Legal Regulatory Guide
RussiaQ1-Q2 2024

Table of contents
INTRODUCTION  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 3TMT .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4Trial of Track & Trace system for radio-electronic products .  .  .  .  .  .  .  .  .  .  .  . 4Extension of the data storage obligations of the Moderators .  .  .  .  .  .  .  .  .  . 5Possible utilization fee for foreign telecommunicationequipment in Russia .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 7

LIFE SCIENCE AND PHARMACEUTICALS .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 8Potential changes to the data exclusivity regime  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 8Acceleration of market launches for generic pharmaceuticals  .  .  .  .  .  .  .  .  . 9Harmonization of Russian and EАEU legislation  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 9EAEU Unified Rules on the Circulation of Veterinary Medicines  .  .  .  .  .  .  . 10
Mandatory labelling of veterinary medicines from 1 October 2024 .  .  .  . 11

CONSUMERS GOODS .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 12
Proposed regulatory framework for marketplaces in Russia .  .  .  .  .  .  .  .  .  .  . 12

GENERAL REGULATORY .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 14
Waste disposal experiment  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 14
Environmental fines: recap of 2023 .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 15
Regular payments for subsoil use: dealing with unfair users .  .  .  .  .  .  .  .  .  . 16
New opportunities for subsoil users .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 16
Development of the labelling system  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 17
Russia’s recent trend of strengthening state control
over alcohol and tobacco turnover .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 19

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Introduction
Dear Readers,
In an ever-evolving regulatory landscape, staying
informed is paramount for businesses operating ininternational markets. We are pleased to present ourlatest Legal Regulatory Guide, a continuation of ourlongstanding tradition of providing comprehensive
regulatory insights tailored to the needs of ourclients. This guide is the result of the collaborative
efforts of our diverse regulatory team, which
comprises experts with extensive knowledge
across various legal domains. Our aim is to equipinternational companies with the critical updates
necessary to navigate the complexities of operatingin Russia.
This edition of the guide delves into several key
themes that are particularly pertinent to businesses
engaged in the Russian market. First, we explore therapidly changing landscape of Technology, Media,
and Telecommunications (TMT) regulations. As
digital transformation accelerates, understanding
the regulatory framework governing these sectors
is essential for companies looking to innovate andexpand their digital footprint.

insights will help businesses remain compliant withevolving laws and standards, ensuring that theycan effectively bring their products to market whilesafeguarding consumer welfare.
Consumer goods regulations are another criticalarea of focus in this guide. With increasing scrutiny
on product safety and marketing practices, it isimperative for companies to stay abreast of thelatest regulatory developments to mitigate risks andenhance consumer trust.
Finally, we address the important topic of waste
management regulations, which are becoming
increasingly significant in light of global
sustainability goals. Our analysis will provide
companies with the necessary guidance to navigate
compliance requirements and adopt best practices
in environmental stewardship.
We trust that this guide will serve as an invaluable
resource for international companies operatingin Russia, empowering them to make informed
decisions in a complex regulatory environment.

Additionally, we provide updates on the life sciences
and pharmaceutical sectors, where regulatorycompliance is not only a legal obligation but also
a vital component of public health and safety. Our

3

Maxim Alekseyev

Dina Kravchenko

Boris Pribylov

Senior Partner

Senior Associate

Senior Associate

E: MAlekseyev@alrud.com

Corporate/M&A, Business
Regulation (Regulatory)

Corporate/M&A, Business
Regulation (Regulatory)

E: DKravchenko@alrud.com

E: BPribylov@alrud.com

ТМТ
Trial of Track & Trace system
for radio-electronic products
Due to the general trend with the expansionof the Track & Trace digital labelling systemcalled “Chestny ZNAK” as part of mandatorylabelling requirements for more and moregroups of products on the Russian market (seemore details), a voluntary labelling experiment4

is currently being conducted for certain groupsof radio-electronic products1.
As recently updated2, the experiment includes
the following stages:

Timeline

Type of radio-electronic products

Stage 1

1 December 2023 –30 November 2024

Various lighting equipment (e.g., luminaires,
portable electric lanterns, different lamps, lightemitting diode (LED) light sources, rectifiers andstatic converters)

Stage 210 June 2024 – 30 April 2025

Laptops, smartphones and different types oftelephone sets

Stage 3

1 July 2024 – 31 August 2025

Different types of printed circuit boards (PCBs)

1

Resolution No. 1993 of the Government of the Russian Federation dated 25 November 2023 “On conducting an experiment to label certain
types of radio-electronic products with means of identification on the territory of the Russian Federation”.

2

Resolution No. 656 of the Government of the Russian Federation dated 23 May 2024 “On amendments to Resolution No. 1993 of theGovernment of the Russian Federation dated 25 November 2023”.

