Inventory of Business Licenses

General information
Name of formality	Certificate of Imported Drug Formula Registration
Type of formality	Certificate
Date of last modification	19.11.2020
Responsible Authorities	Food and Drugs Department
LSIC
Who should complete this business formality?	Those who are officially authorized to import international drugs for distribution in Lao PDR. The manufacturer or parent company that obtains the registration certificate from the relevant country to export drugs via a domestic agency that is officially authorized to operate an imported drug business, with the agreement between the two parties mentioned above.
Qualifications needed by the business to get the formality	A company operating a pharmaceutical business, a domestic pharmaceutical manufacturer obtains a license from the Ministry of Health.
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
List of Required Documents for Imported Drug Registration	Confirmative act
Application for Registration (for Imported Drug)	Confirmative act

REQUIRED DOCUMENTS FORMALITIES - Renew
Name	Type	Comment
List of Required Documents to Extend to Imported Drug Registration	Confirmative act

 

Mean of presentation
Means of presentation
Address of authority	Food and Drugs Department, Ministry of Public Health
Processing Time (Day(s))	0	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?	Refer to the Edict on the Fees and Service Charges No. 003/PO For the license renewal, it shall meet the following conditions: 1. Must be a person who has registered the drug in accordance with the prescribed conditions 2. The registration certificate must be renewed 3 months before the due date. 3. The authority will reject the license renewal in the cases: - Incomplete documents as specified in the application Form 3 - Make no change when notified of some inaccuracies; - Drugs that are on the list of prohibited drugs in Lao PDR; - Drugs that the parent company has canceled or deregistered; - Drugs that the packagings and names have already been registered.

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	0.00	1500000.00	0.00	1500000.00
Comments	Refer to the 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	100.00	600.00	0.00	700.00
Comments	Refer to the Ordinance on the Fees and Service Charges No. 003/PO

   

REQUIRED DOCUMENTS
Document Name	Comment
List of Required Documents to Extend to Imported Drug Registration
List of Required Documents for Imported Drug Registration
Application for Registration (for Imported Drug)

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2019	248	263
2020	94	194