Medicine & Pharmaceuticals

In Ukraine, production and trade in medicines and pharmaceuticals are governmentally regulated. The legislation sets serious requirements for this activity. The principle legislative act regarding production and turnover of medicinal products is The Law of Ukraine “On Medicinal Products” dated 4 April 1996 (hereinafter referred to as the “Law “On Medicinal Products”). The Law “On Medicinal Products” governs legal relationships connected with the creation, registration, production, quality control and trade in medicinal products, defines rights and obligations of the enterprises, institutions, organizations and individuals, as well as the powers of respective officials of state executive authorities.

State regulation of the health care system, sanitary and epidemic well-being of the population, creation, production, quality control and trade in medicinal products and products of medical purpose is carried out by the Ministry of Health Care of Ukraine, as well as its subordinate bodies.

According to the definition in the Law “On Medicinal Products”, medicinal products are substances or their mixture of natural, synthetic or biotechnological origin, which are used for contraception, prevention, diagnostics and treatment of human diseases or change of state and functions of the body.

State Registration of Medicinal Products

Medicinal products are allowed to be used in Ukraine only after their state registration, save certain cases stipulated by the Ukrainian legislation.

Pharmacy-produced medicinal products, which are made of approved active substances and additives by prescription and by orders of patient-care and preventive institutions, are not subject to the state registration.

State registration of medicinal products is carried out on the basis of the application to the Ministry of Health Care of Ukraine or its authorised body and all respective documents attached to the application. Within a month after the consideration of application and all required documents, the Ministry of Health Care of Ukraine or its authorised body makes a decision on the approval or refusal of the medicinal product registration.

Pharmacopeia article or quality control methods for medicinal products, reconciliations of technological regulations and production methods are established by the state registration resolution; medicinal product is given a registration number that enters the State Register of Medicinal Products of Ukraine.

The Law “On Medicinal Products” also envisages that the state registration may be refused if the patent, which covers active intellectual property rights, will be affected as a result of such registration while production, usage, trade in medicinal products.
The procedure of and the charge amount for the state registration of a medicinal product are established by the Cabinet of Ministers of Ukraine.

We draw you attention to the fact that the state registration of medicinal products is carried out only on the results of examinations of registration documents for a medicinal product conducted by the State Enterprise “State Pharmacological Centre of the Ministry of Health of Ukraine”. Examination of the registration documents for a medicinal product is one of the most important stages of medicinal product registration in Ukraine. It is also worth mentioning that state authorities face quite many pharmaceutical and legal issues related to the registration of generic medicinal products in the process of the above-mentioned expertise.

Judicial practice also suggests that it is the registration of generic medicinal products that poses a significant number of legal disputes over the validity of medicinal products registration.

It should also be noted that medicinal products can be used within 5 years starting with the date of state registration on the territory of Ukraine. At the applicant’s will, the period under which the medicinal product is approved to be used on the territory of Ukraine, can be shortened by the decision of the registration authority.

At the expiration of time, during which the registered medicinal product was approved to be used in Ukraine, medicinal product can only be used provided it was re-registered.

Licensing    

Under the Law of Ukraine “On Licensing of Certain Types of Economic Activity” dated 1 June 2000, production, wholesale and retail trade in medicinal products, as well as the production, wholesale and retail trade in veterinary medicines and drugs are subject to licensing. According to the above-mentioned law, medical and veterinary practice, processing of donor blood and its components, production of drugs from them are subject to licensing.

Specific requirements for the licensing procedure are set out in the Licensing Terms of Economic Activity Related to the Production, Wholesale and Retail Trade in Medicinal Products, adopted by a joint Order of the State Committee of Ukraine on Regulatory Policy and Entrepreneurship and the State Inspection on the Quality Control of Medicinal Products, dated 3 March 2009, N 44/27.

Production of Medicinal Products

Medicinal products may be  produced by physical persons or legal entities on the grounds of the licence.

Production of medicinal products can be licensed if appropriate material and technical basis, experienced personnel, as well as conditions for quality control of medicinal products are available. General requirements for the material and technical basis for medicinal products production and production quality control are established by the State Committee of Ukraine on Medical and Microbiological Industry.

Trade in Medicinal Products

On the territory of Ukraine, wholesale and retail trade in medicinal products are carried out by enterprises, institutions, organisations and natural persons – entrepreneurs on the grounds of the licence.

Only registered medicinal products can be sold on the territory of Ukraine, save certain cases stipulated by the legislation.

Furthermore, the trade in medicinal products is carried out only if the quality certificate issued by the producer is available. It is forbidden to sell substandard or expired medicinal products or those without the quality certificate issued by the producer.