Advertising and Promotion of Pharmaceutical Products and Biologically Active Additives in Georgia

General rules of advertisement and specific regulations with respect to advertising of pharmaceutical products and and biologically active additives are provided under the Law of Georgia on Advertising and the Law of Georgia on Drugs and Pharmaceutical Activity.  General definition of an advertisement is information about the goods disseminated by any means and form that is intended for an unlimited group of individuals, and serves to form and maintain interest towards that goods to facilitate the sale.  

Advertising and Promotion of Pharmaceutical Products:

Definition of an advertisement for pharmaceutical products is defined as materials or actions disseminated through media or in any form and by any means that intend to promote the use of pharmaceutical products.

Georgian legislation restricts advertising of a fairly large amount of medicines and for that purpose defines three groups of pharmaceutical products.  Order No. 331 of the Ministry of Internally Displaced Persons from the Occupied Territories, Labor Health and Social Affairs of Georgia determines the list of pharmaceutical products belonging to the first and third groups for advertising and retailing purposes. The following categories fall under restriction:

• Pharmaceutical products belonging to the first group - pharmaceutical products under special control, as well as therapeutic agents equated with pharmaceutical products under special control (mainly consisting of narcotic drugs, psychotropic substances and precursors and substances and therapeutic agent equated to pharmaceutical product under special control).
• Pharmaceutical products belonging to the second group - products, inappropriate use of which may cause considerable damage to human health and life, and/or which may not be administered according to the patient information leaflet only, without a physician's prescription, and which are sold with prescription (Rx products).

It is only allowed to advertise pharmaceutical products belonging to the third group, that may be administered according to the patient information leaflet without a physician's prescription, and are sold without prescription (non-Rx products).  Such product shall be duly admitted on Georgian market, otherwise, advertising of products without relevant marketing authorization in Georgia is prohibited.

Each advertisement of medicines is subject to prior coordination of an advertising text with the relevant controlling authority the LEPL State Regulatory Agency for Medical Activities. Advance coordination of the text with the Agency implies verification of the text against information stated in the patient information leaflet. The advertisement text of a pharmaceutical product may not differ in content from the indications of this product included in the patient information leaflet.  The advertisement must also comply with following rules depending on the type of advertisement: (i) if the advertisement is in printed form, it must contain a warning: “Read the patient information leaflet before use, and consult your doctor for further information on side effects”; (ii) if the advertisement is in non-printed form, the same warning must be given verbally; (iii) if the advertisement is broadcasted on television, where the advertisement can be both seen and heard, the warning must be visible (legibly) for no less than 3 seconds and it shall also be provided verbally.  

Flyers and reference material of factual and informative nature, if the information presented in them refers only to changes of a pharmaceutical product or precautionary measures or information related to health or a disease, if it does not contain a direct or indirect reference to treatment using the pharmaceutical product and providing information on a pharmaceutical product to medical and pharmaceutical personnel (HCPs) is not considered as advertising.  Distribution of pharmaceutical products falling into the first and second groups, as well as pharmaceutical products without relevant marketing authorization in Georgia to the population for advertising purposes is strictly prohibited. 

Advertising of Biologically Active Additives:

In the advertising text of a biologically active additives or a product not registered as a pharmaceutical product it is not allowed to refer to diseases and present them as pharmaceuticals.

Violation of advertising rules may lead to imposition of administrative penalty on the violator.  A manufacturer or distributor of the pharmaceutical product shall be held liable for violating the advertising legislation of Georgia with regard to the content of the information submitted for creation of the advertisement, unless it is proven that the violation occurred because of an advertising producer or a disseminator.