Inventory of Business Licenses

General information
Name of formality	Certificate of Registration of International Drug Formula for Domestic Production
Type of formality	Certificate
Date of last modification	19.11.2020
Responsible Authorities	Food and Drugs Department
LSIC	C - Manufacturing
Who should complete this business formality?	Domestic pharmaceutical factory.
Qualifications needed by the business to get the formality	1. For locally manufactured drugs, those who intend to produce drugs must submit an application for the production of a sample drug according to the Application Form 1. Once a permit for producing sample drug is granted, the manufacturer shall submit the application for registration Form 2 within 3 to 6 months. 2. For imported drugs, those who intend to import drugs from abroad must apply for a permit to import a sample drug according to the Application Form 1. Once a permit for importing a sample drug is granted, the manufacturer shall submit the application for registration Form 2 within 3 to 6 months.
Additional Comment	Only for the registration of a domestic manufactured drug.

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011
Provision on Medicine Registration	1441/MOPH	13.08.2003

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Application Form for Registration (Form No.2)	Confirmative act
Certificate of Analysis	Confirmative act	indicate the methods and attach documents related to the analysis, 2 sets
to be translated	Confirmative act	2 sets
Documents or Evidence for the Efficacy of Drugs	Confirmative act	information about the clinical trails, 1 set
Documents related to Medical Manufacturing	Confirmative act	1 set
Study on the Expired Date of the Medicine	Confirmative act
Labels and Leaflet of Medicine	Confirmative act	1 set
Sample of the Drug for Assessment and Quality Control	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))	0	Pursuant to the regulation on drug registration No. 1441/MOH, the application period is 6 months.

 

RENEWAL INFORMATION
Does the formality have a validity or an expiration date?	YES
How long will the formality be valid for? (in months)	36
What is the process and conditions to get the formality?
What is the process and conditions to renew the formality?	Pursuant to the Presidential Ordinance No. 003/PO.

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	0.00	600000.00	0.00	600000.00
Comments	Pursuant to the Presidential Ordinance on the Fees and Service Charges No. 003/PO.

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
YES	100000.00	300000.00	0.00	400000.00
Comments	Pursuant to the Presidential Ordinance on the Fees and Service Charges No. 003/PO.

   

REQUIRED DOCUMENTS
Document Name	Comment
Application Form for Registration (Form No.2)
Certificate of Analysis	indicate the methods and attach documents related to the analysis, 2 sets
to be translated	2 sets
Documents or Evidence for the Efficacy of Drugs	information about the clinical trails, 1 set
Documents related to Medical Manufacturing	1 set
Study on the Expired Date of the Medicine
Labels and Leaflet of Medicine	1 set
Sample of the Drug for Assessment and Quality Control

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2019	394	0
2020	121	0