OTC Product Registration in UAE

Hassle-Free Over-the-Counter Registration for Quick Market Access

Introduction to OTC Product Registration in DUBAI and its importance

Over the counter (OTC) drugs are the drugs that consumers can easily access without a prescription. The easy access to OTC drugs and the absence of health care professionals' direct supervision brought the necessity of the registration of these drugs to ensure the safety, efficacy and quality.

Why regulatory compliance is essential for OTC product Registration in Dubai

Regulatory compliance is tightly enforced in the pharmaceutical sector for all pharmaceutical products, including over the counter (OTC) drugs. No OTC drug shall be manufactured, imported, or distributed in the UAE unless it has been registered in the Ministry of Health and Prevention (MOHAP) by the UAE’s regulations and guidelines. Regulatory compliance is required for OTC registration to avoid legal penalties, import delays, product recalls and bans. And to ensure a high level of safety and efficacy for patients using the OTC drugs.

Overview of the OTC registration process in the UAE

An OTC product is a simple pharmaceutical product with limited medical usage. Most of the OTC drugs are registered in the UAE as Conventional/Pharmaceutical products, and a few of them are registered as pharmaceutical products for general sale (GSL). Product classification through MOHAP will help the company to know if the product needs to be registered as a conventional/Pharmaceutical, or GSL. The classification is based on the product’s composition, usage, and registration in the country of origin.

OTC Registration Process for Fast and Compliant Product Approval

The first step of OTC registration is the drug classification to determine the category of the product, the route of registration (conventional or GSL), and the channels of retail, either pharmacies only or pharmacies and hypermarkets.

Whether the product will be registered as a pharmaceutical or GSL product, it’s important to prepare a complete dossier with accurate documents and information, and comply with MOHAP requirements to achieve fast and compliant product approval.

Understanding Over-the-Counter Registration

What qualifies as an OTC product?

Over the counter (OTC) drugs are medicinal products that can be bought directly by consumers without a physician’s prescription from Pharmacies, hypermarkets, or any other retail outlets. OTC drugs are intended to treat common health issues and symptoms such as pain, cough, fever, common cold, nausea, allergies, etc.

Regulatory bodies oversee OTC registration.

OTC registration is done in the UAE through the Ministry of Health and Prevention (MOHAP). Marketing Authorisation Holder (MAH) must be registered in MOHAP before product registration, and the company must have a legal entity in the UAE with a medical warehouse, otherwise company can assign a local distributor who can import and distribute pharmaceutical products.

Step-by-Step OTC Registration Process

Company and manufacturer registration: Prepare the company registration file and the manufacturer registration file, including all required documents and complete the registration process on the MOHAP portal.
Submit the product registration application online.
Prepare product registration dossier and upload all required documents.
Pay registration fees online.
Complete the stability and bioequivalence if required.
Complete analysis through a quality control laboratory.
The MOHAP technical committee will do product evaluation, document review, testing, and approval.
Upon product approval, MOHAP will issue the registration certificate, which is valid for 5 years.
Documentation and eligibility requirements
Submission to relevant authorities (Dubai Municipality, MOHAP, etc.)
Product evaluation, testing, and approval
Final certification and compliance confirmation

Common Challenges and How to Overcome Them

There are some challenges that may be faced OTC registration process and causing delays in the registration process or even disapproval of the product.

The incomplete documents cause a delay in the registration process.
Inaccuracy of documentation
Failure to follow authority requirements.
Unawareness of regulatory updates and changes

HERMS global with its expertise in OTC registration, authority requirements, dossier composition, and high knowledge of regulatory updates and changes will help your company to overcome all challenges that may delay or affect the registration process

Avoiding registration delays
Ensuring accurate documentation
Navigating regulatory updates and changes

Reliable Over-the-Counter Product Registration in Dubai for Your Business Growth

HERMS global is a reliable regulatory affairs partner.
Guarantees you a fast-track registration of your Over The Counter product.
Accelerates your product availability in the UAE market.
Allows market expansion and business growth.

Ensuring Market Compliance and Consumer Safety

Why compliance is key to avoiding penalties and product recalls
Importance of maintaining high-quality standards

Benefits of Professional OTC Product Registration in Dubai Services
Partnering with HERMS global can facilitate the registration process and helps you to achieve.

Faster market entry with expert assistance
Reduced risk of rejection and compliance issues
End-to-end support for seamless registration

Unlock Hassle-Free OTC Product Registration in Dubai for Guaranteed Success

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