Abu dhabi: The UAE government has issued a Federal Decree-Law on Veterinary Medical Products and Veterinary Pharmaceutical Establishments. The new legislation aims to protect animal health, ensure food safety, and public health. It was designed to achieve effective national management of the development, approval, manufacturing, marketing, and distribution of these products, in line with international standards.
According to Emirates News Agency, the provisions of the Decree-Law apply to various veterinary medical products, including veterinary preparations, biological products, injectable supplements, raw materials, supplementary products, medical devices, genetically modified organisms for veterinary use, and controlled substances. The law regulates all aspects related to the management of veterinary medical products in the UAE, including their development, manufacturing, registration, pricing, import, export, distribution, possession, sale, and safe disposal. It also establishes rules for advertising and promotion.
The Decree-Law includes guidelines for issuing the National Policy for the Strategic Stockpile of Veterinary Medical Products, pending Cabinet approval. It sets general provisions for developing and manufacturing veterinary medical products, adhering to good practice guidelines issued by the Emirates Drug Establishment. A new provision allows the loan or transfer of specific materials between manufacturers under controlled conditions.
The law prohibits the circulation of counterfeit, defective, or expired products. It sets controls for prescribing and selling veterinary products, stating only qualified veterinarians can alter prescriptions. It also defines the handling of prohibited and restricted substances, with the Emirates Drug Establishment's board able to grant usage exceptions.
For the first time, the decree-law introduces a fast-track process for marketing authorisations of innovative products with high therapeutic value. It also establishes conditions for import, export approvals, and permits, outlining the responsibilities of marketing authorisation holders and their appointed qualified persons.
The provisions apply to veterinary pharmaceutical establishments in the UAE, including those in free zones, covering pharmacies, warehouses, manufacturing plants, marketing offices, and laboratories. Licensing is regulated by the Emirates Drug Establishment and the Ministry of Climate Change and Environment, in coordination with local authorities.
The Decree-Law unifies the regulations for national databases on veterinary products and establishments, aligning them with existing laws on medical products and pharmaceutical establishments. It specifies violations, penalties, and oversight mechanisms, granting a grace period of up to one year for compliance, extendable by Cabinet resolution.