Inventory of Business Licenses

General information
Name of formality	Good Manufacturing Practices Certificate for Traditional Medicine
Type of formality	Certificate
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?	To introduce the implementation of businesses in accordance with the Good Manufacturing Practices of traditional medicine and health supplement products such as production, processing, storage, distribution, import of raw materials, export by various processes to meet the GMP standards.
Qualifications needed by the business to get the formality	Must be a factory engaged in the business of manufacturing traditional medicine
Additional Comment

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
Provision on Good Manufacturing Practice and Drug Quality Control	1021/MOH	11.08.1999

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Request Letter for Certify Traditional Medicine Good Manufacturing Practice (TM GMP)	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))	15	15 official 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?	Renewal conditions are the same as the initial application process

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	0.00	2000000.00	0.00	2000000.00
Comments	Pay the fee for the GMP certificate after obtained the approval

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
YES	0.00	2000000.00	0.00	2000000.00
Comments	Pay the fee for the GMP certificate after obtained the approval

   

REQUIRED DOCUMENTS
Document Name	Comment
Request Letter for Certify Traditional Medicine Good Manufacturing Practice (TM GMP)

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2016
2017