Guidelines for Registration of Pharmaceutical Products in UAE

The registration of pharmaceutical products in the United Arab Emirates (UAE) is a critical process overseen by the Ministry of Health and Prevention (MOHAP) to ensure safety, efficacy, and quality. For companies aiming to market their pharmaceutical products, product registration in Dubai Municipality is a key step, as it aligns with the UAE’s stringent regulatory framework. This process involves submitting detailed documentation, including product composition, clinical data, and manufacturing details, to comply with federal regulations and protect public health.

Health Supplement Product Registration in Dubai

The process for health supplement product registration in Dubai follows a similar rigorous path but is tailored to dietary supplements, vitamins, and other health-related products. These products must be registered with MOHAP’s Drug Department, which evaluates their safety, labeling, and claims. Applicants need to provide a Certificate of Free Sale, Good Manufacturing Practice (GMP) certificates, and detailed product information, including ingredients and intended use. Compliance with UAE standards, such as those set by the Emirates Authority for Standardization and Metrology (ESMA), is mandatory to ensure market approval.

Key Steps for Pharmaceutical Product Registration

1. Pre-Submission Preparation: Compile a dossier with product details, including composition, manufacturing process, stability studies, and clinical trial data. Ensure compliance with MOHAP’s guidelines and international standards like ICH (International Council for Harmonisation).
2. Submission to MOHAP: Submit the dossier through MOHAP’s online portal. For Dubai, additional coordination with Dubai Municipality may be required for specific product categories.
3. Evaluation and Testing: MOHAP reviews the dossier, and products may undergo laboratory testing to verify quality and safety. Health supplements require additional scrutiny for claims and nutritional content.
4. Approval and Registration: Upon successful evaluation, MOHAP issues a registration certificate, valid for five years, allowing the product to be marketed in the UAE.
5. Post-Market Surveillance: Registered products are subject to ongoing monitoring to ensure continued compliance with safety and quality standards.

Documentation Requirements

• Product Dossier: Includes detailed information on active ingredients, excipients, and packaging.
• Certificates: Certificate of Free Sale, GMP certificate, and Certificate of Analysis.
• Labeling and Packaging: Must comply with UAE labeling requirements, including Arabic translations and health claims.
• Clinical Data: Required for pharmaceuticals to demonstrate safety and efficacy; for supplements, data on nutritional benefits may be needed.

Challenges and Tips

Navigating the UAE’s regulatory landscape can be complex due to strict requirements and frequent updates to guidelines. Engaging a local regulatory consultant can streamline the process. Ensure all documentation is complete and accurate to avoid delays. For health supplements, avoid unsubstantiated health claims to prevent rejection. Regularly check MOHAP and ESMA websites for the latest guidelines to stay compliant.

Conclusion

Registering pharmaceutical products and health supplements in the UAE requires meticulous preparation and adherence to MOHAP’s guidelines. By understanding the regulatory requirements and maintaining high standards of documentation, companies can successfully navigate the process and bring their products to the UAE market. For further details, refer to MOHAP’s official portal or consult with regulatory experts.