With respect to Stage 3, the Ministry ofIndustry and Trade is expected to approvemethodological recommendations and theschedule of this stage of the experiment by 31
August 2024.
The pilot project is open to manufacturers,
importers, retailers and wholesalers of thelisted radio-electronic products. To participate,applicants must submit an application to theoperator of the “Chestny ZNAK” system (theCentre for Advanced Technology Development
or CATD). During the pilot period, labelling
codes are provided free of charge. The
experiment is expected to make it possible
to test technologies to apply means ofidentification to goods, work out the procedurefor interaction between market participants
with the labelling system and exclude thepossibility of the use of counterfeit goods.
Based on its results, a decision will be madeon the advisability of introducing mandatorylabelling of radio-electronic products.
Considering the history of experimentswith the Trace & Track system for othertypes of products (e.g., medicines, clothing,tobacco products and dairy products), it isreasonable to assume that the labelling ofradio-electronic products is likely to become
mandatory once the experiment ends. Thus,
manufacturers, importers and sellers oflighting equipment, laptops, smartphones,
telephone sets and PCBs are advised toclosely monitor the on-going experiment andits outcome so that they can be prepared forfurther compliance with mandatory labelling
requirements.

Extension of the data storage obligationsof the Moderators
In 2014, under the so-called “Yarovayalaws”, the legal status of an “organizer of
information dissemination on the Internet” (a“Moderator”) was introduced in Federal Law
No. 149-FZ dated 27 July 2007 “On Information,
Information Technologies and Information
Protection” (the “Information Law”). The
Moderators are entities that work to ensure
the functioning of information systems and/or programmes for electronic computing
machines, which are designed and/or used
to receive, transmit, deliver and/or process
the electronic messages of Internet users. In
essence, the definition is quite broad and may
encompass various communication services,
as well as any websites or mobile applications
that facilitate user-to-user communication,
including chat forums or the functional ability
for users to leave reviews and for other users
to comment on such reviews.
3

5

The Moderators are mostly subject to lawfulinterception obligations with respect tocertain data about its users located in Russia3
and must store the electronic messages ofInternet users for six months and so-called“meta data” (i.e., information on the reception,transmission, delivery and/or processing ofelectronic messages) as well as information
on users for one year on the territory of theRussian Federation. The Moderator is obliged
to provide this information to authorized statebodies that perform operational investigative
activities or ensure the security of the RussianFederation (e.g., the Russian Federal Security
Service). There are also additional obligations
when the Moderator provides for messages tobe encoded.
In addition to the information on a user’s
electronic message and the “meta data” of such

It can be determined whether user data is located in Russia using network addresses identified as Russian at the time of registration or
authorization (mainly IP addresses allocated by Russian telecommunications operators); receipt by the Moderator of geographical data
indicating the location of a user on the territory of the Russian Federation (e.g., data from a GPS device); the provision of the details of
documents issued in Russia at the time of registration; the provision of contact numbers of Russian telecommunications operators orinformation about the location of the person received from an authorized entity.

messages, the actual list of information about
the users that is subject to the Moderators’
data storage obligation is envisaged in
Resolution No. 1526 of the Government of
the Russian Federation dated 23 September
2020 (the “List”). This includes the user’s ID
in the Moderator’s communication service, IP
address, registration data, authorization data,
information about changes or additions tothe user’s telephone number or email address,
as well as other information provided by theuser during registration, information aboutpaid services provided by the Moderator withpayment details (the amount of fees, currency
used, and payment system details) andinformation on the termination of registration.
In 2024, the List was augmented with
supplementary user data, which must be
stored in Russia for the period stipulatedby the Moderator and may be disclosed
to the Russian authorities in accordancewith lawful interception procedures4.
It now also includes factually recorded
information about users in the event thatthe communication service offers the optionof the electronic monitoring of geolocation
as well as the reception, transmission and/or processing of the electronic messagesof such users without registration andauthorization. Thus, the Moderator data
storage obligation now undoubtedly covers
details about unregistered and authorizedusers, including geolocation data.
Additionally, the Moderators now also store
details about the acceptance, transmission,delivery and processing of electronic
messages carried out with the use of electronic
payment system technologies, including
information about means of payment,
monetary transactions and the correspondent
identifier of the payment system. The data to
be recorded includes the currency, amount,

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paid service or goods (if any), and otherdata specified when conducting a monetarytransaction. Transactions must also include
the identifier of the payment system, currency,
amount, paid service or goods (if any), andother data specified when carrying out amonetary transaction.
There are also further plans to extend theModerators’ data storage obligations withregard to user data. Recently, the Ministry of
Digital Development, Communications andMass Media proposed that currently available
information about user IP addresses in the
List be supplemented with the details of
the ports used by the user and the Internet
communication service used to register,
authorize and terminate the user5.
According to an explanatory note from theregulator, an analysis of law enforcement
practice shows that the lack of advanced
information about IP addresses and user
ports at state agencies makes it impossible
to identify a specific user if network addresstranslation (NAT) technology is used, or
to find users of IP addresses allocated tousers of virtual servers (VDS/VPS), virtualprivate networks (VPNs) and proxy servers.
Consequently, if adopted, the amendments
to the List would facilitate the investigative
activities of the Russian authorities whenaccessing user data stored by the Moderator.
As such, we see a growing trend towards
the List being expanded with additional
information about communication service
users for the purposes of law enforcement andlawful interception. It is crucial that companies
with the legal status of a Moderator pay close
attention to any legislative changes that may
affect them to ensure that they are prepared
to comply with any necessary changes.

