Advertising Prescription Drugs to Doctors in Russia Remains Legal. Fines for Unmarked Ads Have Risen to 500,000 Rubles
A regulatory manager removes a banner featuring a prescription drug from a patient-facing website, proofreads a physician booklet line by line, and cross-checks every phrase against the Package Insert (PI). It seems that all risks have been closed off. A fine arrives from a different angle: a missing ad token (ERID) in a Telegram post read by three hundred practicing neurologists.
This is what compliance in Rx marketing has looked like for the past year and a half. Advertising content is governed by the same standards as a decade ago. The new level of risk stems from technical marking, advertising revenue levies, and bans on specific platforms. Not a single one of these three requirements was on pharma compliance checklists back in 2024.
What Is Allowed and What Is Forbidden in Prescription Drug Advertising
Advertising of prescription-only medicines is aimed exclusively at Health Care Professionals (HCPs). Part 8 of Article 24 of Federal Law No. 38-FZ of March 13, 2006, «On Advertising» (hereinafter, Law No. 38-FZ) permits such advertising in only two formats: at medical and pharmaceutical exhibitions, seminars, and conferences, as well as in specialized printed publications for doctors and pharmacists. Advertising whose consumers are strictly medical and pharmaceutical workers is not exempt from this restriction; it obeys the same content requirements as any other drug advertising.
Content is equally controlled. Part 6 of Article 24 of Law No. 38-FZ permits stating the properties and methods of application of a drug strictly within the scope of the indications listed in its Package Insert. The Package Insert (PI) and the Summary of Product Characteristics (SmPC) are formed according to the requirements of EEC Council Decision No. 88 of November 3, 2016. It is this document that defines which formulations exist within the legal field for a specific drug. Advertising cannot cite the fact of clinical trials required for registration as proof of superior benefits, nor can it include patient testimonials or stories of recovery.
A separate rule applies to drugs containing narcotic drugs and psychotropic substances. Part 9 of Article 24 of Law No. 38-FZ bans their advertising entirely, except at the same professional venues: exhibitions, seminars, and specialized publications. Distributing samples of such drugs during promotional campaigns is prohibited without exception (Part 10, Article 24, Law No. 38-FZ).
In parallel, a prohibition exists on the recipient’s side. Article 74 of Federal Law No. 323-FZ of November 21, 2011, «On the Basics of Health Protection of Citizens in the Russian Federation» (hereinafter, Law No. 323-FZ) prohibits doctors and pharmaceutical workers from accepting gifts, cash, or paid entertainment from companies, entering into agreements to prescribe specific drugs, or receiving samples for distribution to patients. Amendment No. 150-FZ of June 7, 2025 preserved the structure of this prohibition. The wording was expanded: any remuneration is subject to restriction, with the exception of payments under agreements for clinical trials, as well as pedagogical or scientific activities performed by the doctor.
The definition of advertising itself warrants separate attention. The Law on Advertising classifies as advertising any information distributed to an indefinite group of persons that is intended to generate interest in a product. A personal letter to a specific doctor addressing them by name, a personalized scientific digest by subscription, or a chatbot response to a direct inquiry from a specific specialist usually falls under the category of targeted communication with a defined recipient, for which this definition does not apply. The boundary here is thin, depends on the actual content of the message, and is evaluated on a case-by-case basis. The status of a specific material is therefore best agreed with legal counsel based on the text of the message, regardless of the channel format.
The industry complements these regulations with self-regulation. The Association of International Pharmaceutical Manufacturers (AIPM, also operating under the name AMFP) has maintained a Code of Good Practice since 1998: the document outlines general principles for promoting pharmaceutical products, standards for advertising information, restrictions on interaction with HCPs, and the definition of a gift as applied to the pharmaceutical market. The Code is regularly updated to reflect changes in Russian legislation and revisions of the equivalent document from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
Compliance with the Code is mandatory only for member companies of the association, and violations are reviewed by a special commission within AIPM, up to recommending a company’s expulsion from membership. For the rest of the market, the Code carries no legal force. Companies outside AIPM still use it as a benchmark when developing internal compliance policies. The Code’s standards on interaction with doctors and the formatting of advertising materials are typically stricter than the requirements of Article 74 of Law No. 323-FZ and Article 24 of Law No. 38-FZ.
