Registration of medicines products in Ukraine

Production of pharmaceutical companies is a special part of modern industry. Pharmaceutical products include all medications, obtained by synthesis or by biotechnology, which affect the physiological functions of the organism and used for the prevention and treatment of various diseases. For the medicines manufacture used a range of active substances both natural and synthetic in origin. Medical products also include disinfectants, curative cosmetics, a variety of medical supplements and herbal treatments.

Special categories of medicines:

Immunobiological – vaccines, toxoids, immunoglobulins, sera, bacteriophages, interferons, bacterial preparations.

Herbal preparations – preparations, obtained through processing of herbal substances, by: extraction, distillation, extraction, fractionation, purification, concentration, fermentation.

Homeopathic medicine – or any medicinal product, manufactured from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure.

Ready for use radiopharmaceutical – contains one or more radionuclides (radioactive isotopes) included for medical purpose.

Every pharmacological product must pass the full range of clinical and preclinical trials in the prescribed manner and obtain a licence issued by authorised body.

In the CIS is used the classification of drugs according to their pharmacological effects on the human body or medical purpose. In international practice there is a so-called ATC Classification (Anatomical Therapeutic Chemical), which divides drugs into groups according to the indications for their use.

Manufacture of medicines must comply with the legislation of the country where they are made, and the goal is to enter the world market it has to comply with international requirements of GMP (Good Manufacturing Practice). This system of rules, regulations and guidelines has been developed specifically for the manufacture of medicines, medical equipment, diagnostic devices, as well as food and a variety of food and dietary supplements. GMP standard aims to evaluate and adjust parameters of the medicines production and guarantees the quality of laboratory testing.