4

The amendments were introduced by Resolution No. 342 of the Government of the Russian Federation dated 20 March 2024 “Onamendments to Resolution No. 1526 of the Government of the Russian Federation dated 23 September 2020”.

5In May 2024, the draft amendments to Resolution No. 1526 of the Government of the Russian Federation dated 23 September 2020 were
published for public discussion on the regulation.gov.ru portal. It is currently undergoing a regulatory impact assessment (available here in
Russian only).

Possible utilization fee for foreign telecommunicationequipment in Russia
According to recent public statements fromthe Russian Minister of Digital Development,
Communications and Mass Media andinformation from reputable mass media
outlets, the Russian government is currently
considering an initiative to introduce autilization fee for foreign manufacturersof telecommunications equipment to levelout prices with domestic manufacturers.
This mechanism is expected to be a part of
telecommunications sector development
strategy in Russia until 2035 and should serve
as one of the methods to finance measures
to support the production and introductionof domestic telecommunications equipment.
In particular, in order to expand support forthe production and introduction of domestic
telecom equipment, a proposal has been madeto co-finance domestic developers’ expenses
on the development of equipment, as well as
to provide soft loans to domestic equipment
manufacturers to stockpile components for the
future production of equipment.
The legal concept of “utilization fees” was first
introduced in Russian law in 2012. At present,
it only exists in relation to vehicles imported
to or manufactured in the Russian Federation
to ensure free utilization for their end owners6.
It applies to wheeled vehicles (chassis),self-propelled machines and their trailers
and is paid by both foreign and domestic
manufactures. The purpose of the utilization
fee is to ensure environmental safety,
including the protection of human health andthe environment against the harmful effects
of vehicle operation, taking into account theirtechnical characteristics and wear and tear.

6

7

In terms of how the initiative would affectthe telecommunications sector, no further
comments on the governmental proposal areavailable so far. Yet, market participants fearthat the introduction of this measure could
lead to a significant increase in equipment
costs and a reduction in the quality oftelecommunications services.
On a separate note, one could argue thatsuch regulatory measures are a violationof the national treatment standard, which
ensures competitive equality and prohibits
discriminatory treatment between domestic
and foreign investors and investments under
the General Agreement on Tariffs and Trade(GATT 1947), since they will only apply toforeign manufacturers. The Russian Federation
is subject to the provisions of GATT 1947
due to its active membership in the World
Trade Organization (WTO). Nevertheless,
we recommend monitoring such legal
developments and proposals if your company
imports telecommunication equipment to
Russia due to the general localization and“technological sovereignty” trend in the lightof the current geopolitical situation.

See Article 21.1 of Federal Law No. 89-FZ dated 24 June 1998 “On Production and Consumption Waste”.

Life Science andPharmaceuticals
Potential changes to the data exclusivity regime
Draft Law No. 635933-8 on amendments tothe data protection regime that applies tothe results of clinical trials (the “Draft Law on
Clinical Trials”) has been submitted to the State
Duma of the Russian Federation.
The Draft Law on Clinical Trials proposes
making it impossible to apply the exclusivity
regime for clinical trials data in theregistration of medicines intended for use in (i)emergencies and (ii) pandemics, as well as in
the event of (iii) a shortage or (iv) the risk of its
occurrence.
The current regulations do not provide aclear answer about whether data protection
measures apply to the relationships that arise
from the state registration of pharmaceuticals
in Russia, particularly in cases of drug shortages
or confirmed risks of shortages, as well as
during emergencies (e.g., related to the spreadof infectious diseases). According to Article
13 of the Federal Law “On the Circulation of
Medicines”, the registration of drugs intended
for use in military actions, emergencies andthe prevention and treatment of dangerous

8

diseases is conducted based on procedures
established by the Russian government.
To implement this, two government resolutions
were adopted: Resolution No. 441 (3 April 2020)
and Resolution No. 593 (5 April 2022), which
create exceptions to the general registration
process in order to ensure rapid access tothe necessary medications. However, neither
resolution mentions whether data protection
measures may be applied. This absence isconsistent with the purpose of data protection,
which is to extend the monopoly of original
drug developers without hindering access tothe necessary treatments for the healthcare
system and patients.
In practice, questions may arise regarding thelegality of registering reproduced or biosimilardrugs under Resolution No. 593, especiallyduring confirmed shortages, which could
potentially lead to conflicts involving the
Ministry of Health, the Prosecutor’s Office andthe courts. Current judicial practices have been
adverse in this regard and pose significant risks
for the application of data protection measures,

even in cases of critical drug shortages,
which could result in the refusal to register orannulment of registrations obtained under the
aforementioned resolutions.
Such conflicts may deter manufacturers fromsupporting the domestic healthcare systemamidst international sanctions, which could
ultimately lead to drug shortages and increasedsocial tension. To mitigate these risks, aproposal has been made to amend the relevant
sections of the Federal Law to prevent theartificial unavailability of medications for theRussian population.

The purpose of the Draft Law on Clinical Trials
is to fill the legislative gap from the lack ofregulation of the data protection regime ofclinical trials during the state registration of
medicines in the event of a defect. As such,the Draft Law on Clinical Trials is designed toprevent the risk of the artificial unavailability of
medicines for the Russian population.
If adopted, the Draft Law on Clinical Trials
would enter into force on the day of its official
publication.

