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)