Requirements for advertising medicinal products and food supplements in Armenia

According to the legislation of the Republic of Armenia, advertising is the spread of information, through various media, on legal and physical persons, goods, ideas, or initiatives intended to form or maintain interest in those physical and legal persons, goods, or undertakings.

Based on the presented analysis of judicial practice, the concept of “advertising” can be defined as the spread of information — among an indefinite number of people via different information media — on legal and physical persons, goods, ideas or initiatives intended to form or maintain interest in those physical and legal person, goods or initiatives.

Advertising, as information, has several features that allow it to be identified as such. It can be expressed in various ways, such as words, graphics, photographs, audio and video images, music, color and other means.

It must be published and reach the consumer through various information channels.

Key advertising features include:

(i) providing the opportunity to personalize a specific legal or natural person, product, idea or undertaking;

(ii) dissemination through at least one medium;

(iii) intended for distribution to a circle of unknown persons;

(iv) focus on creating and maintaining interest in the advertised object.

The absence of at least one of these features excludes the qualitative characterization of information as advertising.

Also, advertising must meet the following requirements:

a) be legal (must not mislead the consumer in any way);

b) be reliable (must contain reliable information about the characteristics, nature, composition, preparation time, purpose, features, conditions of use, compliance with the standard, country of origin, results of research and testing of the product);

c) be appropriate (it should not discredit moral standards, should not contain expressions, comparisons and images that promote discrimination on any basis, should not discredit any person or government body); And

d) be in the Armenian language (can be combined in two or more foreign languages, the total volume, visual, color or lighting solution of which should not extend beyond the surface of the Armenian text and should not contain information that is not included in the Armenian text).

In particular, when talking about medicines, it is necessary to refer to the concept defined for them by current legislation. In the Republic of Armenia, such legislation includes the Law on Medicines.

According to the legislation of the Republic of Armenia, Medicinal product is defined as any substance of human and/or animal and/or vegetable and/or chemical and/or biotechnological origin in an appropriate dosage and dosage form and the requisite packaging and labeling, which presented as having properties for treating or preventing disease in human beings or animals or may be used in or administered either to restore, correct or modifying physiological functions by exerting a pharmacological and/or immunological and/or metabolic action, or to making a medical diagnosis.

In the case of advertising of food additives, only the general advertising requirements established by law, which regulate advertising practices in general, apply.

As a general rule, advertising a medicinal product that is not registered in the Republic of Armenia, is not controlled in the Republic of Armenia, or is manufactured in a pharmacy with a prescription or pharmacology is prohibited.

This rule ensures control over the quality, safety, and effectiveness of medicines offered on the market and protects consumers' rights and interests.

Registered medicines generally undergo a process of quality, safety, and effectiveness assessment by relevant regulatory authorities before being approved for sale and use. Advertising of such medications is usually based on data confirmed by these authorities and provides reliable and objective information about the product.

On the other hand, medicinal products that have not undergone this assessment or are not registered in accordance with regulatory requirements may pose a risk to consumer health due to insufficient quality and safety controls. Therefore, advertising of such products is prohibited to protect public health and safety.

Advertising of medicinal products can be carried out only after obtaining a license to sell the relevant medicinal product.

According to Armenian legislation, advertising a medicinal product is the dissemination of information that promotes its purpose, supply, sale, use, and consumption, aimed at creating or maintaining interest in it.

Advertising of medicines includes the following forms:

a) Advertising of drugs to consumers, that is, to ultimate users or patients who may consume the medicine.

b) Advertising of a medicinal product among persons working in the medical and pharmaceutical system and medical institutions, including doctors, pharmacists and other healthcare professionals.

c) Visits by representatives of medicinal sellers operating in the medical and pharmaceutical system, including visits to medical institutions to provide information about products.

d) Providing a free sample of a medicinal product for review and use by persons working in the healthcare sector or patients.

e) Any other type of medicinal advertising that may be undertaken to promote the product in the market.

Advertising of medicines, medical equipment, and treatment methods is controlled by the Ministry of Health of the Republic of Armenia and the Health and Labor Inspection body. The first one issues a separate permit for advertising a medicinal product for the duration of the license to import the medicinal product. To issue such permission, the advertiser must submit to the Ministry of Health of the Republic of Armenia the text of the advertisement in documentary and electronic form or an advertising video.

Advertising of a medicinal product must meet certain requirements to ensure the safety and awareness of consumers.

In accordance with these requirements, advertising must not contain the following materials:

a) Give the impression that the use of this medicinal product does not require medical advice or medical intervention.

b) Guarantee the absolute effectiveness of the drug, the absence of side effects, or the superiority of its effect over other treatments or medicinal products.

c) Assure that the person will be completely healthy after taking the medicine.

d) Claim that non-use of a drug will result in deterioration of a person's health, with the exception of advertising carried out as part of universal vaccination programs.

e) be oriented in children.

f) Contain references to guarantees from scientists, medical professionals or other renowned individuals or public organizations that may promote the use of the medical product.

g) Suggest using the medicine for food or cosmetic purposes.

h) Assert that the safety and effectiveness of the medicine are due to its natural origin.

i) May lead to incorrect self-diagnosis by describing or detailing medical history.

j) Contain statements about improving health accompanied by incorrect, alarming, or misleading wording.

k) Contain false concepts that are not related to the use of the medicine.

Compliance with these requirements in an advertising campaign helps to prevent misinformation and protect the health and interests of consumers.

 

Authors: Marine Khachatryan, Evelina Khostikyan.