Inventory of Business Licenses

General information
Name of formality	Certificate of Product Information Change
Type of formality	Certificate
Date of last modification	19.11.2020
Responsible Authorities	Food and Drugs Department
LSIC
Who should complete this business formality?	Owner of a pharmaceutical product (drug)
Qualifications needed by the business to get the formality	Owner of a pharmaceutical product (drug)
Additional Comment

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011
Provision on Medicine Registration	1441/MOPH	13.08.2003

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment

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))	90	The application period is 3 months

 

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?	Depends on the validity of the certificate

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	50000.00	0.00	0.00	50000.00
Comments	As advised by the authority

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
YES	50000.00	0.00	0.00	50000.00
Comments	As advised by the authority

   

REQUIRED DOCUMENTS
Document Name	Comment

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2019	79	0
2020	40	0