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.

MOH-Registration

Step-by-Step MOH Product Registration Process

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Pre-Qualification and Account Setup

  • 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.
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Submit the 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.
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Technical Evaluation

  • MOHAP reviews the submitted documents and technical dossier.
  • Additional clarifications or product samples may be requested for laboratory testing.
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Committee Approval

  • The Ministerial or Technical Committee evaluates the product for compliance with UAE regulations.
  • Address any queries raised by the committee to proceed with approval.
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Issuance of Registration Certificate

  • 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.

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Required Documents for MOH Pharmaceutical Product Registration

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).

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.

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.

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.

Benefits of Medical Device Registration in Dubai, UAE

Legal Market Access

Safety and Trust

Brand Growth & Recognition

Export Opportunities

Government Contracts Access

Regulatory Compliance

Requirements for MOHAP Product Registration

Company Registration

UAE-based company or agent must be registered with MOH. Manufacturers need a valid license from their home country.

Authorized Local Agent

Foreign manufacturers must appoint a UAE-based distributor, importer, or consultant as their authorized representative.

Approval from Drug Department

Companies must obtain pre-qualification approval from the MOHAP Drug Department or related technical committees.

Compliance with MOHAP Standards

The applicant must comply with Good Manufacturing Practices (GMP) and other MOHAP regulations.

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FAQS (Frequently Asked Questions)

What is the validity period of MOHAP product registration certificates?

MOHAP product registration certificates are typically valid for five years and must be renewed before their expiration.

Are there penalties for selling unregistered pharmaceutical or medical products in the UAE?

Yes, selling unregistered products can result in severe penalties, including fines, product confiscation, and legal action.

How long does the product evaluation process take after application submission?

The evaluation process usually takes up to 45 working days, depending on the complexity of the product and completeness of the documents.

Can modifications to a registered product be made, and what is the process?

Yes, modifications such as label changes or composition updates require a separate variation application and approval from MOHAP.

What is the role of a local agent in the MOHAP registration process for foreign manufacturers?

A local agent acts as the authorized representative to submit applications, liaise with MOHAP, and ensure regulatory compliance for foreign manufacturers.