Licensing of pharmaceutical activities and drugstores

Retail trade by medicines

In fact, retail trade by medicines refers to the activity of purchasing, storing and selling finished medicines manufactured (produced) in a drugstore, through a drugstore and its structural divisions directly to citizens for personal consumption, health care institutions (except for drugstore establishments), as well as enterprises, institutions and organizations without the right to resale them. According to the current legislation, only drugstores are allowed to carry out activities in the field of retail trade by medicines. These include:

  • Drugstore;
  • Drugstore kiosk, that is, a division of a drugstore that can sell medicines that do not require a doctor’s prescription;
  • Drugstore point – a subdivision of a drugstore located in the territory of a hospital or a clinic.

Conducting such activities is possible only with the appropriate license.

License for retail trade by medicines

Before organizing retail trade by medicines, you need to decide on the organizational and legal form of your activity.

Drugstores can be created by both legal entities and individual entrepreneurs. Therefore, you first need to choose the desired organizational and legal form and register either the relevant legal entity (private enterprise, LLC, JSC), or to register as an individual entrepreneur.

After that, the taxation system is chosen. Drugstores – legal entities are usually subject to a general taxation system with the payment of income tax, since it is beneficial for them.

Remember that in any case, wholesale and retail sales of drugs and other medicines are subject to obligatory licensing. The license for this type of activity is issued by the State Service on Medicines and Drugs Control.

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Our services: license for a drugstore, opening a new subdivision

To obtain a license, as well as when opening a new subdivision, collect the following information:

  1. Information on the state of the material and technical base of a business entity;
  2. Information on the availability of personnel, indicating their educational and qualification levels.

After 2012, in which the need to obtain a passport of a drugstore institution was canceled, it is enough to attach this information to an application for a license in order to freely confirm the possibility of conducting pharmacological activities.

Documents required to open a drugstore

In addition to the application for a license itself, you will also need to submit:

  • Plan-scheme of premises from BTI;
  • Lease contract or ownership to a premise
  • Extract from the USR;
  • Copies of diploma, work record book and assessment certificate of the drugstore head;
  • Pharmacist’s diploma;
  • Certificate of the absence of control over the activities of the license applicant of persons – residents of other states who carry out armed aggression against Ukraine (in the meaning 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 militaryforces against Ukraine.Such information is submitted in any form in accordance with the requirements of paragraph 9 of these License Terms.
  • Power of attorney for an authorized representative
  • List of documents submitted for obtaining a license.

How to sell medicines on the Internet

With the adoption of the Law of Ukraine “On Amendments to Article 19 of the Law of Ukraine “On Medicines” regarding the implementation of electronic retail trade by medicines”, drugstores will be able to sell medicines through their websites. Before that, they must be entered in the register of organizations entitled to carry out electronic retail trade by medicines.

Also, on the website of an online drugstore, the option of providing online consultations by a pharmacist should be available for buyers, and prescription drugs can be sold in online pharmacies with an electronic prescription.

At the same time, in order to carry out this activity, it is also necessary to obtain an appropriate license.

Terms of registration

The term for issuing a license after submitting all the necessary documents, as well as after paying the administrative fee, according to the information of the Portal of electronic services of Ukraine, is 10 days. However, it must be taken into account that the total term for preparing all documents, equipment of the premises, selection and recruitment of personnel can take a lot of time, so make sure that competent lawyers will deal with the issue of legal support, since not only the term, but in general the entire result of obtaining a license will depend on this.

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