Table of Contents

Introduction

Dubai’s thriving healthcare market and world-class infrastructure have made it a key hub for the pharmaceutical industry. Whether you are a manufacturer, distributor, or importer, pharmaceutical product registration in Dubai is a legal requirement before selling medicines in the UAE.
The process is overseen by MOHAP (Ministry of Health and Prevention) and ensures that only safe, effective, and high-quality drugs reach the market.

1. Why You Need to Register Pharma Products in Dubai
  • Legal Compliance: It is mandatory under UAE law to register all pharmaceutical products before import, distribution, or sale.
  • Market Access: Without MOHAP approval, products cannot be marketed or sold in Dubai or other emirates.
  • Consumer Safety: Ensures that medicines meet UAE safety, efficacy, and quality standards.

2. Key Regulatory Authority

The MOHAP Drug Department is responsible for evaluating and approving:

  • Prescription medicines
  • Over-the-counter (OTC) drugs
  • Herbal medicinal products
  • Biological & biotech medicines
  • Medical nutritional supplements with therapeutic claims

3. Requirements for Pharma Product Registration in Dubai

A. Company Requirements

Before registering a product, your company must:

  • Have a valid trade license with pharmaceutical activity.
  • Appoint a Local Authorized Agent (UAE-based).
  • Be registered with MOHAP as a licensed importer/distributor.

B. Product Requirements

  • Certificate of Pharmaceutical Product (CPP) from the country of origin.
  • Manufacturing License of the factory.
  • GMP (Good Manufacturing Practice) certificate.
  • Free Sale Certificate (if applicable).
  • Complete dossier in CTD (Common Technical Document) format.
  • Product label & packaging artwork (Arabic & English).

4. Step-by-Step Process for Pharmaceutical Product Registration in Dubai

Step 1: Company Registration with MOHAP

Register your company online on the MOHAP portal as a manufacturer or distributor.

Step 2: Appoint a Local Agent

Only UAE-based companies with a pharmaceutical trade license can submit applications to MOHAP.

Step 3: Prepare Product Dossier

The dossier should comply with GCC & MOHAP guidelines and include quality, safety, and efficacy data.

Step 4: Submit Application via MOHAP e-Services

  • Fill out the online form.
  • Upload documents.
  • Pay the product registration fee.

Step 5: Technical & Scientific Review

MOHAP reviews the application and may request clarifications, additional testing, or stability data.

Step 6: Approval & Issuance of Product Registration Certificate

Once approved, you will receive a MOHAP registration certificate valid for 5 years.

5. Fees & Timeline
  • Registration Fees: AED 5,000 – AED 10,000 (approx., depends on product type).
  • Timeline: 3 – 6 months, depending on document completeness and product category.

6. Tips for Faster Approval
  • Ensure all documents are attested by the UAE Embassy in the country of origin.
  • Use clear and accurate translations (Arabic & English).
  • Work with a specialized pharma regulatory consultant for a smooth process.

7. FAQ – Pharma Product Registration in Dubai
Can foreign companies register a pharmaceutical product without a UAE presence?
No, you must appoint a local authorized agent with a UAE trade license.
Is re-registration required?
Yes, every 5 years or upon major product changes.
Are herbal medicines registered the same way?
Herbal medicinal products follow similar MOHAP registration but with different documentation.

Conclusion

Registering pharmaceutical products in Dubai is a mandatory step for entering the UAE healthcare market. Compliance with MOHAP regulations ensures consumer safety and builds trust with healthcare professionals and patients.

For faster approval and hassle-free registration, work with an experienced pharma regulatory consultant in Dubai.

Book a Consultation with MajuBiz.