Welcome To RegXComply
UAE Supplement Registration & Regulatory Compliance — Fast, Accurate, Reliable
Securing supplement registration is essential for companies manufacturing, importing, or distributing vitamins, minerals, herbal, or dietary products in the UAE. At RegXComply, our end-to-end solutions ensure your products comply with MOHAP, Dubai Municipality, and Emirates Health Authority requirements, minimizing risk and accelerating market entry.
Understanding the Regulatory Requirements:
In the UAE, dietary supplements are regulated to protect public health and ensure product safety. The primary regulatory authority is the Ministry of Health and Prevention (MOHAP), but depending on the emirate, the Dubai Municipality and Emirates Health Authority (EHA) may also have jurisdiction. Compliance involves careful evaluation of product composition, labeling, manufacturing practices, and safety documentation.
Key regulatory requirements include:
Product Composition & Safety : All ingredients must meet UAE safety standards, including approved dosages, permitted additives, and prohibited substances.
Labeling Compliance: Labels must accurately display ingredient lists, nutritional information, usage instructions, warnings, and claims in both Arabic and English. Mislabeling can lead to fines, delays, or registration rejection.
Documentation & Dossier: A complete product dossier is mandatory, including scientific evidence, safety studies, quality certificates (e.g., GMP), and detailed product specifications.
Manufacturing & Import Compliance : Supplements must be manufactured in GMP-certified facilities, and importers must maintain full traceability and records to ensure accountability.
Post-Market Surveillance : Authorities may request additional information or conduct inspections to verify ongoing compliance and adherence to UAE regulations.
The registration process is comprehensive and may involve multiple rounds of clarifications or document revisions. Common challenges include incomplete documentation, mislabeling, or incorrect product classification. RegXComply guides clients at every stage, anticipating regulatory challenges, preparing robust submissions, and maintaining ongoing compliance.
By ensuring that all supplements are accurately registered and compliant, your business can avoid penalties, accelerate market entry, build consumer trust, and establish a strong, long-term presence in the UAE market.
Our Services
1. Product Assessment & Classification
- Evaluate product formulation and intended use
- Determine regulatory category and submission pathway
2. Dossier Preparation
- Compile safety, efficacy, and formulation documentation
- Review labeling and claims compliance
3. Authority Submission & Follow-Up
- Submit registration to MOHAP and local authorities
- Address queries and provide additional information
4. Labeling & Compliance Review
- Ensure Arabic and English label compliance
- Update labels per authority feedback
5. Approval & Certification
- Receive final registration approval
- Provide documentation for import, distribution, and retail
FAQ
Frequently Asked Questions
Who needs to register dietary supplements in the UAE?
Any manufacturer, importer, or distributor intending to sell supplements in the UAE.
What documents are required for registration?
Product dossier, safety & efficacy data, labeling samples, trade license, and GMP certificates.
How long does registration take?
Typically 4–8 weeks, depending on product complexity and authority review time.
Are there fees associated with supplement registration?
Yes, fees vary based on product type and authority. We assist in fee calculation and submission.
Can I modify a registered supplement?
Yes, updates to formulation, labeling, or packaging must be submitted to the authority for approval.
Don’t Risk Regulatory Delays — Register Your Supplements in the UAE Today
Avoid shipment issues, fines, or market rejection. Book a consultation with RegXComply’s UAE supplement registration specialists and get a step-by-step roadmap for seamless approval.
200+
Companies Advised
500+
Product Registered
$25M+
Cost Savings