The Law on Medicines and Medical Devices /2010/ which governed the relations regarding the manufacture, import, export, storage, sale, distribution, use, and control of human and veterinary medicines, including traditional drugs, biopreparations, diagnostics, medical devices, and biologically active products has been revised and passed by the Parliament of Mongolia on June 5, 2024.
The revised Law has become effective from October 1, 2024. Compared to the previous law, this new amendment regulates broader relations and additional requirements for certain activities.
New definitions
The previous law defines 25 terms, while the new law defines 40 terms, including all of the terms defined in the previous law. Namely, terms such as trade names of medicines, pharmaceutical agents, international names of medicines, pharmacovigilance, base price, medical supplies, herbal drugs, and original medicines have been newly defined and regulated in this regard
License /special permit/
The 2010 law granted five types of licenses for activities related to medicines and medical devices: manufacturing, import, export, sale, and supply. However, the new law has reduced the number of licenses to three: "manufacturing-export" licenses, which combine manufacturing and export permits, and "import-supply" licenses, which cover both import and supply operations. The licenses shall apply to the following products:
| (i) Manufacturing-export license | (ii) Import-supply license |
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| *Raw materials for manufacturing may be imported, and the manufactured products and raw materials may be supplied with this license. | |
| (iii) Sales license | |
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Special conditions:
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Monitoring and regulation
State registration
The revised law mandates the person who registers imported medicines and pharmaceutical agents in the state register to have a import-supply license. Foreign pharmaceutical manufacturers can register their medicines in Mongolia through their subsidiaries /LLC/, which must obtain an import-supply license. However, legal entities established in the legal form of "representative offices" which are not allowed to engage in profit-making activities and not eligible to apply for licenses, cannot register imported medicines or pharmaceutical agents.
Advertisement of medicines
As per the previous law, advertising of medicines (except for prescribed medicines, those only used in hospitals, narcotic and psychoactive drugs) were carried out on the basis of a regular permit. On the other hand, the revised law restricts medicine advertising to manufacturers and suppliers. In other words, only entities holding manufacturing-export or import-supply licenses can advertise medicines.
Further, the previous law's lack of clarity regarding advertising channels led to inconsistent practices. The revised law has streamlined this by specifying that advertising of medicines can be conducted through television, radio, billboards, professional publications, and official websites with proper permits. Social media advertising of medicines in electronic environments is prohibited.
Activities for awareness of medicines
Activities for awareness of prescription only and hospital-use medicines shall be carried out by healthcare professionals licensed to engage in treatment and prescription employed by (i) manufacturers, (ii) suppliers, and (iii) representative offices of foreign pharmaceutical manufacturers. The activity shall be oriented only to healthcare professionals.
Healthcare professionals are obliged to report to the relevant authorities about advertising and awareness activities related to medicines, medical devices and health supplements that contain false, incomplete, unclear, unscientific information, and information that does not comply with laws, rules, regulations, standards, and guidelines.
The following shall be prohibited in awareness activities:
- promoting unregistered medicines, medical devices, and health supplements;
- involving healthcare professionals in network business, providing any form of incentives, providing credit hours;
- healthcare professionals to receive any form of support, such as receiving gifts, donations, incentives, travel, foreign or domestic training.
Representative offices of foreign pharmaceutical manufacturers
As per the revised law, representative offices of foreign pharmaceutical manufacturers are subject to the following responsibilities:
- submit the certificate and power of attorney for operating in the territory of Mongolia to the state administrative body responsible for medicine and medical devices;
- conduct quality, safety, and therapeutic activity studies of the represented manufacturer's products in accordance with relevant laws, rules, regulations, and guidelines to ensure quality and safety;
- quarterly submit reports and information on surveillance study and awareness activities to the state administrative body responsible for medicines and medical devices.
In addition, it is prohibited to provide credit hours or any form of incentives during training conducted to introduce one's own products to the market.
Liability
In the case of violation of legal requirements, the following punishments are imposed depending on the type of the infringement, including:
- confiscation of items and tools used in committing the infringement, and illegally acquired funds and income;
- claiming damages and compensations;
- revocation of license;
- a fine of ~USD 147.3 – 1,473.4 for individuals;
- a fine of ~USD 1,473.4 – 14,734 for legal entities.
The table below shows some of the infringements and applicable sanctions:
| № | Infringement | Sanction |
| 1. | Infringement of requirements, obligations, prohibititions, established standards and procedures regarding the holders of (i) manufacturing-export; (ii) import-supply; and (iii) sale licenses |
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| 2. | A healthcare professional has participated in advertising for medicines, medical devices, and health supplements |
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| 3. | Advertised medicines, medical devices, or health supplements prohibited by law, or advertised in a manner prohibited by law |
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| 4. | Engaging health workers in hidden advertising of medicines, medical devices, and health supplements, network business, and provided incentives in any form, in order to increase profits |
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| 5. | Violation of requirements, obligations, standards, and established procedures for awareness activities of medicines |
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| 6. | Violation of procedures for detection, evaluation, surveillance, prevention and control of adverse drug reactions |
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References:
1. Law on Medicine and Medical Devices (2024) - https://legalinfo.mn/mn/detail?lawId=17140713569541
2. Law on Medicine and Medical Devices (2010) - https://legalinfo.mn/mn/detail/85
3. Law on Infringement (2017) - https://legalinfo.mn/mn/detail/12695
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
