MOH Product Registration in Dubai
- Ensure Regulatory Compliance
- Access UAE Healthcare Market
- Boost Consumer Trust
- Expand Export Opportunities
- Secure Legal Approval
The Ministry of Health and Prevention (MOHAP) in Dubai regulates pharmaceutical and medical product registration, ensuring strict safety and quality compliance. Companies must meet specific requirements to complete the process.
From application submission to certification, MOHAP’s Drug Department rigorously evaluates each step. Manufacturers, consultants, and importers must provide accurate documentation to ensure successful registration.
- The applicant (manufacturer or authorized local agent) creates an account on the MOHAP portal.
- Complete the pre-qualification process to confirm eligibility for submitting the registration application.
- Submit the product registration application through the MOHAP portal.
- Upload required documents, including the Certificate of Pharmaceutical Product (CPP), GMP certificate, and product dossiers.
- Pay the applicable registration fees.
- MOHAP reviews the submitted documents and technical dossier.
- Additional clarifications or product samples may be requested for laboratory testing.
- The Ministerial or Technical Committee evaluates the product for compliance with UAE regulations.
- Address any queries raised by the committee to proceed with approval.
- Upon approval, MOHAP issues the registration certificate, allowing the product’s import, distribution, and sale in the UAE.
- The certificate is valid for a specific period ( (e.g., 5 years)) and must be renewed before expiration.
The cosmetic product registration process in Dubai typically takes 2 to 4 weeks, depending on the complexity of the product and the accuracy of the submitted documents.
Step-by-Step MOH Product Registration Process
Required Documents for MOH Pharmaceutical Product Registration
1. Company Registration Documents
Valid trade license issued by the UAE authority. Certificate of company registration with MOHAP. Authorization letter for the local agent (for foreign manufacturers).
2.Product-Specific Documents
Certificate of Pharmaceutical Product (CPP): Issued by the competent authority in the country of origin. Good Manufacturing Practice (GMP) Certificate: Proof of adherence to GMP standards. Free Sale Certificate: Verifying that the product is freely sold in the country of origin. Certificate of Analysis (CoA): Detailed analysis of the product’s composition and quality. Product Composition List: Complete list of active and inactive ingredients with percentages.
3. Technical Documents
Product dossier (technical file) compliant with MOHAP guidelines. Stability studies for the pharmaceutical product. Labeling and packaging artwork compliant with MOHAP requirements. Patient information leaflet (PIL) or instruction manual for medical products.
4.Legal and Regulatory Documents
Power of Attorney (POA) for the local agent, notarized and attested. Declaration of conformity from the manufacturer. Safety and efficacy studies, if applicable.