{"id":48352,"date":"2025-05-20T10:00:15","date_gmt":"2025-05-20T10:00:15","guid":{"rendered":"https:\/\/my.legal500.com\/developments\/?post_type=legal_developments&p=48352"},"modified":"2025-05-20T10:00:15","modified_gmt":"2025-05-20T10:00:15","slug":"overview-of-the-law-on-medicines-and-medical-devices","status":"publish","type":"legal_developments","link":"https:\/\/my.legal500.com\/developments\/thought-leadership\/overview-of-the-law-on-medicines-and-medical-devices\/","title":{"rendered":"Overview of the Law on Medicines and Medical Devices"},"content":{"rendered":"

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. <\/strong> <\/p>\n

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.<\/p>\n

New definitions<\/h4>\n

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.<\/p>\n

License \/special permit\/<\/h4>\n

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: \u201cmanufacturing-export<\/strong>\u201d licenses, which combine manufacturing and export permits, and \u201cimport-supply<\/strong>\u201d licenses, which cover both import and supply operations. The licenses shall apply to the following products:<\/p>\n\n\n\n\n\n\n\n\n\n
(i) Manufacturing<\/strong>–<\/strong>export<\/strong> license<\/strong><\/td>\n(ii) Import-supply license<\/strong><\/td>\n<\/tr>\n
\u00b7 Medicines, narcotic drugs, psychoactive drugs, medical equipment, laboratory diagnostic equipment, medical supplies<\/td>\n<\/tr>\n
\u00b7 Biopreparations, their raw materials, traditional medicines<\/td>\n<\/td>\n<\/tr>\n
*<\/em>R<\/em>aw materials for <\/em>manufacturing may be imported, and the manufactured products and raw materials may be supplied with this license.<\/em><\/td>\n<\/tr>\n
(iii) Sales license<\/strong><\/td>\n<\/tr>\n
\u00b7 Medicines, medical devices, narcotic drugs<\/td>\n<\/tr>\n
Special conditions:<\/p>\n

\u00b7 Licensees shall establish 1 pharmacy outskirts of the capital where there are not enough pharmacies per every 10 pharmacy licenses holding in the capital.<\/p>\n

\u00b7 Licensees shall establish 1 pharmacy in remote municipal unit (soum) where there are not enough pharmacies per every 3 pharmacy licenses holding in the capital of provinces.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Monitoring and regulation<\/h4>\n

State registration<\/u><\/em><\/p>\n

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 \u201crepresentative offices\u201d which are not allowed to engage in profit-making activities and not eligible to apply for licenses, cannot register imported medicines or pharmaceutical agents.<\/p>\n

Advertisement of medicines<\/u><\/em><\/p>\n

As per the previous law, advertising of medicines (except for prescribed medicines, those only used in hospitals, narcotic and psychoactive drugs<\/em>) 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.<\/p>\n

Further, the previous law\u2019s 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.<\/p>\n

Activities for awareness of medicines<\/u><\/em><\/p>\n

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.<\/p>\n

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.<\/p>\n

The following shall be prohibited in awareness activities:<\/p>\n