The UAE government has enacted a Federal Decree-Law on Veterinary Medical Products and Veterinary Pharmaceutical Establishments.
The legislation aims to protect animal health, ensure food safety and public health, according to a statement by the Emirates News Agency (WAM).
It was designed to achieve management of the development, approval, manufacturing, marketing, and distribution of these products, in line with international standards.
UAE government enacts veterinary medical products law to protect animal health, food safety
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 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, manufacturing, or distribution within the UAE were also established based on terms and controls.
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 provisions regulating the development and manufacturing of veterinary medical products in line with the guidelines and controls of practice issued by the Emirates Drug Establishment, and standards recognised internationally. 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 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 veterinarian who is qualified and licensed.
UAE bans false, expired veterinary medical products under federal law
The decree-law 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 authorised 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 procedures, aligned with quality, safety, and efficacy requirements and international agreements, for granting marketing authorisations for veterinary medical products of therapeutic value.
The legislation 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 authorisation for veterinary medicinal products and the 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.
UAE veterinary medical products decree-law grants one-year grace period for compliance
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 jurisdiction and after obtaining the approvals from the local authority. The provisions also include regulations for monitoring and inspecting these establishments.
In the Decree-Law, the provisions for establishing and managing 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, penalties, and punishments for violators. It also regulates the mechanism of the oversight committees at the Emirates Drug Establishment, the Ministry of Climate Change and Environment, and the 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.
