Advertising of medicines and biologically active additives in Mongolia
I. RULES OF ADVERTISING
Key regulations, definitions
Advertising of medicines and biologically active additives are regulated by (i) the Law of Mongolia on Medicines and Medical Devices and (ii) the Law of Mongolia on Advertisement, as well as (iii) the Procedure for Regulating the Issuance of a Permit for Advertisement of Medicines and Biologically Active Products (the “Procedure”).
“Medicine” means a preparation of synthetic or animal plant, or mineral substances in a specific form, used in appropriate dosages and quantities, for the prevention, diagnosis, treatment, and immunization of human, animal, and animal diseases (Art.3.1.1 of Law on Medicines and Medical Devices).
“Biologically active products” means products that support human body functions, supplement with necessary minerals, and prevent any diseases (Art.3.1.25 of Law on Medicines and Medical Devices). In other words, it shall be understood as biologically active additives or vice versa under this document.
“Advertisement” means information distributed through mass media or in other channels by individual, business entity or organization in order to increase market demand of goods, works, services, project or operation and to attract attention of potential customers (Art.3.1.1 of the Law on Advertising).
Registration & permit
Prior to dissemination of the advertisement, (i) medicines and biologically active additives must be registered in Mongolia, and (ii) a regular permit for advertisement must be obtained.
An advertisement video (recorded on CD, flash drive, hard disc, etc.) and its content converted to text shall be required among other things for obtaining a permit for dissemination of advertisements. The materials submitted to the state central administrative body in charge of medicines shall be reviewed and discussed by the Pharmacological subcommittee of the Human medicine’s council.
The permit for the advertisement is issued for a period of 1 (one) year. In the case of extension, the applicant must apply within 1 (one) month prior to expiration of the permit.
Disseminating channels
a) Channels for healthcare professionals
Prescription, narcotic, and psychoactive medicines may be advertised only through channels for health care professionals who are licensed to carry out professional activities of treatment, dispensing, nursing, midwifery, and rehabilitation. Channels for health care professionals are not specifically stipulated by law, however, under the Procedure, persons advertising its products may cooperate with health care professionals without violating the following prohibitions:
- Give or promise to give gifts, donations, and bonuses to health care professionals to increase the sales of its products;
- Organize contests, promotions, and lotteries for the purpose of prescribing medicine or advising customers;
- Use all kinds of economic incentives to take part in health institutions’ procurement of medicines.
b) Professional publications, mass media
Non-prescription medicines and biologically active products may be advertised through professional publications and mass media.
Advertising (subliminal advertising) of medicines and biologically active additives online through social media (Facebook, Twitter, Instagram, Live, Blog, TikTok, telephone enquiry service, online pharmacy, and official website) is prohibited.
Requirements
Drug advertisement information must be based on pharmacological indicators and clinical research results, regardless of the drug form. The ads content may include accurate and factual information on contraindications, side effects, cautions, quality, safety and risks contained in the certified instructions for use.
The following are prohibited in medicine advertising:
- To advertise in the press and media for the purpose of importing and selling medicines;
- To advertise medicines directing to children;
- To advertise prescription medicines;
- To provide information that may lead to denial of medical advice, treatment, or surgery;
- To mislead consumers that the medicine is rare, important, unique, very active, the result is better than other medicine, safe, without side effects, new drug, patented;
- To publicize the provision of incentives or price reductions for the purchase of medicines and medical equipment;
- To advertise medicines not registered in the State register;
- To advertise hospital-based medications in order to sell through pharmacy and other ways;
- To advertise the medicine hiding the side effects and prohibitions;
- To issue a warranty on the effect of the medicine in advance;
- To advertise the medicine with a commercial name only without generic names.
Also, it shall be prohibited to advertise and sell prescription-medicines, hospital-based and pediatric medications online.
Involving social influencers who are not qualified in the science of medicine and pharmacy in advertisement, information, and discussion is prohibited.
II. PRACTICAL ISSUES
With the emergence of new channels for information including but not limited to social media, there is a growing demand to broaden the channels permitted for advertisement. However, the current laws only allow mass media (TV, radio, etc.) and professional press. Online advertising (subliminal advertising) through social media is prohibited according to the Procedure. This prohibition creates ambiguity regarding the permissibility of advertising on social media platforms, resulting in different practices. For example, there are instances where advertisements are effectively placed on social media platforms like Facebook, Instagram, etc., whereas, our clients have faced refusal when applying for a permit to disseminate ads through these platforms.
III. COURT/ADMINISTRATIVE PRACTICES
No cases till date.
References:
1. “The Law of Mongolia on Medicines and Medical Devices”
https://legalinfo.mn/mn/detail/85
2. “The Law of Mongolia on Advertising”
https://legalinfo.mn/mn/detail/259
3. “The Law on Health”
https://legalinfo.mn/mn/detail/49
4. “Procedure for Regulating the Issuance of a Permit for Advertisement of Medicines and Biologically Active Products”
https://mmra.gov.mn/?id=201015
