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Licensing Pharmacist to Establish a Domestic Wholesale of Drug and Medical Product
药师开办药品及医疗产品国内批发许可
ໃບອະນຸຍາດວິຊາຊີບເພສັດຊະກໍາ ເພື່ອສ້າງຕັ້ງບໍລິສັດຂາຍຍົກພາຍໃນ ຢາ ແລະ ຜະລິດຕະພັນການແພດ
Individuals or legal entities that intend to engage in the wholesale business of pharmaceuticals and medical products from local manufacturers or import-export companies to operate wholesaling activities for pharmacy in Lao PDR. Apply at Food and Drugs Department.
Who needs this
Individuals or legal entities that intend to engage in the wholesale business of pharmaceuticals and medical products from local manufacturers or import-export companies to operate wholesaling activities for pharmacy in Lao PDR.
Requirements
- 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
- The setting of the wholesale business operation must have 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 non-medical products retailer
- There must be a clean and standard storage place with a width of 6 meters, a length of 12 meters and an appropriate height. Must have an accounting clearing system, animals and insects’ prevention system, a cooling system, lighting, temperature and humidity monitoring device. Inside the warehouse must have necessary equipment, a refrigerator with a temperature not to exceed 2-8 Celsius with temperatures measuring devices in the case of drugs to be kept in cold temperature such as rectal suppository or other drugs (Good Wholesaling Practice (GWP) and Good Storage Practice).
Documents — first application
| Document | Note |
|---|---|
| Curriculum Vitae | with photo (taken within 1 year) |
| Application Form | |
| Certification of Health | issued within 3 months |
| Address Certification | with photo (taken within 3 months) |
| Photo (3x4) | 3 photos (taken within 1 year) |
| Education Certificate | a copy |
| 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. |
| Certificate of Resignation from Public Servant | or Appointment Letter from the organization (if it is a state-enterprise) |
| Location Map of the Company | of the wholesale company |
| Floor Plan of the Buildings, Office, and Warehouse | |
| Certificate of Ownership of the House | or Lease Agreement |
| Copy of Enterprise Registration Certificate | |
| Report for the location inspection | from the relevant authorities before an approval |
| Feasibility Study of Medical and Medical Devices Business | indicate the name of the products and its origins |
Documents — renewal
| Document | Note |
|---|---|
| Certification of Health | issued within 3 months, 1 copy |
| Address Certification | with photo (taken within 3 months), 1 copy |
| Court Clearence | 1 copy |
| Report for the location inspection | from the FDD authorities, 1 copy |
| Application form for renewal | 1 copy |
| Licensing Pharmacist | The original license that is expired or nearly expired, 1 copy |
| Location Map | that has been approved, 1 copy |
| Performance report | of the company, branches and wholesales in the past 2 years, 1 copy - the import-export company has to submit the import evidence, 6 copies |
| Future Plan of the company, branches and wholesales | 1 copy |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Order on the Establishment of Medicine and Medical Device Business Operation (Revised)
- Presidential Ordinance on Fees and Service Fees
How to submit
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 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.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 12 months
- Renewal process
- The renewal shall be undertaken within 3 months before the expiration of the Formality.