Overview of the Law on medicines and medical devices /revised/
OVERVIEW OF THE LAW ON MEDICINES AND MEDICAL DEVICES /REVISED/
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.
