Licensing Pharmacist to Establish a Drug and Medical Products Distributing Branch
ໃບທະບຽນວິຊາຊີບເພສັດຊະກຳ ເພື່ອສ້າງຕັ້ງສາຂາຈຳໜ່າຍຜະລິດຕະພັນໂຮງງານຜະລິດຢາ ແລະ ຜະລິດຕະພັນການແພດ
| General information | ||
|---|---|---|
| Type of formality | Certificate | |
| Date of last modification | 19.11.2020 | |
| Responsible Authorities | Food and Drugs Department
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| LSIC | ||
| Who should complete this business formality? |
Individuals or legal entities that established as a branch to represents the factory in drugs and medical products distribution that have been delivered from the factory that it represents. |
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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 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 Factory, which must be approved by the Ministry of Health. The products must be registered or reported by the drug and medical products factory. |
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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 | within 3 months |
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| Address Certification | with photo (taken within 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 | A private sector has to certify the employment location and this is required to be certified by the public sector at the provincial authority. |
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| Certificate of Resignation from Public Servant | or an Appointment Letter from the organization (in case 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 Aggreement |
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| Copy of Enterprise Registration Certificate | ||||
| Report for the location inspection | from the relevant authority before an approval |
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| Feasibility Study of Medical and Medical Devices Business | indicate the name of the products |
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| Location map of the factory's branch | ||||
| REQUIRED DOCUMENTS FORMALITIES - Renew | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Certification of Health | within 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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| Report for the location inspection | from the FDD authority, 1 copy |
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| Application form for renewal | 1 copy |
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| Licensing Pharmacist | the original license that is expired or nearly expired |
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| Location Map | that has been approved, 1 copy |
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| Performance report | of the company, branches, and wholesale in the last 2 years, 1 copy |
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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? | Applicants must apply for a license renewal within 3 months prior to the expiry date. | |
| ISSUING FEES | ||||
|---|---|---|---|---|
| Has application fees? | Service fees | Certificate fees | Application fees | Total fees |
| YES | 0.00 | 200000.00 | 0.00 | 200000.00 |
| 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 | 100000.00 | 0.00 | 100000.00 |
| Comments |
Refer to the Presidential Ordinance No. 003/PO |
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