Treidlia Biovet Pty Ltd and Australian Pesticides and Veterinary Medicines Authority

This matter concerned an application by Tréidlia Biovet Pty Ltd for an extension of an emergency use permit (PER14835) for its unregistered veterinary product, Custom R-Pilus. The Australian Pesticides and Veterinary Medicines Authority (APVMA) had refused to extend the permit, finding that Tréidlia Biovet had not satisfied the requirements of the Agricultural and Veterinary Chemicals Code Act 1994 (the Code). The decision was reviewed by A Poljak SM.

The court was required to determine whether the APVMA was satisfied that the requirements of section 112(2)(e) and (f) of the Code would continue to be met in respect of the permit. Specifically, this involved assessing whether the use of Custom R-Pilus would continue to meet the safety criteria under section 112(2)(d) and whether there were reasonable grounds for Tréidlia Biovet not applying for the product's registration under section 112(2)(f). The APVMA's refusal was based on concerns regarding the adequacy of stability data provided by Tréidlia Biovet and the lack of reasonable grounds for not pursuing registration.

The SM found that while Tréidlia Biovet had provided some stability data, it was insufficient to demonstrate the product's safety over its entire shelf life, particularly given the permit had been extended multiple times. The SM also considered Tréidlia Biovet's arguments that registration was not commercially viable and that there were difficulties involved in the registration process. However, the SM noted that the APVMA had indicated a willingness to adopt a flexible approach, including a "multi-strain dossier" process, to facilitate registration. Ultimately, the SM concluded that Tréidlia Biovet had not established that the product would not yield sufficient economic return to cover registration costs, nor that there were reasonable grounds for not applying for registration.

Consequently, the decision under review, which affirmed the APVMA's refusal to extend the emergency use permit, was affirmed.