Herbal medicine registration in UAE

Transform Herbal Innovations into Market-Ready Certified Products

• Introduction to herbal medicine registration in the UAE

Herbal medicine is a product contain active ingredients extracted from any part of a plant or product with herbal ingredient which has a medical claim and intended to be used as prophylactic or therapeutic or other human health benefits.

Herbal medicine needs to be registered in Ministry of Health and Prevention (MOHAP) to ensure the safety, quality, and efficacy of the herbal medicinal product. Importers, manufacturers, and local distributors must apply for the registration, submit all the required documents, and undergo all the requested test to make the herbal medicine available in the market.

• Importance of regulatory compliance for herbal products

It is necessary to emphasize that no herbal product shall be manufactured, imported, exported, advertised, sold, or distributed in the UAE unless it has been registered in accordance with Ministry of Health and Prevention (MOHAP) Regulations

Following UAE regulations is essential for legal business operations, public health and safety, and consumer rights protection. Regulatory compliance is tightly enforced by MOHAP to all medicinal products. Companies may avoid legal penalties, import delays, product recalls, and bans by following these standards and developing consumer and stakeholder confidence. Furthermore, regulatory compliance is frequently required for product registration, market entry, and long-term economic success in the UAE. It also shows a company's dedication to quality, openness, and ethical business practices in a heavily regulated and competitive industry.

• Overview of the UAE's regulatory bodies for herbal medicine (MOHAP, Dubai Municipality, etc.)

Dietary supplements are regulated in UAE by two main regulatory bodies according to product ‘s ingredients, function, and other factors.

1. MOHAP: Regulates the registration of herbal medicine. Herbal medicine is any supplement contains natural or herbal ingredients and has a medical claim (treat, prevent, diagnose, or cure any disease). 

2. Dubai Municipality: Regulates the registration of health supplement. Health supplement is any supplement with no active ingredients and has no medical claim. Health supplements products shall not be intended to treat, diagnose, prevent, or cure any disease.

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Steps for Registering Herbal Products in the UAE

1. First step is online application of herbal medicine registration on MOHAP portal.

2. Submit all the required documents online.

3. Your application and documents will be reviewed by the competent committee.

4. The applicant applies for analysis certificate through analysis section in drug department and submit all required documents and samples.

5. The relevant committee will review all the documents to ensure herbal medicine is meeting the requirements. 

6. If herbal medicine is meeting requirements, drug department will issue the registration certificate which is valid for 5 years.

Understanding Herbal Medicine Registration Requirements

• What qualifies as a herbal medicine product?

Herbal Medicine is a labeled medicinal product from natural source. Any medicinal product from plant origin is called herbal medicine. Herbal medicine have one or more active ingredient extracted from any part of a plant (stem, leaf, flower, root,… etc.), and used to treat or recover health.

Herbal medicine can be formulated in topical, oral, or rectal form.

• UAE regulations governing herbal product registration

Company must comply with UAE regulations and submit all supported documents as; stability study, bioequivalence study, pharmacodynamics, pharmacokinetics, therapeutic efficacy and adverse reactions if available.

Herbal product must have an insert leaflet has all product information as; product name and generic name, active and inactive ingredients, indication and dosage, mode of administration…etc

Step-by-Step Herbal Product Registration Process

• Document Preparation: Required certificates, ingredient lists, and safety reports

• Application Submission: Submitting the product details to the regulatory authorities

• Product Evaluation & Testing: Ensuring compliance with safety and efficacy standards

• Final Certification & Market Approval: Obtaining approval for sale in UAE markets

• Companies applying for herbal product registration in MOHAP should have a medical store license.

• Manufacturing site should be registered in MOHAP prior to product registration.

• Online application on MOHAP portal

• Submission of all required and supported documents online

• Follow up with quality control department for analysis report.

• MOHAP will issue a registration certificate valid for 5 years.

Common Challenges & How to Overcome Them

• Avoiding registration delays

• Ensuring accurate documentation

• Meeting safety and efficacy standards

It is very important to accelerate the registration process and avoid any delays by making sure that registration file is meeting the guidelines before submission. HERMS global will assist you to achieve that by;

• Helping you to register company and manufacturer to enable product registration.

• Reviewing all the documents to ensure meeting UAE safety and efficacy guidelines.

• Medical writing of any missing documents 

• Labels reviewing, validation and modification.

• Close follow up with quality control department to accelerate analysis process.

Why Choose Us for the Best Herbal Medicine Registration?

HERMS global with its extensive expertise in Regulatory affairs, will simplify the registration process of your herbal product in MOHAP, and ensure the product and documents are complying with the guidelines.

Herms Global has an extraordinary track record in the UAE market, having developed good working connections with regulatory bodies and staying current on the most recent revisions in rules and categorization criteria. This enables us to predict and avoid frequent registration difficulties, saving clients valuable time and money while avoiding delays, rejections, and compliance concerns. Herms Global understands that the process of registering herbal medicine products in Dubai might be intimidating. That is why we are here to make the process simple and stress-free. From document preparation and ingredient inspection to artwork and label verification, we manage every aspect to guarantee your product meets all MOHAP regulations. But we don't stop there; our staff takes a hands-on, personalized approach to preparing your business for true success in the UAE market. With extensive regulatory experience and strong local relationships, we work swiftly and efficiently to get your items licensed, minimize costly delays, and help your firm develop confidently.
 

Expert Guidance & Regulatory Knowledge

• Extensive experience in UAE herbal product registration

• In-depth knowledge of compliance requirements

 Faster & Hassle-Free Registration Process

• Efficient documentation handling

• Minimized risk of delays or rejections

 End-to-End Support & Compliance Assurance

• Assistance from product assessment to final certification

• Post-registration support for renewals and updates

 Expert herbal product registration in Dubai UAE

• Contact us for a free consultation

• Quick and efficient registration services

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