Regulatory Affairs

The role of the Regulatory Affairs Department is to ensure that the products manufactured and marketed by Jurox meet the requirements of the relevant regulatory authorities. These requirements are generally designed to ensure that products are manufactured to a consistently high quality, are effective for the intended purpose, and are safe to animals, to users, to consumers of animal products and to the environment.

The regulations covering these aspects of safety, quality and efficacy vary in complexity and detail from country to country.

In Australia, the regulatory role is carried out by the Australian Pesticides and Veterinary Medicines Authority (APVMA – www.apvma.gov.au) .The APVMA evaluates products in conjunction with the individual States and with expert advice from government Agencies on toxicology, human health, environment and occupational health and safety.Before new products can be approved by APVMA, Jurox needs to demonstrate that the safety and efficacy criteria set by the regulator are met. This process can involve the conduct of laboratory and field studies, sometimes in differing environments, to demonstrate that the product is safe and effective for the purposes claimed.

If the product is for use on food-producing animals, studies must be carried out to ensure that residue levels at the withdrawal time are below the limits prescribed by the Department of Health, or by the bodies which set these limits internationally. Consideration is also given as to whether the proposed use of the product may pose an unacceptable risk to overseas trade.

The APVMA also reviews chemistry and manufacturing data to satisfy itself that the product can be manufactured to a high standard of quality that is consistently reproducible, and that it will retain its integrity under the proposed storage conditions. The manufacturing site is subject to regular inspection to ensure that products are manufactured according to the approvals given, and that the factory is operated according to standards of Good Manufacturing Practice which are equivalent to World Health Organization (WHO) standards.

Approval of registration of a product is not the end of the process. Legislation requires that reports of any adverse events associated with particular products are provided to the regulator, and reviews can be initiated by APVMA if evidence becomes available that safety or efficacy criteria may be compromised.

The Regulatory Affairs Department of Jurox is kept busy ensuring that the company’s extensive range of products continues to satisfy the wide-ranging requirements of the various regulatory bodies.