Law on Drugs and Medical Products (Amended)
药品与医疗产品法（修订版）
ກົດໝາຍວ່າດ້ວຍ ຢາ ແລະ ຜະລິດຕະພັນການແພດ (ສະບັບປັບປຸງ)
Summary
This Law prescribes the management rules for pharmaceuticals and medical products, aiming to ensure their quality, safety, and efficacy, and to safeguard public health. This Law applies to the production, importation, sale, and use of pharmaceuticals and medical products, specifying the obligations and responsibilities of relevant parties, and establishing licensing and regulatory requirements to regulate market order and prevent the circulation of non-compliant products.
Articles
Article 1
Article 1 (Amended) Purpose
This Law prescribes principles, regulations, and measures concerning the management, supervision, and inspection of pharmaceutical and medical products, in order to carry out the aforementioned work efficiently and effectively, aiming to ensure that pharmaceutical and medical products meet standards, are of quality, efficacy, and reasonable price, thereby ensuring the safety and health of all citizens, enabling alignment with regional and international standards, and contributing to the defense and construction of the nation.
Article 2
Article 2 (Amended) Medicines and Medical Products
Medicines refer to a substance or a combination of multiple substances, including mixtures of active and inactive ingredients.
Medical products refer to any substance or material used in the medical field, including other medical products commonly used in society.
Article 3
Article 3 (Amended): Interpretation of Terms
The terms used in this Law shall have the following meanings:
1. Bioequivalence study means a clinical trial conducting bioequivalence research on a generic drug compared to the original drug, to assess and compare the equivalence of their therapeutic efficacy;
2. Generic drug means a drug produced to have pharmacological properties similar to the original drug, such as disintegration, distribution, absorption, and other properties;
3. Original drug means a drug that has undergone preliminary research, safety and efficacy studies following drug research steps, sequential testing from animals to humans, detailed pharmacological studies, and for which the researcher has applied for patent registration of the formulation;
4. New drug means a finished drug product or traditional medicine that has not been previously sold or used within the territory of the Lao People's Democratic Republic, and is newly produced or newly imported;
5. Advanced therapy medicinal product means a product composed of living cells, tissues, or genes, used for repair, treatment, or replacement;
6. Counterfeit drugs and medical products means finished drug products, traditional medicines, medical devices, health products, cosmetics, chemicals for public health, and household hazardous chemical products that are forged or counterfeited from correctly registered or declared products;
7. Substandard drugs and medical products means finished drug products, traditional medicines, medical devices, health products, cosmetics, chemicals for public health, and household hazardous chemical products whose composition does not conform to the registered or declared content;
8. Expired (degraded) drugs and medical products means finished drug products, traditional medicines, medical devices, health products, cosmetics, chemicals for public health, and household hazardous chemical products whose physical or chemical properties have changed from their original form or standards before the expiration date;
9. Pharmaceutical profession means a profession related to drugs, such as preparation, selection, testing, compounding, and dispensing of drugs;
10. Essential drugs means drugs listed in the essential drugs list of the Lao People's Democratic Republic;
11. Price management means the determination and control of prices for drugs and medical products.
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