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License for wholesale trade in medicines

Manufacturing and wholesale sale of medicinal products on the territory of Ukraine is possible only if there is a corresponding license confirming the existence of this right.

You must obtain a license to conduct such activities:

  • manufacturing of medicines and medicines
  • both wholesale and retail sales of medicines
  • import of drugs abroad.

The process of obtaining a license is quite time-consuming and expensive. It is not excluded that there may be any delays in the processing of certain documents, which significantly slows d the process itself. Also, to issue the appropriate permits, you must have certain knowledge and skills in the legal field.

Difficulties in obtaining a license for wholesale trade in medicines also lie in the fact that it is necessary for the licensing subject to provide mandatory relevant documents that confirm information about compliance with all requirements, including both technological and qualification ones.

It is important that the room in which the sale or manufacture of drugs will be carried out meets the requirements of sanitary and hygienic standards and is equipped with all necessary equipment. Also, the room must necessarily relate to non-residential fund. The pharmacy must be located no higher than the first floor for the convenience of customers. Another important requirement is the availability of a qualified pharmacist in the state, whose experience in this field is not less than two years.

To obtain a license for retail and wholesale trade, the licensee must provide such a list of documentation:

  • Application for a license granting the right to trade in medicines;
  • Proof of sufficient material and technical resources and highly qualified personnel must be provided;

Before issuing a license, the authorized body submits an application to the inspection authorities within 3 working days to verify the authenticity of the information specified in the application. If the data is authentic and the material and technical base meets the established requirements, the licensing authority decides to issue a license. If errors were found in filling out the documentation or inaccuracies were found, the organization can submit its application for consideration no earlier than 10-20 business days. The licensing authority reviews the submitted documentation within 10 working days. At the end of this period, a decision is made to issue or refuse.

Obtaining a license for the possibility of wholesale and retail trade in medicines is a complex procedure that has many pitfalls. Therefore, it is best to contact specialists who are highly qualified and cooperate with government agencies.

With the help of our specialists you will be able to issue the necessary documents as soon as possible without any problems. Our specialists provide full support to the client until the license is obtained.

Dmytro Kasyanenko

Lawyer, managing partner of the Kasyanenko & Partners Law Firm. Since 2002, he has gained extensive legal experience in key positions in business structures and the public sector in the field of law and finance.

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