicinal products.
Turnkey Pharmacy License
After submitting documents and passing the inspection by the licensing authority, the client successfully obtained a license for the retail sale of medicinal products.
This allowed her to officially open a pharmacy and start pharmaceutical operations in compliance with legal requirements.
Today, the pharmacy operates legally, has a proper material and technical base, and meets all requirements for:
- storage of medicinal products;
- quality control of medicines;
- organization of pharmaceutical activities.
Client Result
Thanks to comprehensive legal support, the client received:
- a properly organized pharmacy premises;
- avoidance of costly rework after renovation;
- full compliance with licensing requirements;
- a turnkey pharmacy license.
Planning to open a pharmacy or pharmacy outlet?
We can help you:
- prepare premises for licensing;
- check compliance with requirements;
- obtain a pharmacy license without refusals or delays.
Юридичні послуги для медичного бізнесу та лікарів
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