Inventory of Business Licenses

General information
Name of formality	Import-Export-Transit Permit of Controlled Drugs
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 individual or organizations that intend to: - Import for production, distribution, or possession of controlled drugs - Export - Transit Must obtain approval from the Ministry of Health when the import of the controlled drugs.
Qualifications needed by the business to get the formality	- Pharmaceutical factory and Import-Export of Pharmaceutical company which has been duly registered with the conditions that can import-export and distribution; - Pharmaceutical store class I and II which has been duly registered with the conditions that can retail in accordance with doctor’s prescription; - State hospital at a central and local level or private hospital with a license in accordance with condition that can distribute or retail by a pharmacist as per doctor’s prescription.
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 16
Order on the Management of Narcotics and Psychotropic Substances	456/MOPH	19.04.2006	Article 9, 10, 11 and 12
Decision on the List of Controlled Drugs for Distribution and Sales and Prescription and List of General Drugs for Distribution-Sales and General Use	1498/MOH	25.11.2002

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Purchase Order	Confirmative act
Invoice	Confirmative act
Packing List	Confirmative act
Import Authorization	Confirmative act
Certificate of Drug Registration	Confirmative act
Certificate of Pharmaceutical Product (CPP)	Confirmative act
Certificate of Analysis	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))	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	20000.00	0.00	3000.00	23000.00
Comments	Based on the recommendation from the authority.

   

REQUIRED DOCUMENTS
Document Name	Comment
Purchase Order
Invoice
Packing List
Import Authorization
Certificate of Drug Registration
Certificate of Pharmaceutical Product (CPP)
Certificate of Analysis

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2016
2017	20	0
2018	7	0
2019	16	0
2020	11	1