Mechanisms to appeal against an APVMA decision

The APVMA gives full consideration to all data presented for the registration of a product to ensure the product meets accepted standards for safety and efficacy. It has the right to refuse registration if insufficient data are presented or it the data presented demonstrates that the product is either not effective or not safe for humans, animals, the environment and trade.

Applicants have the right to obtain a formal written statement from the APVMA setting out the findings of an evaluation, with references to the materials on which those finding were based and reasons for the APVMA's decision. Applications must be in writing and should be lodged with the APVMA Corporate Secretary within 28 days of a decision.

An applicant may apply, in writing, for the APVMA to reconsider a decision under section 166 of the Agvet Code. Following reconsideration, the APVMA may either confirm, set aside or vary its decision.

In addition, under section 167 of the Agvet Code, the decisions of the APVMA to vary the conditions of a registration and to approve a label can be reviewed by the Administrative Appeals Tribunal (AAT), subject to the Administrative Appeals Tribunal Act 1975. An application to the AAT must be in writing, accompanied by the required filing fee and be lodged within 28 days of the APVMA's notice.