Pricing Mechanism and Drug Policy Committee: Article 36 and Ministerial Decision No. 130/2019

1. Key takeaways

Article 36 establishes the Drug Policy Committee, responsible for policies on circulation, pricing and monitoring. The EDE service page for medical device marketing authorization lists laboratory requirements and specific device pricing among the required documents, which shows that pricing is a component of the device application. Ministerial Decision No. 130/2019 provides the largest sample of pricing intervention: 410 products were reduced in price, by reductions of 2%-77%, of which 183 were locally produced and 227 were of regional and global production. Our judgment is that although the device sector has not yet seen a price reduction decision of the same scale, the pricing and monitoring policy authority under Article 36 is already in place; companies should treat pricing documents as auditable material rather than a formalistic form, and should leave room in quotations for a required downward adjustment.

• Article 36 establishes the Drug Policy Committee with authority over circulation, pricing and monitoring policy.
• The EDE device marketing authorization service page lists laboratory requirements and specific device pricing among the required documents.
• Ministerial Decision No. 130/2019: 410 products reduced in price by 2%-77%; 183 locally produced, 227 regional and global production.
• Only specific device categories require pricing documents; confirm by classification letter before preparing them.

2. Legal basis

The sources range from the current committee provision and the EDE service page to the historical ministerial decision and the repealed former law, as set out below.

3. Expert insights

Insight 1: Pricing authority and its application to devices must be read separately. Our professional judgment is that the wording of Article 36 points to circulation, pricing and monitoring policy, while devices enter through the specific device pricing element of the application listed on the EDE service page; the two are not the same layer. The reason is that the EDE service page requires pricing documents only for specific devices, not for all devices. On the trade-off, first use a classification letter to confirm whether the product falls in a category requiring pricing documents, and only then decide the depth of the file, so as to avoid a return for submitting redundant material for a product that does not require pricing.

Insight 2: Ministerial Decision No. 130/2019 is a reference for policy intensity, not a direct basis for devices. The judgment is that the decision targeted generic medicines and cannot be applied to devices directly, but it demonstrates the scale at which the authority deploys its pricing tools: 410 products and reductions of 2%-77%. The reason is that Article 36 has institutionalized the pricing policy authority, and the historical sample shows that once the authority is used it carries scale effects. On the trade-off, device companies should leave margin for a required downward adjustment when pricing, and should not lock multi-year distribution agreements to a single maximum price.

Insight 3: Repeal of the former law does not change the pricing risk at the commercial level. The judgment is that Federal Law No. 8/2019 was repealed by No. 38/2024 with effect from 2025-01-02, so pricing under Article 5 of the former law and the prohibition on selling above the set price under Article 8 are no longer direct bases, but the pricing and monitoring policy authority of Article 36 carries on. The reason is that repeal and succession are two sides of the same process. On the trade-off, continue to execute at the approved pricing, and delete from distribution agreements any clause permitting sale above the approved price.

4. Practical recommendations

• Before submitting the registration application, use a classification letter to confirm whether the product falls in a category requiring pricing documents, avoiding redundant submissions.
• Prepare pricing documents as auditable material: itemize the cost structure, reference country prices and quotation logic, and keep update records.
• Leave room for downward adjustment in quotations; do not lock multi-year distribution agreements to a single maximum price, and instead include a price adjustment clause.
• Delete from distribution agreements any clause permitting sale above the approved pricing, and replace it with execution at the approved pricing.
• Follow subsequent developments in pricing and monitoring policy under Article 36, and include the pricing documents in the annual review checklist.
• Link pricing with the 5-year validity of the EDE marketing authorization, and at renewal re-verify whether the pricing documents still match the actual selling prices.

5. Verification checklist

• □ A classification letter has been used to confirm whether specific device pricing documents must be submitted
• □ The pricing documents contain the cost structure, reference country prices and quotation logic, with update records retained
• □ Quotations leave room for downward adjustment, and distribution agreements contain a price adjustment clause rather than a fixed maximum price
• □ Clauses permitting sale above the approved pricing have been deleted from distribution agreements
• □ The pricing documents have been included in the annual review checklist
• □ Pricing is re-verified in linkage with the Article 7 5-year renewal node
• □ The policy intensity of Ministerial Decision No. 130/2019 has been filed as a reference for pricing strategy

Further reading: Article No. 46, Advertising and Promotion Approval: Articles 44-47 and Validity from 30 Days to 1 Year; Article No. 50, 2026 Outlook: The Executive Regulation, Reference Authority List Updates and UDI Digital Traceability; Article No. 36, The Full Fee Picture: AED 100 / 500 / 5,000 / 2,500 and Budgeting.

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team manages adverse event reporting and recall coordination with MOHAP, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com