Key provisions of the decree-law

• Regulating the provisions for the management of veterinary medical products, including provisions for their manufacture, registration, pricing, import, export, distribution, sale, possession, use, safe disposal, advertising, publicity, and promotion.
• Regulating the provisions for licensing, monitoring, transferring, and assigning ownership of veterinary pharmaceutical establishments to others, and the cases that warrant their precautionary closure.
• A fast track with simplified procedures for granting marketing approvals for innovative veterinary medical products of therapeutic importance.
• Defining the obligations of the holder of the marketing rights for veterinary medical products.
• For the first time, the loaning or transfer of excipients, solvents, preservatives, and carriers between veterinary medical product manufacturers or contracting companies is permitted, subject to specific controls.
• Regulating the provisions of the pharmacovigilance system to ensure the safe use of veterinary medical products and to reduce side effects and adverse reactions.
• Promoting investment and supporting innovation and development in the veterinary medical industries sector.

United Arab Emirates - The UAE government has issued a federal decree-law on veterinary medical products and veterinary pharmaceutical establishments, which aims to protect animal health, ensure food safety and public health, enhance the effectiveness and safety of veterinary medical products, and achieve effective national management of procedures for developing, approving, manufacturing, marketing, and trading veterinary medical products in record time and costs and in accordance with the best international standards.

Regulation of veterinary medical products

The provisions of the Decree-Law apply to veterinary medical products, including: veterinary preparations, which include veterinary biological products and veterinary supplements prepared for injection, veterinary raw materials, veterinary supplementary products, veterinary medical devices, genetically modified organism products prepared for veterinary medical use, controlled and semi-controlled materials and products, and veterinary chemical precursors.

All regulations pertaining to the management of veterinary medical products in the country have been established, including provisions for their development, manufacturing, registration, pricing, import, export, handling, distribution, possession, sale, display, remarketing, use, safe disposal, advertising, and promotion. Regulations have also been established for the classification of veterinary medical products intended for import, local manufacturing, or distribution within the country, based on specific standards and controls.

The decree-law also specified the provisions relating to the issuance of the national policy for the strategic stock of veterinary medical products after its adoption by the Cabinet.

Regulations for the development and manufacture of veterinary medical products

The decree-law included general provisions regulating the development and manufacturing of veterinary medical products in accordance with the rules, guidelines, and standards of good practice issued by the Emirates Drug Authority, which are aligned with internationally recognized guidelines and 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, subject to specific regulations.

Prohibitions related to veterinary medical products

The decree-law prohibited the trading of counterfeit, defective, expired, or gray market medical products, and set controls for the prescription and sale of veterinary medical products, such as prohibiting the dispensing or changing of a veterinary prescription except by a qualified and licensed veterinarian, and also prohibited the dispensing of veterinary antibiotics without a prescription or their use for preventive purposes, immunity enhancement, or growth stimulation.

The decree-law also specified the provisions for trading prohibited and restricted veterinary materials. It prohibited the manufacture, import, export, or re-export of prohibited materials, and specified the areas in which trading of restricted materials is permitted. It also allowed the Board of Directors of the Emirates Drug Authority to grant an exception for the use of any of the restricted materials in areas other than those specified, according to a decision issued by the Board that specifies the conditions, controls, and cases in which an exception may be granted for the import, manufacture, trading, or use of any of the prohibited materials.

The decree-law specified the controls for the personal use of veterinary medical products, prohibiting their importation, possession, or acquisition for personal use by any person upon entering or leaving the country, or their importation or dispatch through shipping companies, unless they are unavailable in the country and have no equivalent alternatives, after obtaining the approval of the Emirates Drug Authority.

The provisions relating to the pharmacovigilance system in the country have been organized to ensure the safe use of veterinary medical products and to reduce side effects and adverse reactions, including provisions relating to the prohibition of importing, stopping distribution, preventing circulation, suspending, recalling or withdrawing the veterinary medical product at the state level by the Emirates Drug Authority.

Marketing regulations for veterinary medical products

The decree-law established the regulations and conditions for issuing marketing authorizations for all types of veterinary medical products by the Emirates Drug Authority. It also ensured that marketing authorizations for all types of veterinary vaccines would be granted in accordance with the country's animal disease control policies, through a list of approved veterinary vaccines jointly developed by the Ministry of Climate Change and Environment and the Emirates Drug Authority. For the first time, 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 therapeutic importance, as well as other veterinary medical products that meet the relevant conditions and regulations. The decree-law also included provisions for protecting innovations in the veterinary medical industry.

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 defined the obligations of the owner of the marketing rights for veterinary medical products and the person qualified and appointed by him.

Regulation of veterinary pharmaceutical establishments

The provisions of the decree-law also apply to veterinary pharmaceutical establishments in the country, including free zones, and include: veterinary pharmacies, veterinary medical warehouses and stores, veterinary medical product factories, contracting companies for the manufacture of veterinary medical products, marketing offices, pharmaceutical consulting offices, pharmaceutical laboratories, contracting companies for research and development, veterinary non-clinical and clinical research entities, bioequivalence centers, and veterinary biobanks.

All provisions relating to the licensing of veterinary pharmaceutical establishments in the country have been regulated by the Emirates Drug Authority and the Ministry of Climate Change and Environment, each within its jurisdiction and after obtaining the necessary approvals from the competent local authority, and provisions for monitoring and inspecting these establishments, issuing approvals for their transfer and assignment of ownership to others, the prohibitions related to them, and the cases that warrant their precautionary closure.

Investment and research in the veterinary medical industries sector

Emphasis was placed on the importance of investing in the veterinary medical industries and supporting innovation and development within this sector, thereby contributing to industrial growth and sustainable economic development. Regulations pertaining to non-clinical and clinical research on veterinary medical products were also addressed.

The provisions for establishing and managing national databases for regulating veterinary medical products and veterinary pharmaceutical establishments in the country were harmonized with the provisions of the Federal Decree-Law on Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments. Frameworks for cooperation and joint coordination between the Emirates Drug Authority, the Ministry of Climate Change and Environment, and the relevant local authority were also established.

The decree-law specified the violations, disciplinary penalties, and deterrent punishments for violators, and regulated the mechanism of work of the oversight committees in the Emirates Drug Authority, the Ministry of Climate Change and Environment, and the competent local authority. It granted those covered by the provisions of this decree-law a grace period to adjust their situations, not exceeding one year from the date of its implementation, which is extendable by a decision of the Cabinet.

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