Acceleration of market launches for genericpharmaceuticals
Draft Law No. 592805-8 on amendments
to the Civil Code of the Russian Federation
concerning the free use of medicine-related
inventions (the “Draft Law on Generics”)
proposes amending Article 1359 of the
Civil Code of the Russian Federation by
supplementing the list of actions that do notconstitute an infringement of the exclusive
right to an invention.
In particular, according to the Draft Law on
Generics, the following actions would notconstitute an infringement of the rights toan invention: (i) use of the invention withrespect to a medicine for development, (ii)preclinical and clinical research, (iii) testing,(iv) state registration, (v) standardizationand quality control, (vi) production, (vii)storage, (viii) transportation and import to
the Russian Federation, (ix) registration of the
maximum retail price and (x) offering for sale(e.g., conclusion of supply agreements with
distributors and pharmacies).
The current patent restrictions on original
medicines do not allow generics to bepromptly introduced to the market. At
present, manufacturers must wait for thepatent to expire before they can initiate
the development and state registration of
medicines. Thus , according to the Draft Law
on Generics, Russian generics manufacturers
would be granted the right to carry out all
the preparatory actions needed to launch the
medicine as soon as the patent of the original
medicine expires.
If adopted, the Draft Law on Generics would
apply to legal relations arising on or after 24
February 2022 and to obligations that are due
after 23 February 2022.

Harmonization of Russian and EАEU legislation
Federal Law No. 1-FZ dated 30 January2024 on the harmonization of Russian
legislation with EAEU legislation (the “Lawon Harmonization”) entered into force on 30
January 2024 (except for certain provisions).

9

One of the most significant provisions of the
Law on Harmonization is the regulation ofdata protection in clinical trials. Under the
newly adopted Law on Harmonization, legal
protection is now provided both during thestate registration of a medicine and during
EAEU registration.
The legal protection period is four years fora generic medicine and three years for abiosimilar medicine, and an application for theregistration of medicines may be submitted
after these periods expire. The results of the
preclinical and clinical trials of the medicine
cannot be used for commercial purposes
without the consent of the right holder forsix years following the registration of the
medicine.
Please also see our Legal Regulatory Guide
Russia. Q3-Q4 2023 on this topic.
In addition, the Council of the EAEU has
adopted Unified Rules for Pharmaceutical
Inspections of Pharmacovigilance Systems of
Pharmaceutical Manufacturers (Decision of

the Council of the EAEU No. 29 dated 12 April
2024 on amending Decision of the Council of
the EAEU No. 83 dated 3 November 2016). The
Rules provide for:• A unified procedure for pharmaceuticalinspections in EAEU member states• A unified approach to interaction between
the authorized bodies of EAEU member
statesThe unification of the Rules at the EAEU level
will level out differences in pharmaceuticalinspections in different EAEU member states.
Moreover, the adoption of the Unified Rules
will minimize cases of repeated inspectionsof pharmaceutical manufacturers by multiple
pharmaceutical inspectors from different EAEU
member states.

EAEU Unified Rules on the Circulationof Veterinary Medicines
The Unified Rules on the Circulation of Veterinary Medicines in the EAEU, which wereapproved by Decision No. 1 of the Council of the EAEU dated 21 January 2022, enteredinto force on 13 March 2024.
According to the newly adopted Rules, an application for the registration of a veterinary
medicine may be submitted in any EAEU member state at the discretion of the manufacturer
or its legal representative. However, there are transitional provisions as follows:A) The registration of veterinary medicines,
which was started and not completed as of 13
March 2024, shall be carried out in accordancewith the national legislation of the EAEU
member state.
B) Until 31 December 2027, it is allowed toregister veterinary medicine according to thenational legislation of the EAEU member state,but only for circulation in the territory of that
EAEU member state. In this case, registration
certificates are valid for five years.

C) Registration certificates for veterinary
medicine that were issued before 13 March2024 are valid in the EAEU for the periods
established by the national legislation of the
EAEU member state, but not later than 31
December 2027.
D) Veterinary medicines registered before
13 March 2024 may be circulated in the EAEU
with the labelling placed on the packaging inaccordance with the national legislation of the
EAEU member state until the date of expiry of
their registration certificates.

After the expiry of the transitional provisions, veterinary medicines must be
registered in accordance with the EAEU Unified Rules.

10

Mandatory labelling of veterinary medicinesfrom 1 October 2024
According to the newly adopted Resolution No. 675 of the Government of the RussianFederation dated 27 May 2024, mandatory labelling of veterinary medicines will starton 1 October 2024. Mandatory labelling will be introduced with the following stages:
A) Entities engaged in the sale of veterinary
medicines must register in the “Chestny ZNAK”
system from 1 September 2024.

C) Information on the retail sales ofveterinary medicines must be submitted from
1 March 2025.

B) Manufacturers and importers ofveterinary medicines must start labelling
goods and submitting information to the“Chestny ZNAK” system about the introductionof goods into circulation from 1 October 2024.

