UAE Introduces New Law to Improve Medicine Rules – Federal Decree-Law No. 38 of 2024

Abu Dhabi, 15 May 2025 — In a decisive move toward modernizing its healthcare infrastructure, the United Arab Emirates has enacted Federal Decree-Law No. (38) of 2024 titled “Governing Medical Products, Pharmacists and Pharmaceutical Establishments.” The new legislation introduces a comprehensive legal framework covering all aspects of medical products and pharmaceutical activities, and repeals the previous Federal Law No. (8) of 2019.

📌 Key Highlights by Article:

🧾 Article 1 – Definitions

The law provides exhaustive definitions including “Pharmaceutical Product,” “Biopharmaceutical Product,” “Advanced Medical Treatment Products,” “Marketing Approval,” and “Pharmacovigilance,” ensuring consistent terminology across stakeholders.

📌 Article 2 – Scope of Application

The law applies to products like pharmaceutical and biopharmaceutical items, cosmetics, supplements, genetically modified products, and all establishments and professions in the pharmaceutical field, including in free zones.

📋 Articles 3–5 – Regulation of Marketing

No medical product may be circulated, manufactured, or sold in the UAE without prior Marketing Approval from the Emirates Drug Establishment (EDE). Exceptions are granted to certain compounded products.

✅ Articles 6–10 – Approval Categories

Standard, Conditional, and Emergency Use Marketing Approvals are detailed. Strict requirements include Good Manufacturing Practice (GMP) certification, safety data, and intellectual property compliance.

⚠️ Articles 11–14 – Emergency & Fast-Track Approvals

Special provisions allow EDE to expedite approvals in public health emergencies or when no alternatives are available, including life-saving medications.

❗ Articles 15–17 – Resubmissions & Cancellations

Changes in formulation, usage, or safety data require fresh approvals. The EDE is empowered to revoke approvals if regulatory violations or safety risks are identified.

🔒 Article 18 – Intellectual Property

Innovative products and those with new active ingredients are granted regulatory data protection as per executive regulation timelines.

🚫 Article 19 – Scientific Fraud

Pharmaceutical companies are prohibited from falsifying or plagiarizing research used in marketing or product approvals.

💰 Article 20 – Product Pricing

Approved products must have a registered price, determined by the EDE Board of Directors.

🧪 Articles 25–27 – Clinical Research & Manufacturing

Clinical trials must be preceded by non-clinical research. Manufacturing is subject to licensing and GMP compliance.

🏭 Article 30 – Investment Promotion

The Cabinet will issue a resolution offering incentives to boost investment and R&D in the UAE’s pharmaceutical industry.

📢 Articles 44–47 – Advertising Controls

No advertising is allowed without EDE approval. Advertising must be truthful, evidence-based, and not misleading. Controlled substances cannot be advertised to the public.