Certificate of Registration for Domestic Manufactured Traditional Medicine
ໃບຢັ້ງຢືນການຂຶ້ນທະບຽນຢາພື້ນເມືອງທີ່ຜະລິດພາຍໃນ
| General information | ||
|---|---|---|
| Type of formality | Other | |
| Date of last modification | 09.12.2020 | |
| Responsible Authorities | Food and Drugs Department
|
|
| LSIC | Q - Human health and social work activities | |
| Who should complete this business formality? |
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. |
|
| 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. |
|
| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| 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 |
|||
| REQUIRED DOCUMENTS FORMALITIES - Renew | ||||
|---|---|---|---|---|
| Name | Comment | |||
| 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 |
|||
| 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 | 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. |
| 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? | 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. | |
| 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) |
|||
