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Federal Law No. 61-FZ “On circulation of medicines”.

Country/Territory
Russian Federation
Document type
Legislation
Date
2010 (2018)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Pests/diseases Registration Research Standards Transport/storage Data collection/reporting Access-to-information
Geographical area
Arctic, Asia and the Pacific, Black Sea, Caspian Sea, CIS (Commonwealth of Independent States), Eastern Europe, Europe, Europe and Central Asia, North Pacific, North-West Pacific
Entry into force notes
This Federal Law enters into force on 1 September 2010.
Abstract

This Federal Law regulates relations arising in connection with the application, development, preclinical studies, clinical testing, expertise, state registration, standardization and quality control, production, manufacturing, storage, transportation, import into the Russian Federation, export from the Russian Federation, advertising, release, trade, transfer, use and destruction of medicines. Development of medicines, including veterinary drugs, includes the search for new pharmacologically active substances, further study of their medicinal properties, preclinical research, development of technologies for the production of pharmaceutical substances, development of compositions and technologies for the production of medicines. A preclinical study of a medicinal product for veterinary application shall be performed by application of scientific methods of estimations with a view of reception of proofs of safety, quality and efficiency of a medical product, including definition of term of its removal from an organism of an animal, with a view of maintenance of safety of products of animal origin after application of an appropriate medical product. Clinical studies of medicinal products for veterinary use are conducted in veterinary organizations and organizations engaged in the breeding, cultivation and maintenance of animals for the purpose: (a) establishment of drug transferability by healthy animals; (b) selection of optimal dosages of drugs and treatment course for a specific group of animals with a certain disease; (c) establishment of safety and efficacy of the drug intended for treatment of certain animal diseases or effectiveness of the drug for prevention of diseases of healthy animals; and (d) exploring the possibility of expanding the indications for the use of the registered medicinal product and identifying previously unknown side effects. Reports on the results of the preclinical study of a medicinal product and clinical study of a medicinal product for veterinary use shall be prepared by the developer of the medicinal product taking into account the conclusions of the organizations participating in the organization and conduct of these studies. Pharmaceuticals made by pharmacies, veterinary pharmacies, individual entrepreneurs on prescriptions for medicines and requirements of medical shall not be subject to state registration. Developer of veterinary drugs must submit application for state registration of veterinary drugs to the federal executive body performing state registration of veterinary drugs. Expertise of the quality of the medicine, including veterinary drugs, and expertise of the ratio of the expected benefit to the possible risk of using the medicine for veterinary use shall be performed in the time period of 110 working days from the date of receipt of expert opinion on the aforesaid issues. This Federal Law consists of XVI Chapters divided into 71 Articles. Chapter I lays down general provisions. Chapter II establishes plenary powers of the federal executive bodies, regional executive bodies of the Russian Federation related to circulation of medicines. Chapter III regards state pharmacopoeia. Chapter IV regards state control of circulation of medicines. Chapter V regards development, preclinical studies of medicines, as well as clinical studies of medicines for veterinary use. Chapter VI regards performance of state registration of medicinal products. Chapter VII deals with clinical testing of medicinal products for medical use, contract for the performance thereof, rights of patients participating in such testing. Chapter VIII deals with manufacturing and labelling of medicinal products. Chapter IX regards import to and export from the Russian Federation of medicinal products. Chapter X regards pharmaceutical activity. Chapter XI regards destruction of medicinal products. Chapter XII regards state regulation of prices for medicinal products. Chapter XIII regards monitoring of efficiency and safety of medicinal products circulating on the territory of the Russian Federation. Chapter XIV regards information related to medicinal products. Chapter XIV-1 regards restrictions on organization performing activities related to circulation of medicinal products. Chapter XV establishes liability. Chapter XVI lays down final provisions.

Full text
Russian
Website
pravo.gov.ru

References - Legislation

Implemented by

Order No. 282 of the Federal Veterinary and Phytosanitary Supervision Service validating the Procedure for suspension of trade and use of veterinary drugs.

Legislation | Russian Federation | 2021

Keyword: Animal health, Drugs, Enforcement/compliance

Source: FAO, FAOLEX

Order No. 555 of the Ministry of Agriculture validating the Regulation on good pharmacy practice of veterinary drugs.

Legislation | Russian Federation | 2020

Keyword: Animal health, Drugs, Transport/storage, Internal trade, Access-to-information

Source: FAO, FAOLEX

Amended by

Federal Law No. 105-FZ amending Federal Law No. 61-FZ “On circulation of medicines”.

Legislation | Russian Federation | 2020

Keyword: Public health, Hazards, Risk assessment/management, Authorization/permit, Internal trade

Source: FAO, FAOLEX

Federal Law No. 98-FZ amending some legislative acts of the Russian Federation related to prevention and liquidation of emergencies.

Legislation | Russian Federation | 2020

Keyword: Public health, Hazards, Risk assessment/management, Authorization/permit, Registration, Radiation, Internal trade

Source: FAO, FAOLEX

Federal Law No. 67-FZ amending Article 60 of the Federal Law No. 61-FZ “On circulation of medicines” and Article 38 of the Federal Law No. 323-FZ “On the fundamentals of protection of the public health”.

Legislation | Russian Federation | 2020

Keyword: Public health, Policy/planning, Governance, Hazards, Risk assessment/management

Source: FAO, FAOLEX