License for Wholesale/Retail Trade of Medical Preparations

In Ukraine, any pharmaceutical activity is strictly regulated by law, as the quality of this activity directly affects people’s life and health. That is why wholesale or retail trade of medical preparations requires specialized licensing.

According to Ukrainian legislation, obtaining a license for trade in medical preparations requires a whole set of organizational, qualification, technical, and other requirements. Therefore, seeking professional legal assistance is the best solution in this matter.

Our law firm has extensive experience in the field of licensing. Qualified specialists will provide a full package of services: from consultations to handing over a ready-made license for legal business activity.

The process of obtaining a license for retail and wholesale trade of medicinal products involves a series of energy-consuming measures.

In Ukraine, the body responsible for issuing the license is the State Service of Ukraine on Medicines and Drug Control (Derzhliksluzhba).

A license for pharmaceutical activity in Ukraine is issued indefinitely.

Before applying to the licensing authority, it is necessary to meet all legal requirements regarding the premises where the trade of medicinal products will be carried out. It should be noted that the criteria differ somewhat for wholesale and retail trade. It is also mandatory that the staff have the appropriate education and qualifications. In addition, the existence of an organizational base for pharmaceutical activity is required.

The next step is preparing the relevant package of documents to be submitted to the licensing authority. This includes:

• application;

• extract from the Unified State Register (USR);

• copy of the passport of the pharmacy institution (structural unit);

• information on the availability of appropriate material, technical, and organizational base, as well as staff qualifications.

If there are no grounds for refusal, the licensing authority must notify the territorial body within three days to conduct an inspection. The inspection must be scheduled no later than the 6th working day from the date of registration of the application. If the inspection is successful, a report is drawn up and sent back to the licensing authority.

Based on the report, a license is issued or a refusal with recommendations that must be fulfilled before reapplying.

Obtaining a license for wholesale/retail trade of medical preparations is a rather complex process that requires knowledge and time. That is why, by entrusting professionals, you can be sure that all legal requirements will be met and you will achieve a positive result.