Pharmaceutical regulatory terms used in Russia and EAEU

Adverse reaction (adverse drug reaction)

Unintentional adverse reaction of the body that may be associated with the use of a medicinal product (paragraph 50.1 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Active Pharmaceutical Substance (Active Pharmaceutical Ingredient, API)

Medicinal substance in the form of one or several active substances having pharmacological activity regardless of the nature of origin, which is intended for production, manufacture of medicinal products and determines their efficacy (paragraph 2 in the edition of the Federal Law dated 22.12.2014 N 429-FZ)

Batch of a medicine

Certain quantity of a medicine manufactured in the course of one technological cycle by the manufacturer;

Bioequivalence of medicinal products

Achievement of comparable indicators of absorption rate, extent of arrival to the site of action and excretion rate of one or more active substances having pharmacological activity when using medicinal products for medical use having the same international nonproprietary (or chemical or grouping) name, in equivalent dosages and by the same route of administration (item 12.4 introduced by the Federal Law dated 27.12.2019 N 475-FZ)

Bioequivalence study of a medicinal product

Type of clinical study of a medicinal product, which is carried out to determine the rate of absorption and excretion of one or more active substances with pharmacological activity, the amount of the medicinal product reaching the systemic bloodstream, and the results of which make it possible to conclude on the bioequivalence of a reproduced medicinal product in a certain dosage form and dosage, corresponding to the form and doses (paragraph 45 in the edition of the Federal Law dated 22.12.2014 N 429-FZ)

Biological medicinal products

Medicinal products, the active substance of which is produced or isolated from a biological source and for determination of properties and quality of which a combination of biological and physicochemical methods is required. Biological medicinal products include immunobiological medicinal products, medicinal products derived from blood, blood plasma of humans and animals (except for whole blood), biotechnological medicinal products, genotherapeutic medicinal products;

Biosimilar medicinal product (biosimilar)

Biological medicinal product similar in quality, efficacy and safety parameters to the reference biological medicinal product in the same dosage form and having an identical route of administration (item 12.2 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

Biotechnological medicinal products

Medicinal products, the production of which is carried out using biotechnological processes and methods (including DNA recombinant technology, technology of controlled expression of genes encoding biologically active proteins in prokaryotes and eukaryotes, including modified mammalian cells), hybridomics and monoclonal antibody methods (item 7.1 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

Circulation of medicines

Development, preclinical testing, clinical trials, expert examination, state registration, standardization and quality control, manufacturing, compounding, storage, transportation, import into the Russian Federation, export from the Russian Federation, advertising, dispensation, distribution, transfer, use and destruction of medicines;

Common technical document

Set of documents and materials consisting of several sections: administrative documentation, chemical, pharmaceutical and biological documentation, pharmacological, toxicological documentation, clinical documentation and submitted simultaneously with the application for state registration of a medicinal product for medical use in the format established by the authorized federal executive body (p. 21.1 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Comprehensive evaluation of a medicinal product

Evaluation of a registered medicinal product including analysis of information on comparative clinical efficacy and safety of the medicinal product, evaluation of economic consequences of its use, study of additional consequences of the use of the medicinal product in order to make decisions on the possibility of inclusion of the medicinal product in the list of vital and essential medicinal products, normative legal acts and other documents determining the procedure for the provision of medical care, or its exclusion from the said list, acts and documents (paragraph 55 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Counterfeited medicine

Medicine supplied with false information on the composition and/or manufacturer;

Developer of a medicinal product

Organization that has rights to the results of preclinical studies of a medicinal product, clinical studies of a medicinal product and (or) to the technology of production of a medicinal product (ed. Federal Law of 22.12.2014 N 429-FZ)

Dosage form

Condition of a medicinal product corresponding to the modes of administration and use thereof, and ensuring the required therapeutic effect;

Dosage

Content of one or more active substances in quantitative terms per unit dose or unit volume or unit mass according to dosage form or for some types of dosage forms the amount of active substance released from the dosage form per unit time (paragraph 5.1 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

