A Case Study : Registration of Health Supplements in UAE

Navigating the complex regulatory landscape of a new market can be a daunting task for any company looking to expand internationally. This is where Artixio, a global leader in regulatory affairs and market access solutions, steps in. Artixio specializes in providing comprehensive guidance and support for companies in the life sciences sector, ensuring compliance with local regulations and facilitating smooth market entry. Leveraging Artixio's expertise, our Swiss life science company aims to register and launch their health supplement, a wake-up supplement designed to energize users in the morning, in the UAE market.

Client

A Swiss based company specializing in clinically validated nutrition products, primarily operating in Switzerland. The company's objective is to expand its market presence to the UAE. One of their flagship products is a wake-up supplement designed to help users wake up energized in the morning.

Client Business Need

The primary goal is to navigate the regulatory framework for health supplements in the UAE to successfully register the wake up health supplement in the UAE market.

Challenges in Registration of Health Supplements in UAE

• Regulatory Landscape: Understanding the specific requirements for health supplements in the UAE.

• Registration Process: Identifying the steps involved in registering health supplements in the UAE.

• Timeline: Estimating the duration required for the registration process. To effectively plan the launch date and related activities, as well as coordinate production and supply chain logistics, it is crucial to estimate the duration required for the registration process.

• Fees: Calculating the associated costs for registration and compliance.

• Local Presence: The company was not registered within any of the Emirates of the UAE and lacked a trade license for health supplements.

• Regulatory Understanding: The company did not fully understand the requirements and regulations for health supplements in the UAE.
  

Artixio Solution for Registration of Health Supplements in UAE

Artixio, a registered company in Dubai with an active trade license for health supplements, provided a comprehensive solution:

• Company and Product Registration: Registered the Swiss Life Science Company and its product in the UAE.

• Montaji Account Creation: Created a Montaji account for the client to facilitate the registration process.

• Composition Review: Conducted a review of the product's composition to ensure it did not contain any restricted or banned substances.

• Labeling Review: Ensured the product labeling complied with UAE regulations.

• Claims Assessment: Assessed the product claims to ensure they were compliant with regulatory standards.

• Documentation Preparation Artixio helped prepare all necessary product information and documentation as per UAE regulations.

• Submission Package: Prepared the complete submission package with all necessary documentation.

• Submission in Montaji: Submitted the application through the Montaji system and followed up on the process.

• Submission and Follow-Up Artixio managed the submission process and maintained regular follow-up with the regulatory authorities to track the progress of the application. They also obtained an advertising permit for the product.
  

Outcome

• Successful Registration: Achieve official registration of heath supplement in the UAE.

• Market Entry: Launch Health Supplement in the UAE market, adhering to all regulatory standards.

• Growth: Expand market presence and increase sales in the UAE.

• Seamless Entry: Achieve a smooth and efficient market entry with no queries from Dubai Municipality during the application review.

With Artixio’s support, the Swiss life science company was well-positioned to achieve its expansion goals and capitalize on the growing demand for health products in the UAE. The comprehensive assistance provided by Artixio in navigating the regulatory landscape ensured the successful registration and market entry of wake up supplement, demonstrating Artixio’s expertise and reliability in the field of regulatory affairs and market access solutions.