In Ukraine, as in most civilized countries of the world, the retail trade of medicinal products is a type of activity that requires a special permit (license). The procedure for obtaining such a license, the list of mandatory requirements that are the basis for its issuance are approved in the Licensing conditions for conducting economic activities in the production of medicinal products, wholesale and retail trade of medicinal products, import of medicinal products (except for active pharmaceutical ingredients), approved by the Resolution of the CMU No. 929 dated November 30, 2016.

Therefore, if you decide to engage in this type of activity, we advise you to carefully study these requirements and responsibly approach the preparation of all necessary documents.

To obtain this license, the applicant submits an application and its annexes to the State Service of Ukraine for Medicinal Products and Drug Control.

! A mandatory condition for issuing a license for the retail trade of medicinal products is the availability of a material and technical base and qualified personnel.

The procedure for obtaining a license for the retail trade of medicinal products is one of the most expensive in terms of time, resources and documents. Current legislation establishes a number of requirements (organizational, technological, other), without compliance with which the chances of successfully issuing a license are small. Among the main requirements:

- the premises of the pharmacy must be non-residential and located on the 1st floor (except in certain cases);

- the area of the pharmacy and its functional premises should be:

 

• • cities - not less than 50 sq.m. (area of the trading hall - not less than 18 square meters);
  • in settlements and urban-type settlements - not less than 40 square meters. meters (the area of the trading hall is not less than 18 square meters);
  • in the village, - not less than 30 square meters. meters (area of the trading hall - at least 10 square meters, medicine storage room - at least 6 square meters; staff room - at least 4 square meters);

 

- availability of an officially employed pharmacist with at least two years of work experience;

- employees' workplaces are equipped with devices to protect employees from direct droplet infection;

- availability of a cabinet, racks, safe, thermometers, hygrometers, etc.;

- daily wet cleaning and compliance with a number of sanitary and hygienic requirements;

- creation of appropriate conditions for access to the pharmacy for people with disabilities.

After submitting the documents, provided they meet the established requirements, the applicant (licensee) is subject to an inspection to ensure compliance with the license conditions. Such an inspection is carried out by the territorial body of the State Service of Ukraine for Medicinal Products and Drug Control.

A decision on issuing a license or refusing to issue it within 10 working days.

 

LIST OF DOCUMENTS NECESSARY FOR OBTAINING A LICENSE FOR THE RETAIL TRADE OF MEDICINAL PRODUCTS

1) data on the business entity (natural or legal entity);

2) a document confirming ownership or use of the premises in which the pharmacy will be located (certificate of ownership, lease agreement);

3) information about the manager of the pharmacy (a copy of his higher education diploma, certificates of advanced training), as well as information about his employment at the main place of work;

4) information about the material and technical base and personnel of the applicant;

5) information on the lack of control over the activities of the licensee of persons - residents of other states, who carry out armed aggression against Ukraine (in the sense given in Article 1 of the Law of Ukraine "On the Defense of Ukraine") and/or whose actions create conditions for the emergence of a military conflict and the use of military force against Ukraine;

6) power of attorney for an authorized representative.

 

A license for the retail trade of medicinal products is issued within 10 working days from the date of receipt of the application and is valid indefinitely.

An administrative fee is charged for the issuance of a license - in the amount of 1 subsistence minimum, effective on the day the licensing authority makes a decision to issue a license (payment is made no later than ten working days from the date of publication of the decision to issue a license on the official website).