UAE Government Introduces Comprehensive Federal Decree-Law For Medical Products And Pharmacy Regulation

The UAE Government has introduced a Federal Decree-Law to oversee medical products, the pharmacy profession, and pharmaceutical establishments. This law aims to position the UAE as a reliable global hub for pharmaceutical and medical industries. It seeks to enhance pharmaceutical security and streamline processes related to the development, approval, manufacturing, marketing, and distribution of medical products while adhering to international standards.

The Decree-Law applies to all medical products, including drug products, medical devices, healthcare products, biological products, dietary supplements, cosmetics, and genetically modified organism products intended for medical use. It also covers chemical precursors and controlled substances for both human and veterinary use. The legislation governs all pharmaceutical establishments and biobanks within the UAE, including those in free zones.

Pharmaceutical establishments such as pharmacies, pharmacy chains, compounding pharmacies, medical warehouses, manufacturing facilities, marketing firms, consulting firms, laboratories, research entities, bioequivalence centres, biobanks, and other specified entities are subject to this law. The Decree-Law regulates licencing aspects for these establishments. It includes provisions for ownership transfers and temporary suspensions.

The Emirates Drug Establishment is responsible for licencing and monitoring manufacturing facilities and related companies. Biobanks and research entities fall under either the Emirates Drug Establishment or local health authorities. Pharmacies and medical stores in government health facilities are regulated by the Ministry of Health or local health authorities.

The Decree-Law encourages investment in the pharmaceutical sector by introducing an incentive framework aimed at attracting investments. This framework will be established based on a proposal by the Chairman of the Emirates Drug Establishment in consultation with relevant stakeholders. The law also protects innovation through a regulated mechanism for documents related to innovative medical products.

For the first time, the Emirates Drug Establishment can develop and update the UAE Pharmacopeia. It can approve reference pharmacopeias and issue guidelines aligned with international principles. The law sets conditions for granting marketing authorisations for medical products. It introduces a fast-track approval pathway for innovative therapeutic products ensuring compliance with international quality standards.

Comprehensive Management of Medical Products

The legislation covers all aspects of managing medical products from development to safe disposal. It includes general provisions for developing and manufacturing these products in line with good practice guidelines issued by the Emirates Drug Establishment. The law allows transferring excipients between licenced facilities within the UAE with approval from the Emirates Drug Establishment.

The Decree-Law regulates advertising and promotion of medical products under supervision from the Emirates Drug Establishment. It defines pricing provisions for these products and establishes a "Pharmaceutical Policies Committee" working under the Chairperson of the Board of Directors of the Emirates Drug Establishment.

Licencing Requirements

Pharmacy practitioners must obtain a licence from either the Ministry of Health or competent local health authorities. The law specifies pharmacists' duties along with activities authorised for clinical pharmacists. Additionally, it regulates pharmacovigilance systems ensuring safe use of medical products while reducing adverse reactions.

This legislation introduces regulations for establishing national databases for medical products and pharmaceutical facilities in the UAE. Disciplinary measures include written warnings or financial fines ranging from AED1,000 to AED1 million depending on severity along with possible licence suspension or revocation.

Entities covered under this law have one year to comply with its provisions which may be extended through a Cabinet decision if necessary.

With inputs from WAM