Classification of a product

Service completion duration

10 working days

Service fees

Classification of product Fees: AED 500

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About the Service

This service allows the classification of products of all types and forms based on Presentation /Composition / Use and Design. Requirements may vary based on the nature of the product, risk class and regulatory status.

Service Process

1
Login to the MoHAP website or smart app using the UAE PASS
2
Fill the product details
3
Attach the required documents
4
Make payment & submit the application

Conditions & Requirements

The purpose of the Classification letter is to inform you about the laws governing your products within UAE.
The classification letter identifies the product classification if the product needs or does not need registration by MOHAP. If it is determined that it needs registration by MOHAP, it must be registered in MOHAP according to the class identified in the classification letter.
Classification is available for all types of Companies and for Individuals.
For more information regarding the conditions and requirements, please check the resources.

FAQ’s

How do I select the appropriate account for product classification through the submission process?
- Agent (link with your existing account)- If you have a valid drug store license issued by UAE MOHAP licensing department then select this account type.
- Other: Other authority licensed establishments, Examples: Trade license, Free zone license etc. (Establishment name and city should be similar to the Trade license/ Free zone license etc.).
- Individuals: if you don’t have any establishment license in UAE (Applicant Name should be similar to the Emirates ID/ Passport).
How do I modify the account details?
Fill or correct the user details: - go to top left corner of the screen - click on ‘account’ - settings- account details- fill/ correct information & press save button.
How do I follow my application status?
Check the dashboard frequently for comments from MOHAP Officers.

Service completion duration

10 working days

Service fees

Classification of product Fees: AED 500

Service channels

MOHAP Website
MOHAP Mobile App

Service locations

Mohap Website
MOHAP Smart Application

Support

Payment channels

E- Payment

Target audience

Medical warehouses
Pharmaceutical manufacturers
Local facilities
Individuals

Resources

Sector name

Health Regulation

Main service

Medical, Pharmaceutical and Drug Licencing and Registration

Service Code

110-04-008-000

Service Classfication

Transactional

Service Type

Government to Business

Related Services

This service is not linked with other service

Service Bundle

This service is not linked with any service packages

Number of Users

745

Number of Transactions

5498

Notes

Video tutorial of applying for this service

View video

Required Documents

Emirates ID or the applicant’s passport or trade license or drug store license (depends on the user type) (mandatory)
Certificate from the regulatory authority of the country-of-origin, related to the submitted product (copy of the CPP/free sale certificate/CFG/CE/ISO) along with English or Arabic translation (mandatory) [CPP: Certificate of pharmaceutical product; CFG: Certificate to foreign government; CE: European conformity; ISO: International organization for standardization with submitted product name]
A photo of the product (mandatory)
Leaflet/product information in English/Arabic (mandatory)
Product catalogue for medical devices
Inner pack label with clear and readable product name and information (artwork)
Outer pack label with clear and readable product name and information (artwork)
Composition Certificate (Active/ Inactive ingredient list with each ingredients quantity)/ MSDS (applicable for product that have Medicinal/Chemical Ingredients in it) MSDS: Material Safety Data Sheet.
Registration and Marketing Status in other Countries (Copy of the Certificates along with English or Arabic Translation from Reference Countries approved by UAE MOHAP (Reference Country List Attached Above) / CE Certificate from EU approved Notified Body for the submitted Product) [CE: European Conformity. EU: European Union.]
Product Sample in their Final Original Pack (Upon Request)
MOHAP Quality Control Lab Analysis Report (Upon Request)
Letter of Authorisation from Marketing Authorization Holder (Upon Request)