UAE Introduces New Law to Regulate Medicines, Pharmacies, and Medical Products

The UAE has implemented a comprehensive new law to oversee and regulate medical products, pharmaceutical establishments, and pharmacies, aiming to enhance safety, efficiency, and innovation in the sector.

Announced on December 29, 2024, the law applies to medical devices, pharmaceutical products, healthcare items, biological products, dietary supplements, and cosmetics. It also includes biobanks and pharmaceutical establishments within free zones.

Key Provisions and Objectives

The law establishes a robust framework for licensing, supervising, and monitoring pharmaceutical establishments and biobanks. It addresses ownership transfers and defines the roles of the Emirates Drug Establishment, the Ministry of Health, and local health authorities.

Violations of the law are subject to strict penalties, including license suspension, closure, cancellation, and fines up to Dh1 million for establishments and Dh500,000 for individuals.

Main Features of the Law

• Comprehensive Regulation: Governs the development, manufacturing, pricing, marketing, distribution, and safe disposal of medical products.

• Marketing Authorisations: Introduces mechanisms for exclusive, conditional, and emergency use authorisations, including fast-track approvals for innovative products.

• Protection and Innovation: Protects pharmaceutical innovations and establishes a system to foster investment in the sector.

• Pharmaceutical Policies Committee: Proposes policies for pricing, circulation, and monitoring of medical products.

• Pharmacovigilance Procedures: Ensures the safe use of medical products and reduces side effects.

• Strategic Inventory: Implements a national policy for the strategic reserve of medical products.

Covered Entities and Products

The law applies to a wide range of products, including:

• Medical and drug products

• Healthcare items and cosmetics

• Genetically modified organisms for medical use

• Biological products and dietary supplements

• Hazardous and controlled chemical precursors

The establishments regulated under this law include:

• Pharmacies and pharmacy chains

• Compounding pharmacies

• Pharmaceutical laboratories

• Marketing and consulting firms

• Medical warehouses and biobanks

• Contract research and development organisations

Responsibilities of Regulatory Bodies

The Emirates Drug Establishment and local health authorities have clearly defined roles, including:

• Licensing and monitoring pharmacies, biobanks, and medical establishments.

• Approving the import, export, and advertisement of medical products.

• Issuing Good Practices certificates and overseeing compliance.

• Coordinating the safe disposal of medical products.

Collaboration and Oversight

The law mandates coordination between the Ministry of Health, Emirates Drug Establishment, and local authorities. This includes sharing licensing information, integrating databases, and collaborating on inspections to ensure compliance.

With this law, the UAE strengthens its position as a regional leader in healthcare innovation and pharmaceutical regulation, prioritising public safety and industry advancement.

 

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