D) Data on veterinary medicines supplied
to veterinary medical institutions andagricultural holdings must be submitted
from 1 September 2025.

However, veterinary medicines manufactured up to 30 September 2024 inclusive that
do not have labelling codes may be sold until their expiry date.
Please note that the application of means of identification on the consumer packaging
of veterinary medicines (including in the form of stickers) will not require any changes
to the documents included in the registration dossier.
NB!	Prior to the adoption of a decision on mandatory labelling, an
experiment on the voluntary labelling of veterinary medicines waspreliminarily conducted from 25 December 2023 to 31 August 2024.

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Consumers goods
Proposed regulatory framework
for marketplaces in Russia
On 5 March 2024, a draft law proposing a
new regulatory framework for marketplaces
was introduced to the lower house of theRussian Parliament (the State Duma). It
mainly regulates relations between individual
sellers, marketplace platform operators andthe points of delivery owners (the “Draft
Law”)7. Additionally, the Draft Law grants
additional warranties to consumers, inter alia,
by prohibiting marketplaces from demanding
compensation and other payments frombuyers in connection with the return of goods,
as well as by introducing requirements toensure the reliability of information about
goods and sellers on marketplaces.

market position (i.e., a marketplace withmore than a 20% market share); and theaggregator’s infrastructure (i.e., points ofdelivery, sorting centres, and software used in
the process of the delivery/receipt of goods
sold on the marketplace). In light of such
legal definitions, a proposal has been made to
introduce mandatory contractual provisions
that would be included to agreements
concluded by the owners of marketplaces
with individual sellers (aggregator’s service
agreement) and the points of delivery owners(an agreement concluded between an
aggregator of information on the goods owner
and a point of delivery owner).

The Draft Law specifies the legal status of
the following subjects: an aggregator of
information on goods (i.e., marketplace) and
its owner; an aggregator with a significant

In addition, the Draft Law obliges marketplaceowners to publish templates of the above
agreements on their e-commerce platform
and provide a transparent and clear statement

7

12

Draft Law No. 568223-8 “On the State Regulation of Trade Activities of Aggregators of Information on Goods in the
Russian Federation and on Amendments to the Federal Law ‘On the Principles of State Regulation of Trade Activities
in the Russian Federation’” (with regard to introducing the legal regulation of the activities of aggregators of
information on goods) (available here in Russian only).

of their terms of service, and to prevent
marketplaces from imposing unfavourable
conditions on sellers. The Draft Law also
prohibits the inclusion of any other services(marketing, logistics) in an aggregator’s
service agreement. The Draft Law pays specificattention to aggregators with a significant
market position, since it places additional
obligations on such major platforms comparedwith general aggregator owners.
Under the Draft Law, the Federal Antimonopoly
Service (“FAS of Russia”) would be the body
responsible for monitoring compliance bymarketplaces with their regulatory obligations.
At present, the FAS of Russia may alreadymonitor major marketplaces that are qualified
as “digital platforms” under the Fifth “Digital”
Antimonopoly Package8, since the moratorium
on antitrust inspections of IT companies,
including “digital platforms”, was recently
lifted with respect to certain violations9.

points if this limit is exceeded, since this
could be detrimental to the small businesses
involved as well as to customers, and could
slow down the development of e-commerce inRussia.
As such, due to the negative comments, adelay in the further consideration of the Draft
Law or any new amendments in subsequentversions could be expected, including thepossible “freezing” of the Draft Law in the
Russian parliament. Nevertheless, if yourbusiness in Russia meets the criteria ofan aggregator of information on goods(i.e., marketplace), we recommend closely
monitoring the development of the Draft Law
as well as other legal initiatives concerningmarketplace regulation because it is steadily
evolving and alternative initiatives may be
proposed.

If adopted, the Draft Law is expected toenter into force from 1 March 2025 (this date
may be rescheduled due to delays in thelawmaking process). Nevertheless, certain
provisions of the Draft Law received criticism
from the business community and a numberof governmental stakeholders. In particular,
the Association of E-commerce Companies,
the Ministry of Industry and Trade and the FAS
of Russia did not support the idea of setting
a market share limit for marketplaces andpreventing them from opening new delivery

13

8

On 1 September 2023, the Fifth “Digital” Antimonopoly Package came into force, which regulates the operationof marketplaces by introducing new criteria for dominance in digital markets and formally preventing abuse bymarketplaces (Federal Law No. 301-FZ “On Amendments to the Federal Law ‘On the Protection of Competition’” dated
10 July 10 2023). See more details about these legislative changes here.

9

The moratorium on antitrust inspections of IT companies was introduced in 2022 and was supposed to last until
the end of 2024. However, it was lifted from 28 March 2024 due to the large number of complaints from small
and medium-sized companies as well as consumers about violations by dominant entities (Resolution No. 340 of
the Government of the Russian Federation dated 20 March 2024 “On Amendments to Resolution No. 448 of theGovernment of the Russian Federation dated 24 March 2022”). See more details here.

