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Food Supplement Registration in United Arab Emirates

Regulatory Authority

Emirates Drug Establishment

Regulatory Website

Registration Timeline

12 Days

Registration Fee

200 AED.

License Validity

5 Years

Requirements for Food Supplement Registration in UAE

Details about the product: Explain the precise composition of the dietary supplement, including the quantities of the active components and any added excipients or additives. Give a clear explanation of the health supplement’s intended use and purpose. Describe the suggested dosage for the dietary supplement. 

Declare the product’s package amount and size. Indicate how many units or servings each blister pack, bottle, box, or other type of pack has. Information on safety, including crucial safety details such possible adverse effects, precautions, and contraindications.

Data on safety and quality: Offer proof of the health supplement’s quality and safety. Stability studies, analytical method validation, final product testing specifications, toxicological data, and certifications of analysis from reliable laboratories are a few examples of this.

Packaging and labeling: Verify that the packaging and labeling adhere to the standards established by the regulatory body, such as the Emirates Authority for Standardization and Metrology (ESMA). Included in this are the precise ingredient list, easy-to-follow dose guidelines, batch number, manufacturer, expiration date, storage conditions, allergen information, and product claims.

Production Data: It is essential to submit comprehensive production data that demonstrates compliance with legal and quality standards when registering a health supplement in Dubai (UAE). This entails outlining the production procedure, emphasizing any distinctive features, and giving details regarding the facilities, accreditations, and adherence to Good Manufacturing Practices (GMP). Outlining the processes for quality control, such as validation procedures, testing protocols, and documenting standards, is crucial.

Importer information: If you are not the manufacturer, provide the details of the authorized importer or distributor in Dubai (UAE). This information is necessary for ensuring traceability and compliance with import regulations.

 

Process to Register Food Supplements in UAE

  • Application submission: Complete all necessary paperwork and send it to the regulatory body—such as ESMA—along with the registration application form. To prevent delays in the review process, be sure that all of the material is true and comprehensive.
  • Review of the application: After examining the supporting documentation, the regulatory body may ask for more details or clarification if necessary. This is an essential step in assessing the quality, safety, and compliance of your dietary supplement.
  • Product testing and sampling: The regulatory body may carry out product testing and sampling as a part of the review procedure to confirm adherence to quality and safety requirements. This makes it more likely that the product will fulfill the necessary requirements.
  • Registration fees: As directed by the regulatory body, pay the relevant registration fees

Approval

Certificate issuance: If your application is accepted, you will receive a registration certificate attesting to the fact that your health supplement complies with Dubai’s regulations (UAE). This certification is a necessary document for product marketing and sales in the Dubai (UAE) market.

Compliance with labeling and packaging: Verify that the labeling and packaging of your products meet the specifications given in the registration certificate. Before moving on with production and distribution, make any necessary modifications to ensure that the product meets the approved standards.

Market launch: You can now introduce your health supplement to the Dubai (UAE) market if you have the registration certificate in your possession and the packaging and labeling are compliant. To efficiently reach your target audience, plan your distribution routes and marketing strategies.