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Licensing Pharmacist for Factory

ໃບທະບຽນວິຊາຊີບເພສັຊກຳສຳລັບໂຮງງານ

General information
Name of formality Licensing Pharmacist for Factory
Type of formality Other
Date of last modification 09.12.2020
Responsible Authorities Food and Drugs Department
LSIC Q - Human health and social work activities
Who should complete this business formality?
Individuals or legal entities that intend to apply for the establishment of a manufacturing factory, processing room, a pharmacy must apply for a pharmacy licensing in accordance with the regulations of the Ministry of Health.
Qualifications needed by the business to get the formality
Applicants must create a feasibility study, a construction technical analysis (plan), as well as a reforestation plan for the medicinal natural resources. This includes Excavation; Harvesting requires the use of appropriate methods and techniques for each season which must have a minimal impact on plants and animals propagation for the sustainability of medicinal natural resources.
Additional Comment
Newly requested or renewal of the Licensing pharmacist must be proposed and reviewed by the District Health Office, Provincial/Capital Department of Health and then submitted to the Food and Drug Department for consideration in accordance with the regulations. After obtaining the license, the individual and the legal entity must fulfill the obligations under the agreement of the licensing agency to contribute to the restoration.

LEGAL FRAMEWORK
Name Number Date Comment
Law on Drugs and Medical Products (Amended) 07/NA 21.12.2011
Provision on the Manufacture of Medicine and Medical Products 937/MOH 12.05.2004
Presidential Ordinance on Fees and Service Fees 003/PO 26.12.2012 Chapter IX, Article 45-47, Pages 89-92
Decree on Medical Pharmacognosy 155/PM 30.09.2003

REQUIRED DOCUMENTS FORMALITIES - First time
Name Type Comment
Certificate of Pharmacist Practices Confirmative act
                                                                         
Enterprise Registration Certificate Confirmative act
                                                                         
Feasibility Study of the Manufacturing Technique Confirmative act
                                                                         
Feasibility Study of the Construction Technique Confirmative act
                                                                         
Request Letter Confirmative act
                                                                         
Licensing Pharmacist Confirmative act
                                                                        issued by the Ministry of Health 
Retirement Card or Resignation Letter Confirmative act
                                                                        or Public Servant Certificate 
Curriculum Vitae Confirmative act
                                                                         
Certification of Health Confirmative act
                                                                         
Court Clearence Confirmative act
                                                                         
Address Certification Confirmative act
                                                                         
Photo (3x4) Confirmative act
                                                                        taken within 6 months 
Certificate of Ownership Confirmative act
                                                                        or Lease Agreement 
Location Map Confirmative act
                                                                         
Certificate of Location Confirmative act
                                                                        from Food and Drug authority in the province or Vientiane Capital 
Certificate of Nationality Confirmative act
                                                                        for an alien person 

REQUIRED DOCUMENTS FORMALITIES - Renew
Name Type 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)) 30 The law does not specify the period for consideration, but the authority suggests that the normal consideration period is no more than 30 days
 
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?
 
ISSUING FEES
Has application fees? Service fees Certificate fees Application fees Total fees
YES 0.00 400000.00 0.00 400000.00
Comments
Ordinance on Fees and Service Charges, No. 003/PO, 
Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92)
 
RENEWAL FEES
Has renewal fees? Service fees Certificate fees Renewal fees Total renewal fees
YES 0.00 400000.00 0.00 400000.00
Comments
Ordinance on Fees and Service Charges, No. 003/PO, 
Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92)
     
 

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