A law was signed to extend the authorization to import medicines in foreign packaging into Russia
December 28, 2024
Federal Law No. 494-FZ dated 26.12.2024 amends part 3.2 of Article 47 of Federal Law No. 61-FZ dated April 12, 2010 “On Circulation of Medicines”, according to which importation into the Russian Federation and circulation in the Russian Federation of medicines in packages intended for circulation in foreign countries is permitted until December 31, 2025, in case of a deficit of such medicines in the Russian Federation or a risk of its occurrence due to anti-Russian sanctions.
The document starts on 01.01.2025 (with the exception of Articles 10, 15, 32, 33 and 35, which entered into force on the day of its official publication (published on the Official Internet Portal of Legal Information http://pravo.gov.ru – 26.12.2024), and a number of other provisions, which enter into force at a later date).
Link: http://publication.pravo.gov.ru/document/0001202412260023?index=1
Recommendations on registration of medical devices in the EAEU approved
December 27, 2024
The Board of the Eurasian Economic Commission at its meeting on December 23 approved the Methodological Recommendations on the content and structure of documents of the registration dossier of a medical device and the examination of the safety, quality and effectiveness of a medical device for the purposes of its registration.
This document entered into force from the date of its publication on the official website of the EAEU http://www.eaeunion.org – from December 27, 2024.
Methodological Recommendations define, taking into account law enforcement practice, approaches to the expert examination of safety, quality and efficacy of medical devices, as well as unify approaches to the type and content of evidentiary materials (documents) of a medical device manufacturer submitted for expert examination to prove the safety and efficacy of a medical device and to prepare its registration dossier in accordance with the Rules for Registration and Expert Examination of Safety, Quality and Efficacy of Medical Devices.
Methodological Recommendations include requirements to the content and structure of the documents of the registration dossier, and also define the components of the examination of safety, quality and efficacy of medical devices: assessment of the description of the medical device, compliance of the medical device with general requirements, risk analysis, analysis of the report on clinical evidence of efficacy and safety of the medical device, analysis of reports on the results of inspection of the production of the medical device, examination of documentation for the purpose of making changes to the registration dossier.
The new Methodological Recommendations replaced the Methodological Recommendations on the examination of safety, quality and effectiveness of medical devices for the purpose of their registration within the EAEU and the Methodological Recommendations on the content and structure of documents of the registration dossier of a medical device adopted by the Commission on 21.05.2019.
Link: https://eec.eaeunion.org/news/prinyaty-rekomendatsii-po-registratsii-meditsinskikh-izdeliy-v-eaes-/
Registration certificates for nine medicines canceled
December 20, 2024
The Ministry of Health has withdrawn nine registration certificates (RCs) for medicinal products from the State Register of Medicinal Products (SRMP). All of them were revoked on the basis of applications from authorized legal entities of the companies holding the certificates.
Reg. certificates of five medicinal products were revoked by Minskintercaps, a company from Belarus: four antioxidant vitamin and mineral complexes: Antioxicaps, Antioxicaps with iodine, Antioxicaps with selenium and Antioxicaps with zinc. Also the drug of this manufacturer “Riboxin” (international nonproprietary name “inosine”) was excluded from the register. Other drugs with the same active ingredient are still available on the market.
Bristol Myers Squibb withdrew the reg. certificate for the antitumor drug Sprysel (proteintyrosine kinase inhibitor, international nonproprietary name dasatinib), while the registered dasatinib of this manufacturer and more than ten other domestically produced drugs with the same active substance remained in the GRLS.
Lucetam by Egis (international nonproprietary name piracetam) was also excluded from the register. Another 73 drugs with the same active ingredient remained in the register.
Link: https://grls.rosminzdrav.ru/Default.aspx
Plans to oblige owners of marketplaces to verify the reliability of information on dietary supplements
December 13, 2024.
Bill No. 794537-8 “On Amending the Law of the Russian Federation ‘On Protection of Consumer Rights’” (hereinafter – the Bill) was submitted to the State Duma of the Russian Federation on 11.12.2024.
The bill establishes the obligation of the owner of the aggregator of information about goods (services) to independently verify the reliability of the information provided to the consumer about the quality and the main consumer properties of dietary supplements, its composition, manufacturer, it is proposed to supplement Part 2 of Article 26_1 of the Law of the Russian Federation of 07.02.1992 № 2300-1 “On Protection of Consumer Rights” with the corresponding norm.
According to the explanatory note to the draft law, in the event that the information declared by a supplier of biologically active food supplements (BAAs) is found to be unreliable, the aggregator of information on goods (services) is obliged to suspend the sale of BAAs until the identified violations have been eliminated.
According to the authors of the bill, it is possible to prevent the sale of dietary supplements that do not meet the stated characteristics, as well as dietary supplements that are dangerous to the health of citizens, if organizations that undertake to sell goods remotely, will check the reliability of information about the properties of dietary supplements before their placement in their catalogs.
Link: https://sozd.duma.gov.ru/bill/794537-8.
New rules for the State registration of medical devices are approved
December 04, 2024.
Decree of the Government of the Russian Federation No. 1684 of 30.11.2024 approves the Rules for State Registration of Medical Devices, including the specifics of registration of domestic medical devices.
The requirements for medical organizations conducting tests of medical devices were approved.
Clause 5 of the Rules states that state registration of medical devices is carried out on the basis of the results of technical tests, toxicological studies, clinical trials, which are forms of conformity assessment of medical devices taking into account classification depending on the potential risk of their use, inspection of production, analysis of evidentiary materials of the manufacturer (producer) of a medical device, examination of quality, effectiveness and safety of medical devices taking into account the classification of medical devices and their use.
The document enters into force on 01.03.2025 (except for certain provisions). The rules approved by this decree of the Government of the Russian Federation will be in force until December 31, 2026.
Link: http://publication.pravo.gov.ru/document/0001202411300042?index=1
Additional requirements for the turnover of alcohol-containing non-food products
December 01, 2024.
30.11.2024 Federal Law No. 433-FZ “On Amending Certain Legislative Acts of the Russian Federation” signed by the President of the Russian Federation.
State control over production and turnover of alcohol-containing non-food products is strengthened.
From March 1, 2025, mandatory labeling of alcohol-containing non-food products with means of identification is introduced. Organizations engaged in its production and (or) turnover, as well as sole proprietors engaged in the retail sale of products, will have to submit information on the volume of its production and turnover to the relevant GIS in accordance with the rules approved by the Government.
A ban is introduced on the production of alcohol-containing non-food products by separate subdivisions of organizations that produce alcohol. In case of turnover of such products without labeling or with fake means of identification, the license will be annulled in court.
Until March 1, 2027, the term for the use of a paper TTN as a document certifying the legality of the production and turnover of ethyl alcohol, alcoholic and alcohol-containing products is extended.
From the day of official publication of the Federal Law till December 31, 2025 it is allowed to produce absolute ethyl alcohol (rectified ethyl alcohol containing no more than 0.2 percent of water by volume), including denatured absolute ethyl alcohol, by organizations licensed to produce, store and supply produced bioethanol, within the volumes established by the federal executive body authorized to control (supervise) in the field of production and turnover of ethyl alcohol, as well as by the federal executive body authorized to control (supervise) in the field of production and turnover of ethyl alcohol.
The document starts on 30.11.2024 (except for certain provisions).
Link: http://publication.pravo.gov.ru/document/0001202411300027
Author
Dmitriy Kovalev
Send message
Please describe your situation and we will find an optimal solution for your business.
info@konsugroup.com