Digital Marking and New Levies Have Changed the Cost of Communicating with Physicians
Three developments in 2025 left advertising content untouched, yet affected every digital placement channel.
First: marking. The requirement to obtain a unique advertising identifier (ERID) via an Advertising Data Operator (ADO) has been in effect since 2022. Fines for its absence became widespread practice specifically in 2025-2026.
Part 16 of Article 14.3 of the Code of Administrative Offenses of the Russian Federation (hereinafter, the Administrative Code) establishes a fine for placing online advertising without an ERID or with violations of its display requirements: from 200,000 to 500,000 rubles for legal entities. Part 15 of the same article penalizes failure to submit or distortion of data in the Unified Register of Internet Advertising (ERIR) with a fine of 200,000 to 500,000 rubles for legal entities. Fines accumulate per unmarked publication, so a series of posts without tokens can add up to a multi-million-ruble total.
Directly exempted from marking are email newsletters and push notifications sent to a company’s own contact database. Roskomnadzor clarified this in Letter No. 03-97847 of October 24, 2023: such messages are classified as transmission over telecommunications networks and do not fall under the definition of online advertising, so the requirements of Article 18.1 of Law No. 38-FZ do not apply to them. For pharmaceutical companies, this means the following: an email digest sent to a registered database of physicians does not require marking, while a targeted post in a Telegram channel for doctors must receive an ERID token before publication.
Second change: mandatory levies on internet advertising revenue. Article 18.2 of Law No. 38-FZ took effect on April 1, 2025, introducing a 3% fee on the revenue of ad distributors, ad system operators, and intermediaries from placing advertising for a Russian audience. The legal basis is Federal Law No. 479-FZ of December 26, 2024; payment procedures are detailed in Government Decree No. 1224 of August 15, 2025. Payers must settle no later than the 5th day of the third month following the reporting quarter.
Certain categories of market participants are exempt from the levy, including radio and TV broadcasters, as well as official online media outlets and news agencies meeting state-participation criteria. The full list of exceptions is contained in Paragraph 12 of Article 18.2 of Law No. 38-FZ. Formally, the levy is paid by the platform or intermediary. Economically, it is built into the placement cost. Pharma marketing budgets for digital channels aimed at physicians have grown by this amount, regardless of the creative content.
Third change: a direct ban on placing advertising on Meta’s platforms. Targeted advertising through Instagram and Facebook ad accounts has been unavailable since 2022, when Meta was recognized in Russia as an extremist organization. On September 1, 2025, an amendment to Article 38 of Law No. 38-FZ came into force, banning the mere posting of advertising content on resources belonging to extremist and undesirable organizations, regardless of the method of placement. Liability arises under the same Article 14.3 of the Administrative Code and extends both to new publications and to failure to remove promotional posts placed on these platforms in the past.
Legal precedent regarding missing ERIDs is already accumulating. In 2024, the Arkhangelsk Regional Court upheld a 100,000-ruble fine against the chief editor of an online outlet for a tokenless publication on a website, while Roskomnadzor fined a legal entity the same amount for unmarked advertising in a Telegram channel in Nizhny Novgorod. Both cases involved ordinary consumer goods. Inspection logic is the same across every sector: platforms and Federal Antimonopoly Service (FAS) moderation apply the same rules to physician-targeted ads as to mass-consumer advertising.
