New law to regulate medical products in UAE: Up to Dh1 million fine for violators

Dubai: The UAE Government has enacted a Federal Decree Law to govern medical products, the pharmacy profession and pharma establishments.

As details of the law were released today, it was disclosed that disciplinary penalties include temporary suspension of licence, precautionary closure, licence cancellation and fines of up to Dh1 million for establishments and Dh500,000 for practitioners.

The law applies to medical devices, pharmaceutical products, healthcare items, biological products, supplements, and cosmetics.

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.

It governs biobanks and pharmaceutical establishments, including those in UAE free zones, and applies to pharmacy practitioners across the country including free zones. The law aims at ensuring sector organisation, pharmaceutical security, and efficient oversight of development and distribution processes.

The key provision of the law include:

• Regulating the management of medical products, including their development, manufacturing, registration, pricing, import, export, circulation, distribution, possession, sale, marketing, use and safe disposal.

• Regulating the issuance of marketing authorisations for medical products, including exclusive authorisation, conditional authorisation and emergency use authorisation.

• Developing a fast track for granting marketing authorisations for innovative medical products of therapeutic importance.

• Setting a system to protect innovations in the pharmaceutical industry sector with mechanisms and period of regulatory protection.

• Establishing the Pharmaceutical Policies Committee responsible for proposing policies related to the circulation, pricing and monitoring of medical products.

• Developing a system to foster investment and innovation in the pharmaceutical industry sector.

• Organising pharmacovigilance procedures to ensure the safe use of medical products and reduce side effects.

• Organising the issuance of the national policy for the strategic inventory of medical products.

• Drug Products.

• Medical Devices.

• Pharmaceutical products.

• Health Care Products.

• Genetically Modified Organism products for medical use.

• Biological Products.

• Dietary supplements.

• Cosmetics.

• Chemical precursors, controlled, semi-controlled, hazardous and toxic products.

The law covers the following pharmaceutical establishments and biobanks operating in the state including free zones.

• Pharmacies and Pharmacy Chains.

• Compounding Pharmacies.

• Pre-Clinical and Clinical Research

• Entities.

• Bioequivalence Centers.

• Pharmaceutical Laboratories.

• Factories and Contract

• Manufacturing Organisations.

• Marketing Firms.

Pharmaceutical Consulting Firms.

• Medical Warehouses and Medical

• Stores.

• Biobanks.

• Contract Research and

Development Organisations.

• Other establishments as per cabinet resolution.

The Decree- Law defines the roles and responsibilities related to regulating the medical products and pharmaceutical establishments and biobanks as follows:

Emirates Drug Establishment:

• Issuing Marketing Authorisations for medical products.

• Issuing approvals and permits for import, export and re-export of medical products.

• Issuing approvals for advertising medical products.

• Issuing Good Practice Certificates.

• Suspending and withdrawing medical products at the state level.

• Licensing and monitoring factories and contract manufacturing organizations, medical warehouses, medical stores, marketing firms, pharmaceutical consulting firms and pharmaceutical laboratories.

Emirates Drug Establishment and local health authorities, each within its jurisdiction”

• Issuing approval for the safe disposal of medical products.

• Licensing and monitoring biobanks, pre-clinical and clinical research entities, contract research and development organizations, and bioequivalence centres.

Ministry of Health and Prevention and local health authorities, each within its jurisdiction:

• Licensing practitioners of pharmacy profession.

• Suspending medical products in government and private health facilities.

• Licensing and monitoring pharmacies, pharmacy chains, compound pharmacies, blood storage units in hospitals, and medical stores in government health facilities with activity limited to storage.

The Decree-Law also mandates coordination between the relevant entities regarding mutual notification of licenses issued, the integration of databases and joint monitoring procedures for establishments