Inventory of Business Licenses

General information
Name of formality	Import Authorization of Controlled Chemicals
Type of formality	Other
Date of last modification	18.12.2020
Responsible Authorities	Food and Drugs Department
LSIC
Who should complete this business formality?	Any individuals or organizations that intend to import controlled chemicals for production, distribution, or possession.
Qualifications needed by the business to get the formality	Any authorized individuals or authorized organizations that can carry out the production, import, export, distribution, purchase, transportation, a transit of precursors to use in food and drug from the Ministry of Health or other relevant authority.
Additional Comment	- The importer company must submit the original of the Import Authorization to an export company or factory. - In case the Import Authorization is expired or there are any changes the importer company must return the certificate to the Food and Drug Department to renew or amend such Import Authorization. - The importer company must attach a drug sale report (Based on the format) determined by the Food and Drug Department. - The Import Authorization cannot use as an Import Permit of medicine products.

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011	Article 12
Order on the Management of Narcotics and Psychotropic Substances	456/MOPH	19.04.2006	Article 9, 10, 11 and 12
Order on the List of Narcotics and Psychotropic Substances	08/MOPH	04.01.2005	Article 1 an 2

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Application Form	Confirmative act	by the FDD
Annual Importation Plan of Chemical	Confirmative act	from the Ministry of Health or relevant sectors
Copy of Related Registration Certificates and other Permits	Confirmative act	such as Enterprise Registration Certificate, Business Operating License, Chemical Importation Plan and Certificate of Factory Establishment

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))	14

 

RENEWAL INFORMATION
Does the formality have a validity or an expiration date?	YES
How long will the formality be valid for? (in months)	0
What is the process and conditions to get the formality?
What is the process and conditions to renew the formality?	- This permit is valid from the signing date until 31 December of that year. - It does not need to renew the import authorization. In case there is no importation during the specified period the import authorization will be eliminated.

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	0.00	0.00	3000.00	3000.00
Comments	Based on the recommendation from the authority.

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
YES	0.00	0.00	3000.00	3000.00
Comments	Based on the recommendation from the authority.

   

REQUIRED DOCUMENTS
Document Name	Comment
Application Form	by the FDD
Annual Importation Plan of Chemical	from the Ministry of Health or relevant sectors
Copy of Related Registration Certificates and other Permits	such as Enterprise Registration Certificate, Business Operating License, Chemical Importation Plan and Certificate of Factory Establishment

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2020	53	0