How to Register Herbal Medicine Products in Dubai, UAE?

HERBAL PRODUCT REGISTRATION

1.certificate of registration of the manufacturer in the Ministry of Health UAE.

Natural products are tiny molecules that are produced naturally by any creature including primary and secondary metabolites. They include ting molecules, for example, urea, and complex structures, for example, Taxol. As they may just be isolable in little amounts, have interesting biological activity as well as chemical structures, natural product synthesis represents an interesting challenge in organic chemistry.

The broadest meaning of natural product is anything which is produced by life, and including the likes of the biotic materials (e.g. silk, wood), bio-based materials (e.g. corn-starch, bioplastics), bodily fluids (for example milk, plant exudates), and other natural materials (for example soil, coal).

2.An Application Form for registering a Herbal product.

Natural products are those chemical substances or compounds which are isolated from the living organism. It may be in the form of primary or secondary metabolites. Plant optional metabolites are organic phytochemicals or compounds which are not directly involved in normal development, growth, or reproduction of the plan.

The compounds are characterized into four different groups as indicated by their biosynthetic origin: alkaloids, polyketides, phenylpropanoids, and terpenoids. Since over 200,000 structures of normal products from plants are known, just chose compounds and groups are present.

It must be filled-in through a company except for Agent’s information that is filled-in through the Agent in the UAE.

3. A Free Sale Certificate (FSC) or Certificate of Pharmaceutical Product (CPP). 

It must by the competent authority stamped and signed by the authorized person as well as attested from the UAE Embassy and in the country of origin. It must contain:

• Name and address of the manufacturer.
• Product trade name
• Product license/registration number and date in the country of origin.
• A statement confirming that the product is produced under GMP conditions.
• Composition (active and inactive ingredients with their quantities (not in the percentage) per unit dose).
• Shelf life and storage conditions.

Process of Registering Herbal Products with the UAE Ministry of Health

Registering herbal products with the UAE Ministry of Health entails a meticulous process to ensure adherence to regulatory standards. Companies are required to furnish comprehensive documentation elucidating product composition, safety, and efficacy.

Steps for Registering Herbal Products in the UAE:

• Prepare detailed documentation outlining the herbal product.
• Submit the documentation to the regulatory authority.
• Undergo evaluations, including testing and trials.
• Obtain approval.
• Maintain compliance to ensure market access.

The ministry conducts comprehensive evaluations, encompassing laboratory testing and clinical trials, to evaluate product quality and suitability for market entry. Upon successful review, approval is granted, enabling the legal sale and distribution of herbal products in the UAE.

If the above information is not included in the Certificate of Pharmaceutical Product, a separate document that must be legalized by the competent authority is required. 

Leaflet (Package insert)

It must by the competent authority stamped and signed by the authorized person and it should contain:

• Product trade name, form, and pack size.
• Manufacturer name and address.
• Full composition.
• Indications.
• Dosage, route, and instruction of administration.
• Adverse effects.
• Interactions and contraindications.
• Special precautions or warnings.
• Storage conditions.
• Date of last revision of the leaflet.

Our expert consultants will assist you in herbal product registration in Dubai UAE. For more information, contact us on Contact Us or mail at info@msz.ae