UAE Introduces New Law to Regulate Medicines and Pharmaceutical Businesses

In strict regulations, the UAE has formulated a new law to regulate medicines, pharmacies, and the pharmaceutical business. This is in order to make the environment of operation more organized, safe, and efficient within the industry. The law was announced on 29 December and sets out a robust framework for licensing, supervision, and oversight of the pharmaceutical establishment and biobanks across the country, including those in free zones.

Key Provisions of the New Law to Regulate Medicines

It covers a broad range of health items, materials, and services, including drugs, medical devices, healthcare items, biological items, supplements, and cosmetics. It also regulates biobanks and pharmaceutical establishments by determining certain operating and management rules.

Some of the provisions of the law include:

• Comprehensive Regulation: Management of medical products, from development and manufacturing to sale and disposal, is comprehensively arranged, including their import, export, and distribution processes.
• Marketing Authorizations: The law introduces a marketing authorization granting system under which marketing authorization may be exclusive, conditional, or for emergency use. It also creates a fast-track process for innovative medical products deemed to provide relevant therapeutic benefits.
• Pharmaceutical Policies Committee: There will be a new committee for the purpose of managing policies regarding pricing, circulation, and surveillance of medical products.
• Investment and Innovation: It also has provisions for enhancing investment and innovation largely in the pharmaceutical industry while protecting the innovations of the industry through regulatory protection.
• Pharmacovigilance: A well-structured system of monitoring for the safe use of medical products is in place to reduce side effects and ensure patient safety..

Penalties for Violations

Offenders of the law would be liable to such penalties as suspension of licenses for a limited period, precautionary closure, or even cancellation of licenses. The fines may go up to Dh1 million for establishments and Dh500,000 for individuals.

Oversight and Licensing Authorities

The law clearly defines the roles of some of the key authorities, such as:

• Emirates Drug Establishment (EDE): The EDE will be responsible for licensing medical products, approving imports and exports, managing advertisements, compliance with Good Manufacturing Practice (GMP) standards, and linking all factories, medical warehouses, and pharmaceutical consulting firms.
• Ministry of Health and the Local Health Authorities: It is the authorities that manage the licensing of pharmacy professionals, oversee pharmacies, and suspend medical products in government and private health facilities. This law ensures that all pharmaceutical establishments-stores, research entities, and biobanks- must function in strict accordance with safety and regulatory standards. Furthermore, it encourages greater collaboration between local authorities and federal authorities to ensure medical and scientific oversight and accountability in the pharmaceutical sector.

Effects of the Law on the Industry

This law is believed to usher important changes in prompting transparency, improving public health safety, and positioning the UAE as a leader in the regulation of pharmaceuticals in the region.