General Regulatory

Waste disposal experiment
On 1 September 2024, an experiment on thedisposal of waste from goods and packaging
will begin (the “Experiment”). Participationin the experiment is mandatory. Under the
Experiment, importers (from non-EAEU
countries) must fulfil duties related to thedisposal of waste from the use of numerous
types of goods and packaging. The Experimentwill end on 31 December 2025.
With regard to controlled products andpackaging imported from 1 September 2024
until 1 September 2025, prior to the dayon which they are released by the customs
authority for domestic consumption, importersmust:• Pay an environmental fee or provide
notification about the independent disposalof waste. In the latter case, they must obtaina bank guarantee or conclude a surety
agreement for the payment of the fee. The
waste disposal contract must be concluded

14

with a legal entity or sole proprietor fromthe register of users.
• Submit reports on the weight of imported
goods and packaging to the waste
accounting system through their personalaccount.
With regard to controlled products andpackaging imported from 1 January 2024 until
31 December 2025, the following must be
submitted to the waste accounting system:• Reporting on the weight of goods andpackaging• Reporting on the self-disposal of waste fromgoods and packaging
The reporting must be submitted by 15 April
2025 for the period from 1 January 2024
until 31 December 2024 and by 15 April
2026 for the period from 1 January 2025

until 31 December 2025. Importers may
send information to the Ministry of Natural
Resources by 15 September 2025 about any
problems that may arise in the performance of
their duties.
In particular, controlled products andpackaging include:• Trousers and breeches made of other textile
materials for men or boys
• New pneumatic rubber tyres and tyres forpassenger cars, buses, motorcycles, bicycles,
as well as for vehicles and machines used inconstruction, mining or industry• Household washing machines, including
those with a spin cycle• Lead-acid batteries• Plastic packaging products made ofpolypropylene• Rigid cylindrical aluminium containers witha capacity of no more than 1 litre• Coated, impregnated or laminated bleachedplastic paper and cardboard (except adhesives)
weighing more than 150 g per 1 m2
If a product is included in the above list,
but its packaging is not, this means that theExperiment is still being conducted withrespect to it. If a product is not in the above list,
but its packaging is, then the Experiment is not
being conducted with respect to both items.
The Experiment will initiate another stage
in its development, which will require more
reporting and qualifications connected withecological issues. The Experiment is highly
likely to become permanent after it ends, andthe experiment period offers opportunities
to communicate with the authorities andexpress any relevant concerns, so it would be
advisable to be prepared for it in advance.

Environmental fines: recap of 2023
The growing control of the Federal Service
for Supervision of Natural Resources(“Rosprirodnadzor”) over environmental damage
started about four years ago (please refer to thebenchmark Nornickel case - collapse of a fueltank near Norilsk, Siberia in the Regulatory Guide
for the II-III quarters of 2020).
Based on its Annual Report, in 2023,
Rosprirodnadzor filed 1,190 claims forenvironmental damage against companies andindividual entrepreneurs for a total of RUB
226.82 billion.
One of the incidents in 2023 accounted for
RUB 146.6 billion, or almost two-thirds of thetotal amount of claims filed. It was a claim
against Svetlovsky Vodokanal (Kaliningrad
Region) for compensation for damages fromthe discharge of untreated water into the
Kaliningrad Bay of the Baltic Sea.

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However, there is a considerable gap between
the claims and the amounts recovered: only
RUB 3.6 billion out of RUB 226.82 billion wererecovered in 2023.
The state authorities are having challenges
collecting fines due to the violators’ lackof sufficient funds and their subsequentbankruptcy.
According to Svetlana Radionova, head of
Rosprirodnadzor, the watchdog is implementing
a major experiment to consult businesses oncompliance with environmental requirements
during the early stages of implementing newinvestment projects. Radionova believes sucha preventive approach will be more effective
than imposing fines. Nevertheless, this position
should not be treated as an exemption fromcompensation for damages if we are talking
about stable businesses.

Regular payments for subsoil use:
dealing with unfair users
Amendments10 intended to improve the legal
framework concerning regular payments
for the use of subsoil enter into force on
1 September 202411.

years for subsoil plots located in the Arctic
and similar zones and 10 years for subsoil
plots in internal sea waters, territorial seas oron the continental shelf.

Subsoil users are charged regular payments
for subsoil use separately for each typeof subsoil use: (i) geological study for theprospecting and evaluation of mineraldeposits, (ii) exploration of mineral deposits
and (iii) construction and operation ofunderground facilities.

The payments will be doubled during the firstyear of the new licence, increased 10 times
for the second year and 100 times for thethird and subsequent years compared withthe previous year when the term of the initiallicence expires. This measure encourages
subsoil users to meet their obligations in goodfaith and ensure the efficient use of subsoil
plots.

The amendments cover a wide range of issues.
Let’s consider the most significant ones.
First, they aim to deal with “sleeper” licences.
The rates of regular payments will be
increased if a subsoil user fails to conductgeological exploration of a mining plot within
the timeframe envisaged by law and applies
for an extension of the licence term. In thebase scenario, such a statutory term does notexceed five years for most subsoil plots, seven

Second, the amendments propose taking
into account slightly different factors while
determining the rate of regular payments:
climatic, landscape and geographicalconditions, the size of subsoil plots, types ofminerals, duration of subsoil use, extent ofgeological study of the territory and degreeof risk.

