Federal Decree-Law No. 38 of 2024 governing Medical Products, Pharmacists and Pharmaceutical Establishments.

This Decree-Law, comprising 181 articles and 1 Table in Appendix, aims to regulate the production, import, distribution, and oversight of medical products, as well as the licensing and professional standards and responsibilities for pharmacists and pharmaceutical establishments. This ensures quality, safety, and compliance in the healthcare and pharmaceutical sectors. It applies to hazardous medical products (including pharmaceutical products, medical equipment, health care products, biopharmaceutical products, food supplements, cosmetics, and genetically modified organism products intended for medical use) as well as chemical precursors and controlled, semi-controlled, hazardous, and toxic substances for human or veterinary use, the pharmacy profession for state employees including those in free zones, and all pharmaceutical establishments and biobanks operating within the State, including in free zones.
Key provisions concern (i) Regulation of Medical Products (Marketing, Safety, Quality), establishing that all medical products require Marketing Approval from the Emirates Drug Establishment (EDE) before circulation, which may be cancelled if safety concerns arise or if approval is withdrawn in the country of origin. Approved products must follow the regulated pricing set by the Emirates Drug Establishment Board of Directors, and innovative products receive intellectual property protection under the Executive Regulations; (ii) Regulation of Pharmaceutical Establishments, such as pharmacies, medical warehouses, manufacturing facilities, biobanks, pharmaceutical labs, marketing offices, consulting offices, and others, all of which must obtain specific licenses to operate. Manufacturing within the UAE further requires a licensed facility that complies with Good Manufacturing Practice (GMP) standards and Article 126 controls; (iii) Import, Export, Re-export Controls, under which it is possible to restrict or prohibit import or export of products that pose a risk to public health or may be used for illegal purposes; (iv) Pharmacovigilance and Post-Market Surveillance, establishing that marketing rights holders must monitor product performance, report safety issues, and follow EDE pharmacovigilance guidelines; (v) Obligations of Marketing Rights Holders, who must appoint qualified UAE-resident personnel for compliance and pharmacovigilance, designate a lead entity, and maintain sufficient stock to guarantee supply and prevent monopolistic behavior; (vi) Advertising Controls requiring prior approval from the EDE for medical product advertising; (vii) Disposal and Destruction of Medical Products; (viii) Measures Against Scientific Fraud, under which pharmaceutical establishments must not engage in distortion, fraud, theft, or plagiarism of scientific research related to medical products; (ix) Incentives and Investment Promotion to attract investment and support innovation in the medical industries sector; (x) Governance Bodies, including the establishment of the Pharmaceutical Policy Committee, responsible for proposing policies on circulation, pricing, and monitoring of medical products in the state.