Traditional Drug Registration Agreement
传统药注册协议
ຂໍ້ຕົກລົງວ່າດ້ວຍ ການຂຶ້ນທະບຽນຢາພື້ນເມືອງ
Summary
This regulation governs the production, processing, import, and export of traditional medicines in Laos, focusing on registration principles, exemption cases, and application procedures to ensure drug quality and safety.
Articles
Article ມາດຕາ 1
Article 1 Objective and Scope
This agreement establishes principles, regulations, and measures for the management of production, processing, import-export, and circulation of traditional medicines in the market and public health network to ensure quality, efficacy, and safety, in accordance with regional and international standards and regulations.
Article ມາດຕາ 2
Article 3 Scope of Application
This agreement applies to individuals, legal entities, management organizations or operators engaged in the production, processing, import-export, storage and distribution of traditional medicines in the Lao PDR.
Clause [|
Principles of Registration
Article ມາດຕາ 3
Article 4 Principles of Registration of Traditional Medicines
The general principles of registration of traditional medicines are: to be in accordance with the national drug policy, in line with the direction of public health service work, to promote the use of traditional medicines in combination with modern medicines, in compliance with the Law on Drugs and Medical Products, the Decree on Medicinal Resources, the list of medicinal plants, trees, and animals, the risk classification list determined by the Ministry of Health, and the list of prohibited plants as officially determined.
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