Efficacy of a medicinal product

Characteristics of the degree of positive effect of a medicinal product on the course, duration or prevention of a decease, or rehabilitation, as well as for maintenance, prevention or interruption of pregnancy;

Excipients

Substances of organic or non-organic origin used in the process of manufacturing and compounding of medicinal products in order to give the latter required physicochemical properties;

General pharmacopoeial monograph

Document approved by the authorized federal executive body and containing a list of quality indicators and (or) quality control methods of a particular pharmaceutical form, medicinal plant raw materials, descriptions of biological, biochemical, microbiological, physicochemical, physical, chemical and other methods of analysis of a medicinal product, as well as requirements for reagents, titrated solutions, indicators used for the purposes of this analysis (ed. Federal Law of 22.12.2014 N 429-FZ)

Generic medicinal product

Medicinal product for medical use, which has an equivalent qualitative composition and quantitative composition of active substances in an equivalent dosage form to the reference medicinal product, or a medicinal product for veterinary use, which has the same qualitative composition and quantitative composition of active substances in the same dosage form, bioequivalence or therapeutic equivalence to the reference medicinal product  has been demonstrated by appropriate studies (paragraph 12 in the edition of the Federal Law of 27.12.2019 N 475-FZ)

Grouping name of a medicinal product

Name of a medicinal product that does not have an international nonproprietary name or a combination of medicinal products used for the purpose of combining them into a group under a single name based on the same composition of active substances (item 17.1 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

Herbal medicinal product

Medicinal product manufactured or compounded of one type of herbal medicinal raw material or several types of such raw materials and being distributed as packed in the secondary (retail) packaging;

Herbal medicinal raw material

Fresh or dried plants or parts thereof used for manufacturing of medicines by institutions producing medicines, or for compounding of medicinal products by pharmacy institutions, veterinary pharmacy institutions and individual entrepreneurs holding pharmaceutical licenses;

Holder or owner of the registration certificate of a medicinal product

Medicinal product developer, manufacturer of medicinal products or other legal entity holding the right to hold a registration certificate, which are responsible for the quality, efficacy and safety of the medicinal product (p. 26.1 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Homeopathic medicinal product

Medicinal product produced or manufactured from a pharmaceutical substance or pharmaceutical substances in accordance with the requirements of the general pharmacopoeial articles for homeopathic medicinal products or in accordance with the requirements of the pharmacopoeia of the country of the manufacturer of such medicinal product (paragraph 15 in the edition of the Federal Law dated 22.12.2014 N 429-FZ)

Immunobiological medicinal products

Medicinal products intended for formation of active or passive immunity or diagnostics of the presence of immunity or diagnostics of specific acquired change of immunological response to allergizing substances. Immunobiological medicinal products include vaccines, anatoxins, toxins, sera, immunoglobulins and allergens (paragraph 7 in the edition of the Federal Law dated 22.12.2014 N 429-FZ)

Infringing medicine

Medicine being in circulation in violation of the civil law;

Interchangeable medicinal product

Medicinal product with proven therapeutic equivalence or bioequivalence to the reference medicinal product, having equivalent qualitative composition and quantitative composition of active substances, composition of excipients, dosage form and route of administration (item 12.3 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

International non-proprietary name of a medicinal product (INN)

Name of the active substance of a pharmaceutical substance recommended by the World Health Organization (ed. Federal Law of 22.12.2014 N 429-FZ)

List of vital and essential medicines (Essential Drugs List, EDL)

List of medicines for medical use approved by the Government of the Russian Federation that provide priority health care needs for the prevention and treatment of diseases, including those prevailing in the structure of morbidity in the Russian Federation (ed. Federal Law of 13.07.2020 N 206-FZ)

Manufacturing of medicines

Activity in manufacturing of medicines carried out by institutions engaged in manufacturing of medicines at one, several or all stages of the technological process, as well as in storage and distribution of medicines manufactured;

Manufacturing site

Territorially separate complex of a medicinal product manufacturer intended for performance of the entire medicinal product manufacturing process or a certain stage thereof (item 31.1 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

