UAE Introduce Strict Pharmaceutical Law with Fines Up to Dh1 Million

Announced on Sunday (December 29), the UAE has implemented a comprehensive new law to regulate medicines, pharmacies, and pharmaceutical establishments, including those operating in free zones. The law covers a wide range of products such as medical devices, pharmaceutical products, healthcare items, biological products, supplements, and cosmetics. It also governs the operations of biobanks and pharmaceutical establishments across the country.

Key Features of the New Law

1. Expanded Scope of Regulation: The law encompasses the development, manufacturing, registration, pricing, import, export, circulation, distribution, possession, sale, marketing, use, and safe disposal of medical products.
   • Covered products include:
     • Medical devices
     • Pharmaceutical products
     • Healthcare items
     • Biological products
     • Dietary supplements
     • Cosmetics
     • Chemical precursors, controlled, semi-controlled, hazardous, and toxic products
2. Pharmaceutical Establishments and Entities: The law applies to a variety of organizations, including:
   • Pharmacies and pharmacy chains
   • Compounding pharmacies
   • Pre-clinical and clinical research entities
   • Bioequivalence centres
   • Pharmaceutical laboratories
   • Factories and contract manufacturing organizations
   • Marketing firms
   • Pharmaceutical consulting firms
   • Medical warehouses and stores
   • Biobanks
   • Contract research and development organizations
3. Licensing and Supervision Framework: The law establishes a framework for licensing, supervising, and overseeing 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.
4. Marketing Authorisations:
   • Regulates the issuance of marketing authorisations for medical products, including exclusive, conditional, and emergency use authorisations.
   • Introduces a fast-track process for granting marketing authorisations for innovative medical products of therapeutic importance.
5. Protection of Pharmaceutical Innovations:
   • Sets mechanisms to protect innovations in the pharmaceutical industry and establishes periods of regulatory protection.
6. Pharmaceutical Policies Committee:
   • Establishes the committee responsible for proposing policies related to the circulation, pricing, and monitoring of medical products.
7. Pharmacovigilance and Safety:
   • Organizes pharmacovigilance procedures to ensure the safe use of medical products and reduce side effects.
8. Strategic Inventory:
   • Develops a national policy for the strategic inventory of medical products to ensure long-term availability.
9. Investment and Innovation:
   • Creates systems to foster investment and innovation in the pharmaceutical sector, further solidifying the UAE’s position as a leader in healthcare innovation.

Penalties for Non-Compliance

Violators of the law face severe disciplinary actions, including temporary suspension of licenses, precautionary closures, license cancellations, and hefty fines. Establishments may incur penalties of up to Dh1 million, while individual practitioners face fines of up to Dh500,000.

Objectives of the Law

This law aims to safeguard public health by ensuring high standards in the development and distribution of medical products. It reinforces the UAE’s commitment to fostering innovation while maintaining strict oversight of the pharmaceutical industry.

Public Awareness and Compliance

Residents are urged to purchase medical products only from licensed establishments and report any suspicious activities to the authorities. Regular inspections and a robust monitoring framework ensure adherence to these regulations.

The UAE continues to lead in healthcare regulation with this landmark legislation, ensuring a safer and more innovative pharmaceutical landscape for all.