Licenses library · 695
Certificate of Imported Drug Formula Registration
进口药品配方注册证明
ໃບຢັ້ງຢືນທະບຽນຢາ ຕໍາລາຢາສາກົນທີ່ນໍາເຂົ້າ
Those who are officially authorized to import international drugs for distribution in Lao PDR. The manufacturer or parent company that obtains the registration certificate from the relevant country to export drugs via a domestic agency that is officially authorized to operate an imported drug business, with the agreement between the two parties mentioned above. Apply at Food and Drugs Department.
Who needs this
Those who are officially authorized to import international drugs for distribution in Lao PDR. The manufacturer or parent company that obtains the registration certificate from the relevant country to export drugs via a domestic agency that is officially authorized to operate an imported drug business, with the agreement between the two parties mentioned above.
Requirements
- A company operating a pharmaceutical business, a domestic pharmaceutical manufacturer obtains a license from the Ministry of Health.
Documents — first application
| Document | Note |
|---|---|
| List of Required Documents for Imported Drug Registration | |
| Application for Registration (for Imported Drug) |
Documents — renewal
| Document | Note |
|---|---|
| List of Required Documents to Extend to Imported Drug Registration |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Provision on Medicine Registration
How to submit
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 0 The application period is 6 months.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 36 months
- Renewal process
- Refer to the Edict on the Fees and Service Charges No. 003/PO For the license renewal, it shall meet the following conditions: 1. Must be a person who has registered the drug in accordance with the prescribed conditions 2. The registration certificate must be renewed 3 months before the due date. 3. The authority will reject the license renewal in the cases: - Incomplete documents as specified in the application Form 3 - Make no change when notified of some inaccuracies; - Drugs that are on the list of prohibited drugs in Lao PDR; - Drugs that the parent company has canceled or deregistered; - Drugs that the packagings and names have already been registered.