The UAE government issues a federal decree law regarding veterinary medical products and veterinary pharmaceutical facilities

The UAE government issued a federal decree law regarding veterinary medicinal products and veterinary pharmaceutical facilities, which aims to protect animal health, ensure food safety and public health, enhance the effectiveness and safety of veterinary medicinal products, and achieve effective national management of procedures for developing, approving, manufacturing, marketing and trading veterinary medicinal products at record times and costs and in accordance with the best international standards.
The provisions of the decree law apply to veterinary medicinal products, including: veterinary preparations, which include veterinary biological products, veterinary supplements prepared for injection, veterinary raw materials, veterinary complementary products, veterinary medical methods, genetically modified organism products prepared for veterinary medical use, controlled and semi-controlled materials and products, and veterinary chemical precursors.
All provisions related to the management of veterinary medical products in the country have been regulated, including provisions for their development, manufacture, registration, pricing, import, export, circulation, distribution, possession, sale, display, remarketing, use, safe disposal, advertising, publicity and promotion. Provisions for the classification of veterinary medical products to be imported, manufactured locally, or traded within the country have also been regulated based on specific standards and controls.
The decree law also specified the provisions related to issuing the national policy for the strategic stock of veterinary medical products after its approval by the Council of Ministers.
The decree law includes general provisions regulating the development and manufacture of veterinary medical products in accordance with the rules, guidelines and standards of good practice issued by the Emirates Drug Corporation and consistent with internationally recognized guidelines and standards. For the first time, the loan or transfer of excipients, solvents, preservatives and carrier materials between veterinary medical products factories or contracting companies was permitted according to specific controls.
The decree law prohibited the circulation of counterfeit, defective, expired, or gray market medical products, and specified controls for prescribing and selling veterinary medical products, such as prohibiting the dispensing or changing of a veterinary prescription except by a specialized and licensed veterinarian. It also prohibited dispensing veterinary antibiotics without a prescription or using them for preventive purposes, enhancing immunity, or stimulating growth.
The decree law also specifies the provisions for the circulation of prohibited veterinary substances and restricted substances, prohibiting the manufacture, import, export or re-export of prohibited substances, specifying the areas in which the circulation of restricted substances is permitted, and allowing the Board of Directors of the Emirates Drug Corporation to grant an exception to the use of any of the substances. Restricted items in areas other than those specified in accordance with a decision issued by the Council specifying the conditions, controls, and cases in which an exception may be granted for importing, manufacturing, trading, or using any of the prohibited materials.
The decree law specified the controls for the personal use of veterinary medical products, as it was prohibited to bring, possess, or bring them for personal use with any person when entering or leaving the country, or to bring or send them through shipping companies, unless they are not available in the country and do not have equivalent alternatives, after obtaining the approval of the Emirates Medicines Corporation.
The provisions related to the pharmacovigilance system in the country have been regulated to ensure the safe use of veterinary medicinal products and limit side effects and adverse negative interactions, including provisions related to banning the import, stopping the distribution, preventing the circulation, suspending, recalling or withdrawing the veterinary medicinal product at the state level by the Emirates Medicines Corporation.
The decree law specified the controls and conditions for issuing marketing approvals for all types of veterinary medicinal products by the Emirates Drug Corporation. The decree law also included granting all types of marketing approvals for veterinary vaccines in line with policies for combating animal diseases in the country through an approved list between the Ministry of Climate Change and Environment and the Emirates Drug Foundation for veterinary vaccines.
The decree law created, for the first time, a fast track with simplified procedures consistent with quality, safety, effectiveness and international agreements requirements, to grant marketing approvals for innovative veterinary medicinal products of therapeutic importance and other veterinary medicinal products that meet the relevant conditions and controls. The decree law includes provisions related to the protection of innovations in the veterinary medical industry sector.
The decree law also specified the controls and conditions for issuing approvals and permits for the import, export and re-export of veterinary medical products, and specified the obligations of the holder of the right to market veterinary medical products and the person qualified and appointed by him.
The provisions of the decree law also apply to veterinary pharmaceutical facilities in the country, including free zones, which include: veterinary pharmacies, veterinary medical warehouses and stores, veterinary medical product factories, contract companies for manufacturing veterinary medical products, marketing offices, pharmaceutical consulting offices, pharmaceutical laboratories, contract research and development companies, veterinary non-clinical and clinical research destinations, bioequivalence centers and veterinary biobanks.
All provisions related to the licensing of veterinary pharmaceutical facilities in the country have been regulated by the Emirates Drug Corporation and the Ministry of Climate Change and Environment, each within the limits of its jurisdiction and after completing the necessary approvals from the competent local authority, and the provisions for oversight and inspection of these facilities, issuing approvals to transfer them and transfer their ownership to others, prohibitions related to them, and cases requiring their precautionary closure.
Emphasis was placed on the importance of investing in the veterinary medical industries sector and supporting innovation and development in this sector in a way that contributes to the development of the industrial sector and sustainable economic development. Provisions relating to non-clinical and clinical research of veterinary medicinal products have also been regulated.
The provisions for establishing and managing national databases to regulate veterinary medicinal products and veterinary pharmaceutical facilities in the country have been unified with the provisions of the federal decree law regarding medicinal products, the pharmacy profession, and pharmaceutical facilities. And organizing the frameworks of cooperation and joint coordination between the Emirates Pharmaceutical Corporation, the Ministry of Climate Change and Environment, and the competent local authority.
The decree law specifies violations, disciplinary penalties, and deterrent penalties for violators, organizing the work mechanism of the oversight committees at the Emirates Drug Corporation, the Ministry of Climate Change and Environment, and the competent local authority, and granting those covered by the provisions of this decree law a period of no more than one year from the date of its implementation, extendable by a decision of the Council of Ministers to reconcile their situations.