This Law, comprising 38 articles, establishes a regulatory framework for veterinary products. It provides that no veterinary product may be imported, marketed, handled, or commercially produced unless it is registered with the competent authority in the country. Local veterinary products may not commence commercial production before registration, and where a product registration application is approved, the applicant must obtain a veterinary product warehouse license before a registration certificate can be issued. Under Article 3, the competent authority is responsible for regulating veterinary products and related entities. Its responsibilities include (i) registering veterinary product companies and factories; (ii) registering veterinary products; (iii) reviewing technical reports issued by international organizations and authorities concerning veterinary products and companies and taking appropriate action; (iv) monitoring veterinary products before and after marketing, including reviewing reports from hospitals and veterinary clinics regarding product quality and safety; (v) maintaining a list of veterinary products prohibited for use in certain animals; (vi) setting veterinary product prices; (vii) licensing local veterinary product factories and warehouses; and (viii) authorizing the release of imported veterinary products. The Law further permits the competent authority, under Article 15, to approve the importation of unregistered veterinary products when necessary. It prohibits the importation, handling, or marketing of any registered veterinary product that has been modified without prior approval from the competent authority. However, unregistered veterinary products may be imported for research purposes, subject to prior approval. The Law also requires compliance with good storage and distribution practices for veterinary products. In addition, the competent authority is tasked with establishing committees responsible for registering veterinary product companies and factories (including production lines) to ensure compliance with good pharmaceutical manufacturing practices during the registration process. Article 27 sets out violations under the Law, including counterfeiting or attempting to counterfeit veterinary products; manufacturing, importing, storing, selling, or distributing counterfeit, expired, decomposed, or unregistered products; using misleading information or advertisements for promotional purposes; manufacturing or possessing packaging intended for counterfeiting; and conducting activities such as import, export, manufacture, marketing, or sale in violation of the Law or its implementing regulations. Violations also include providing false information, withholding information required by the competent authority, failing to comply with decisions issued by the competent authority, and selling or promoting veterinary products without a license. To ensure compliance with the Law and its implementing regulations, the competent authority may inspect veterinary products and seize relevant items through authorized officials empowered with judicial seizure authority under the applicable laws. Finally, the Agricultural Cooperation Committee is empowered to interpret, propose amendments to, and modify the Law, and is also responsible for adopting its implementing regulations.
2011-12-01