Abu Dhabi: The UAE has introduced a new law aimed at regulating medical products, pharmacies, and pharmaceutical businesses.
The law focuses on enhancing organization, security, and efficient oversight of the development, manufacturing, and distribution processes.
Announced on December 29, the law covers medical devices, pharmaceutical products, healthcare items, biological products, supplements, and cosmetics, as well as biobanks and pharmaceutical establishments operating across the country, including those in free zones.
Key provisions of the law include;
- Establishing frameworks for licensing, supervising, and overseeing pharmaceutical establishments, including biobanks.
- Governing the ownership transfer of pharmaceutical businesses and setting the roles for the Emirates Drug Establishment, the Ministry of Health, and local health authorities.
- Regulating the issuance of marketing authorizations for medical products, including exclusive, conditional, and emergency use authorizations.
- Developing a fast track for granting marketing authorizations for innovative medical products of therapeutic importance.
- Implementing mechanisms to protect innovations in the pharmaceutical sector and regulating the period of regulatory protection.
- Creating a Pharmaceutical Policies Committee to propose policies related to medical products’ circulation, pricing, and monitoring.
- Fostering investment and innovation within the pharmaceutical industry sector.
The law also establishes a national policy for the strategic inventory of medical products and organizes pharmacovigilance procedures to ensure safe use and reduce side effects.
Violators of the law may face disciplinary actions such as temporary suspension of licenses, precautionary closure, cancellation of licenses, and fines of up to Dh1mn ($272,480) for establishments and Dh500,000 ($136,240) for practitioners.
The Decree-Law provides a regulatory framework for licensing, supervising, and overseeing pharmaceutical establishments and biobanks, addressing ownership transfers and defining the roles of the Emirates Drug Establishment, the Ministry of Health, and local health authorities. pic.twitter.com/mHwZEeXaOe
— UAEGOV (@UAEmediaoffice) December 29, 2024
The law covers;
- Medical products, drug products, medical devices, pharmaceutical products, healthcare products, genetically modified products for medical use, biological products, dietary supplements, cosmetics, and hazardous chemicals.
- Pharmacies, pharmacy chains, compounding pharmacies, pharmaceutical laboratories, factories, contract manufacturing organizations, marketing firms, pharmaceutical consulting firms, medical warehouses, medical stores, biobanks, and contract research organizations.
Key responsibilities of Emirates Drug Establishment;
- Licensing medical products for sale, approving the import/export of medical products, and approving advertisements.
- Issuing certificates for Good Practices and overseeing the licensing of pharmaceutical establishments, including factories and medical warehouses.
- The law also outlines the responsibilities of local health authorities and the Ministry of Health, including licensing pharmacy professionals, suspending medical products in both government and private health facilities, and licensing pharmacies, medical stores, and blood storage units in Government hospitals.
Coordination between the relevant entities is emphasized, ensuring that information about issued licenses is shared, databases are integrated, and establishments are monitored effectively.