Wara Samar
9th January 2025
UAE Tightens Pharmaceutical Regulations with New Law and Up to Million-Dirham Penalties
The UAE Government has introduced a landmark Federal Decree-Law aimed at regulating medical products, the pharmacy profession, and pharmaceutical establishments. This comprehensive legislation represents a significant step toward solidifying the UAE’s position as a globally trusted hub for the pharmaceutical and medical industries while ensuring adherence to international standards. The Decree-Law seeks to enhance pharmaceutical security, streamline processes for development, approval, manufacturing, marketing, and distribution of medical products, and maintain competitive costs and timelines that align with global benchmarks.
The provisions of the Decree-Law encompass a wide array of medical products, including drug products, medical devices, pharmaceutical products, biological products, dietary supplements, cosmetics, and genetically modified organism products intended for medical use. It also regulates chemical precursors, controlled substances, and hazardous materials for both human and veterinary use. Furthermore, the law applies to all pharmaceutical establishments, including those located in free zones, such as pharmacies, compounding pharmacies, medical warehouses, manufacturing facilities, marketing firms, pharmaceutical laboratories, and biobanks.
A robust framework for licensing, monitoring, and supervising pharmaceutical establishments and biobanks is established under the new legislation. This includes provisions for ownership transfers, temporary suspensions, precautionary closures, and license revocations. The Emirates Drug Establishment, the Ministry of Health and Prevention, and local health authorities share responsibilities in implementing these provisions. For example, the Emirates Drug Establishment oversees licensing and monitoring of manufacturing facilities, medical warehouses, marketing firms, and pharmaceutical laboratories, while local health authorities are tasked with supervising pharmacies, medical stores, and hospital blood storage units within their respective jurisdictions.
To foster innovation and attract investments, the law introduces a fast-track approval pathway for innovative medical products of therapeutic importance. It also establishes a regulated protection mechanism for data related to these products, ensuring the protection of intellectual property and encouraging the development of groundbreaking medical solutions. Additionally, the Cabinet will design an incentive framework to stimulate growth and innovation in the medical industries, further bolstering the sector’s appeal to investors.
The Emirates Drug Establishment is now authorised to develop, publish, and update the UAE Pharmacopeia for the first time. This includes setting guidelines and standards for good practices aligned with internationally recognised principles. The Decree-Law also regulates all aspects of managing medical products, such as development, manufacturing, registration, pricing, import, export, circulation, marketing, sale, and safe disposal. It sets comprehensive guidelines for advertising, promotion, and re-export activities under the supervision of the Emirates Drug Establishment.
In a bid to ensure compliance, the Decree-Law prescribes strict penalties for violations. Pharmaceutical establishments and biobanks face financial fines ranging from AED 1,000 to AED 1 million, while pharmacy practitioners can be fined up to AED 500,000. Severe breaches may result in temporary suspension of licenses for up to six months or complete revocation. Entities and individuals have been granted a one-year grace period to align with the law, with the possibility of an extension through a Cabinet decision.
The legislation also strengthens pharmacovigilance systems, ensuring the safe use of medical products and reducing adverse reactions. National databases for medical products, pharmaceutical facilities, and biobanks will be established to enhance transparency and accountability. By implementing these measures, the UAE is taking a transformative step toward safeguarding public health and fostering innovation within the pharmaceutical sector. This comprehensive approach not only sets rigorous standards but also positions the UAE as a leader in the global medical and pharmaceutical landscape.
Join the Conversation at MedTech World Dubai
MedTech World invites you to explore MedTech regulations and industry trends at the panel, “Beyond Borders: Global vs GCC MedTech Perspectives” at MedTech World Dubai. Engage with key voices comparing global and GCC approaches to innovation and policy. Join us on February 23–24 at the InterContinental Festival City Hotel to learn more and be part of the dialogue. Reserve your spot today.
