Definition of terms
Опубліковано 04.06.2020 о 01:23According to the Law of Ukraine “On Medicinal Products” in the legislation on medicinal products, the terms are used in the following meaning:
medicinal product – any substance or combination of substances (one or more APIs and excipients) that has properties and is intended for the treatment or prevention of diseases in humans, or any substance or combination of substances (one or more APIs and excipients) , which may be intended to prevent pregnancy, to restore, correct or alter physiological functions in a person by performing a pharmacological, immunological or metabolic action or to establish a medical diagnosis;
falsified medicinal product – a medicinal product that is intentionally marked non-identically (inconsistently) with the information (one or more of them) about a medicinal product with the appropriate name entered in the State Register of Medicinal Products of Ukraine, as well as a medicinal product intentionally counterfeited, and does not correspond to the information (one or more of them), including the composition, about the medicinal product with the appropriate name, which are entered in the State Register of Medicinal Products of Ukraine.
Medicines include: API, in bulk products; finished medicines (drugs, medicines, medicines); homeopathic remedies; means used to detect pathogens, as well as to control pathogens or parasites; medicines, cosmetics and food additives;
finished medicines (medicines, drugs, medicines) – dosed medicines in the form and condition in which they are used, which have passed all stages of production (manufacture), including final packaging;
active pharmaceutical ingredient (drug, active substance, substance) (hereinafter – API or active substance) – any substance or mixture of substances intended for use in the manufacture of a medicinal product and during this use becomes its active ingredient. Such substances have a pharmacological or other direct effect on the human body, as part of finished forms of drugs they are used to treat, diagnose or prevent disease, to change the condition, structures or physiological functions of the body, to care for, treat and relieve symptoms;
Excipient (excipient) – any substance of a dosage form that is not an API or a finished medicinal product and accordingly does not have a pharmacological, immunological or diagnostic effect, is included in the medicinal product and is necessary for its production (manufacture), storage and / or use ;
narcotic medicines – medicines classified as narcotic in accordance with the legislation;
poisonous medicines – medicines classified as poisonous by the central executive body, which ensures the formation of state policy in the field of health care;
potent medicines – medicines referred to as potent by the central executive body, which ensures the formation of state policy in the field of health care;
radioactive drugs – drugs that are used in medical practice due to their properties to ionizing radiation;
The State Register of Medicines of Ukraine is a normative document that contains information on medicines permitted for production and use in medical practice;
pharmacopoeial article – a normative and technical document that sets requirements for the drug, its packaging, conditions and shelf life and methods of quality control of the drug;
technological regulations for the manufacture of a medicinal product (hereinafter – the technological regulations) – a regulatory document that defines the technological methods, technical means, norms and standards for the manufacture of a medicinal product;
State Pharmacopoeia of Ukraine – a legal act that contains general requirements for medicines, pharmacopoeial articles, as well as methods of quality control of medicines;
quality of the medicinal product – a set of properties that give the medicinal product the ability to satisfy consumers in accordance with its purpose and meet the requirements established by law;
shelf life of medicines – the time during which the medicine does not lose its quality if stored in accordance with the requirements of regulatory and technical documentation;
dosage form – a combination of the form in which the drug is presented by the manufacturer (release form), as well as the form in which the drug is intended for use, including the physical form (form of application);
“in bulk” products – any medicinal product intended for the manufacture of a finished medicinal product, which has passed all stages of the technological process, except for the stage of packaging and / or final packaging and labeling.
The meaning of other terms is determined by the legislation and special dictionaries of terms of the World Health Organization.
The meaning of other terms is determined by the legislation and special dictionaries of terms of the World Health Organization.
According to the Law of Ukraine “On licensing of certain types of economic activity” the terms are used in the following meaning:
revocation of the license – deprivation of the licensee by the licensing body of the right to conduct a certain type of economic activity;
production (manufacturing) – activities related to the production, which includes all stages of the technological process, as well as the sale of products of its own production;
economic activity – any activity, including business, legal entities, as well as natural persons – entrepreneurs, related to the production (manufacture) of products, trade, provision of services, performance of works;
licensee – a business entity that has received a license to conduct a certain type of business activity subject to licensing;
license – a document of the state standard, which certifies the right of the licensee to carry out the specified type of economic activity within a specified period in the event of its establishment by the Cabinet of Ministers of Ukraine subject to the license conditions;
licensing conditions – an exhaustive list of organizational, qualification and other special requirements established taking into account the requirements of the laws, which are obligatory for fulfillment in carrying out the types of economic activity subject to licensing;
licensing – issuance, renewal and revocation of licenses, issuance of duplicate licenses, maintenance of license cases and license registers, control over compliance by licensees with license conditions, issuance of orders to eliminate violations of license conditions, as well as orders to eliminate violations of legislation in the field of licensing;
place of carrying out by a natural person – entrepreneur of economic activity subject to licensing – territory, premises that meet the requirements of licensing conditions and belong to a natural person – entrepreneur on the right of ownership and / or use;
licensing body – an executive body determined by the Cabinet of Ministers of Ukraine, a state collegial body authorized by law, a specially authorized executive body of councils for licensing certain types of economic activity;
license fee – a one-time payment made by a business entity for obtaining a license;
repeated violation – commission by the licensee during the term of the license of repeated violation of certain license conditions after application of sanctions for a similar violation;
order to eliminate violations of license conditions – the decision of the licensing authority on the need to eliminate the licensee within the prescribed time violations of license conditions;
order to eliminate violations of legislation in the field of licensing – the decision of the specially authorized body for licensing on the need to eliminate the licensing authority within the prescribed time violations of legislation in the field of licensing;
business entity – a legal entity registered in the manner prescribed by law, regardless of its organizational and legal form and form of ownership, which conducts business activities, except for public authorities and local governments, as well as a natural person – entrepreneur and investor, including a foreign contractor who is a party to a production sharing agreement in accordance with the Law of Ukraine “On Production Sharing Agreements”, its contractor, subcontractor, supplier and other contractor performing works provided for in the production sharing agreement on the basis of agreements with the investor;
trade – any transactions carried out under contracts of sale, mines, supplies and other civil law agreements that provide for the transfer of ownership of goods.
