President issues federal law for regulation of veterinary products

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DUBAI / WAM

President His Highness Sheikh Khalifa bin Zayed Al Nahyan has issued Federal Law No. 09 of 2017 regulating the handling, trading, marketing and circulation of veterinary products considering its direct impact on animal and public health, as well as the environment at large.
The move emphasises the critical role of veterinary medicines and related products in animal production and protection. Aiming to reduce spread of epidemic and infectious diseases and consequent increase in biosecurity rates, the regulation will help ensure food safety, contributing to achieving UAE vision 2021 objectives that prioritise the protection and development of livestock.
Under the law, Ministry of Climate Change and Environment (MOCCAE) is mandated to facilitate licensing and registration of companies and factories, as well as veterinary products, review technical rep- orts received from international organisations or bodies on veterinary products and companies, monitor markets, collect reports from hospitals or veterinary clinics and publish lists of prohibited veterinary products.
The regulation introduces veterinary products by their ingredients that can cure or alter physiological functions in animals. It obligates co-mpanies, factories and warehouses of veterinary products in the country to obtain the required license from the Ministry prior to commencing the practice of any activity.
The regulation also outlines best practices for the storage of valid products and the safe disposal of destroyed or expired products without contributing to environmental pollution. According to the law, administrative penalties for violations include the warning, closure of company/plant/warehouse of veterinary products for a minimum of six months or, in some cases, even permanent closure. A penalty of AED10,000 to AED 500,000 will be imposed on those possessing, selling, marketing, manufacturing, importing, storing or handling a counterfeit, corrupt or expired veterinary product. While a penalty of AED5,000 to AED500,000 will be imposed on any person, who imports, transports or markets any registered veterinary product modifying its data without obtaining approval of Ministry as stated in Article 24.
Imprisonment along with a fine of AED20,000 to AED100,000 or one of these penalties will be applied in the event of importing samples of any veterinary product for research or marketing purposes without obtaining the Ministry’s approval.
The law also details that imprisonment along with a fine of AED50,000 to AED500,000 or one of the two penalties will be applied for the use of a veterinary factory or related facilities for any other purpose without the approval of the Ministry.
A penalty of AED10,000 to AED 200,000 shall be levied for the submission of incorrect information related to a veterinary product, failure to provide information requested by the Ministry, or the use of inaccurate information in the media for the promotion of a veterinary product. Companies are not allowed to advertise a veterinary product in the media without approval in accordance with the conditions specified by the law.
All local and foreign companies should be registered with the Ministry prior to commencing any veterinary product related activity in the UAE. Licenses should be renewed every five years. The applicant must have a warehouse license for the wholesale trade of veterinary products. In case of forgery or tampering of documents, companies will be closed permanently or their products prohibited in the market.
Manufacturing of unregistered and non-prohibited veterinary products will be permitted for export purposes in accordance with conditions and controls prescribed by the executive regulations of this law.
Veterinary companies, factories and warehouses must notify the Ministry regarding any change in the veterinary product or manufacturer, warnings issued by the company regarding the safety and efficacy of the product or if manufacturing or trading has been suspended in the country of origin. Repeated complaints about veterinary products also should be reported. The Ministry may prohibit the import or prevent the circulation, withdraw or retrieve the veterinary product, suspend or cancel the registration in case modifications are made without the approval of the Ministry, or if reports of the toxicity or severe side effects or existence of a defect in its quality or effectiveness are not submitted.
MOCCAE may discontinue the use of certain products on the recommendation of relevant international organisations or supervisory bodies. It may withdraw the registration or stop imports from the country of origin in the event of incorrect information provided in the registration file, failure to renew the license after 180 days from the expiry date, or in any other instances specified by the executive regulations of this law.
The employees appointed by a decision of the Minister of Justice in agreement with the Minister of Climate Change and Environment shall have the authority to take actions against any violation of the provisions of this law and the regulations and decisions issued thereunder.
Existing veterinary companies, factories and warehouses should comply with the provisions of this law within six months from the date of its implementation. They can gain an extension period of six months as per the Cabinet decision. The Cabinet will issue a decision shortly, specifying the prescribed fees in accordance with the provisions of this law.
The federal law will come into effect from the date of its publication in the UAE Official Gazette. Details of the executive regulations stipulated by the law will be issued within six months from the date of law issuance. Any provision contrary to the provisions of this law shall be repealed.

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