The UAE has introduced a new law to regulate veterinary medical products and pharmaceutical establishments, aiming to enhance safety standards, protect animal health, ensure food safety, and safeguard public health.
This legislation establishes a unified national framework for the development, approval, manufacturing, marketing, and distribution of veterinary medical products.
The law covers a wide range of veterinary products, including biological preparations, injectable supplements, raw materials, supplementary products, medical devices, genetically modified organisms for veterinary use, and controlled or semi-controlled substances, including chemical precursors.
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The new law comprehensively regulates all aspects of veterinary medical product management, including manufacturing, registration, pricing, import, export, distribution, possession, sale, display, use, safe disposal, advertising, and promotion.
The legislation also provides clear terms and controls for classifying veterinary products intended for import, local manufacturing, or distribution within the UAE.
It sets stringent provisions for licensing and oversight of veterinary pharmaceutical establishments and outlines rules for the transfer and assignment of ownership, including conditions for precautionary closures due to non-compliance.
A notable aspect is the fast-track, simplified approval process for innovative veterinary medical products with proven therapeutic value, while marketing authorisation holders must ensure compliance with national safety and quality standards.
For the first time in the UAE, the law permits the loan or transfer of excipients, solvents, preservatives, and carriers between manufacturers or contracting companies, under strict regulatory conditions.
The legislation strengthens the national pharmacovigilance system, ensuring safe use of veterinary medical products and minimizing adverse reactions. It fosters investment and innovation in the veterinary medical industry by creating a clear, modern regulatory environment.
Additional protections prevent the circulation, trade, or storage of counterfeit, defective, or expired veterinary medical products. The law enforces strict controls on prescribing and dispensing, allowing changes to a veterinary prescription only by qualified, licensed veterinarians.
The law also sets comprehensive rules for prohibited and restricted substances, banning the manufacturing, import, and export of prohibited veterinary substances, specifying areas where restricted substances can be handled, and authorizing the Emirates Drug Establishment’s Board of Directors to grant exceptions when justified.
