Pharmacy Warehouse Licensing in Ukraine: What Are The Requirements?

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A pharmacy warehouse (depot) is a health care facility, a place used for storing medicine stock, medical property, as well as having a license for their wholesale distribution.

The problem of licensing a warehouse is a large number of requirements for the premises, employees and the documentation to be submitted when applying for licensing.

Today we will tell you more about what you need to pay attention to when obtaining a Pharmacy Warehouse License.

You may also like: How To Undergo The Licensing Inspection

What are the requirements for the pharmacy warehouse location?

The warehouse shall: 

  • be located in a separate building; 
  • or occupy an isolated separate room with its own separate entrance in specially equipped permanent buildings. 

An ideal location would be a non-residential building that meets the building requirements, fire safety and sanitary and epidemiological standards.

The total area must be at least 250 square meters. It’s worth remembering that medicinal products that require certain storage conditions (e.g., with psychotropic substances), require separate equipped rooms.

A pharmacy warehouse shall have the following main compartments: 

  • A reception room; 
  • A commodity room; 
  • An expedition department.

In addition, it is necessary to equip service and household premises for staff (restroom, storage room for household or other equipment). 

There are a number of other requirements for the location of the access area for transport and the internal structure of the warehouse. We can provide you with complete information based on the premises you have.

You may also like: Do You Need To Obtain A Pharmacy Passport?

What are the requirements for the employees of the pharmacy warehouse?

Employees who carry out the selection, picking and packaging of orders need to periodically undergo appropriate training.

The warehouse should consist of staff members who have the appropriate education and qualifications: 

pharmacists and junior specialists with at least a bachelor’s degree in pharmaceutics.

The positions of heads and deputy heads of the warehouse may be occupied only by employees who have the appropriate diploma of educational institutions of III-IV accreditation levels. These positions may not be held on a part-time basis. 

Employees are subject to mandatory medical check-ups during recruitment. 

Related article: Wholesale Trade In Pharmaceutical Products

What are the requirements for documents for licensing a pharmacy warehouse?

In addition to a license application, an applicant shall also submit:

  • Information on all drugs trading establishments - that is, the so-called material and technical base. The statements shall also contain information about the qualified personnel of the pharmacy;
  • A copy of the licensee’s passport, which may contain a stamp of the relevant authority about the refusal of the individual to accept an individual taxpayer identification number because of his/her religious beliefs;
  • Information that the licensee’s activities are not controlled by representatives of other countries that are carrying out armed aggression against Ukraine and/or actions that lead to the development of military conflict and the use of military force against Ukraine. 

In addition to this application and supporting documents, the applicant shall also submit 2 copies of the list of documents submitted.

If you want to register a pharmacy warehouse in Ukraine easily and safely, don’t hesitate to call us. We can both check your premises for compliance with all the licensing requirements and submit the documents for you.

Publication date: 16/03/2020
Marina Losenko

About author

Name: Marina Losenko

Position: Associate

Education: National Aviation University

Knowledge of languages: Russian, Ukrainian

Email: [email protected]

Marina Losenko is a lawyer of the company, specializing in corporate law and intellectual property law.

Marina has extensive experience of registration and dissolution of enterprises, charities and non-governmental organizations, representative offices of foreign companies as well as formalization of changes to registration information of the entities.

For quite a long time she has been working in the field of licensing and obtained licenses for different types of business activities including sale of medicines (license for activities of drugstores); wholesale of pesticides and agrochemicals; activities with scrap; activities with hazardous wastes; operations with scrap of precious metals and gemstones; private security services; transportation; tour services; use of redio frequency resource; IPTV services, etc.

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