Article 1. Legislation on Medicines
The legislation on medicinal products shall comprise the Law and other legislation acts adopted in connection with it.
Article 2. Definition of Terms
In the legislation on medicinal products terms shall be used in the following meaning:
Medicinal products are substances or their mixtures, of natural, synthetic, or biotechnological nature used for prevention of pregnancy, for prophylaxis, diagnosis, and treatment of human diseases, or intended to change the physiological state and functions of the organism.
Medicinal products shall include: active agents (substances); finished medicinal products (medicinal preparations, drugs, medicaments); homoeopathic agents; agents used to detect and eliminate pathogenic organisms or parasites; cosmetic products and medicinal supplements to food products;
Finished medicinal products (medicinal preparations, drugs, medicaments) are dosage medicinal products in a form designed for usage;
Active agents (substances) are biologically active agents capable to change the state and the functions of the organism or having prophylactic, diagnostic, or therapeutic action and used to manufacture finished medicinal products;
Excipients are additional substances necessary to manufacture finished medicinal products;
Narcotic medicinal products are those as defined by the legislation;
Poisonous medicinal products are those as defined by the Ministry of Health of Ukraine;
Drastic medicinal products are those as defined by the Ministry of Health of Ukraine;
Radioactive medicinal products are those used in medical practice to produce ionising irradiation due to their properties;
The State Register of the Medicines of Ukraine shall be the regulatory document comprising data on medicinal products permitted for manufacture and use in medicinal practice;
The pharmacopoeial monograph shall be the standard and technical document establishing the requirements for the medicine, its packaging, conditions of storage, shelf-life, and quality control methods;
The technological regulations on manufacturing the medicine (hereinafter referred to as 'technological requirements') shall be the regulatory document specifying technological methods, technical means, norms and standards for the manufacture of the medicine;
The State Pharmacopoeia of Ukraine shall be the legislative document including the general requirements for medicinal products, pharmacopoeial monographs, and also quality control methods for medicinal products;
Quality of the medicine shall be the sum of the properties which make the medicine capable to satisfy consumers and to meet the requirements established by the legislation;
Shelf-life of medicinal products shall be the period of time within which the medicine shall not lose its quality pursuant to the requirements of the standard and technological documentation.
The meaning of other terms shall be specified by the legislation and by special dictionaries of terms issued by the World Health Organisation.
Article 3. State Policy in the sphere of development, manufacturing, quality control, and sale of medicines
The state policy in the sphere of development, manufacturing, quality control, and sale of medicinal products shall be directed to support scientific research work, development, and introduction of new technologies, and also development of the manufacture of highly effective and safe medicinal products, which meet the demands of the population for medicinal products of proper quality and in assortment by means of utilising relevant national programs, priority financing, rendering of low interest credits, tax remissions etc.
With the aim of protecting health of the citizens of Ukraine, the State shall ensure the availability of those medicinal products most in need, protect citizens in case of damage to their health after taking prescription-only medicinal products, and also shall establish the privileges and guarantees for special population groups and categories of citizens, providing them with medicinal products in case of illness.
Article 4. State administration in the sphere of
development, manufacturing, quality control, and sale of medicines
The Verkhovna Rada of Ukraine shall determine the State policy and shall regulate the development, manufacture, quality control, and sale of medicinal products.
The Cabinet of Ministers of Ukraine through the system of the State executive authorities shall implement the state policy in the sphere of development, manufacture, quality control, and sale of medicinal products, shall provide the elaboration and performance of the relevant State programs and others within the limits of its authority, and shall control implementing the legislation on medicinal products.
Regulation in the sphere of development, manufacture,
quality control, and sale of medicinal products within the limits of their competence shall be performed by the Ministry of Health of Ukraine, the State Committee of Ukraine on Medical and Microbiological Industry, and special state bodies authorised by them.
SECTION II
Article 5. Subjects of Development of Medicines
Medicinal products may be developed by enterprises, institutions, organisations, and citizens. The author (and co-author) of the medicinal products shall be the natural person (persons) developing the medicine by inventive, research work. Such person (persons) shall have the right to be rewarded for use of the medicine invented by him (them). Reward may be given in any form not prohibited by the legislation.
The author (and co-authors) may submit an application to Ukraine's State Committee on the Issues of Intellectual Property to obtain a patent on the medicine. Justification for the decision to issue a patent shall be the positive opinion of the Ministry of Health of Ukraine or of the body authorised by it.
The material and non-material rights connected with the development and manufacturing of the medicine shall be regulated according to the legislation.
Article 6. Pre-clinical study of Medicines
Pre-clinical study of medicinal products shall provide for chemical, physical, biological, microbiological, pharmacological, toxicological, and other scientific research in order to determine their specific action and safety.
Procedure for conducting pre-clinical study of medicinal products, the requirements for conditions of the conduct of separate researches, and also procedure for conducting expert assessment of materials pertinent to the pre-study of medicinal products shall be specified by the Ministry of Health of Ukraine, taking into account the standard procedures used internationally.
Article 7. Clinical Trial of Medicines
Clinical studies of medicinal products shall be performed in order to establish or prove the efficacy and safety of medicinal product. They may be performed at specified health care settings as determined by the Ministry of Health of Ukraine or by the body authorised by it.
Before the start of clinical studies of medicinal products, the enterprises, institutions, organisations, or the citizens shall submit an appropriate application to the Ministry of Health of Ukraine or to the body authorised by it.
This application shall be annexed by materials containing general information on the medicine, the results of its pre-clinical examination, samples of the medicine, and the proposal for the clinical testing program.
The following are required before a decision may be taken on the clinical trial application for clinical testing: Positive opinions on the expert assessment of the pre-clinical data as to the safety and efficacy of the medicine;
Data supporting a positive benefit-risk ratio, such that any adverse drug reactions (ADRs) of the medicine shall be considerably lower than the expected positive effect.
The procedure for performing the expert assessment of the clinical data shall be specified by the Ministry of Health of Ukraine or by the body authorised by it.
The applicant for clinical trials shall have the right to receive information concerning the clinical testing of the medicine, to acquaint himself with the results of the clinical experts appraisal, and may request a substitution of specialised health care setting where the clinical trial is performed.
Clinical study of medicinal products shall be performed following obligatory appraisal of the ethical, moral, and legal aspects of the clinical testing program by Ethics Committees that are established and operate under health care settings where the clinical trials are conducted.