Import-Export-Transit Authorization of Drugs or Psychotropic Substances
ໃບອະນຸຍາດທາງການກ່ອນຈະນຳເຂົ້າ-ສົ່ງອອກ-ສົ່ງຜ່ານຢາ ຫຼື ວັດຖຸອອກລິດຕໍ່ຈິດ-ປະສາດ
| General information | ||
|---|---|---|
| Type of formality | Other | |
| Date of last modification | 17.12.2020 | |
| Responsible Authorities | Food and Drugs Department
|
|
| LSIC | Q - Human health and social work activities, All sectors | |
| Who should complete this business formality? |
Any individuals or organizations that intend to: - Import for production, distribution, or possession of drugs or Psychotropic Substances - Export - Transit Must obtain approval from the Ministry of Health first. |
|
| Qualifications needed by the business to get the formality |
- Pharmaceutical factory and Import-Export of Pharmaceutical company which has been duly registered with the conditions that can import-export and distribution; - Pharmaceutical store class I and II which has been duly registered with the conditions that can retail in accordance with doctor’s prescription; - State hospital at the central and local level or private hospital with a license in accordance with condition that can distribute or retail by a pharmacist as per doctor’s prescription. |
|
| Additional Comment |
- The importer company must submit the original of the Import Authorization to an export company or factory. - In case the Import Authorization is expired or there are any changes the importer company must return the certificate to the Food and Drug Department to renew or amend such Import Authorization. - The importer company must attach a drug sale report (Based on the format) determined by the Food and Drug Department. - The Import Authorization cannot use as an Import Permit of medicine products. |
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| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application Form for Import-Export-Transit Authorization of Drugs or Psychotropic Substances | ||||
| Certificate of Good Manufacturing Practice (GMP) | ||||
| Certificate of Drug Registration | ||||
| Certificate of Pharmaceutical Product (CPP) | ||||
| Certificate of Analysis | ||||
| Sales and Purchase Agreement | between the supplier and hospital (copy) |
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| Documents Related to the Winning of the Bidding | ||||
| Sample of the Import Authorization of Psychotropic Substances | download this file to see the sample of Import Authorization of Psychotropic Substances |
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| REQUIRED DOCUMENTS FORMALITIES - Renew | ||||
|---|---|---|---|---|
| Name | Comment | |||
| 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)) | 14 | |
| RENEWAL INFORMATION | ||
|---|---|---|
| Does the formality have a validity or an expiration date? | YES | |
| How long will the formality be valid for? (in months) | 6 | |
| What is the process and conditions to renew the formality? | In case the certificate is expired, the renewal of the license can be extended until 31 December of that year. | |
| ISSUING FEES | ||||
|---|---|---|---|---|
| Has application fees? | Service fees | Certificate fees | Application fees | Total fees |
| YES | 0.00 | 0.00 | 3000.00 | 3000.00 |
| Comments |
Based on the recommendation from the authority |
|||
| RENEWAL FEES | ||||
|---|---|---|---|---|
| Has renewal fees? | Service fees | Certificate fees | Renewal fees | Total renewal fees |
| YES | 0.00 | 0.00 | 3000.00 | 3000.00 |
| Comments |
Based on the recommendation from the authority |
|||
