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License to Excavate Materia Medical Pharmacognosy Resources

ໃບອະນຸຍາດຂຸດຄົ້ນຊັບພະຍາກອນທໍາມະຊາດທີ່ເປັນຢາ

General information
Name of formality License to Excavate Materia Medical Pharmacognosy Resources
Type of formality License
Date of last modification 03.10.2017
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 excavate, extract and harvesting medicinal plants, animals, plants and minerals, which includes pharmaceutical from natural resources or any material derived from natural sources, such as plants, animals, and minerals that can be used as raw materials for traditional medicine or drug. 

Applicants must apply for a specific license to excavate and harvest the medicinal natural resources, under the list of plants, animals, medicinal plants and minerals specified by the Ministry of Health in Decree 155/PM (to be included in list I, II, III), Medicinal plants book and 119 items.
Qualifications needed by the business to get the formality
Applicants must develop a plan for reforestation of the medicinal natural resources. 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
Permitted Individuals and organizations must comply with the obligations of the licensing organization to contribute to the maintenance and restoration of the ecosystem

LEGAL FRAMEWORK
Name Number Date Comment
Decree on Medical Pharmacognosy 155/PM 30.09.2003
Law on Drugs and Medical Products (Amended) 07/NA 21.12.2011 Article 4, 5, 12, 13, and 14
Instruction Implementing the Prime Minister Decree on Medical Pharmacognosy No. 155/PM 252/MOH 06.06.2007

REQUIRED DOCUMENTS FORMALITIES - First time
Name Type Comment
Factory Operation Certificate Formality
                                                                         
Certificate of Annual Tax Payment Formality
                                                                         
Licensing Pharmacist Confirmative act
                                                                        issued by the Ministry of Health 
Permit to Excavate the Non-timber Forest Product Confirmative act
                                                                         
Information on the Area of Excavation Survey Confirmative act
                                                                        Certified by the Provincial Department of Agriculture and Forestry 
Annual Summary Report of the Previous Year Confirmative act
                                                                        for a factory that applies for a permit to excavate annually must have a summary report from the previous year 
Certificate for Enterprise Registration of Company Limited Formality
                                                                         
Feasibility Study Confirmative act
                                                                         
Request Letter Confirmative act
                                                                         

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)) 20 The law does not specify the period for consideration, but the authority suggests that the normal consideration period is no more than 30 days (specific legislation is being prepared for the consideration of such documents).
 
RENEWAL INFORMATION
Does the formality have a validity or an expiration date? YES
How long will the formality be valid for? (in months) 12
What is the process and conditions to get the formality?
What is the process and conditions to renew the formality? The conditions for the license renewal reserves only for the factories that operate in traditional medicine business that have been licensed by the Ministry of Health, and license is valid from year to year.
 
ISSUING FEES
Has application fees? Service fees Certificate fees Application fees Total fees
YES 0.00 2000000.00 0.00 2000000.00
Comments
Ordinance on Fees and Service charges, No. 003/PO, 
Dated 26.12.2012 (Chapter IX, Article 45-47, page 89-92)
 
RENEWAL FEES
Has renewal fees? Service fees Certificate fees Renewal fees Total renewal fees
NO 0.00 0.00 0.00 0.00
Comments
Ordinance on Fees and Service charges, No. 003/PO, 
Dated 26.12.2012 (Chapter IX, Article 45-47, page 89-92)
     
 

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