Inventory of Business Licenses

General information
Name of formality	Certificate of Analysis
Type of formality	Certificate
Date of last modification	23.11.2020
Responsible Authorities	Food and Drugs Department
LSIC	Q - Human health and social work activities
Who should complete this business formality?	Any individual, legal entity, or organization intending to conduct a business related to food and drugs must first obtain a research sample certified by the Food and Drugs Department (as defined in the law).
Qualifications needed by the business to get the formality	Have a delivery note from the Food and Drugs Department/Business Unit
Additional Comment

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011
Law on Food (Revised)	33/NA	24.07.2013
Order on the Management of Safe Food Production, Exportation and Importation	856/MOPH	12.05.2006
Decision on Drinking Water in the Closed Containers	585/MOH	12.05.2006
Presidential Ordinance on Fees and Service Fees	003/PO	26.12.2012

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Delivery Note from Food and Drug Department	Confirmative act
Sample of Products or Chemical Subtances	Confirmative act	send in quality and amount as defined in the criteria

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))	0	The period of the analysis depends on the items needed to be analyzed (for example, the analysis of drinking water for registration or the extension of 14 items under the Decision on Drinking Water in a Closed Container will take about 1 month)

 

RENEWAL INFORMATION
Does the formality have a validity or an expiration date?	NO
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?	- According to the Decision on Drinking Water in Closed Containers - If it is a pharmaceutical product, a health-related analysis will be issued for each production lot (Lot No.) - Certificate of analysis for the product registration (Regulation on Registration)

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	0.00	0.00	0.00	0.00
Comments	The fee for analyzing each item is based on the Ordinance on Fees and Service Charges No. 003/PO, dated 26 December 2012 (Article 47, III, pp. 93-95). - Agreement between the user and the provider of the research service

 

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
Delivery Note from Food and Drug Department
Sample of Products or Chemical Subtances	send in quality and amount as defined in the criteria

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2019	148	182
2020	62	75