Licensing Pharmacist to establish a Drug and Medical Product Import-Export Company
ໃບອະນຸຍາດວິຊາຊີບເພສັດຊະກໍາ ເພື່ອສ້າງຕັ້ງບໍລິສັດຂາອອກ-ຂາເຂົ້າ ດ້ານຢາ ແລະ ຜະລິດຕະພັນການແພດ
| General information | ||
|---|---|---|
| Type of formality | Certificate | |
| Date of last modification | 03.10.2017 | |
| Responsible Authorities | Food and Drugs Department
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| LSIC | Q - Human health and social work activities | |
| Who should complete this business formality? |
Individuals or legal entities that intend to establish export-import companies in the field of drug and/or medical product |
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| Qualifications needed by the business to get the formality |
1. Shall have a Lao pharmacist or pharmacist assistant (Mid-Level Practitioners) in Lao National which has a diploma or certificate of completion in the pharmaceutical profession granted by the relevant educational institution both domestic and international. Licensed by the MoH and have at least 5 years of experience in the pharmaceutical field. If is a government officer, must have an official appointment letter, must be a person that is not under trial or abandoning the position or facing disciplinary actions due to the error in pharmacist profession or dealing narcotics; 2. The setting of import-export business must have an area of at least more than 20 square meters, is a specific room, not mixed with residential or accommodation and other non-pharmaceutical or medical products retailer; 3. Have a clean place to store products and meet the standard of minimum width 6 meters, 12 meters length and an appropriate height, have the accounting clearing system, animals and insects prevention system and cooling system, lighting, temperature and humidity monitoring system. Inside the warehouse must have necessary equipment, a refrigerator with a temperature not to exceed 2-8 Celsius with temperatures measuring devices in the case of drugs to be kept in cold temperature such as rectal suppository or other drugs (Good Wholesaling Practice (GWP) and Good Storage Practice). |
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| Additional Comment |
After the Industry and Commerce sector reviewed and issued the Enterprise Registration Certificate. The Food and Drug Department will then issue a Licensing Pharmacist for the Drug and Medical Products import-export company, which must be approved by the Ministry of Health to operate a business in drug and medical product. |
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| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application Form | ||||
| Photo (3x4) | 3 photos (taken within 1 year) |
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| Education Certificate | a copy |
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| Certificate of Pharmacist Practices | the private sector must certify the employment location and it must be certified by the public sector (at the provincial level) |
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| Certificate of Resignation from Public Servant | or Appointment Letter from the organization (if it is a state-enterprise) |
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| Floor Plan of the Buildings, Office, and Warehouse | ||||
| Certificate of Ownership of the House | or Lease Agreement |
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| Copy of Enterprise Registration Certificate | ||||
| Feasibility Study of Medical and Medical Devices Business | indicate the product's names and its origin |
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| Certification of Health | Issued within the last 3 months |
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| Address Certification | with photo (taken within 3 months) |
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| Curriculum vate | with photo (taken within 1 year) |
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| Court Clearence | ||||
| Location Map of the Company | of the wholesale company |
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| Report for the location inspection | from the related authorities before the approval |
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| REQUIRED DOCUMENTS FORMALITIES - Renew | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application form for renewal | 1 copy |
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| Licensing Pharmacist | the original copy of the expired or nearly expired copy |
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| Certification of Health | Issued within the last 3 months, 1 copy |
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| Address Certification | with photo (taken within 3 months), 1 copy |
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| Court Clearence | 1 copy |
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| Location Map of the Company | that has been approved, 1 copy |
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| Performance report | of company, branches, wholesales in the past 2 years, 1 copy - for import-export company, it is required to submit the copies of import evidence, 6 copies |
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| Future Plan of the company, branches and wholesales | 1 copy |
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| Report for the location inspection | from FDD authorties, 1 copy |
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| 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)) | 120 | Applications shall be submitted to the Food and Drug district bureau or the provincial Food and Drug section where the company is located. The application will then be evaluated, reviewed and approved by each level of local authority before transferring to the Food and Drug Department. Ultimately, the Minister of Health will be a signatory for the license. |
| RENEWAL INFORMATION | ||
|---|---|---|
| Does the formality have a validity or an expiration date? | YES | |
| How long will the formality be valid for? (in months) | 24 | |
| What is the process and conditions to renew the formality? | The renewal shall be undertaken within 3 months before the expiration of the Formality. | |
| ISSUING FEES | ||||
|---|---|---|---|---|
| Has application fees? | Service fees | Certificate fees | Application fees | Total fees |
| YES | 0.00 | 1000000.00 | 0.00 | 1000000.00 |
| Comments |
Refer to the Presidential Ordinance 003/PO |
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| RENEWAL FEES | ||||
|---|---|---|---|---|
| Has renewal fees? | Service fees | Certificate fees | Renewal fees | Total renewal fees |
| YES | 0.00 | 500000.00 | 0.00 | 500000.00 |
| Comments |
Refer to the Presidential Ordinance 003/PO |
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