The scale of oversight is visible in the 2024 results. FAS reviewed 19,789 applications concerning alleged violations of advertising legislation, opened 4,209 cases, and issued 2,202 penalty rulings totaling 161.3 million rubles. Violations related to advertising of medicines and medical devices accounted for 4% of the total. Since October 2024, FAS has also held the authority to conduct unannounced inspections of companies that claim product superiority over competitors without documentary evidence.
| Parameter | Before 2025 | 2025-2026 |
|---|---|---|
| Rx advertising at closed events and in specialized media | Permitted, Part 8, Article 24, Law No. 38-FZ | Same requirements; frequency of unannounced FAS inspections has increased |
| Digital ad marking | ERID mandatory since 2022 | Fine for missing ERID: 200,000-500,000 rubles for legal entities (Part 16, Article 14.3, Administrative Code) |
| Online placement cost | No additional levies | Plus a 3% levy on platform revenue (Article 18.2, Law No. 38-FZ, since April 1, 2025) |
| Posts on Instagram and Facebook | Only targeted advertising through the platform’s own ad account was banned | Placement of advertising posts on the platform itself is banned (since September 1, 2025) |
Action Plan
Audit the wording in HCP materials. Cross-check every statement about product properties against the text of the Package Insert and the SmPC per EEC Decision No. 88. Remove references to clinical trials as proof of superiority, as well as any recovery stories or patient testimonials: these elements are directly prohibited by Part 1 of Article 24 of Law No. 38-FZ.
Set up marking before launching a digital campaign. Obtain an ERID token via an ADO for every creative going to a Telegram channel, a specialized portal, or a closed physician community. Verify that the end advertiser’s contract details are transmitted to the ERIR correctly and without delay; registration deadline: before the creative is published.
Separate email newsletters, personalized outreach, and targeted posts into different budget lines. Materials addressed to a specific physician and mailings to a company’s own database generally do not require marking; public targeted posts on social networks and messaging apps require it without exception. At the same time, confirm with your agency and the platforms which party in the chain is already paying the 3% levy under Article 18.2 of Law No. 38-FZ, and reflect this cost item in the media plan a quarter ahead.
Shut down activity on Instagram and Facebook. Delete or archive old promotional posts on these platforms, since liability also applies to failing to remove previously published material. Move the budget to permitted channels: specialized media, industry events, Telegram, VKontakte.
Update agreements with medical representatives and Key Opinion Leaders (KOLs). Review remuneration wording for compliance with Article 74 of Law No. 323-FZ as amended on June 7, 2025. Payment is permitted only under clinical trial agreements or for a doctor’s scientific or teaching work; any other payouts or gifts fall outside this list of exceptions.
What unites these three 2025 requirements is that none of them can be resolved by a marketing department acting alone: marking means a contract with an ADO and technical integration, the 3% levy means budget planning and work with the finance department, and the platform ban means revising media plans together with legal. Companies that reduce Rx marketing responsibility to a single compliance manager more often get fined right at the intersection of these areas.
Regulatory Basis:
1. Roskomnadzor Letter No. 03-97847 of October 24, 2023
2. Federal Law No. 38-FZ of March 13, 2006, «On Advertising» (Articles 18.1, 18.2, 24, 25, 38)
3. Federal Law No. 479-FZ of December 26, 2024 (legal basis for the internet advertising levy)
4. Government Decree No. 1224 of August 15, 2025 (procedure for paying the internet advertising levy)
5. Federal Law No. 61-FZ of April 12, 2010, «On Circulation of Medicines»
6. Federal Law No. 323-FZ of November 21, 2011, «On the Basics of Health Protection of Citizens in the Russian Federation» (Article 74, as amended June 7, 2025 by No. 150-FZ)
7. Code of Administrative Offenses of the Russian Federation No. 195-FZ of December 30, 2001 (Article 14.3)
8. Eurasian Economic Commission Council Decision No. 88 of November 3, 2016, «On Approval of Requirements for the Package Insert of a Medicinal Product»
9. Code of Good Practice of the Association of International Pharmaceutical Manufacturers (AIPM/AMFP)