Business
UAE introduces new vet law to strengthen food safety and animal health
The UAE government has introduced a sweeping Federal Decree-Law regulating veterinary medical products and veterinary pharmaceutical establishments, marking a significant step in strengthening national systems for animal health, food safety and public health.
The legislation creates a unified governance framework for the development, approval, manufacturing, marketing and distribution of veterinary medical products in line with international standards.
The provisions of the new Decree-Law apply to veterinary medical products, including:
- Veterinary preparations such as veterinary biological products and injectable supplements
- Veterinary raw materials
- Genetically modified organisms intended for veterinary use
- Veterinary supplementary products
- Veterinary medical devices
- Controlled or semi-controlled substances, as well as veterinary chemical precursors
UAE veterinary law
The law regulates all aspects of veterinary medical product management in the UAE, covering development, manufacturing, registration, pricing, import, export, distribution, possession, sale, display, remarketing, use, safe disposal, advertising and promotion.
It also establishes detailed provisions for classifying products intended for import, local manufacturing or distribution in the UAE based on specific terms and controls.
The Decree-Law outlines the process for issuing the National Policy for the Strategic Stockpile of Veterinary Medical Products, following Cabinet approval.
It sets out general provisions for the development and manufacturing of veterinary medical products in accordance with good practice guidelines issued by the Emirates Drug Establishment and internationally recognised standards.
For the first time, the loan or transfer of excipients, solvents, preservatives and carriers between manufacturers or contracting companies is permitted under defined controls.
It sets controls for prescribing and selling veterinary medical products and prohibits the dispensing or alteration of veterinary prescriptions except by a qualified and licensed veterinarian.
Prohibited substances
The Decree-Law also details the handling of prohibited and restricted veterinary substances.
It bans the manufacturing, import, export and re-export of prohibited substances, defines the areas where restricted substances may be handled, and authorises the Board of Directors of the Emirates Drug Establishment to grant exceptions for uses outside the approved scope.
In a sector first, the law introduces a fast-track process for marketing authorisations for innovative veterinary medical products of high therapeutic value, using simplified procedures aligned with quality, safety and efficacy requirements and international agreements.
It sets the controls and conditions for issuing approvals and permits for the import, export and re-export of veterinary medicinal products, and defines the obligations of the marketing authorisation holder and their appointed qualified person.
The provisions also apply to veterinary pharmaceutical establishments in the UAE, including those in free zones.
These include veterinary pharmacies; veterinary medical warehouses and stores; veterinary medical product manufacturing plants; contract manufacturing companies; marketing offices; pharmaceutical consulting offices; and pharmaceutical laboratories.
The Emirates Drug Establishment and the Ministry of Climate Change and Environment will regulate licensing processes for these establishments, each within its respective jurisdiction and following the necessary approvals from the competent local authority. The law also specifies monitoring and inspection mechanisms.
Licences and penalties
The Decree-Law unifies the provisions for establishing and managing national databases related to veterinary medical products and veterinary pharmaceutical establishments, aligning them with the Federal Decree-Law on Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments.
It also sets out violations, disciplinary penalties and punishments for non-compliance.
Entities covered by the law will have a maximum grace period of one year from the date of enactment to rectify their status, with the possibility of extension by Cabinet resolution.
