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Licensing Pharmacist for 1st Class Pharmacy

ໃບທະບຽນວິຊາຊີບເພສັດຊະກຳສຳລັບທຸລະກິດຮ້ານຂາຍຍ່ອຍຢາ ຂັ້ນ 1

General information
Name of formality Licensing Pharmacist for 1st Class Pharmacy
Type of formality Certificate
Date of last modification 19.11.2020
Responsible Authorities Food and Drugs Department
LSIC
Who should complete this business formality?
Pharmacist that have a diploma of higher education in pharmaceutical field.
Qualifications needed by the business to get the formality
1. Must be a Lao National with permanent residence in Laos for at least 5 years;
2. Foreigners or non-Lao National that has a permanent residence in Lao PDR, but has to go through a Lao Pharmaceutical Education System and licensed by the MoH;
3. Pharmacist from private or public sector have rights to open pharmacy during or outside the working hour, but has to have at least 2 years of working experience for a rural area, more than 3 years for Municipal areas and can have an official licensed assistant;
4. Shall be a person that is not under trial or abandoning position or under disciplinary due to the error in Pharmaceutical Profession;
5. Must be fully healthy.
Additional Comment

                                                    

LEGAL FRAMEWORK
Name Number Date Comment
Law on Drugs and Medical Products (Amended) 07/NA 21.12.2011
Order on Retail Pharmacy Shop (Amended) 2922/MOPH 21.09.2016 Article 3, 19.1, 22, 23
Presidential Ordinance on Fees and Service Fees 003/PO 26.12.2012

REQUIRED DOCUMENTS FORMALITIES - First time
Name Type Comment
List of Drugs based on INN Confirmative act
                                                                        that intend to sell in the retail pharmacy 
Site Inspection Certificate Confirmative act
                                                                         
Plan on Room and Tools Arrangement Confirmative act
                                                                         
Application Form Confirmative act
                                                                         
Curriculum Vitae Confirmative act
                                                                        with photo (taken within 1 year), 1 copy 
Education Certificate Confirmative act
                                                                         
Retirement Card or Resignation Letter Confirmative act
                                                                        or Certificate of Public Servant 
Certification of Health Confirmative act
                                                                         
Address Certification Confirmative act
                                                                         
Certificate of Pharmacist Practices Confirmative act
                                                                         
Photo (3x4) Confirmative act
                                                                        taken within 1 year 
Location Map Confirmative act
                                                                        of the pharmacy that has been approved 
Certificate of Ownership of the House Confirmative act
                                                                        or Lease Agreement 
Court Clearence Confirmative act
                                                                         
Certificate of Nationality Confirmative act
                                                                        for an alien applicant 

REQUIRED DOCUMENTS FORMALITIES - Renew
Name Type Comment
Application form for renewal Confirmative act
                                                                         
License of the last year Confirmative act
                                                                         
Site Inspection Certificate Confirmative act
                                                                        from FDD authorities 
List of Drugs and Medical Products Confirmative act
                                                                         
Remark Confirmative act
                                                                        for the license that does not have space for a stamp, it is required to attach 3 photos (size 3x4) 
Certification of Health Confirmative act
                                                                         
Address Certification Confirmative act
                                                                         
 
Mean of presentation
Means of presentation
Address of authority Food and Drugs Department, Ministry of Public Health
Processing Time (Day(s)) 0 No specific consideration period. The application for license to open a pharmacy of every class must be supplied in completed as described in Article 19.1. to the health authority of provincial/capital Department of Health in each level, health authority of the district bureau and provincial food and drug section shall conduct an inspection of the premise to evaluate and supply the information to Ministry of Health for the consideration. The Ministry of Health will be in charge of Licensing Pharmacist for 1st class Pharmacy approval.
 
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 get the formality?
What is the process and conditions to renew the formality? Licensing Pharmacist is valid for 2 years. 3 months before the date of expiry, the business must apply for a renewal. (Article 23 - Decisions of the Ministry of Health on Pharmacy (Amended) 2922/MoH 21.09.2016). The provincial/capital department of health will be in charge on approving the license renewal. Prior to the approval by the provincial level, the provincial/capital Department of Health (Food and Drug Section) must forward the application and summary of the evaluation to the Food and Drug Department in order to review and present to the Ministry of Health first.
 
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 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 100000.00 0.00 100000.00
Comments
Refer to the Ordinance on fees and service charges 003/PO
     
 

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