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Certificate of Registration for Domestic Manufactured Dietary Supplement
国产膳食补充剂注册证明
ໃບຢັ້ງຢືນການຂຶ້ນທະບຽນຜະລິດຕະພັນເສີມສຸຂະພາບທີ່ຜະລິດພາຍໃນ
Those who have the right to register health supplements are factories or import-export companies with an enterprise registration certificate issued by the Ministry of Industry and Commerce. On the backside of such certificate must state: import and distribute health and food supplement product. Apply at Food and Drugs Department.
Who needs this
Those who have the right to register health supplements are factories or import-export companies with an enterprise registration certificate issued by the Ministry of Industry and Commerce. On the backside of such certificate must state: import and distribute health and food supplement product.
Requirements
- All procedures must in accordance with the regulations of the Ministry of Health
Documents — first application
| Document | Note |
|---|---|
| Application for a license to produce a sample dietary supplement for the registration of domestic manufactured dietary supplement formula | 1. Proposal from a factory/processing lab, 2 copies 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. Supporting documents referring to the origin of the formula and properties,1 set |
| Application for the registration of domestic manufactured dietary supplement | 1. Proposal from a factory/processing lab, 2 copies 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 dietary supplement | 1. Proposal from a factory/processing lab, 2 copies 2. Copies of the enterprise registration certificate and licensing pharmacist, 1 copy 3. The previous certificate, 1 copy 4. Box, container, label (every size), 2 sets 5. Prescription (Lao/English), 2 sets 6. Supporting documents of sources of raw materials (medicinal plants), 1 set 7. Certificate of Analysis of Raw Materials,1 set 8. Documents about method/techniques/procedures for production and processing, 1 set 9. Final product analysis certificate, 1 set 10. Samples to inspect and monitor quality (production package shall match the analysis certificate) of every size |
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 The law does not specified the consideration period, but the official states that the usual consideration period will not exceed 180 days. 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 3 months to consider as well.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 36 months
- Renewal process
- Health Supplement Registration Certificate 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.