New opportunities for subsoil users
There has been a whole range of significant
improvements to the Law on Subsoil in Russia
in 2024, which market players have long been
waiting for.
The following changes12 became effective on
1 March 2024:
1.	 Licence holders are granted the right toconvert their exploration licences intomining licences without going throughthe competitive bidding process (i.e., withthe authorization of the authorized statebodies) once written-off reserves or spentsubsoil waste from previous exploration
licence holders have been accounted for on
the state balance sheet.
The Russian Minister of Natural Resources
and Environment stressed out that sucha modification to the rules for obtaining
licences for the next stage of subsoil

10 Federal Law No. 619-FZ dated 19 December 2023 “On Amendments to Article 43 of the Law of the Russian Federation‘On Subsoil’”.
11 Except for certain specific cases when its effect will be postponed.
12 Federal Law No. 598-FZ dated 29 December 2022 “On Amendments to the Law of the Russian Federation ‘On Subsoil’and Article 2 of the Federal Law ‘On Production and Consumption Waste’”.

16

exploration would redress the historicalinjustice when companies that held
exploration licences and were investing
resources to mine had to initiate an auction
at which they had to compete for the plot
with third parties.

bromine, boron, magnesium and potassium)
within the boundaries of the licenced plots.
It is essential to understand that this rightis conditional upon the preparation of therelated project documentation (changes
thereto).

This change is expected to maximize theincorporation of previously used mineraldeposits in the Russian economy.

This amendment should save costs andenable companies to switch to a “closedcycle” production process.

2.	 The amendments entitle subsoil users with
exploration and mining licences to (i) buildand operate underground facilities not
related to the mining of minerals (including
to store carbon dioxide)13 and (ii) placegroundwater in rock formations after
extracting useful components (e.g., lithium,

3.	 In addition, a six-month moratorium has
been lifted on the re-licensing of a subsoil
area following the early revocation ofa licence. This involves cases when, forinstance, a company holding a licence isliquidated or a licence holder applies forthe early termination of a licence.

Development of the labelling system
In recent years, Russia has been developing
its Honest Sign national track and trace
digital labelling system (“Honest Sign”), which
ensures control over counterfeit products,
in an effort to supervise the transportationof goods throughout the country. A general
overview of the system can be found in our
newsletter “The Russian Government has

adopted rules for the digital labelling of new
products and procedure for access to labellinginformation” or on the official Honest Sign
website (the latter is available in English andChinese).
The Honest Sign system continues to expand
and will encompass the following categories:(A)	Non-alcoholic beer (from 1 September 2024)(B)	Bicycles and bicycle frames (from 1 September 2024)(C)	Cider and pear cider (from 1 September 2024)(D)	Certain fermented sparkling and non-sparkling beverages with alcohol
concentration of no more than 7% (from 1 September 2024)(E)

Certain biologically active food additives (from 1 September 2024)(F)	Certain perfumery and cosmetic products intended for hand hygienewith antimicrobial effects declared in the consumer packaging
labelling, as well as surface disinfectants and skin antiseptics(from 1 September 2024)(G)

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Medical gloves (from 1 March 2025)

13 Except for underground facilities that dispose of I-V hazard
class production and consumption waste.

At present, numerous goods are undergoing experiments with labelling:(A)	Edible vegetable oils packaged in consumer packaging(25 December 2023 – 31 August 2024)(B)	Medicinal products for medical use and raw materials used for the
production of medicinal products for medical use (29 December 2023 –31 December 2024)(C)	Certain types of canned food (12 February 2024 – 31 August 2024)(D)	Certain types of building materials in consumer packaging(15 March 2024 – 1 December 2024)(E)	Certain types of alcoholic beverages with alcohol concentration of up to
9% inclusive (1 July 2024 – 31 August 2025)(F)

Certain types of medical devices (1 September 2024 – 31 August 2025)(G)	Medicinal products for veterinary use (25 December 2023 – 31 August 2024)(H)

Animal feed (25 December 2023 – 31 August 2024)(I)	Perfumery, cosmetics and household chemicals (15 January 2024 –28 February 2025)(J)

Selected types of printed materials (1 April 2024 – 31 August 2025)(K)

Certain types of heating devices (1 April 2024 – 28 February 2025)(L)	Selected types of cable and wire products (20 May 2024 – 28 February 2025)(M)

Fibre-optic products (1 December 2023 – 1 December 2024)(N)

Radio electronic products (1 December 2023 – 31 August 2025)14(O)

Technical means of rehabilitation (15 October 2023 – 31 August 2024)(P)

Certain types of children’s goods (20 December 2023 – 1 December 2024)

Based on all the previous labelling legislative
practices, we assume that the experiments
will ultimately result in the adoption of
obligatory labelling. On 3 May 2024 theMinistry of Industry and Trade also proposed
conducting an experiment to label numerous
types of groceries. The experiment would
include spices, bread snacks, sauces, vinegar,
ready-made soups, and certain vegetables.

18

The government has also proposed that
alcohol-containing non-food products withan ethyl alcohol content of more than 10%of the volume of finished products should
be labelled with identification marks of theHonest Sign tracing system and be traced
using this system.

