UAE Government Introduces Federal Decree-Law Regulating Veterinary Medical Products And Establishments

The UAE has introduced a Federal Decree-Law concerning Veterinary Medical Products and Veterinary Pharmaceutical Establishments. This legislation aims to safeguard animal health, food safety, and public health. It establishes a framework for the development, approval, manufacturing, marketing, and distribution of veterinary products, adhering to international standards.

The law encompasses various veterinary medical products such as biological products, injectable supplements, raw materials, supplementary products, medical devices, genetically modified organisms (GMOs) for veterinary use, and controlled substances. It regulates their development, manufacturing, registration, pricing, importation, exportation, distribution, possession, sale, display, remarketing, usage, disposal, advertising and promotion.

Veterinary pharmaceutical establishments in the UAE are subject to this decree-law. These include veterinary pharmacies and warehouses in free zones. The Emirates Drug Establishment and the Ministry of Climate Change and Environment oversee licensing these establishments within their jurisdictions after obtaining local authority approvals.

The decree-law also outlines provisions for establishing national databases to regulate veterinary medical products and pharmaceutical establishments. These align with existing laws on medical products and pharmaceutical practices. Monitoring and inspection regulations are included to ensure compliance with the law.

The decree-law includes provisions for issuing a National Policy for the Strategic Stockpile of Veterinary Medical Products. This policy requires Cabinet approval before implementation. Additionally, it introduces a fast-track process for granting marketing authorisations for innovative veterinary products with high therapeutic value.

For the first time in this sector, the law permits the loan or transfer of excipients between manufacturers under specific conditions. It prohibits counterfeit or expired product circulation while setting controls for prescribing and selling veterinary medical products.

Handling Prohibited Substances

The decree-law defines handling prohibited and restricted substances. Manufacturing or trading prohibited substances is banned. The Board of Directors of the Emirates Drug Establishment can grant exceptions for restricted substances outside specified uses.

It also establishes controls for issuing permits related to importing and exporting veterinary medicinal products. Obligations of marketing authorisation holders are defined along with responsibilities of appointed qualified persons.

Compliance Requirements

The decree-law specifies violations and penalties for non-compliance. Oversight committees at relevant authorities will regulate operations under this law. Entities have up to one year from enactment to comply with its provisions; extensions may be granted by Cabinet resolution if needed.

This comprehensive legislation aims to enhance regulatory oversight in the UAE's veterinary sector while aligning with global standards to ensure safety and efficacy in veterinary medical practices.

With inputs from WAM