Inventory of Business Licenses

General information
Name of formality	Certificate of Free Sales
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?	The Import-export company, processing room that has been registered the product with the Food and Drug Department, Ministry of Health.
Qualifications needed by the business to get the formality	Must be an import-export company, or a processing room to be able to apply for a Certificate of Free Sale
Additional Comment

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011
Presidential Ordinance on Fees and Service Fees	003/PO	26.12.2012	Chapter IX, Article 45-47, Pages 89-92

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Application Form	Confirmative act
Certificate of Product Registration	Confirmative act	issued by the Food and Drug Department
Sales and Purchase Agreement	Confirmative act
Enterprise Registration Certificate	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))	5

 

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 Certificate of Free Sale is valid for 1 year. 3 months prior to the expiry date, the applicant must apply for the renewal in accordance with the documents required by the Food and Drug Department.

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	0.00	50000.00	0.00	50000.00
Comments	Ordinance on Fees and Service Charges, No. 003/PO, Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92), the certificate fee is 50,000 LKA/item

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
YES	0.00	50000.00	0.00	50000.00
Comments	Ordinance on Fees and Service Charges, No. 003/PO, Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92), the certificate fee is 50,000 LKA/item

   

REQUIRED DOCUMENTS
Document Name	Comment
Application Form
Certificate of Product Registration	issued by the Food and Drug Department
Sales and Purchase Agreement
Enterprise Registration Certificate

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2016
2017	7	0
2018	0	0
2019	0	0
2020	0	0