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Certificate of Registration for Domestic Manufactured Traditional Medicine
国产传统药品注册证明
ໃບຢັ້ງຢືນການຂຶ້ນທະບຽນຢາພື້ນເມືອງທີ່ຜະລິດພາຍໃນ
Applicants that are eligible to register the traditional medicine are factories, import-export companies that operate the business in traditional medicine, which are properly licensed by the health sector. Apply at Food and Drugs Department.
Who needs this
Applicants that are eligible to register the traditional medicine are factories, import-export companies that operate the business in traditional medicine, which are properly licensed by the health sector.
Requirements
- All procedures must in accordance with the regulations of the Ministry of Health
Documents — first application
| Document | Note |
|---|---|
| Application for Producing Domestic Manufactured Traditional Medicine | 1. Proposal from a factory/processing lab, 1 copy 2. Enterprise registration certificate, 1 copy 3. Licensing pharmacist, 1 copy 4. Box, container, label (every size), 2 sets 5. Prescription (Lao/English), 2 sets 6. Documents about method/techniques/procedures for production and processing, 1 set 7. Supporting documents referring to the properties and the origin of the formula, 1 set |
| Application for the Registration of Domestic Manufactured Traditional Medicine | 1. Proposal from a factory/processing lab, 1 copy 2. Notification to submit Form 2 from the Food and Drugs, 1 copy 3. Box, container, label (all sizes), 2 sets 4. Prescription (Lao/English), 2 sets 5. Supporting documents referring to the properties and the origin of the formula, 1 set 6. Supporting documents of sources of raw materials (medicinal plants),1 set 7. Certificate of Analysis of Raw Materials (Medicinal Plants), 1 set 8. Documents about method/techniques/procedures for production and processing, 1 set 9. Final product analysis certificate, 1 set 10. Documents about the result of product validity study or references, 1 set 11. Samples to inspect and monitor quality (production package shall match the analysis certificate) of every size |
Documents — renewal
| Document | Note |
|---|---|
| Application for the Registration Renewal of Domestic Manufactured Traditional Medicine | 1. Proposal from a factory/processing lab, 1 copy 2. The previous certificate (Original), 1 copy 3. Box, container, label (every size), 2 sets 4. Prescription (Lao/English), 2 sets 5. Supporting documents of sources of raw materials (medicinal plants), 1 set 6. Certificate of Analysis of Raw Materials, 1 set 7. Documents about method/techniques/procedures for production and processing, 1 set 8. Final product analysis certificate (Quality certified by the Medical and Traditional Medicine Institute), 1 set |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Presidential Ordinance on Fees and Service Fees
How to submit
- Means of presentation
- At the Authority Offices
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 180 Each time the applicant has to submit Form 1 first, which will take 3 months to consider. After Form 1 has been considered, the applicant then will be able to submit Form 2 which will take 6 months to consider.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 36 months
- Renewal process
- Certificate of registration for Traditional Medicine is valid for 3 years; 3 months prior to the expiry date, the applicant must apply for the renewal in accordance with the documents required by Food and Drug Department.
Additional comment
Authorized individuals and organizations must comply with the obligations of the licensing agency to contribute to the maintenance and restoration of the ecosystem.