License to Operate Business for the Production of Hazardous Chemicals for Household Use
ໃບອະນຸຍາດທາງດ້ານວິຊາການເພື່ອດຳເນີນທຸລະກິດກ່ຽວກັບການຜະລິດ ຜະລິດຕະພັນເຄມີອັນຕະລາຍທີ່ນຳໃຊ້ໃນຄົວເຮືອນ
| General information | ||
|---|---|---|
| Type of formality | Other | |
| Date of last modification | 23.12.2020 | |
| Responsible Authorities | Food and Drugs Department
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| LSIC | Q - Human health and social work activities | |
| Who should complete this business formality? | 
                                                        Any individuals or organizations that intend to operate a business for the production of household chemical products.  | 
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| Qualifications needed by the business to get the formality | 
                                                        - Must be pharmacist or chemist or technical staff with experienced or has trained in this sector. - Have the necessary facilities to ensure the application of Good Manufacturing Practices such as the availability of a production room, a storage room that complies with requirements and with the necessary equipment.  | 
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| Additional Comment | 
                                                        The entrepreneur must have the Enterprise Registration Certificate from Industry and Commerce Sector first then can apply for this License.  | 
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| LEGAL FRAMEWORK | ||||
|---|---|---|---|---|
| Name | Number | Date | Comment | |
| Law on Drugs and Medical Products (Amended) | 07/NA | 21.12.2011 | Article 12 | |
| Presidential Ordinance on Fees and Service Fees | 003/PO | 26.12.2012 | Article 45.5.3 | |
| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Certification of Health | ||||
| Address Certification | ||||
| Photo (3x4) | 3 photos (taken within 1 year)  | 
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| Education Certificate | copy  | 
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| Court Clearence | ||||
| Curriculum Vitae | ||||
| Certificate of Ownership | or Lease Agreement, attach with the location map of the office  | 
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| List of Chemical Substances to Use/Produce | ||||
| Formula | ||||
| Manufacturing Process | ||||
| Related Registration Certificates | ||||
| 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)) | 10 | In case the document is completed as required. | 
| 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 applicant applies for renewal within 3 months prior to the expiration date. | |
| ISSUING FEES | ||||
|---|---|---|---|---|
| Has application fees? | Service fees | Certificate fees | Application fees | Total fees | 
| YES | 0.00 | 200000.00 | 5000.00 | 205000.00 | 
| Comments | 
                                                        The fee is based on 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 | 200000.00 | 5000.00 | 205000.00 | 
| Comments | 
                                                        The fee is based on the Ordinance No. 003/PO  | 
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