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Prikhodko&Partners
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Legal services for medical businesses and doctors
Licensing of business activities License to sell medicines

Iryna An

Attorney

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med-advokat@prikhodko.com.ua

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Medical lawyer. Specializes in protecting the rights of doctors and patients, handling medical malpractice and liability cases, supporting disability determination and appeals procedures, and providing legal analysis of medical documentation.

License to sell medicines

Obtaining a license to sell medicines is a key step for those who plan to officially carry out activities in the sphere of their circulation in Ukraine. The presence of a permit for an entrepreneur is also a necessary condition for legal, safe and responsible business. The main conditions, the procedure for obtaining and the requirements for the applicant are given in the Licensing Conditions, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 929. In the article we will examine the main provisions of them.

Types of licenses for the sale of medicines

License for (electronic) retail trade in medicines

This type of permit is granted to a business entity to carry out activities related to the purchase, storage and direct sale of finished medicinal products to end consumers through special points of sale (pharmacy or pharmacy) or via the Internet. Such activities are also aimed at supplying medicinal products to healthcare institutions, delivery to enterprises, institutions and organizations to ensure their activities. In addition, to engage in electronic retail trade in medicines, the applicant must also be included in a special List.

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License for wholesale trade in medicines

This permit gives entrepreneurs the right to carry out activities related to the purchase of medicines from their direct manufacturers, storage, transportation and further sale to consumers. The place of such activities must be a licensed pharmacy warehouse, which must meet the requirements for its area, equipment, personnel, quality control, etc.

It is worth noting that quite often, when obtaining one of the types of sales licenses, applicants also simultaneously initiate the procedure for obtaining a license for the import of medicines. This significantly expands their capabilities, as it allows them to trade in medicines not only of domestic manufacturers, but also of foreign manufacturers.

It will also be useful: License for import of medicinal products

Who can obtain a license for the sale of medicines?

When applying for a relevant permit, a business entity must ensure:

official registration of a legal entity or individual entrepreneur with KVED 46.46 (wholesale), 47.73 (retail);
trade only in medicines registered in Ukraine (the presence of patents for them);
availability of specially equipped premises and transport (must be in its private ownership or the right to use, lease);
implementation of an effective quality system;
availability of personnel whose level of qualification and experience allows carrying out the necessary activities for the sale and storage of medicines;
conducting and documenting self-inspections to assess compliance with the requirements of good distribution practice;
compliance with appropriate personnel hygiene procedures (health care, personal hygiene, special clothing);
proper power supply, heating, lighting, ventilation in pharmacies and pharmacy warehouses;
carrying out medical practice in separate premises of the pharmacy (after obtaining a medical practice license);
entering information about dispensed medicines into the Register of Medical Records of the Ministry of Health;
compliance with the requirements of the Law of Ukraine “On Advertising”, in particular regarding the features of advertising pharmaceutical products.

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What documents are required to obtain a license?

To obtain a license, the applicant must submit to the licensing authority (the State Service of Ukraine for Medicines and Drug Control) an established package of documents that complies with the Licensing Conditions approved by the Resolution of the Cabinet of Ministers of Ukraine No. 929:

first, an application for obtaining the appropriate permit;
second, documentation on the material and technical base and personnel qualifications – information from Appendix 5 and 6 of the Licensing Conditions (describing in detail the premises, equipment and other resources that ensure the proper implementation of retail trade), property agreements, certificates (diplomas) of key employees;
third, a correctly completed Appendix 24 to the Licensing Conditions, which indicates the website’s compliance with the requirements, qualifications in the field of online trading, a list of equipment (title documents for it) for completing orders (if we are talking about online retail);
finally, information about the lack of control over activities by residents of other countries, including the aggressor state.

It is worth emphasizing that the list above is not exhaustive and may provide for the provision of other documents to obtain a license. More detailed information about the documents and the cost of professional legal support for obtaining the appropriate type of license can be found by contacting one of our specialists for a consultation.

What is the price of obtaining a license to sell medicines?

As a general rule, the administrative fee for submitting documents to the licensing authority and initiating such a procedure is one subsistence minimum (3028 UAH as of April 2025). If the applicant wishes to obtain permits to engage in various types of sales activities, or has several pharmacy warehouses, this amount increases in proportion to the number of licenses.

Obtaining a license to sell medicines not only legitimizes business in the pharmaceutical sector, but also confirms the entrepreneur’s compliance with high quality and safety standards. Lawyers Prikhodko and Partners will help you prepare all the necessary documentation, go through all the stages of the procedure and obtain one of the types of such a license in the shortest possible time. To find out the cost of legal support, fill out the form below.

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License to sell medicines

Types of licenses for the sale of medicines

License for (electronic) retail trade in medicines

License for wholesale trade in medicines

Who can obtain a license for the sale of medicines?

What documents are required to obtain a license?

What is the price of obtaining a license to sell medicines?

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