UAE Enacts Comprehensive Federal Law to Regulate Medical and Pharmaceutical Industries

The UAE Government has introduced a transformative Federal Decree-Law aimed at strengthening the country’s position as a global hub for pharmaceutical and medical industries. This groundbreaking legislation governs medical products, pharmacy practices, and pharmaceutical establishments, aligning with international standards to foster innovation and attract investment.

The law applies to a wide array of medical products, including drugs, medical devices, dietary supplements, cosmetics, and hazardous materials for human and veterinary use. It also regulates pharmaceutical establishments such as pharmacies, manufacturing facilities, research entities, and biobanks, including those operating in free zones.

Key objectives of the law include enhancing pharmaceutical security, expediting the development and approval of medical products, and streamlining manufacturing, marketing, and distribution processes. It introduces competitive timelines and cost structures to ensure compliance with global best practices.

Highlights of the Legislation 

• Comprehensive Scope: Covers various medical and healthcare products, including those with genetically modified organisms and controlled substances.
• Regulation of Establishments: Governs all pharmaceutical entities, including pharmacies, research facilities, and storage units, with specific oversight responsibilities assigned to the Emirates Drug Establishment and local health authorities.
• Support for Innovation: Introduces frameworks to protect intellectual property and fast-track approvals for innovative therapeutic products.
• Licensing and Compliance: Establishes strict guidelines for licensing, monitoring, and supervising pharmaceutical facilities and practitioners.

Incentives for Investment
To encourage growth and development in the pharmaceutical sector, the law includes an incentive framework for investors. The UAE Cabinet will issue decisions to implement this framework, fostering innovation and collaboration across the medical industry.

Focus on Safety and Standards
The Decree-Law mandates the development of the UAE Pharmacopeia and sets clear guidelines for good manufacturing practices. It also prioritizes pharmacovigilance, ensuring the safe use of medical products while minimizing side effects and adverse reactions.

Penalties for Non-Compliance
Strict measures are outlined for violations, with penalties ranging from written warnings to financial fines of up to AED 1 million. Severe breaches may result in license suspension or revocation. Entities have been granted a one-year grace period to comply, with the possibility of extensions.

This legislation marks a significant milestone in the UAE’s journey to becoming a leader in the global medical and pharmaceutical industries. It reflects the country’s commitment to fostering a robust healthcare ecosystem while maintaining the highest standards of quality and safety.