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;