Licenses library · 693
Permit of Imported Drugs Registration
进口药品注册许可
ໃບອະນຸຍາດຂໍຂື້ນທະບຽນຢານໍາເຂົ້າ
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 the pharmaceutical business, a domestic pharmaceutical manufacturer obtains a license from the Ministry of Health.
Documents — first application
| Document | Note |
|---|---|
| Application form | |
| Nomination Letter | 1 set |
| Certificate of Good Manufacturing Practice (GMP) | 1 set |
| Certificate of Pharmaceutical Product (CPP) | 1 set |
| Certificate of Drug Registration | 1 set |
| A label and a packaging insert or leaflet | 3 sets |
| List of countries in which the product has been registered | signed by a company director and stamped |
| Patent information |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Provision on Medicine Registration
How to submit
- Means of presentation
- At the Authority Offices
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 0 The application period is 3 months.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 6 months
- Renewal process
- The permit cannot be renewed and it can be used only once.