Inventory of Business Licenses

General information
Name of formality	Import Permit (Controlled Chemical)
Type of formality	Other
Date of last modification	18.12.2020
Responsible Authorities	Food and Drugs Department
LSIC	Q - Human health and social work activities
Who should complete this business formality?	Any individuals or organizations that intend to import for use, production, or distribution of controlled chemicals must obtain approval from the Ministry of Health at the time of actual importation.
Qualifications needed by the business to get the formality	Any authorized individuals or authorized organizations that carry out the production, import, export, distribution, purchase, transportation, a transit of general chemicals to use in food and drug from the Ministry of Health.
Additional Comment	- Before import-export-transit of the controlled drugs the authorized importer must obtain an import authorization from the Ministry of Health. - The import company must declare the import authorization and relevant documents to the food and drug authority at the checkpoint each time. In case there is any change in the import authorization the import company must return the original of the import authorization to the Food and Drug Department in order to amend such import authorization.

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011	Article 12 and 16
Order on the Management of Narcotics and Psychotropic Substances	456/MOPH	19.04.2006	Article 9, 10 and 12
Order on the List of Narcotics and Psychotropic Substances	08/MOPH	04.01.2005	Article 1 and 2

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Application Form for Import Permit of Controlled Chemical	Confirmative act
Purchase Order	Confirmative act
Invoice	Confirmative act
Packing List	Confirmative act
Import Authorization of Controlled Chemicals	Formality
Copy of Related Registration Certificates and other Permits	Confirmative act	such as Enterprise Registration Certificate, Business Operating License and Certificate of Factory Establishment
Sample of Import Permit (Controlled Chemical)	Confirmative act	download to see the sample of Import Permit for Controlled Chemical

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))	3

 

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	20000.00	0.00	3000.00	23000.00
Comments	Based on the recommendation from the authority

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
NO	0.00	0.00	0.00	0.00
Comments

   

REQUIRED DOCUMENTS
Document Name	Comment
Application Form for Import Permit of Controlled Chemical
Purchase Order
Invoice
Packing List
Import Authorization of Controlled Chemicals
Copy of Related Registration Certificates and other Permits	such as Enterprise Registration Certificate, Business Operating License and Certificate of Factory Establishment
Sample of Import Permit (Controlled Chemical)	download to see the sample of Import Permit for Controlled Chemical

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2016	5	0
2017	11	0
2018	4	0
2019	8	0
2020	53	0