Registering Medicines and Medical Devices in the UAE 2026: The Transfer of Authority From MOHAP to the Emirates Drug Establishment

Since 2 January 2025, registering medicines, medical devices, and licensing most pharmaceutical establishments in the UAE has transferred from the Ministry of Health and Prevention (MOHAP) to the Emirates Drug Establishment (EDE) — the federal authority empowered under Federal Decree-Law No. (38) of 2024.

EDE as an independent institution was established under a separate instrument — Federal Decree-Law No. (28) of 2023 — a full year before the substantive law governing medical products was even issued; these are two distinct instruments that should not be conflated.

The complete transfer of 44 core regulatory functions from MOHAP to EDE was completed on 29 December 2025, per an official WAM announcement.

MOHAP has not been removed from the regulatory system entirely: the Ministry retains licensing of community and compounding pharmacies, along with certain administrative functions performed jointly with EDE.

⚠ Companies continuing to use previous MOHAP procedures and contacts for products now under EDE jurisdiction risk delays in application review — all relevant applications since late 2025 are filed through the EDE portal, not MOHAP.

1. Two Different Laws: Do Not Confuse EDE’s Establishment With Substantive Regulation

The Emirates Drug Establishment was established as a federal authority under Federal Decree-Law No. (28) of 2023 — this instrument is the basis for EDE’s very existence as an institution, with its own budget, leadership, and staff.

Substantive regulation of medical products, the pharmacy profession, and pharmaceutical establishments is set out in a separate, later instrument — Federal Decree-Law No. (38) of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Establishments, issued 1 October 2024.

ℹ The official text of the Cabinet Resolution on EDE fees expressly cites both instruments together — Federal Decree-Law No. 28 of 2023 (EDE’s establishment) and Federal Decree-Law No. 38 of 2024 (substantive regulation) — confirming these are two distinct, though related, legal bases.

2. The Full Timeline: From Law to Actual Handover

Date	Event
29 September 2023	The Emirates Drug Establishment (EDE) established under Federal Decree-Law No. (28) of 2023 — as an independent federal authority
1 October 2024	Federal Decree-Law No. (38) of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Establishments issued
14 October 2024	Published in the Official Gazette
29 December 2024	First published on the uaelegislation.gov.ae portal
8 January 2025	Official circulation of the law
2 January 2025	Effective date of Federal Decree-Law No. 38 of 2024, replacing Federal Law No. 8 of 2019
29 December 2025	Transfer of 44 core services from MOHAP to EDE completed (per WAM)
24 February 2026	EDE introduced a multiple-authorised-agent requirement per medical product

⚠ The issuance, gazette publication, circulation, and effective dates of Federal Decree-Law No. 38 of 2024 differ by up to three months — a pattern typical of UAE federal law-making that warrants care when determining the applicable version for a specific date.

3. What Federal Decree-Law No. 38 of 2024 Replaces

Federal Decree-Law No. (38) of 2024 fully replaces Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments, including all its later amendments.

Implementing regulations issued under the previous Federal Law No. 8 of 2019 remain in effect to the extent they do not contradict the new 2024 law — a transitional provision, not an automatic repeal of the entire prior regulatory framework.

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4. Dividing Functions Between EDE and MOHAP

Authority	Functions as of July 2026
Emirates Drug Establishment (EDE)	Registration and marketing approval of medicines and medical devices; licensing pharmaceutical establishments (factories, warehouses, medical stores, marketing offices); import/export permits; pharmacovigilance; GMP certification
Ministry of Health and Prevention (MOHAP)	Licensing community and compounding pharmacies; certain administrative functions performed jointly with EDE

⚠ A key distinction: if the planned activity is a factory, warehouse, medical store, or marketing office, licensing runs through EDE; if it is a community or compounding pharmacy, jurisdiction remains with MOHAP.

5. The Marketing Approval Requirement

No medical product may be circulated, manufactured, or sold in the UAE without prior Marketing Approval from EDE.

