Licensing Pharmacist to establish a branch of Drug and Medical Product Company
ໃບທະບຽນວິຊາຊີບເພສັດຊະກຳ ເພື່ອສ້າງຕັ້ງສາຂາບໍລິສັດຢາ 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 | ||
| Who should complete this business formality? |
Individuals or legal entities that intend to establish a drug and medical branch (sales agent) for the parent company (import-export company) whose products have been registered or reported. |
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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 on pharmaceutical profession granted by the relevant educational institution both domestic and international Licensed by the MoH and have at least 4 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 branch must be a clean place, with an area of at least 20 square meters or more, is a specific room, not mixed with residential or accommodation and other non-pharmaceutical or medical products retailer; There must be a clean and standard storage place with a width of 4 meters, a length of 8 meters and an appropriate height. 3. Must have an accounting clearing system, animals and insects prevention system, a cooling system, lighting, temperature, and humidity monitoring device inside the warehouse and must be monitored on a regular basis, etc. 4. The warehouse must have the necessary equipment, such as floor mats, product cabinets, and product handling equipment, tools used to monitor the warehouse system, and follow the principles of good storage, which are specified in good wholesale regulations. (GWP) |
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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 branch of the Drug and Medical Products company, which must be approved by the Ministry of Health. The products must be registered or reported by the drug and medical products import-export company (parent company). |
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| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application Form | ||||
| Curriculum Vitae | with photo (taken within 1 year) |
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| Certification of Health | issued within 3 months |
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| Address Certification | with photo (taken 3 months), 1 copy |
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| Address Certification | with photo (taken 3 months) |
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| Photo (3x4) | 3 photos (taken within 1 year) |
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| Education Certificate | a copy |
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| Court Clearence | ||||
| Certificate of Pharmacist Practices | the private sector is required to certify to employment location and this has to be certified by the public sector at the provincial level. |
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| Certificate of Resignation from Public Servant | or an Appointment Letter from the organization (if it is a state-enterprise) |
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| Location Map | of the branches |
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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 | ||||
| Report for the location inspection | from the relevant authorities before an approval |
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| Feasibility Study of Medical and Medical Devices Business | indicate names of the products and its origins |
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| REQUIRED DOCUMENTS FORMALITIES - Renew | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Certification of Health | issued within 3 months, 1 copy |
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| Location Map | that has been approved, 1 copy |
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| Court Clearence | 1 copy |
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| Report for the location inspection | from the FDD authorities, 1 copy |
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| Application form for renewal | 1 copy |
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| Licensing Pharmacist | an original license that is expired or nearly expired |
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| Performance report | of the company, branches, and wholesale in the last 2 years, 1 copy - for import-export company, it is required to submit the evidence of import, 6 copies |
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| Future Plan of the company, branches and wholesales | 1 copy |
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| Mean of presentation | ||
|---|---|---|
| Means of presentation | ||
| Address of authority | Food and Drugs Department, Ministry of Public Health | |
| Processing Time (Day(s)) | 90 | 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 | 500000.00 | 0.00 | 500000.00 |
| Comments |
Refer to the Presidential Ordinance No. 003/PO |
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| RENEWAL FEES | ||||
|---|---|---|---|---|
| Has renewal fees? | Service fees | Certificate fees | Renewal fees | Total renewal fees |
| YES | 0.00 | 250000.00 | 0.00 | 250000.00 |
| Comments |
Refer to the Presidential Ordinance No. 003/PO |
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