2.1. BASIC PRINCIPLES OF PROMOTION

2.1.1. Promotion should encourage the appropriate use of a pharmaceutical product by presenting it objectively.

2.1.2. An advertisement for pharmaceutical products should be such as to clearly identify the product as a pharmaceutical product.

2.1.3. Promotion should not be disguised. It is not permitted to promote a pharmaceutical product under the semblance of post-registration clinical (interventional) studies or observational (non- interventional) clinical, epidemiological studies, or marketing studies. Such studies should be undertaken primarily for scientific and research purposes and should not be designed to encourage prescription of the pharmaceutical product by healthcare professionals. Any materials sponsored by a pharmaceutical company, whether or not promotional in nature, should have a clear indication of the sponsor.

2.1.4. The use of «hotlines» for advertising pharmaceutical products is not permitted.

2.1.5. When a pharmaceutical company’s employees are making a presentation for healthcare professionals at any event or when authoring a publication they should be clearly identified as employees of the relevant pharmaceutical company.

2.2. REGISTRATION STATUS

2.2.1. Only registered pharmaceutical products may be promoted in the Russian Federation and only to the extent of their registered indications for use.

2.2.2. The requirement of sub-clause 2.2.1 above does not in any way restrict the disclosure of information regarding any pharmaceutical product for the purpose of transmitting it to shareholders or to other persons entitled by law to receive such information.

This requirement also does not suggest a breach of the scientific community’s right to exchange of scientific information related to non-registered pharmaceutical products, provided that the provision of such information is not a way of promoting the pharmaceutical product.

2.3. STANDARDS OF ADVERTISING INFORMATION

2.3.1. Advertising for pharmaceutical products should comply with requirements of the existing Russian legislation on advertising.

2.3.2. Advertising for pharmaceutical products should contain, and not contradict, objective, accurate, and current information, which is based on duly approved information on the pharmaceutical product (including the labeling and the package leaflet).In order to comply with this clause, when advertising a pharmaceutical product, it is permissible to include in the material various “digital” forms of access to an expanded amount of information (for example, QR codes, links, etc.), allowing you to obtain objective, reliable, balanced and relevant information in real time subject to compliance with the requirements of the legislation and this Code.

2.3.3. Manufacturers should strive for advertising to reflect the main characteristics of the pharmaceutical product. An advertising of a pharmaceutical product should not guarantee pharmaceutical product’s positive effect, effectiveness, safety or absence of side effects.

2.3.4. Advertising information should be clear, exact, balanced, honest, objective, and sufficiently complete to enable the recipient to form an objective opinion as to the therapeutic value of the pharmaceutical product concerned. Advertising information should be based on an up-to-date evaluation of all relevant factual evidence and reflect that evidence clearly. Advertising information should not mislead by distorting, exaggerating, or omitting any significant information, or in any other way.

Ambiguity must be avoided. Any advertising information, including but not limited to, comparative advertising must not be offensive. The term “new” may be used to describe a pharmaceutical product, irrespective of its dosage form, only if it has been launched into market no more than a year ago or if a new indication has been registered no more than a year ago.

Absolute or all-encompassing claims should be used with caution and only when corresponding explanations and substantiations are available.

2.3.5. Advertising information about a pharmaceutical product should be supported by appropriate scientific evidence. Such evidence should be made available upon request. Companies should deal with such requests for information in good faith and should provide objective data consistent with the received request.

2.3.6. Comparative advertising should be correct, compare identical characteristics, and should not mislead consumers through the absence of any significant information in the advertisement.

2.3.7. Advertising materials on electronic media, except for audio and video materials, are subject to the requirements set forth in clauses 3.2 and 4.2 of this Code. Audio and video material is subject to the requirements of existing Russian legislation on advertising.

2.4. USE OF EXPERT CONCLUSIONS, REFERENCES TO THE RESULTS OF STUDIES, AND QUOTATIONS

2.4.1. Upon use in advertising materials of expert conclusions and references to the results of studies / observations, the source of said information and the dates on which it was obtained should be indicated.

2.4.2. Upon use in advertising materials of quotations from medical or scientific literature or     a person’s public appearances, the source of the quotation / name of the author, and the date and place of the publication / the appearance must be indicated.

2.5. PROMOTION ON THE INTERNET

2.5.1. The promotion of pharmaceutical products on the Internet, including but not limited to, their promotion through the placement of banners, active hyperlinks, postings on websites, in blogs and social networks, and on message boards, forums, and other similar web sites should comply with the general requirements for advertising and the special requirements for advertising of pharmaceutical products established under the legislation of the Russian Federation. In particular, in the case of websites related to pharmaceutical products:

• the identity of the pharmaceutical company, which is the source of the corresponding information, and its intended audience, should be apparent;
• the content should be appropriate for the intended audience.

2.5.2. The advertising of prescription pharmaceutical products on the Internet is prohibited. The posting of any information about prescription pharmaceutical products on the Internet is only possible as part of online events (webinars) for healthcare professionals, and on those parts of web sites that are only accessible by healthcare professionals.

2.5.3. The fact that a pharmaceutical company uses advertising agencies and other persons to promote pharmaceutical products on the Internet does not eliminate the company’s liability for violations of this Code.

2.5.4. This Code extends to the promotion of pharmaceutical products on the territory of the Russian Federation on any website, regardless of where the site is hosted, its top-level domain, and the location and internal policies of the pharmaceutical company promoting said pharmaceutical product.

2.5.5. Advertising materials distributed on the Internet, except for audio and video materials, are subject to the requirements set forth in clauses 3.2 and 4.2 of this Code. Audio and video materials are subject to the requirements on advertising of the applicable Russian legislation.

2.6. INFORMATION RELATED TO HUMAN HEALTH AND DISEASES

Pharmaceutical companies may disclose information about diseases and about their prevention and treatment to the general public subject to the following rules:

• said activity should not amount to a licensed medical activity;
• the information in question should be accurate, given in good faith, ethical, and complete; and it should neither replace a doctor’s advice nor call for self-therapy;
• this information should indicate the pharmaceutical company that serves as its source;
• this information should not feature the names of any prescription pharmaceutical products as well as images of such products’ packaging or its elements, or otherwise aim to promote a prescription pharmaceutical product;
• this information should indicate the need to consult a healthcare professional.