Requirements

 Ukraine

Location: Europe

Status: UN Country

Capital City: Kiev (Kyiv)

Main Cities: Kharkov, Dnepropetrovsk, Odessa

Population: 46 000 000

Area: 603 000,7 km2

Currency: 1 hryvnya = 100 kopiyky

Languages: Ukrainian, Russian

REGULATORY SYSTEM OF MEDICAL GOODS IN UKRAINE

The system of registration of medical supplies is a multistage process, which is differentiated depending on the type of product. The peculiarity of the process is transparent and predictability as to timing and expenses. The order of registration of medicines is based on the European legislation, which although is tough enough, but at the same time is accepted in the pharmaceutical community. The process is carried out by the State Pharmacological Center of Ministry of Health of Ukraine with the participation of various competent authorities and expert institutions. Medical supplies are registered in accordance with the special order. Conventionally, registration process can be divided into three phases: examination of documents, toxicological examination and clinical trials. The registration process differs from that adopted in Europe (see above) and in the world and requires both procedural and technical skills and knowledge in the field of production and maintenance of medical equipment. It is also required to know the basics of the legislative framework of Ukraine and the country which manufactures the products. The procedure of state registration of biologically active substances due to the absence of clear institutional and legal framework is formal and represents the quality and safety examination of the drug. Expert sites and institutions authorized by the Ministry of Health are responsible for the examination.

BASIC LABELING LANGUAGE

  • Pharmaceutical products – Ukrainian or Ukrainian with other languages
  • Medical Device - Ukrainian or/and other with the Ukrainian sticker
  • Food Supplements - Ukrainian
  • Cosmetics - Ukrainian or other with the Ukrainian sticker

Timelines of registration vary from 3-4 months to 10-12 months depending on the product type. Official payments level could range 5 to 10 000 USD depending on the product type and periods of registration process.

OUR EXPIRIENCE AND PARTNERS

We can provide a full range of services for clinical trials, registration / renewal of registration of the medicines, medical device, medical supplies, dietary supplements, certification of perfumes and cosmetics, dietary products:

  • Dossier & documentation preparing;
  • Representation of the manufacturer in all authorized organizations (support and control in obtaining a registration certificate);
  • Organization of clinical trials.

We will help you to organize the process of registration quickly, professionally and qualitatively, avoiding the many problems associated with the routine process of registration. Our experts have special knowledge, and managers have many years of experience and the necessary contacts. Today our company supports more than 30 companies in Ukraine.