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)

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.