UAE issues a law to regulate medical products and pharma operations

A comprehensive law for medical products and pharmacies: The UAE introduced a federal decree-law to regulate medical products, pharmacies, and pharma establishments, Wam reports. The law introduces a fast-track approval pathway for innovative medical products of “therapeutic importance,” setting rules for pricing and granting marketing authorizations.

The details: It also safeguards medical data, oversees the pharmacovigilance system in the UAE, and governs the establishment and management of national databases for medical products, pharma facilities, and biobanks. It covers all medical products, including drugs, medical devices, cosmetics, and controlled substances, and applies to entities in the UAE and its freezones.

All under the EDE: The Emirates Drug Establishment (EDE) will monitor and license all manufacturing facilities, medical warehouses, pharma consulting firms and labs, as well as marketing firms, according to the law. It will also supervise the advertising, import, export, and re-export of medical products.

A new committee for pricing medical products: The chair of the EDE’s board will be in charge of supervising a the newly established Pharmaceutical Policies Committee, to regulate the pricing, circulation, and monitoring of medical products, The National reports.

Entities have been granted a one-year grace period to comply with the new legislation, with the possibility of an extension through a cabinet decision. The law includes penalties for violations, ranging from fines to license suspensions or revocations for severe breaches. The financial fines range from AED 1k to AED 1 mn for establishments, and up to AED 500k for pharma practitioners.