The UAE has introduced a comprehensive new law to regulate medicines, pharmacies, and pharmaceutical businesses, aiming to enhance oversight and ensure safe management of medical products.

Announced on December 29, the law applies to a wide range of items, including medical devices, pharmaceutical and healthcare products, dietary supplements, cosmetics, and biological products. It also covers pharmaceutical establishments and biobanks operating across the country, including those in free zones.

The law outlines strict rules for licensing, supervision, and monitoring of pharmaceutical establishments like pharmacies, manufacturing facilities, and research centres. It also defines the roles of the Emirates Drug Establishment, the Ministry of Health, and local health authorities in managing these processes.

Violators of the law face penalties including temporary or permanent license suspension, closure of establishments, and fines of up to Dh1 million for businesses and Dh500,000 for individuals.

Key provisions of the law include:

– Regulating the development, manufacturing, pricing, and distribution of medical products.

– Fast-tracking approvals for innovative and essential therapeutic products.

– Establishing policies to protect pharmaceutical innovation and investment.

– Organising pharmacovigilance to ensure safe usage and minimise side effects.

– Creating a national policy for strategic medical product inventory.

The Emirates Drug Establishment is tasked with issuing licenses, approving imports and exports of medical products, and overseeing advertisements. It also has the authority to suspend or recall unsafe products nationwide.

The Ministry of Health and local health authorities will oversee licensing and monitoring of pharmacy professionals, medical stores, and blood storage units in hospitals. They are also responsible for ensuring safe disposal of medical products and maintaining compliance across private and public healthcare facilities.

This law underscores the UAE’s commitment to fostering innovation and maintaining high standards in its healthcare and pharmaceutical sectors.