Inventory of Business Licenses

General information
Name of formality	Permit to Produce Sample Drug for Domestic Drug Formula Registration
Type of formality	Other
Date of last modification	19.11.2020
Responsible Authorities	Food and Drugs Department
LSIC
Who should complete this business formality?	Domestic drugs manufacturer.
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

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	Confirmative act
Drugs Labels of all Packing Sizes	Confirmative act	2 sets
Documents on Drug Management	Confirmative act

REQUIRED DOCUMENTS FORMALITIES - Renew
Name	Type	Comment

 

Mean of presentation
Means of presentation
Address of authority	Food and Drugs Department, Ministry of Public Health
Processing Time (Day(s))	0	Pursuant to the Regulation on Drug Registration 1441/MOH, the application period is 3 months.

 

RENEWAL INFORMATION
Does the formality have a validity or an expiration date?	YES
How long will the formality be valid for? (in months)	6
What is the process and conditions to get the formality?
What is the process and conditions to renew the formality?	Pursuant to the Regulation on Drug Registration 1441/MOH

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	100000.00	0.00	0.00	100000.00
Comments

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
YES	100000.00	0.00	0.00	100000.00
Comments

   

REQUIRED DOCUMENTS
Document Name	Comment
Application Form
Drugs Labels of all Packing Sizes	2 sets
Documents on Drug Management

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2019	21	0
2020	6	0