Registration of Pharmaceutical Product for General Sale

Average Service Time

This service enables the customers to submit applications to register simple 45 working days
pharmaceutical products with limited medicinal usage, which cannot be considered
medicines and are intended for general sale. These include products such as dietary
supplements,medical cosmetics and medical disinfectants.
Payment channels

E-Payment

Department name Sector Main Service Service Code

Target Audience
Drug Health Regulation Medical, 110-04-011-000
Pharmaceutical and Drug Medical warehouses, local
Licencing and Registration pharmaceutical manufacturers,
marketing officers

Service Locations
MOHAP Website
Service Classification Variation / Auxiliary Service Type www.mohap.gov.ae
Transactional Variation Government to Business
MOHAP Smart App

Related Services
This service is not linked
Service Process to any other services

01 To apply for e-services, create an account on MOHAP website or smart app with a username and password.

Service Bundle
02 Submit the request through the electronic service and complete the payment to meet all conditions. This service is not linked
to any bundles

03 The competent technical committees will deliberate the registration of products and recommendations will
be submitted to the competent ministerial committee.
Contact Details
Email:
04 Declarations shall be addressed to the concerned companies stating the committee's decisions via the e-
[email protected]
system.
[email protected]

05 The customer will follow up with the Pharmacological Analysis Section of at the Drug Department.

06 The company should complete the requirements and submit them online.

07 The relevant technical and ministerial committees will re-deliberate the registration of products that have
been deferred in advance as soon as companies complete the requirements.
Service Fees
Application fees:
08 Issuing certificates of registration of products that have been approved for registration following fulfilling all
conditions and requirements. Registration certificates are valid for five years effective the date of AED 100
committee approval.

09 Issuing pharmaceutical certificates (for locally manufactured pharmaceutical products) valid for one year Registration of a pharmaceutical
effective the date of issuance. product for general sale:
AED 5000

Required Documents
Sustainable
Certificate of pharmaceutical product in accordance with the WHO (World Health Organization)
system or a certificate of free sale of the product issued by the competent authorities in the
Development Goals
country of origin and certified by the Embassy of the United Arab Emirates. It should contain the
following information:

Product Brand Name: If the brand name required to be registered in UAE is different from the
name in the country of origin, this shall be made clear in the certificate, besides stating the
reason for that and making both names clear with an emphasis on their conformity in terms
of formulation and other specifications

The detailed formulation of the product contains active and inactive substances with their
quantities and functions of inactive substances

Name of the company entitled to marketing/ manufacturing/ manufacturing sites/

subcontract manufacturers along with their addresses

One sample of the product Notes

A valid registration certificate of the manufacturing company issued by MOHAP-UAE with Marketing Authorization Holder
intended production line
companies must be registered by
Halal certificate issued by certified authorities and organizations MOHAP before they could register
their products.
A statement issued by the company confirming that the product to be registered is free of
hormones, heavy metals, antibiotics, steroids, pig derivatives and any other natural or chemical
substances that have a harmful impact on human beings biologically and behaviorally

If the product contains animal derived substances, the animal type and the part extracted from it
should be mentioned with the percentage of alcohol used "if any and why it is used"

A copy of the certified contract signed between the marketing company and local agent indicating
the products for which the agent will be responsible

A certified certificate from the competent authorities of the country of origin stating that the
materials used in manufacturing the product is free from mad cow disease and its causes (if the
product contains substances classified as potential substances for transmitting the disease)
(Bovine Spongiform Encephalopathy (BSE)/ Transmissible Spongiform Encephalopathies (TSE)
free certificate)

A copy of the outer and inner cover and the leaflet printed on letterhead paper stamped by the
company and signed by the authorized person

Detailed composition certificate (active & inactive ingredients with their quantities)

Summary of product characteristics (SPC)

Requirements & Conditions

Marketing authorization holder companies must be registered by MOHAP before they could register
their products.

The applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license.

Service Channels

MOHAP Website: www.mohap.gov.ae MOHAP Smart App

Resources
Portal manual_637716056042464487
Login user manual_637716056042643318
Help manual_637716056041058138
Pricing rules

FAQs
1. What are the fees for the registration of a pharmaceutical product for general sale?
Application: AED 100
Registration of a pharmaceutical product for general sale: AED 5,000

2. What is the average length of time for the registration of a pharmaceutical product for general sale?
45 working days

3. What is the target group for a pharmaceutical product registration service with general sales?
Drug warehouses, local pharmaceutical manufacturers, marketing officers

4. What are the conditions and requirements for obtaining a pharmaceutical product registration service with general sales?
Marketing authorization holder companies and product manufacturing sites must be registered in MOHAP prior to the registration of their products.
The applicant must be a medical warehouse licensed by the Ministry of Health and Prevention and must hold a valid license.