Regulations on the Processing, Production, and Use of Biological Products, Genes, and Stem Cells
生物制品、基因与干细胞加工、生产及使用管理规定
ຂໍ້ຕົກລົງວ່າດ້ວຍ ການຄຸ້ມຄອງການປຸງແຕ່ງ, ຜະລິດ, ນຳໃຊ້ ຜະລິດຕະພັນຊີວະພາບ, ຢີນ ແລະ ສະເຕັມເຊວ
Summary
This regulation governs the processing, production, use, and testing of biological products, genes, and stem cells in Laos, with the core requirement that individuals or organizations engaging in related activities must obtain permission from the Ministry of Health and comply with import, export, and quality management regulations.
Articles
Article ມາດຕາ 1
Article 2 Management of Processing, Production, Use, and Testing of Biological Products
Management of processing, production, use, and testing of biological products means all management related to research, consideration of investment, involving production, processing, and import-export, storage, research and testing, product registration, including pre- and post-use or distribution inspection, and management of biological products.
Management of processing, production, use, and testing of cell and stem cell products means the process of using raw materials derived from human tissues, which must obtain approval from the ethics committee, consisting of cells and stem cells needed for processing for testing, use, or production through a process into finished products, and through standardized processes that have been certified by specific accreditation according to relevant technical regulations.
Article ມາດຕາ 2
Article 4 Principles on the processing, production, experimentation and use of biological products, genes and stem cells
Individuals, legal entities or organizations, domestic and foreign, conducting business related to the processing, production, experimentation and use of biological products, genes and stem cells for treatment and cosmetic enhancement in the Lao PDR must obtain permission from the Ministry of Health.
Article ມາດຕາ 3
Article 3 State Policy
The State has a policy to promote that everyone in society can access quality services, promote business operations and health services in accordance with the laws on processing, production, testing and use of biological products, genes and stem cells, with the Ministry of Health being the manager.
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