Medicinal products

Dosage forms of medicines used for prophylaxis, diagnostics, treatment of disease, rehabilitation, as well as for maintenance, prevention or interruption of pregnancy;

Medicinal drug

Substances or combinations thereof coming in contact with the human or animal body, penetrating into the organs and tissues of the human or animal body, used for prophylaxis, diagnostics (except for substances or combinations thereof not coming in contact with the human or animal body), treatment of disease, rehabilitation, as well as for maintenance, prevention or interruption of pregnancy, as may be derived from blood, blood plasma, human or animal organs and tissues, plants and minerals by synthesis methods or using biological technologies. Medicines include pharmaceutical substances and medicinal products;

Narcotic medicines

Medicinal products and pharmaceutical substances containing narcotic drugs and included in the List of Narcotic Drugs, Psychotropic Substances and Precursors Thereof, which are subject to control in the Russian Federation in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation, including, but not limited to the Single Convention on Narcotic Drugs, 1961;  

Normative document

Document containing a list of quality characteristics and quality control methods for a medicine for medical use as determined under the relevant expert examination results, established by the manufacturer;

Original medicinal product

Medicinal product with a new active substance, which was first registered in the Russian Federation or in foreign countries based on the results of preclinical studies of medicinal products and clinical studies of medicinal products confirming its quality, efficacy and safety (paragraph 10.1 introduced by the Federal Law of 27.12.2019 N 475-FZ)

Orphan medicinal products

Medicinal products intended exclusively for diagnosis or pathogenetic treatment (treatment directed at the mechanism of disease development) of rare (orphan) diseases;

Pharmaceutical activities

Activities including wholesale trade in medicinal products, their storage, transportation and (or) retail trade in medicinal products, including by remote method, their dispensing, storage, transportation, manufacture of medicinal products;(ed. Federal Law of 03.04.2020 N 105-FZ)

Pharmacopoeial monograph

Document approved by an authorized federal executive body and containing a list of quality indicators and quality control methods for a medicinal product (ed. Federal Law of 22.12.2014 N 429-FZ)

Pharmacopoeial reference standard

Reference standard produced in accordance with the pharmacopoeial article (p. 19.2 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Pharmacovigilance

Activity for monitoring the efficacy and safety of medicinal products aimed at detection, evaluation and prevention of undesirable effects of medicinal products (p. 52.1 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Pharmacy organization

Organization, a structural subdivision of a medical organization engaged in retail sale of medicinal products, including by remote method, storage, transportation, manufacture and dispensing of medicinal products for medical use in accordance with the requirements of the Federal Laws (ed. Federal Laws of 25.11.2013 N 317-FZ, of 03.04.2020 N 105-FZ)

Poor quality medicine

Medicine not complying with the requirements of the pharmacopoeia monograph or, in case of non-availability thereof, with the requirements of the normative documentation or normative document;

Preclinical testing of a medicine

Biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other trials of a medicine by means of scientific methods of assessment for the purpose of obtaining evidence of safety, proper quality and efficacy of the medicine;

Prescription for a medicinal product

Medical document of the established form containing the prescription of a medicinal product for medical use, issued by a medical professional for the purpose of dispensing a medicinal product or its manufacture and dispensing on paper or with the consent of the patient or his/her legal representative in the form of an electronic document signed with the use of an enhanced qualified electronic signature of a medical professional, or a document of the established form containing the prescription of a medicinal product for medical use, or a document of the established form containing the prescription of a medicinal product for medical use (ed. by Federal Laws of 29.07.2017 N 242-FZ, of 02.08.2019 N 297-FZ)

Psychotropic medicines

Medicinal products and pharmaceutical substances containing psychotropic substances and included in the List of Narcotic Drugs, Psychotropic Substances and Precursors Thereof, which are subject to control in the Russian Federation in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation, including, but not limited to the Convention on Psychotropic Substances, 1971;

Quality of a medicine

Compliance of a medicine with the requirements of the pharmacopoeia monograph or, in case of non-availability of the latter, of the normative documentation or normative document;

Radiopharmaceutical medicines

Medicines which contain one radionuclide or several radionuclides (radioactive isotopes) in ready-to-use form;

