Introduction

In the UAE, pharmaceutical pricing is not purely commercial – it is a regulated component of the registration process. Pricing approval is integrated within MOHAP’s evaluation framework and must align with official pricing policies.

Failure to prepare an accurate pricing submission can delay approval even if the technical dossier is complete.

1- Pricing as a Regulatory Step

Pricing review typically occurs during or after technical evaluation. Approval of the product does not automatically guarantee pricing approval.

Manufacturers must submit:

• Country of origin price certificate
• Public price documentation
• Proposed CIF price
• Justification for price positioning

2- Reference Pricing Considerations

MOHAP may evaluate:

• Reference country prices
• Regional GCC pricing comparisons
• Therapeutic category benchmarking
• Generic vs. originator pricing structures

Incorrect or unsupported price declarations may result in revision requests.

3- CIF & Margin Structure

Understanding cost structure is essential:

• CIF (Cost, Insurance, Freight)
• Importer margin
• Distributor margin
• Pharmacy margin

Transparent financial documentation strengthens approval probability.

4- Strategic Recommendations

Companies should:

• Align regional pricing strategy before submission
• Ensure documentation consistency
• Avoid price discrepancies between markets