UAE Issues New Law On Medical Products, Bans Trade Of Fake, Unsafe Animal Drugs

The UAE has issued a new law regulating veterinary medical products and pharmaceutical establishments to enhance safety standards, protect animal health, ensure food safety, and safeguard public health.

The legislation establishes unified national oversight for the development, approval, manufacturing, marketing, and distribution of veterinary medical products.

The law applies to a broad range of veterinary products, including biological preparations, injectable supplements, raw materials, supplementary products, medical devices, genetically modified organisms intended for veterinary use, and controlled or semi-controlled substances, including chemical precursors.

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Under the new law, all aspects of managing veterinary medical products are regulated - covering manufacturing, registration, pricing, import, export, distribution, possession, sale, display, use, safe disposal, advertising, and promotion.

It also outlines clear terms and controls for the classification of veterinary products intended for import, local manufacturing, or distribution within the UAE.

The legislation sets strict provisions for licensing and oversight of veterinary pharmaceutical establishments and defines the rules for the transfer and assignment of ownership. It also details the conditions under which precautionary closures may be imposed for non-compliance.

One of the most notable features is a fast-track, simplified process for approving innovative veterinary medical products with proven therapeutic value. The law specifies the responsibilities of marketing authorisation holders to ensure adherence to national safety and quality standards.

For the first time in the UAE, the decree-law permits the loan or transfer of excipients, solvents, preservatives, and carriers between manufacturers or contracting companies, subject to stringent regulatory conditions.

The law also strengthens the national pharmacovigilance system, ensuring the safe use of veterinary medical products and minimising adverse reactions. It supports investment and innovation in the veterinary medical industry by providing a clear, modern regulatory environment.

Additional safeguards prohibit the circulation, trading, or storage of counterfeit, defective, or expired veterinary medical products. The law sets strict controls on prescribing and dispensing, permitting alterations to a veterinary prescription only by qualified, licensed veterinarians.

The law also establishes comprehensive provisions governing prohibited and restricted substances. It bans the manufacturing, import, and export of prohibited veterinary substances, identifies the specific areas where restricted substances may be handled, and authorises the Board of Directors of the Emirates Drug Establishment to grant exceptions when justified.

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