In accordance with the Technical Regulation on medical devices approved by the resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 № 753 the following values are used:
1) commissioning – readiness of a medical device for the first use as intended by the end user and / or consumer;
2) introduction into circulation – the first appearance of a medical device, except for medical devices intended for clinical trials or evaluation of characteristics, on the market of Ukraine for distribution and / or intended use, regardless of whether the medical device is new or completely restored;
3) custom-made medical device – any medical device specially manufactured on the written prescription of a doctor or a person with the appropriate level of professional qualification, which determines the specific design characteristics of this medical device intended only for a specific consumer. A medical device of serial production, the change of characteristics of which is carried out to meet the individual needs of a person engaged in medical practice, or any other professional user, is not a medical device made to order;
4) manufacturer – a legal entity or a natural person – an entrepreneur responsible for the development, manufacture, packaging and labeling of a medical device before putting it into circulation under its own name, regardless of whether such actions are performed by such person or another person authorized to act on its behalf name. The duties of manufacturers are also performed by legal entities or natural persons – entrepreneurs who collect, package, completely reconstruct and / or label one or more finished medical devices and / or define their purpose as medical devices in order to put such products into circulation under their own name. , except for persons who collect a medical device that is already distributed on the market, or adapt it to the needs of a particular consumer;
5) aid – a product that is not a medical device, but intended by the manufacturer specifically for use with a medical device for the proper use of such a product for its intended purpose;
6) general group of medical devices – a group of medical devices that have the same or similar areas of application or are characterized by similar technologies;
7) intended use – the use of a medical device in accordance with the purposes specified by the manufacturer in its labeling and / or instructions for use;
8) clinical data – data on the safety and / or performance characteristics of the medical device, which are detected during its intended use. The source of clinical data is: clinical trial / clinical trials of the relevant product; clinical trial (s) or other studies relating to a similar product for which equivalence to that product can be confirmed and the results of which have been published in the scientific literature; published and / or unpublished reports of other clinical experience with this or a similar product for which equivalence to that product can be confirmed;
9) medical device – any tool, apparatus, device, device, software, material or other product used either separately or in combination with each other (including software provided by the manufacturer for use specifically for diagnostic and / or therapeutic purposes and necessary for the proper functioning of the medical device), intended by the manufacturer for use in order to provide diagnosis, prevention, monitoring, treatment or alleviation of the patient’s disease in case of disease, diagnosis, monitoring, treatment, relief of the patient in case of injury or disability or their compensation, research, replacement, modification or maintenance of the anatomy or physiological process, control of the fertilization process and the main expected effect of which in the body or on the human body is not achieved by pharmacological, immunological or metabolic means, but the functioning of which can contribute;
10) medical device intended for clinical trials – a medical device (except for medical devices for in vitro diagnostics), intended for use by a qualified medical professional during clinical trials;
11) disposable medical device – a medical device intended for use only once for only one patient;
12) subcategory of medical devices – a group of medical devices that have the same scope for their intended purpose or are characterized by a common technology;
13) authorized representative – any legal entity or natural person – entrepreneur who is a resident of Ukraine or registered in accordance with the laws of Ukraine, a representative office of a foreign entity that has duly confirmed authority from the manufacturer to take legal action on its behalf in respect of obligations of the manufacturer established by these Technical regulations. For the purposes of this Technical Regulation, the term “national standards” is used in the meaning given in the Law of Ukraine “On Standardization“;
the terms “declaration of conformity”, “supplier” – in the meaning given in the Law of Ukraine “On Confirmation of Conformity”;
the terms “conformity assessment body”, “risk”, “technical regulations” – in the meaning given in the Law of Ukraine “On standards, technical regulations and conformity assessment procedures”;
the term “medicines” – in the meaning given in the Law of Ukraine “On Medicines“.