New explanations of the FAS Russia on certain aspects of advertising in the field of pharmaceuticals and healthcare

30 June 2020
Julia Kuzmenko
Senior Associate

The latest Explanations of the FAS Russia1 concern the following:

1. REFERENCE TO LICENSE

Specification of the information about the license is not required directly in the advertising of medical activities that are subject to licensing. Verification of the presence of relevant documents is carried out at the request of the advertising distributor in accordance with article 13 of the Law on advertising. The advertiser, in turn, shall provide reports, including information about the availability of a license, mandatory certification and state registration.

2. WARNING LABEL: WHAT TYPE TO USE AND HOW TO CALCULATE

Depending on the type of advertising object, the advertiser is entitled to determine which type of warning to use in advertising:

  1. on the presence of contraindications; or
  2. on the need to read the instructions for use; or
  3. on the need for expert advice.

Thus, advertising of medicines, medical services, including methods of prevention, diagnosis, treatment and medical rehabilitation, and medical devices may indicate one of the types of warnings mentioned above.

The area of the warning shall be calculated based on the ratio of the area of the entire advertising layout and the area of space including the warning text. At the same time, the area of such a warning is calculated based on an analogy with the so-called «font size» used in publishing2.

3. SPECIAL TRAINING: A RESTRICTION ON ADVERTISING

According to part 8 of article 24 of the Law on advertising: «Advertising of medical devices that require special training, is not allowed except in places where medical or pharmaceutical exhibitions, seminars, conferences and other similar events are held, and in specialized printed publications intended for medical and pharmaceutical workers». If in doubt about the attribution of any product to medical devices that require special training, it is advisable to send a letter to the Ministry of Health of the Russian Federation. This issue is not within the competence of the FAS Russia.

1Explanation of the FAS Russia dated 22.06.2020 No. DF/52241/20 «On advertising of medicines, medical devices and medical services, methods of prevention, diagnosis, treatment and medical rehabilitation, methods of folk medicine»
2Pursuant to OST 29.130-97 — Editions. Terms. Definitions.