UAE Issues Federal Decree by Law No. 21 of 2025 on Veterinary Medical Products and Veterinary Pharmaceutical Establishments

The UAE has introduced Federal Decree by Law No. (21) of 2025 Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, an important legislative development governing the regulation, classification, licensing, and safe use of veterinary medical products and related pharmaceutical activities in the country. This law was published in the Official Gazette (No. 809) and will enter into force on 1 January 2026.

Scope and Application of the Law

This Decree by Law applies to all veterinary medical products circulated in the UAE, including veterinary medicinal and biological products, veterinary raw materials, complementary products, veterinary medical devices, genetically modified veterinary products, and any other products designated by a Cabinet decision.

It also applies to veterinary pharmaceutical establishments, whether located on the mainland or in free zones. These include manufacturing facilities, contract manufacturing organizations, warehouses, veterinary pharmacies, laboratories, marketing offices, research entities, bioequivalence centres, veterinary biobanks, and any other establishments licensed to deal with veterinary medical products.

Key Definitions

Article (1) sets out the definitions used in the Decree by Law. These definitions clarify important concepts such as “veterinary medical product”, “veterinary pharmaceutical establishment”, “marketing authorization”, “marketing authorization holder”, and “pharmacovigilance”. These definitions determine how obligations and responsibilities are applied under the law.

Reference Pharmacopoeias and Quality Standards

Under Article (3), veterinary medical products are subject to the approved reference pharmacopoeias and quality standards recognised under Federal Decree by Law No. 38 of 2024 concerning medical products and pharmaceutical establishments. These reference standards apply to veterinary medical products for the purposes of quality, safety, and control testing.

Classification of Veterinary Medical Products

Article (4) assigns the Emirates Drug Establishment responsibility for classifying veterinary medical products that are imported into, manufactured in, or circulated within the UAE. Classification is based on the product’s nature, composition, intended use, and the level of risk it may pose to animal health, human health, and the environment. The classification process is carried out in accordance with standards and controls approved by the Establishment’s Board of Directors.

Under Article (5), the Ministry of Climate Change and Environment, in coordination with the Emirates Drug Establishment, agrees on an official list of veterinary vaccines. Marketing authorisations for veterinary vaccines are issued by the Establishment only for vaccines included in this approved list.

Marketing Authorisation Requirements

Article (7) establishes a general prohibition on the circulation of veterinary medical products without prior approval. No veterinary medical product may be imported, exported, distributed, possessed, sold, re-marketed, or manufactured for circulation in the UAE unless a valid marketing authorisation has been obtained from the Emirates Drug Establishment. Certain compounded veterinary products prepared in licensed veterinary pharmacies may be exempt from this requirement, subject to conditions set by the Establishment. The Cabinet may also grant specific exemptions in limited cases.

Article (8) sets out the conditions and controls for granting marketing authorisation. The applicant must be a licensed veterinary pharmaceutical establishment and must demonstrate that the product meets approved standards of quality, safety, and effectiveness. The applicant must also have systems in place for quality assurance, traceability, pharmacovigilance, and post-marketing monitoring, along with any other requirements specified in the executive regulations.

Manufacturing of Veterinary Medical Products

Under Article (29), veterinary medical products intended for circulation in the UAE may only be manufactured if they have obtained a valid marketing authorisation or emergency use authorisation and are produced in a manufacturing facility licensed by the Emirates Drug Establishment. Products manufactured for export are subject to additional controls and permits, as specified in the executive regulations.

Article (30) authorises the Establishment’s Board of Directors to issue good practice standards, including manufacturing and quality practices, in line with internationally recognised principles. Article (31) regulates the transfer of raw materials and intermediate products between licensed facilities, requiring prior approval to ensure quality and safety.

Obligations of Marketing Authorisation Holders

Articles (23) to (26) impose obligations on marketing authorisation holders. These include appointing qualified persons, ensuring compliance with pharmacovigilance requirements, maintaining accurate product records, reporting changes to product composition or manufacturing processes, and cooperating with inspections and post-marketing monitoring measures. Only approved laboratories may be used for recognised quality testing.

Product Availability and Supply

Under Article (37), licensed establishments must ensure the availability of veterinary medical products and maintain sufficient stock to meet market needs. Refusal to supply products without a valid reason is prohibited, and the Emirates Drug Establishment may take necessary measures to prevent shortages.

Sale Restrictions, Prohibited Products, and Advertising

Article (42) prohibits the circulation of adulterated, expired, defective, counterfeit, or unauthorised veterinary medical products. It also restricts the sale of free samples unless labelling requirements in Arabic and English are met.

Advertising and promotion of veterinary medical products are regulated under Articles (44) and (45). Veterinary products may not be advertised or promoted without prior approval from the Emirates Drug Establishment. Advertising materials must be accurate, supported by scientific evidence, and must clearly disclose any risks or side effects.

Licensing of Veterinary Pharmaceutical Establishments

The Decree by Law sets out detailed licensing requirements for different types of veterinary pharmaceutical establishments. Article (57) governs the licensing of veterinary pharmacies, which must be managed by licensed veterinarians. Article (60) regulates veterinary medical marketing offices, requiring proper licensing and the appointment of a qualified manager. Additional licensing provisions apply to warehouses, manufacturers, laboratories, research entities, consultancy offices, and veterinary biobanks throughout the law.

Prohibited Acts and Enforcement

Article (68) lists prohibited acts, including operating without a licence, trading in adulterated or unsafe products, falsifying documents, and continuing to circulate products after marketing authorisation has been withdrawn. Where violations occur, owners and managers may be held liable if knowledge and responsibility are established. The law provides for inspections, administrative sanctions, licence suspension or revocation, fines, and criminal penalties in serious cases.

Repeal and Transitional Provisions

Article (93) repeals Federal Law No. 9 of 2017 Regarding Veterinary Products, along with any provisions that conflict with the new Decree by Law. Existing regulations and decisions issued under the previous law continue to apply only to the extent that they do not conflict with this Decree by Law, until they are replaced by new implementing regulations.

Conclusion

Federal Decree by Law No. 21 of 2025 establishes a comprehensive legal regime governing veterinary medical products and veterinary pharmaceutical establishments in the UAE. It introduces clear rules on classification, marketing authorisation, manufacturing, licensing, supply, advertising, and enforcement, with the aim of protecting animal health, public health, and product quality across the veterinary sector.