Licensing Pharmacist to Establish a Medical Equipment Factory
ໃບທະບຽນວິຊາຊີບເພສັດຊະກຳເພື່ອສ້າງຕັ້ງໂຮງງານຜະລິດອຸປະກອນການແພດ
| General information | ||
|---|---|---|
| Type of formality | Certificate | |
| Date of last modification | 19.11.2020 | |
| Responsible Authorities | Food and Drugs Department
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| LSIC | C - Manufacturing | |
| Who should complete this business formality? |
Individuals or Organizations that intend to manufacture medical equipment shall obtain the approval and technical permission of the Ministry of Health first. |
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| Qualifications needed by the business to get the formality |
Individuals or organization that intends to engage in the business of Medical equipment manufacturing must meet the additional conditions as follows: 1. Have a pharmacist with at least five years of experience; 2. Never be convicted on drugs or narcotics or medical products; 3. Have pharmaceutical and business ethics; 4. Have competent personnel; 5. Have good health, no mental illness or infectious disease; 6. Have measures to protect the safety and the environment; 7. Have a suitable setting and necessary facilities, a standardized warehouse, and transporting vehicles. The factory also needs to have a production room, a laboratory with complete sets of equipment. |
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| Additional Comment |
Article 4. Conditions on the settings of Drug and Medical products factory (Instructions on Drug and Medical Product Manufacturing 937/MoH 12/05/2004) |
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| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application Form | 1 copy |
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| Curriculum Vitae | with photo (taken within 1 year), 1 copy |
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| Education Certificate | 1 copy |
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| Retirement Card or Resignation Letter | or Resignation Certificate from Public Servant or Appointment Letter of the organization (if it is a state-enterprise), 1 copy |
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| Certificate of Pharmacist Practices | 1 copy |
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| Photo (3x4) | taken within 1 year, 1 copy |
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| Location Map of the Factory | 1 copy |
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| Site Plans of the Factory | 1 copy |
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| Certificate of Ownership of the House | or Lease Agreement, 1 copy |
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| Court Clearence | 1 copy |
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| Certificate of Nationality | for an alien. - for a foreigner, it is required to have the certificates and permits in accordance with the regulations of Lao PDR |
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| Copy of Enterprise Registration Certificate | 1 copy |
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| Feasibility Study of Medical and Medical Devices Business | indicate the product's information, materials, origins, and other relevant technical information, 1 copy |
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| Certification of Health | issued within 3 months, 1 copy |
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| Certification of Health | 1 copy |
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| Address Certification | with photo (taken within 3 months), 1 copy |
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| Report for the location inspection | issued by the FDD authorities, 1 copy |
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| REQUIRED DOCUMENTS FORMALITIES - Renew | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application form for renewal | This application is required to receive official comments from the District Office of Health and Provincial Department of Health before sending to the Food and Drug Department, Ministry of Health for its consideration and approval. |
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| Address Certification | 1 copy |
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| Performance report | and the plan for next year |
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| Licensing Pharmacist | original |
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| Report for the location inspection | issued by the FDD authorities, with 6 copies of evidence on importing materials and packaging tools |
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| Remark | for the license that does not have space for a stamp, it is required to attach 3 photos (size 3x4) |
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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)) | 45 | The application's consideration period is within 45 days |
| RENEWAL INFORMATION | ||
|---|---|---|
| Does the formality have a validity or an expiration date? | YES | |
| How long will the formality be valid for? (in months) | 36 | |
| What is the process and conditions to renew the formality? | Licensing Pharmacist is valid for 3 years. 3 months before the date of expiry, the business must apply for a renewal. Food and Drug Department is in charge of the license approval after the application got approved through the relevant authorities at the district, provincial-capital levels. The conditions for license renewal are related to Section III, Section IV of the Instructions on Drugs and Medical Products Manufacturing No. 937/MOH, 15.05.2004, and other relevant regulations. Conditions for non-renewal are stipulated in Article 6.3 (Instructions on the Drugs and Medical Products Manufacturing No. 937/MOH, 12.05.2004). Temporary suspension or termination of the business operation is subjected to: -Death of the pharmacist. -In case of warning and have been fined more than 3 times - In case of misconduct or violation of the Laws - Has been filed a lawsuit by the affected people and the victims or prosecuted by the court | |
| ISSUING FEES | ||||
|---|---|---|---|---|
| Has application fees? | Service fees | Certificate fees | Application fees | Total fees |
| YES | 500000.00 | 0.00 | 0.00 | 500000.00 |
| Comments |
Refer to the Ordinance on fees and service charges 003/PO |
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| RENEWAL FEES | ||||
|---|---|---|---|---|
| Has renewal fees? | Service fees | Certificate fees | Renewal fees | Total renewal fees |
| YES | 250000.00 | 0.00 | 0.00 | 250000.00 |
| Comments |
Refer to the Ordinance on fees and service charges 003/PO |
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