of April 4, 1996 No. 123/96-BP
This Law regulates the legal relationship connected with creation, registration, production, quality control and realization of medicines including the medicines made from blood of the person and plasma of blood (blood medicines), conversion, transportation, storage and distribution of the components of blood used for production of medicines determines the rights and obligations of the companies, organizations, organizations and citizens, and also powers in this sphere of executive bodies and officials.
The legislation on medicines consists of this Law and other acts of the legislation adopted according to it.
In the legislation on medicines terms are applied in the following value:
medicine - any substance or combination of substances (one or several AFI and excipients) which has properties and is intended for treatment or prevention of diseases at people, either any substance or combination of substances (one or several AFI and excipients) which can be intended for prevention of pregnancy, renewal, adjustment or change of physiologic functions at the person by implementation of pharmacological, immunological or metabolic action or for establishment of the medical diagnosis;
counterfeited medicine - medicine which is purposely marked nonidentically (not respectively) to the data (to one or several of them) about medicine with the corresponding name, entered in the State register of medicines of Ukraine, and also medicine, is purposely counterfeited by different way, and does not correspond to data (to one or several of them), including to structure, about medicine with the corresponding name entered in the State register of medicines of Ukraine.
Treat medicines: AFI, products of "in bulk"; finished pharmaceutical products (medicines, drugs, medicines); homeopathic remedies; the means used for identification of causative agents of diseases, and also fight against causative agents of diseases or parasites; medicinal cosmetics and medicinal impurity to foodstuff;
finished pharmaceutical products (medicines, drugs, medicines) - the dosed medicines in type and condition in which they are applied, passed everything production stage (production), including final packaging;
active pharmaceutical ingredient (medicinal substance, active ingredient, substance) (further - AFI or active ingredient) - any substance or mix of substances which is held for use in production of medicine and during this use becomes its active ingredient. Such substances have pharmacological or other direct action on human body, as a part of ready forms of medicines apply them to treatment, diagnostics or prevention of disease, to change of condition of structures or physiologic functions of organism, to processing and relief of symptoms;
excipient (эксципиент) - any substance of dosage form which is not AFI or ready medicine and respectively does not perform pharmacological, immunological or diagnostic action, enters medicine and it is necessary for its production (production), storage and/or application;
narcotic medicines - the medicines carried to narcotic according to the legislation;
poisonous medicines - the medicines carried to poisonous by the central executive body, providing forming of state policy in the field of health care;
strong medicines - the medicines carried to strong by the central executive body, providing forming of state policy in the field of health care;
radioactive medicines - the medicines applied in medical practice thanks to their capability to ionizing radiation;
The state register of medicines of Ukraine - the regulating document containing data on the medicines permitted for production and application in medical practice;
pharmacopoeian Article - the normative and technical document establishing requirements to medicine, its packaging, conditions and storage duration and methods of quality control of medicine;
production schedules of production of medicine (further - production schedules) - the regulating document in which technological methods, technical means, regulations and standard rates of production of medicine are determined;
The state Pharmacopoeia of Ukraine - the legal act containing general requirements to medicines, pharmacopoeian Articles, and also techniques of quality control of medicines;
quality of medicine - set of the properties giving to medicine capability to satisfy consumers according to the appointment and meet the requirements established by the legislation;
expiration date of medicines - time during which medicine does not lose the quality in case of the storage condition according to requirements of the specifications and technical documentation;
dosage form - combination of form in which medicine is provided by the producer (release form), and also form in which medicine is intended for application, including physical shape (application form);
products of "In bulk" - any medicine intended for production of ready medicine which took place all stages of engineering procedure, except stage of packing and/or final packaging and marking;
The term "the specialized organizations conducting procurements" is used in the value given in provided in the Law of Ukraine "About public purchases". Contents of other terms are determined by the legislation and special dictionaries of terms of the World Health Organization.
The term "person authorized on implementation of purchases in the field of health care" is used in the value given in Bases of the legislation of Ukraine on health care.
State policy in the field of creation, productions, quality control and realization of medicines goes for support of scientific research, creation and implementation of new technologies, and also development of production of highly effective and safe medicines, ensuring needs of the population with drugs of proper quality and in necessary assortment by maintaining the State register of medicines of Ukraine with ensuring public access for persons of implementation to it the appropriate nation-wide programs, priority financing, provision of soft credits, establishment of tax benefits, etc.
For the purpose of realization of the right of citizens of Ukraine to health protection the state provides availability of the most necessary medicines, protection of citizens in case of harming their health as a result of use of medicines on medical appointment, and also establishes privileges and guarantees to separate national groups and categories of citizens on providing them with medicines in case.
The Supreme Council of Ukraine determines state policy and performs legislative regulation of the relations in the field of creation, productions, quality control and realization of medicines.
The Cabinet of Ministers of Ukraine through system of bodies of the state executive authority puts into practice state policy in the field of creation, productions, quality control and realization of medicines, will organize development and implementation of the appropriate nation-wide and other programs within the powers, provides control of execution of the legislation on medicines.
Management in the field of creation, productions, quality control, realization of medicines within the competence performs the central executive body providing forming of state policy in the field of health care, the central executive body realizing state policy in the field of quality control and safety of medicines.
Medicines can be created by the companies, organizations, the organizations and citizens.
The author (coauthor) of medicine is the physical person (persons) which creative activity (which) medicine is created.
It (they) has the right to remuneration for use of the medicine created by it. Remuneration can be performed in any form which is not prohibited by the legislation.
The author (coauthors) can submit the application in the central executive body realizing state policy in the field of intellectual property on receipt of the patent for medicine. The basis for patent grant is the positive conclusion of the central executive body realizing state policy in the field of health care about its patentability.
The property and non-property rights connected with creation and production of medicine are regulated according to the legislation.
Preclinical studying of medicines provides chemical, physical, biological, microbiological, pharmacological, toxicological and other scientific research for the purpose of studying of their specific activity and safety.
Procedure for carrying out preclinical studying of medicines, requirements to conditions of carrying out separate researches, and also procedure for conducting examinations of materials of preclinical studying of medicines are established by the central executive body, providing forming of state policy in the field of health care taking into account the regulations applied in the international practice.
Clinical testing of medicines are carried out for the purpose of establishment or confirmation of efficiency and harmlessness of medicine. They can be carried out in the treatment and prevention facilities determined by the central executive body realizing state policy in the field of health care.
For carrying out clinical testing of medicines of the company, organization, the organization or citizens submit the corresponding application to the central executive body realizing state policy in the field of health care.
The materials containing general information about medicine, results of its preclinical studying, samples of medicine and the draft of the program of clinical trials are enclosed to the application.
The decision on clinical testing of medicine is made in the presence:
positive experimental testimonies of materials of preclinical studying concerning efficiency of medicine and its safety;
convincing data that the risk of side effect of medicine will be much lower than the expected positive effect.
The procedure for conducting examination of materials of clinical testing is established by the central executive body, providing forming of state policy in the field of health care.
The customer of clinical testing has the right to obtain information on the course of carrying out clinical testing of medicine, to get acquainted with results of clinical examination, to initiate the petition for replacement of treatment and prevention facility where clinical testing are carried out.
Clinical testing of medicines are carried out after obligatory assessment of ethical and moral and legal aspects of the program of clinical testing by the commissions on questions of ethics which are created and are effective under treatment and prevention facilities where clinical testing are carried out. The standard regulations on the commission on questions of ethics affirm the central executive body performing forming of state policy in the field of health care.
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