Agreement on Drug Registration
关于药品注册协议
ຂໍ້ຕົກລົງວ່າດ້ວຍ ການຂຶ້ນທະບຽນຢາຫຼວງ
Summary
This regulation governs drug registration management in Laos, with core provisions on drug classification, registration procedures, and principles for registering narcotics and other special drugs, as well as conditions for expedited registration.
Articles
Article ມາດຕາ 1
Article 2 Drug Registration
Drug registration is the submission of general information of the manufacturer and product, quality information, and including or not including pharmacological trials and clinical trials based on applicable legislation and forms, requirements and guidelines that are harmonized in ASEAN and internationally, to ensure the safety, efficacy and quality of drugs before they are circulated for sale within the Lao PDR or exported abroad.
Article ມາດຕາ 2
Article 4 Principles on Registration of Narcotic Drugs
Individuals, legal entities who intend to conduct business of manufacturing or importing narcotic drugs for distribution in the Lao PDR must register such narcotic drug products at the Department of Food and Drugs, Ministry of Health.
Article ມາດຕາ 3
Article 6 Scope of Application
This agreement applies to food and drug regulatory officials, organizations and operators engaged in the production, import-export, storage and distribution of narcotic drugs in the Lao PDR.
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