Permit of Imported Drugs Registration
ໃບອະນຸຍາດຂໍຂື້ນທະບຽນຢານໍາເຂົ້າ
| General information | ||
|---|---|---|
| Type of formality | Other | |
| Date of last modification | 19.11.2020 | |
| Responsible Authorities | Food and Drugs Department
|
|
| LSIC | C - Manufacturing, G - Wholesale and retail trade; repair of motor vehicles and motorcycles | |
| Who should complete this business formality? |
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. |
|
| Qualifications needed by the business to get the formality |
A company operating the pharmaceutical business, a domestic pharmaceutical manufacturer obtains a license from the Ministry of Health. |
|
| Additional Comment | ||
| LEGAL FRAMEWORK | ||||
|---|---|---|---|---|
| Name | Number | Date | Comment | |
| Law on Drugs and Medical Products (Amended) | 07/NA | 21.12.2011 | ||
| Provision on Medicine Registration | 1441/MOPH | 13.08.2003 | Article 7 and 9 | |
| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application form | ||||
| Nomination Letter | 1 set |
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| Certificate of Good Manufacturing Practice (GMP) | 1 set |
|||
| Certificate of Pharmaceutical Product (CPP) | 1 set |
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| Certificate of Drug Registration | 1 set |
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| A label and a packaging insert or leaflet | 3 sets |
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| List of countries in which the product has been registered | signed by a company director and stamped |
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| Patent information | ||||
| 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)) | 0 | The application period is 3 months. |
| 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? | The permit cannot be renewed and it can be used only once. | |
| ISSUING FEES | ||||
|---|---|---|---|---|
| Has application fees? | Service fees | Certificate fees | Application fees | Total fees |
| YES | 100000.00 | 0.00 | 0.00 | 100000.00 |
| Comments |
Refer to the Ordinance on the Fees and Service Charges No. 003/PO |
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| RENEWAL FEES | ||||
|---|---|---|---|---|
| Has renewal fees? | Service fees | Certificate fees | Renewal fees | Total renewal fees |
| NO | 0.00 | 0.00 | 0.00 | 0.00 |
| Comments | ||||
