Licenses library · 774
Import-Export-Transit Authorization of Narcotic Drugs Used in Medicine
医药用麻醉药品进出口过境核准
ໃບອະນຸຍາດທາງການກ່ອນຈະນຳເຂົ້າ-ສົ່ງອອກ-ສົ່ງຜ່ານ ຢາເສບຕິດທີ່ນຳໃຊ້ໃນທາງການແພດ
Any individuals or organizations that intend to: - Import for production, distribution, or possession of narcotic drugs - Export - Transit Must obtain approval from the Ministry of Health. Apply at Food and Drugs Department.
Who needs this
Any individuals or organizations that intend to: - Import for production, distribution, or possession of narcotic drugs - Export - Transit Must obtain approval from the Ministry of Health.
Requirements
- 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.
Documents — first application
| Document | Note |
|---|---|
| Certificate of Good Manufacturing Practice (GMP) | |
| Application Form | by the FDD |
| Certificate of Drug Registration | |
| Certificate of Pharmaceutical Product (CPP) | |
| Certificate of Analysis | |
| Sales and Purchase Agreement | between the supplier and hospital (copy) |
| Documents Related to the Winning of the Bidding |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Order on the Management of Narcotics and Psychotropic Substances
- Order on the List of Narcotics and Psychotropic Substances
How to submit
- Means of presentation
- At the Authority Offices
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 14
Validity and renewal
- Has an expiry date
- YES
- Validity
- 6 months
- Renewal process
- In case the authorization is expired. The authorization can be renewed until 31 December of that year.
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.