14 For more information, please see the article
Trial of Track & Trace system for radio-electronic products

Furthermore, on 20 March 2024 a ban wasenacted on the retail sale of medical products
based on information from the Honest Sign
system.
Overall, the Honest Sign system is expanding
to include vast groups of products and aims
to encompass all the main consumer products
available on the Russian market. The Honest
Sign has proven its effectiveness and isalready being used in numerous productgroups.
As a member of working groups on labellingin foreign chambers of commerce, we are
keeping an eye on the further developmentof the Honest Sign system and are ready toadvise you on recent developments in the
tracing system upon request.

Russia’s recent trend of strengthening state control
over alcohol and tobacco turnover
Recent reforms in alcohol and tobacco
turnover in Russia reflect the overall trend
towards strengthening state control over such
goods. The trend is confirmed by the following
regulatory measures:• Enactment of an experiment to apply
labelling codes on special federal labels of
low-alcoholic beverages. The experimentwill take place from 1 July 2024 until 31
August 2025. The experiment involves
placing labelling codes in machine-readable
form (QR codes) on special federal labelsof low-alcoholic beverages from a specificlist, which includes certain types of finishedalcoholic beverages with alcohol content
of up to 9% inclusive, e.g., honey (including
carbonated and table) beverages.
• Enactment of the national rules for the saleof alcohol on summer verandas startingfrom 1 June 2024. The rules clarified thepossibility and procedure for selling alcoholon summer verandas. It is essential tocomply with the general requirements forthe retail sale of alcohol when providing
catering services and to have documents inplace stating that, in particular, the veranda
meets regional requirements in terms of its
placement and arrangement.
• Enforcement of technical regulations on
alcohol safety starting from 1 July 2025. The

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technical regulations include requirements
for the packaging and labelling of products,
as well as their safety during production,
storage, transportation and sale.
• Extension of an experiment to label alcohol
imported to the Russian Federation withspecial federal labels. Importers may apply
special federal marks on imported alcohol
at customs warehouses in experiment mode
until 31 May 2026.
• A draft law banning the production of
alcohol-containing non-food products toa separate unit that produces alcohol. The
draft law also states that products with an
ethyl alcohol content of more than 28% of
the volume of finished products shall not be
available for purchase and supply at prices
below the minimum cost of alcohol witha similar strength for 0.5 litres during its
purchase and delivery. In any case, the banwill not affect imports and exports. The draft
law also proposes that alcohol-containing
non-food products with an ethyl alcohol
content of more than 10% of the volume
of finished products must be labelled withidentification marks of the Honest Sign
tracking system and be traced in this system.
The Russian government has also proposed
simplifying and accelerating the issuance ofa number of licences for the production andturnover (except retail sale) of ethyl alcohol,
as well as alcoholic and alcohol-containing
products. Per the draft law, it will take up to
20 business days from the registration date of
documents to issue a licence if the application
was sent electronically. At present, it takes 30
calendar days to consider applications andcould take twice as long for additional examinations. There is also a proposal to reduce thenumber of documents that applicants must
submit to the licensing authority.
As for tobacco regulation, the following
restrictive measures have been enacted:• The Ministry of Finance has proposed a listof risk indicators that must be identified
for federal control over the production andturnover of tobacco and nicotine-containing
products, as well as raw materials for theirproduction.
• The government has approved regulations
on the federal state control (supervision)of the production and turnover of tobacco
products, nicotine-containing products andraw materials for their production. The new
regulation establishes rules for controlling
the production and turnover of tobacco,
nicotine-containing products and raw
materials for their production. Inspections
are carried out by the Federal Service forControl of Alcohol and Tobacco Markets andits regional authorities. The regulation alsoestablishes, inter alia, the procedure for
conducting control measures and the out-ofcourt appeal of decisions made by officials.
• The government established that startingfrom 7 April 2024, parties involved in theturnover of raw materials for manufacturing
tobacco and/or nicotine-containing products
must register in the Honest Sign tracking
system.

20• A new type of administrative liability was
introduced: the production and turnover oftobacco, nicotine-containing products andraw materials for their production without alicence or using undocumented equipment
will start being punished under the new
specific article 14.67 of the Administrative
Code of the Russian Federation. Punishment
for legal entities is quite strict – up to
RUB 1 mln with the confiscation of the
manufactured products, equipment, rawmaterials, semi-finished products or otheritems used for the production and turnoverof tobacco products, nicotine-containing
products and/or raw materials for theirproduction, or the administrative suspensionof operations for up to 90 days from thetime of confiscation of the manufactured
products, equipment, raw materials, semifinished products or other items used for the
production and turnover of tobacco products,
nicotine-containing products and/or raw
materials for their production.
Thus, tobacco and alcohol regulation isclearly undergoing constant reforms. Despite
the newly adopted restrictive measures, thegovernment is trying to maintain a balanceof interests among business and consumer
safety by enacting some core shifts only after
regulatory experiments have been conductedtaking into consideration the obstacles andissues that the parties involved in their
turnover have experienced.

Please be aware that all information provided in this brochure wastaken from open sources. Neither ALRUD Law Firm, nor the authorsof this brochure, bear any liability for consequences of any decisions
made in reliance upon this information.

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