Prime Highlights:
- The UAE has launched a new law regulating veterinary products and pharmaceutical establishments to strengthen food safety, animal health, and public health.
- Innovative veterinary products can now receive fast-track approval, encouraging safer and more advanced treatments.
Key Facts:
- The law covers veterinary pharmacies, warehouses, manufacturing plants, laboratories, and contract manufacturers, with licensing and inspections overseen by the Emirates Drug Establishment and the Ministry of Climate Change and Environment.
- Only licensed veterinarians can prescribe or modify veterinary medicines, and the law bans counterfeit, expired, or prohibited products.
Background:
The UAE has introduced a new law to regulate veterinary products and pharmaceutical businesses. This is an important step to improve food safety, animal health, and public health.
The law sets clear rules for making, approving, selling, and distributing veterinary products. It covers many types of products, such as biologicals, injectable supplements, raw materials, genetically modified products, medical devices, and controlled substances.
The law also ensures that all steps, from registration and pricing to import, export, sale, use, advertising, and safe disposal, are carefully regulated under one system. The law also introduces detailed guidelines for classifying products intended for local manufacturing, import, or distribution.
One of the key features of the legislation is the establishment of a National Policy for the Strategic Stockpile of Veterinary Medical Products, to be issued following Cabinet approval. The law further requires that development and manufacturing processes comply with good practice standards set by the Emirates Drug Establishment and internationally recognised guidelines.
In a notable first for the sector, manufacturers will now be allowed to loan or transfer excipients, solvents, preservatives and carriers among themselves under controlled conditions. The law also bans the sale or use of counterfeit, expired, or defective veterinary products.
Only licensed veterinarians can prescribe or change veterinary medicines. The law also bans the use, manufacture, import, and export of prohibited or restricted substances. Exceptions may only be granted by the Board of Directors of the Emirates Drug Establishment.
The law also creates a fast-track approval process for innovative veterinary products that provide high value and meet safety and quality standards.
It covers the licensing and regulation of all veterinary pharmaceutical facilities in the UAE, including free zones. This covers veterinary pharmacies, warehouses, factories, contract manufacturers, marketing and consulting offices, and laboratories. The Emirates Drug Establishment and the Ministry of Climate Change and Environment will manage licensing and inspections with local authorities.
The law also sets up national databases for veterinary products and facilities and establishes rules for inspections and penalties.
Businesses affected by the law have one year to comply, with a possible extension approved by the Cabinet.
