Marketing Authorization Holder (MAH) Registration in the UAE

 

Marketing Authorization Holder (MAH) Registration in the UAE

In the United Arab Emirates (UAE), Marketing Authorization Holder (MAH) registration is a critical step in the pharmaceutical registration process. The MAH is the legal entity responsible for placing a drug on the UAE market and maintaining its regulatory compliance throughout its lifecycle.

Understanding the role and responsibilities of an MAH is essential for pharmaceutical companies seeking to register their products in the UAE.

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What Is a Marketing Authorization Holder (MAH)?

A Marketing Authorization Holder is a company or legal entity that holds the license (marketing authorization) to distribute, market, and sell a pharmaceutical product in the UAE. This entity serves as the primary point of contact with the Ministry of Health and Prevention (MOHAP) and is accountable for ensuring the product complies with UAE laws and regulations.

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Who Can Be an MAH in the UAE?

To act as an MAH in the UAE, the entity must:

• Be based in the UAE (local presence is mandatory)

• Hold a valid pharmaceutical or medical trade license issued by the UAE authorities

• Be either:

  • The manufacturer’s own branch or office in the UAE

  • An authorized local agent or distributor appointed by the foreign manufacturer

Foreign pharmaceutical companies cannot act as their own MAH unless they have a legal entity registered in the UAE.

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Responsibilities of the MAH

The MAH is responsible for:

• Submitting and managing product registration applications

• Ensuring product quality, safety, and efficacy

• Reporting adverse drug reactions (pharmacovigilance)

• Handling product recalls or withdrawals if required

• Communicating with MOHAP on regulatory updates and compliance

• Ensuring the product is marketed according to UAE regulations

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MAH Registration Requirements

To register as an MAH with MOHAP, the following documents are typically required:

1. Trade License (showing the company is licensed to trade in pharmaceuticals or medical products)

2. Authorization Letter from the manufacturer (legalized and attested)

3. Distribution Agreement

4. Good Distribution Practice (GDP) certificate if applicable

5. Company profile and contact details

6. Proof of qualified personnel for regulatory affairs and pharmacovigilance

All documents must be in Arabic or English and may need to be notarized and attested.

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How to Register as an MAH in the UAE

1. Create an account on the MOHAP online registration portal

2. Submit MAH-related documents under the "Company Registration" section

3. Await approval and verification by MOHAP

4. Once approved, proceed with product registration applications using the MAH credentials

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Changing the MAH

If a pharmaceutical company wishes to change the MAH (e.g., switch to a new local distributor), a formal application must be submitted to MOHAP, and:

• A no-objection letter (NOC) may be required from the previous MAH

• New authorization and distribution agreements must be provided

• A product re-evaluation may be triggered in some cases

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Conclusion

The Marketing Authorization Holder plays a central role in drug registration and regulatory compliance in the UAE. Choosing the right MAH — one with experience, regulatory knowledge, and a solid reputation — is crucial for a smooth product registration process and successful market entry.

Whether you're a global pharmaceutical manufacturer or a local distributor, understanding the MAH framework will help ensure that your products meet UAE regulatory standards and stay compliant throughout their lifecycle.