UAE Enacts Two Major Federal Decrees to Advance Health, Biotechnology, and Veterinary Safety Standards

The UAE Government has issued two significant Federal Decree-Laws that advance national health regulation, modernise biomedical frameworks, and strengthen safety across both human and veterinary sectors. Together, the new laws reinforce the country’s long-term vision of aligning its health and life-sciences legislation with global best practices while safeguarding patient wellbeing, animal health, and food security.

Updates to the Law on Organ and Tissue Donation and Transplantation

A key decree amends the Federal Decree-Law concerning the donation and transplantation of organs and tissues, marking an important step in the UAE’s ongoing efforts to modernise its health legislative framework. The amendments expand the scope of the law to include the use of non-human organs -- such as animal-derived or manufactured organs -- reflecting international advances in biomedical innovation and ensuring access to scientifically validated therapeutic options.

The legislation now formally adopts the title “Concerning the Donation and Transplantation of Organs and Tissues” and introduces a new definition for “non-human organ”, covering both animal organs and bioengineered equivalents. Its provisions establish strict regulatory controls for the transplantation of such organs, requiring that the procedure be the most appropriate medical option for the patient.

Removal, use, or manufacturing of non-human organs or tissues will now require licensing from the Ministry of Health and Prevention or relevant health authorities. Comprehensive clinical and laboratory testing, assessment of biological compatibility, clear patient disclosure, and written consent are mandatory. Transplant procedures must also receive prior approval from a dedicated committee.

To promote transparency and traceability, the decree mandates the creation of a national database at the National Centre, recording all non-human organs used in transplantation, including biological composition, clinical trial outcomes, and safety data. Detailed documentation of every stage of the procedure is now compulsory.

The UAE Cabinet is authorised to define procedures for transferring non-human organs and tissues within the UAE or across borders. The law also introduces stringent penalties, including imprisonment and fines ranging from Dh100,000 to Dh2 million, for any violations of controls surrounding transfer or transplantation.

These updates reinforce the UAE’s commitment to high standards in patient safety, ethical medical practice, and a regulated environment for emerging biomedical technologies.

New Federal Decree-Law on Veterinary Medical Products and Veterinary Pharmaceutical Establishments

The second decree establishes a comprehensive framework governing veterinary medical products and veterinary pharmaceutical establishments. Designed to protect animal health, ensure food safety, and safeguard public health, the law regulates the entire lifecycle of veterinary products -- from development and manufacturing to registration, pricing, import, distribution, safe disposal, and promotion.

Its scope covers veterinary preparations, biological products, injectable supplements, raw materials, medical devices, supplementary products, genetically modified organisms intended for veterinary use, controlled and semi-controlled substances, and chemical precursors.

The decree introduces detailed provisions for developing and manufacturing veterinary medical products in line with international good practice guidelines issued by the Emirates Drug Establishment. For the first time, it permits the loan or transfer of excipients, solvents, preservatives, and carriers between manufacturers under strict conditions.

The law prohibits the circulation of counterfeit, defective, or expired veterinary products, and sets out strict rules for prescribing and dispensing medicines -- permitting alterations only by licensed veterinarians. It further defines the handling of restricted or prohibited substances, while authorising exceptions, under specific conditions, through the Board of the Emirates Drug Establishment.

A notable advancement is the introduction of an accelerated approval pathway for high-value, innovative veterinary products, enabling faster access while maintaining safety, quality, and efficacy requirements.

The decree also governs approvals for import, export, and re-export of veterinary medical products, and outlines the responsibilities of marketing authorisation holders and their designated qualified personnel. It extends its provisions to veterinary pharmaceutical establishments across the UAE, including those in free zones, covering pharmacies, warehouses, manufacturing plants, contract manufacturers, marketing offices, consulting offices, and laboratories.

Licensing, inspection, and compliance responsibilities are shared between the Emirates Drug Establishment, the Ministry of Climate Change and Environment, and the relevant local authorities. The legislation also mandates unified national databases for veterinary products and establishments, in harmony with the broader legal framework for medical products and pharmaceutical operations.

Violations are subject to clearly defined disciplinary penalties and operational oversight mechanisms, while affected entities are granted a grace period of up to one year -- extendable by Cabinet decision -- to align with the new requirements.

 

Together, these two Federal Decree-Laws represent a comprehensive upgrade to the UAE’s health and veterinary regulatory systems, supporting innovation while ensuring safety, transparency, and compliance across both human and animal health domains.

 

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