United Arab Emirates- 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 the best international standards.

The provisions of the Decree-Law apply to veterinary medical products, including veterinary preparations, which comprise veterinary biological products and injectable supplements; veterinary raw materials; veterinary supplementary products; veterinary medical devices; genetically modified organisms (GMOs) intended for veterinary medical use; and controlled and semi-controlled substances and products, as well as veterinary chemical precursors.

The law regulates all provisions related to the management of veterinary medical products in the UAE, including their development, manufacturing, registration, pricing, import, export, distribution, possession, sale, display, remarketing, use, safe disposal, advertising, and promotion. The provisions governing the classification of veterinary medical products intended for import, local manufacturing, or distribution within the UAE were also established based on specific terms and controls.

Additionally, the Decree-Law outlined the provisions for issuing the National Policy for the Strategic Stockpile of Veterinary Medical Products, following its approval by the Cabinet.

The Decree-Law stipulated general provisions regulating the development and manufacturing of veterinary medical products in line with the guidelines and controls of good practice issued by the Emirates Drug Establishment, and internationally recognized standards. For the first time, the loan or transfer of excipients, solvents, preservatives, and carriers between veterinary medical product manufacturers or contracting companies was permitted, under specific controls.

The Decree-Law prohibited the circulation or trading of counterfeit, defective, or expired medical products. It also established controls for prescribing and selling veterinary medical products, and prohibited the dispensing or alteration of a veterinary prescription except by a qualified and licensed veterinarian.

The decree-law also defined the provisions for the handling of prohibited and restricted veterinary substances. It banned the manufacturing, import, export, and re-export of prohibited substances, specified the areas in which the handling of restricted substances is permitted, and authorized the Board of Directors of the Emirates Drug Establishment to grant exceptions for the use of any restricted substance in usages outside those specified.

For the first time in the sector, the decree-law introduced a fast-track process with simplified procedures, aligned with quality, safety, and efficacy requirements and international agreements, for granting marketing authorizations for innovative veterinary medical products of high therapeutic value.

The new legislation also established the controls and conditions for issuing approvals and permits for the import, export, and re-export of veterinary medicinal products, and defined the obligations of the holder of the marketing authorization for veterinary medicinal products and the qualified person appointed by them.

The provisions of the Decree-Law also apply to veterinary pharmaceutical establishments in the UAE, including those in free zones. They apply to veterinary pharmacies, veterinary medical warehouses and stores, veterinary medical product manufacturing plants, contract manufacturing companies for veterinary medical products, marketing offices, pharmaceutical consulting offices, and pharmaceutical laboratories, among others.

All provisions related to licensing veterinary pharmaceutical establishments in the UAE are regulated by the Emirates Drug Establishment and the Ministry of Climate Change and Environment, each within its respective jurisdiction and after obtaining the necessary approvals from the competent local authority. The provisions also include regulations for monitoring and inspecting these establishments.

In the new Decree-Law, the provisions for establishing and managing national databases for regulating veterinary medical products and veterinary pharmaceutical establishments in the UAE have been unified and aligned with the provisions of the Federal Decree-Law on Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments.

The Decree-Law specifies violations, disciplinary penalties, and punishments for violators. It also regulates the operational mechanism of the oversight committees at the Emirates Drug Establishment, the Ministry of Climate Change and Environment, and the relevant local authority. Those subject to the provisions of this decree-law are granted a grace period of no more than one year from the date of its enactment to rectify their situations, extendable by a Cabinet resolution.