Certificate of Registration for Import Food Supplement Products
ໃບຢັ້ງຢືນການຂຶ້ນທະບຽນຜະລິດຕະພັນເສີມສຸຂະພາບນຳເຂົ້າ
| General information | ||
|---|---|---|
| Type of formality | Other | |
| Date of last modification | 08.12.2020 | |
| Responsible Authorities | Food and Drugs Department
|
|
| LSIC | Q - Human health and social work activities | |
| Who should complete this business formality? |
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. |
|
| Qualifications needed by the business to get the formality |
All procedures must in accordance with the regulations of the Ministry of Health |
|
| 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. |
|
| LEGAL FRAMEWORK | ||||
|---|---|---|---|---|
| Name | Number | Date | Comment | |
| Law on Drugs and Medical Products (Amended) | 07/NA | 21.12.2011 | Article 13, 15 | |
| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| 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 |
|||
| Application for a license to produce a sample dietary supplement for the registration of domestic manufactured dietary supplement formula | 1. ໃບສະເໜີຂອງໂຮງງານ/ຫ້ອງປຸງແຕ່ງ, ຈຳນວນ 02 ສະບັບ 2. ໃບທະບຽນ ວິສາຫະກິດ, ຈຳນວນ 01 ສະບັບ 3. ໃບທະບຽນ ວິຊາສະເພາະ, ຈຳນວນ 01 ສະບັບ 4. ກັບ, ກ໋ອງ, ສະຫຼາກ ທຸກຂະນາດບັນຈຸ, ຈຳນວນ 02 ຊຸດ 5. ເອກະສານກຳກັບແນະນຳ (ພາສາລາວ/ອັງກິດ, ຈຳນວນ 02 ຊຸດ 6. ເອກະສານອ້າງອີງເຖິງທີ່ມາຂອງສູດຕຳລາ ແລະ ຊັບພະຄຸນ, ຈຳນວນ 01 ຊຸດ |
|||
| REQUIRED DOCUMENTS FORMALITIES - Renew | ||||
|---|---|---|---|---|
| Name | Comment | |||
| 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 Samples to inspect and monitor quality (production package shall match the analysis certificate) of every size |
|||
| Mean of presentation | ||
|---|---|---|
| Means of presentation | At the Authority Offices | |
| Address of authority | Food and Drugs Department, Ministry of Public Health | |
| Processing Time (Day(s)) | 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. |
| RENEWAL INFORMATION | ||
|---|---|---|
| Does the formality have a validity or an expiration date? | YES | |
| How long will the formality be valid for? (in months) | 36 | |
| What is the process and conditions to renew the formality? | 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 the Food and Drug Department. | |
| ISSUING FEES | ||||
|---|---|---|---|---|
| Has application fees? | Service fees | Certificate fees | Application fees | Total fees |
| YES | 100000.00 | 600000.00 | 5000.00 | 705000.00 |
| Comments |
Ordinance on Fees and Service Charges, No. 003/PO, Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92) |
|||
| RENEWAL FEES | ||||
|---|---|---|---|---|
| Has renewal fees? | Service fees | Certificate fees | Renewal fees | Total renewal fees |
| YES | 100000.00 | 600000.00 | 5000.00 | 705000.00 |
| Comments |
Ordinance on Fees and Service Charges, No. 003/PO, Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92) |
|||
