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

Country/Territory
Russian Federation
Document type
Legislation
Date
2020
Source
FAO, FAOLEX
Subject
General
Keyword
Public health Hazards Risk assessment/management Authorization/permit Internal trade
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 the date of its official publication.
Abstract

Article 55 of the Federal Law No. 61-FZ “On circulation of medicines” shall be supplemented with item 1 (1) of the following wording: “Retail sale of medicinal products for medical use (except for prescription medicinal products for a medicinal product, narcotic drugs and psychotropic drugs, as well as alcohol-containing medicinal products with a volume fraction of ethyl alcohol exceeding 25 per cent) can be carried out by pharmacy organizations by remote means. Retail sale of medicinal products for medical use by remote means may be carried out by pharmacy organizations that have a license to carry out pharmaceutical activities and a permit from the federal executive body responsible for monitoring and supervising of health care. The procedure for issuing a permit for the remote retail trade in medicinal products, the requirements for pharmacy organizations that may carry out such trade and the procedure for its implementation, as well as the rules for the delivery of medicinal products to citizens, are established by the Government of the Russian Federation. Information on paid for (dispensed) and received medicines shall be entered into the system for monitoring the movement of medicines for medical use in accordance with the procedure provided for in paragraph 7 of Article 67 of this Federal Law”. Article 55 of the Federal Law No. 61-FZ “On circulation of medicines” shall be supplemented with item 9 of the following wording: “"9. In an emergency situation and/or in the event of a threat of the spread of a disease posing a danger to others, the Government of the Russian Federation has the right, if necessary, to establish a temporary procedure for the retail sale of medicinal products for medical use (except for narcotic drugs and psychotropic drugs, as well as alcohol-containing medicinal products with a volume fraction of ethyl alcohol exceeding 25 percent) by remote means, the procedure for issuing permits for trade provided for in this part, the requirements for pharmacy organizations that can carry out such trade, as well as temporary rules for the delivery of medicines to citizens”.

Full text
Russian
Website
rg.ru

References - Legislation

Amends

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

Legislation | Russian Federation | 2010 (2018)

Keyword: Animal health, Drugs, Pests/diseases, Registration, Research, Standards, Transport/storage, Data collection/reporting, Access-to-information

Source: FAO, FAOLEX