The law applies to a broad range of products — pharmaceutical and biopharmaceutical products, cosmetics, dietary supplements, genetically modified products — and covers all relevant establishments and professions, including those located in free zones.

6. The Local Authorised Representative (LAR)

A foreign manufacturer with no physical presence in the UAE must appoint a Local Authorised Representative (LAR) to deal with EDE on its behalf.

⚠ Effective 24 February 2026, EDE introduced a mechanism requiring the appointment of multiple authorised agents per medical product — intended to reduce supply disruption risk from reliance on a single agent; companies should confirm with EDE or their current LAR how this affects a specific registration certificate and supply channel.

7. Enhanced Liability and Penalties

The new law raises fines for violations to AED 1,000,000 and lengthens imprisonment terms compared with the previous regulation, while also expanding EDE’s powers to conduct inspections and seize non-compliant products.

⚠ Assigning a valid EDE licence to another party automatically results in revocation of that licence — the assignee must apply for a new licence and pay the corresponding fee, regardless of the remaining validity period of the assigned licence.

8. Indicative Fees and Timelines

Service	Indicative fee (2026)
Medical device manufacturing site registration (first-time)	AED 100 (application) + AED 10,000 (processing) = AED 10,100
Import permit for medical products, raw materials, chemicals, precursors outside the prescribed tariff	1% of the total invoice value (per the Cabinet Resolution on EDE fees)

ℹ The standard review period for a new generic registration runs 9–18 months; products already approved by reference regulators (EMA, FDA, MHRA, PMDA) benefit from a shorter verified pathway — confirm the exact timeline for a specific product category directly with EDE.

⚠ a repeat verification pass established the precise identity of the EDE fee resolution, previously cited without a number: Cabinet Resolution No. (40) of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment, issued 16 April 2025 and effective 29 April 2025 (Official Gazette No. 798). The specific fee schedule table itself sits in a separate annex to the resolution and was not re-confirmed directly during this verification pass — the figures cited in this article (AED 10,100 and 1%) come from a secondary source and should be confirmed directly with EDE. The resolution’s official page also notes that, in case of conflict, the Arabic text prevails.

9. Step-by-Step Process for a Foreign Manufacturer

1.     Determine the applicable product category and corresponding establishment type (factory, warehouse, medical store, marketing office).

2.     Appoint a Local Authorised Representative (LAR) licensed by EDE to act on the manufacturer’s behalf.

3.     Register the manufacturing site with EDE before submitting applications for specific products.

4.     Prepare a complete dossier (CTD/eCTD) with bilingual Arabic-English labelling meeting EDE requirements.

5.     Submit the Marketing Approval application through the ede.gov.ae portal.

6.     If approved by a reference regulator (EMA, FDA, MHRA, PMDA), request the accelerated verified review pathway.

7.     Given the 2026 multiple-agent requirement, assess whether an additional authorised agent must be appointed for the specific product.

10. Common Mistakes

•       Continuing to file applications through former MOHAP channels for products already under EDE jurisdiction. Since late 2025, relevant applications are processed through the EDE portal — using an outdated channel delays review.

•       Confusing EDE’s establishment (Federal Decree-Law No. 28 of 2023) with the substantive product-regulation law (Federal Decree-Law No. 38 of 2024). These are two different instruments with different subject matter — citing the wrong one creates confusion in the regulatory basis.

•       Assuming all pharmacy licensing now runs through EDE. Community and compounding pharmacies remain under MOHAP jurisdiction — only factories, warehouses, medical stores, and marketing offices moved to EDE.

•       Ignoring the new multiple-authorised-agent requirement introduced in February 2026. Non-compliance creates risk to the supply chain stability of the specific product.

11. Who This Fits

•       Foreign manufacturers of medicines and medical devices planning UAE market entry. Centralising regulation under a single federal authority, EDE, simplifies engagement compared with the previous distributed structure.

