Licensing Pharmacist to establish Drug and Medical Product Factory
ໃບອະນຸຍາດວິຊາຊີບເພສັດຊະກໍາ ເພື່ອສ້າງຕັ້ງໂຮງງານຜະລິດຢາ ແລະ ຜະລິດຕະພັນການແພດ
| General information | ||
|---|---|---|
| Type of formality | License | |
| Date of last modification | 03.10.2017 | |
| Responsible Authorities | Food and Drugs Department
|
|
| LSIC | ||
| Who should complete this business formality? |
Individuals or organizations that intend to produce drugs and medical products must first obtain the approval and technical permission from the Ministry of Health. |
|
| Qualifications needed by the business to get the formality |
Individuals or organizations that intend to operate drugs and medical products manufacturing business must comply with the additional conditions as follows: 1. A full-time pharmacist that has at least five years of experiences; 2. Never been sanction on drugs or narcotics or medical products; 3. Has a pharmacological and business ethics; 4. Has skilled human resources; 5. Healthy, no mental illness or contracted transmissible diseases; 6. Has a safety and environmental protection measures; 7. Has a suitable site and necessary infrastructures, has a standard warehouse and transport vehicle. Factory must have a manufacturing room, laboratory with full sets of equipment. |
|
| 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) |
|
| REQUIRED DOCUMENTS FORMALITIES - First time | ||||
|---|---|---|---|---|
| Name | Comment | |||
| Application Form | 1 copy |
|||
| Education Certificate | 1 copy |
|||
| Retirement Card or Resignation Letter | or Certificate of Resignation from Public Servant or Appointment Certificate from Organization (if it is a state-enterprise), 1 copy |
|||
| Photo (3x4) | 1 photo (taken within 1 year) |
|||
| Location Map of the Factory | 1 copy |
|||
| Site Plans of the Factory | 1 copy |
|||
| Certificate of Nationality | for an alien. - for a foreigner, it is required to have related certification and permits according to the regulations of the Lao PDR |
|||
| Copy of Enterprise Registration Certificate | 1 copy |
|||
| Feasibility Study of Medical and Medical Devices Business | includes the product information, materials, origins, and other related technical information. 1 copy |
|||
| Certificate of Pharmacist Practices | 1 copy |
|||
| Certificate of Ownership of the House | or Lease Agreement, 1 copy |
|||
| Certification of Health | issued within 3 months, 1 copy |
|||
| Address Certification | taken within 3 months, 1 copy |
|||
| Report for the location inspection | issued by the FDD authority, 1 copy |
|||
| Curriculum vate | with photo (taken within 1 year), 1 copy |
|||
| Court Clearence | 1 copy |
|||
| 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. |
|||
| Certification of Health | 1 copy |
|||
| Address Certification | 1 copy |
|||
| Performance report | and 1-year future plan |
|||
| Licensing Pharmacist | original copy |
|||
| Report for the location inspection | issued by the FDD authority, with evidence on importing raw materials and packaging tools, 6 copies |
|||
| Remark | for the license that does not have space for a stamp, it is required to attach 3 photos (size 3x4) |
|||
| Mean of presentation | ||
|---|---|---|
| Means of presentation | ||
| Address of authority | Food and Drugs Department, Ministry of Public Health | |
| Processing Time (Day(s)) | 45 | The application processing 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. (Article 6, Instructions on the Drugs and Medical Products Manufacturing No. 937/MOH, 12.05.2004). 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 | 0.00 | 500000.00 | 0.00 | 500000.00 |
| Comments |
Refer to the Ordinance on Fees and service charges 003/PO |
|||
| 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 Ordinance on Fees and service charges 003/PO |
|||