Reference medicinal product

Medicinal product used for assessment of bioequivalence or therapeutic equivalence, quality, efficacy and safety of a reproduced medicinal product or a biosimilar medicinal product (biosimilar). The reference medicinal product for medical use shall be the original medicinal product or, if the original medicinal product is not registered or is not in circulation in the Russian Federation or is not in circulation in foreign countries, the reproduced medicinal product or biosimilar medicinal product (biosimilar), which is the first registered among the medicinal products in circulation in the Russian Federation, bioequivalence or therapeutic equivalence, to which the original medicinal product is not registered or is not in circulation in the Russian Federation or is not in circulation in foreign countries. A reference medicinal product for veterinary use is a medicinal product for veterinary use registered in the Russian Federation based on the results of preclinical studies of medicinal products and clinical studies of medicinal products confirming its quality, efficacy and safety (p. 11 in the edition of the Federal Law of 27.12.2019 N 475-FZ

Reference standards

Substances, by comparison with which quality control of investigated medicinal products is performed by means of physico-chemical and biological methods in order to confirm compliance of medicinal products with the requirements of regulatory documentation established in the course of state registration, and which are used for calibration of manufacturer's standard samples of medicinal products used for quality control and other purposes in the circulation of medicinal products (p. 19.1 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Registration certificate of a medicinal product

Document certifying the fact of state registration of a medicinal product;

Registration number

Reference code assigned to a medicinal product in state registration;

Request of a medical organization, veterinary organization

Document of the established form, which is issued by a medical practitioner or a veterinary specialist entitled to do so and contains in writing an instruction to a pharmacy organization or a veterinary pharmacy organization to dispense a medicinal product or to manufacture and dispense it to ensure the therapeutic process in a medical organization, veterinary organization (ed. Federal Law of 02.08.2019 N 297-FZ)

Risk management plan

Detailed description of pharmacovigilance activities aimed at identification, assessment and prevention or minimization of risks associated with medicinal products, including assessment of the effectiveness of these activities (p. 52.2 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Safety of a medicine

Characteristics of a medicine based on comparative analysis of its efficacy and assessment of health hazard;

Subjects of circulation of medicines

Individuals, including, but not limited to individual entrepreneurs, and legal entities engaged in circulation of medicines;

System for monitoring the movement of medicinal products for medical use

Federal state information system for monitoring the movement of medicinal products for medical use from the manufacturer to the end consumer using identification means in relation to medicinal products for medical use (paragraph 56 introduced by the Federal Law of 28.12.2017 N 425-FZ)

Therapeutic equivalence of medicinal products

Achievement of clinically comparable therapeutic effect and indicators of efficacy and safety when using medicinal products for medical use having the same international nonproprietary (or chemical or grouping) name, in equivalent dosages for the same indications for use and with the same route of administration in the same group of patients (item 12.1 in the edition of the Federal Law dated 27.12.2019 N 475-FZ)

Trade name of a medicinal product

Name of a medicinal product assigned by its developer, holder or owner of the registration certificate of the medicinal product (ed. Federal Law of 22.12.2014 N 429-FZ)

Unexpected adverse reaction

Adverse reaction of the organism, which is associated with the use of a medicinal product in doses recommended in the protocol of its clinical trial, investigator's brochure, or with the use of a medicinal product in doses recommended in the instructions for its use for prevention, diagnosis, treatment of a disease or medical rehabilitation of a patient, and the nature, severity or outcome of which does not correspond to the information about the medicinal product contained in the protocol of its clinical trial (clause 52 in the edition of the Federal Law dated 22.12.2014 N 429-FZ)

Veterinary pharmacy institution

Organization, structural subdivision of a veterinary organization engaged in retail sale of medicinal products, including by remote means, storage, manufacture and dispensing of medicinal products for veterinary use in accordance with the requirements of the Federal Law (ed. Federal Law of 03.04.2020 N 105-FZ)

Wholesaler of medicines

Institution engaged in wholesaling, storage and transportation of medicines in compliance with the requirements

© Pharegis LLC, 2023