•       Companies with products already approved by reference regulators (EMA, FDA, MHRA, PMDA). The verified review pathway shortens standard registration timelines.

12. Who This Does Not Fit

•       Operators expecting to license a community or compounding pharmacy through EDE. This establishment category remains under MOHAP jurisdiction, not EDE.

13. When Professional Verification Is Essential

Self-assessment is worth supplementing with specialist advice when: determining the applicable establishment category and corresponding regulator (EDE or MOHAP); preparing a complete registration dossier for complex product categories; and assessing the impact of the multiple-authorised-agent requirement on a specific registration.

FAQ

When was the Emirates Drug Establishment established?

29 September 2023, under Federal Decree-Law No. (28) of 2023 — separate from the 2024 substantive product-regulation law.

When was the transfer of functions from MOHAP to EDE completed?

29 December 2025, per an official WAM announcement — 44 core regulatory functions were transferred.

Did MOHAP retain any authority?

Yes, licensing of community and compounding pharmacies, along with certain administrative functions performed jointly with EDE.

What law did Federal Decree-Law No. 38 of 2024 replace?

Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments, including all its later amendments.

What changed in February 2026 regarding authorised representatives?

EDE introduced a mechanism requiring the appointment of multiple authorised agents per medical product to reduce supply disruption risk.

Key Takeaways

•       EDE was established under Federal Decree-Law No. 28 of 2023 — separate from Federal Decree-Law No. 38 of 2024, which regulates the products themselves.

•       Federal Decree-Law No. 38 of 2024 took effect 2 January 2025, replacing Federal Law No. 8 of 2019.

•       The complete transfer of 44 functions from MOHAP to EDE was completed 29 December 2025.

•       MOHAP retains licensing of community and compounding pharmacies.

•       Since 24 February 2026, a multiple-authorised-agent requirement applies per product.

•       Fines for violations were raised to AED 1,000,000, with expanded EDE inspection and seizure powers.

Summary

Registering medicines and medical devices in the UAE transferred from the Ministry of Health and Prevention (MOHAP) to the Emirates Drug Establishment (EDE) effective 2 January 2025, under Federal Decree-Law No. (38) of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Establishments, which replaced Federal Law No. (8) of 2019. EDE as an institution was established under a separate, earlier instrument — Federal Decree-Law No. (28) of 2023, issued 29 September 2023. The complete transfer of 44 core regulatory functions from MOHAP to EDE was completed 29 December 2025; MOHAP retains licensing of community and compounding pharmacies. No medical product may be circulated, manufactured, or sold in the UAE without EDE’s Marketing Approval. A foreign manufacturer must appoint a Local Authorised Representative (LAR); effective 24 February 2026, EDE requires the appointment of multiple authorised agents per product to reduce supply disruption risk. Fines for violations were raised to AED 1,000,000, with expanded EDE inspection powers.

Sources

• UAE Legislation — Federal Decree-Law No. (38) of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Establishments, official text (uaelegislation.gov.ae)

• UAE Legislation — Cabinet Resolution No. (40) of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment, official text citing Federal Decree-Law No. 28 of 2023 (uaelegislation.gov.ae)

• Ministry of Health and Prevention — MOHAP Announces the Transfer of Selected Services to Emirates Drug Establishment, official page (mohap.gov.ae)

• Baker McKenzie — UAE Enacts New Medical Products Law to Boost Innovation in Pharmaceuticals and Medical Devices (bakermckenzie.com)

• Pinsent Masons — The UAE’s new pharmaceutical law: 10 things businesses should know (pinsentmasons.com)

Disclaimer

This article is for informational purposes only and does not constitute legal, tax, or consulting advice. Exact fees, processing timelines, and document requirements are updated regularly by the regulator — verify current conditions directly on the ede.gov.ae portal and consult a qualified legal adviser in the UAE. Information is accurate as of July 2026.