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

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