The UAE Government has enacted a Federal Decree-Law to regulate medical products, the pharmacy profession, and pharmaceutical establishments. This legislation aims to establish the UAE as a global hub for the pharmaceutical and medical industries. It seeks to enhance pharmaceutical security and streamline processes such as development, approval, manufacturing, and distribution, adhering to international standards and maintaining competitive costs.
The law applies to all medical products, including medicines, medical devices, dietary supplements, cosmetics, biological products, genetically modified products, and controlled substances. It also governs hazardous materials for human and veterinary use. Pharmaceutical establishments such as pharmacies, medical warehouses, manufacturing facilities, research firms, and biobanks operating in the UAE, including free zones, are required to comply. Pharmacy practitioners must obtain licences from the Ministry of Health and Prevention or relevant local authorities, with their roles and responsibilities clearly defined.
The Emirates Drug Establishment, Ministry of Health and Prevention, and local health authorities oversee licensing, monitoring, and compliance. Provisions include ownership transfers, temporary suspensions, precautionary closures, and licence revocations. The legislation also introduces an incentive framework to attract investment and foster innovation within the pharmaceutical sector, focusing on safeguarding data and documents related to innovative medical products.
Violations of the law may result in fines ranging from AED 1,000 ($272) to AED 1M ($272,000) for establishments and up to AED 500,000 ($136,100) for pharmacy practitioners. Severe breaches can lead to licence suspension or revocation. This comprehensive framework reflects the UAE’s commitment to advancing its pharmaceutical industry in line with global standards.
