Welcome To RegXComply
GCC Supplement Registration & Multi-Country Compliance — Fast, Accurate
Expanding dietary supplement sales across GCC countries requires strict adherence to local regulations. RegXComply provides full-service registration support, ensuring compliance with UAE, KSA, and other GCC authorities.
Supplements must comply with multiple regulatory frameworks to be sold across the GCC. RegXComply simplifies the process with end-to-end services: dossier preparation, multi-country authority submission, labeling compliance, and post-registration support. We help FMCG and nutraceutical brands reduce risk, accelerate approvals, and establish a credible market presence across the GCC.
Understanding the Regulatory Requirements:
In the GCC, dietary supplements are regulated to ensure public safety and product integrity. Authorities include:
UAE : MOHAP, Dubai Municipality, EHA
Saudi Arabia : SFDA
Other GCC countries : Local food & drug authorities
Compliance requires evaluation of composition, labeling, documentation, manufacturing, and post-market surveillance.
Key regulatory requirements include:
Product Composition & Safety : All ingredients must meet local permitted dosages; prohibited substances are not allowed.
Labeling Compliance: Arabic and English labeling is required, with accurate ingredients, dosage, and claims.
Documentation & Dossier: Safety studies, GMP certificates, product specifications, and trade licenses are mandatory.
Manufacturing & Import Compliance : Products must be produced in GMP-certified facilities and maintain full traceability.
Post-Market Surveillance : Authorities may conduct inspections or request data to ensure ongoing compliance.
Common pitfalls include mislabeling, incomplete documentation, and incorrect product classification. RegXComply manages multi-country registration efficiently, ensuring smooth approvals and regulatory confidence.
Our Services
1. Product Assessment & Classification
- Determine country-specific regulatory pathways
2. Dossier Preparation
- Compile safety, efficacy, and labeling documentation
3. Authority Submission & Follow-Up
- Submit dossiers to multiple GCC authorities
- Respond to queries efficiently
4. Labeling & Compliance Review
- Ensure compliance across all GCC countries
5. Approval & Certification
- Receive approvals and provide documentation for distribution
FAQ
Frequently Asked Questions
Which GCC countries require supplement registration?
UAE, KSA, Oman, Bahrain, Kuwait, and Qatar all require registration with local authorities.
What documents are required for GCC registration?
Trade license, product dossier, GMP certificates, labeling samples, and safety studies.
How long does registration take across GCC?
Typically 6–12 weeks per country; processes can run concurrently.
Can supplements be registered simultaneously in multiple GCC countries?
Yes, with expert guidance from RegXComply, concurrent submissions are possible.
Do labeling requirements differ per country?
Yes, each GCC country has specific bilingual requirements and claim regulations.
Expand Your Supplement Business Across the GCC with Confidence
Book a consultation with RegXComply to ensure fast, compliant approvals across all GCC countries.
200+
Companies Advised
500+
Product Registered
$25M+
Cost Savings