Inventory of Business Licenses

General information
Name of formality	Import-Export-Transit Authorization of Narcotic Drugs Used in Medicine
Type of formality	Other
Date of last modification	17.12.2020
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 production, distribution, or possession of narcotic drugs - Export - Transit Must obtain approval from the Ministry of Health.
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 the 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	- 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 and 2

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Certificate of Good Manufacturing Practice (GMP)	Confirmative act
Application Form	Confirmative act	by the FDD
Certificate of Good Manufacturing Practice (GMP)	Confirmative act
Certificate of Drug Registration	Confirmative act
Certificate of Pharmaceutical Product (CPP)	Confirmative act
Certificate of Analysis	Confirmative act
Sales and Purchase Agreement	Confirmative act	between the supplier and hospital (copy)
Documents Related to the Winning of the Bidding	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))	14

 

RENEWAL INFORMATION
Does the formality have a validity or an expiration date?	YES
How long will the formality be valid for? (in months)	6
What is the process and conditions to get the formality?
What is the process and conditions to renew the formality?	In case the authorization is expired. The authorization can be renewed until 31 December of that year.

 

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
Certificate of Good Manufacturing Practice (GMP)
Application Form	by the FDD
Certificate of Good Manufacturing Practice (GMP)
Certificate of Drug Registration
Certificate of Pharmaceutical Product (CPP)
Certificate of Analysis
Sales and Purchase Agreement	between the supplier and hospital (copy)
Documents Related to the Winning of the Bidding

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2018	4	0
2017	4	0
2018	4	0
2020	6	0
2019	5	2