On 1 July 2014 a suite of legislative changes were introduced that affect how agricultural and veterinary (agvet) chemicals are registered and regulated by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Summary of major changes
The main changes affect applications for permits and approvals and registrations and include the following matters.
- The APVMA will be operating under a new compliance and enforcement framework which has given the APVMA broader enforcement powers to ensure compliance. The APVMA can now give formal warnings and enforceable directions. Wider sanctions for failure to comply, such as injunctions, infringement notices, enforceable undertakings and civil penalty provisions have also been introduced.
- Applicants can request pre-application assistance (for example, a face-to-face meeting with the APVMA) to help them understand how to submit a complete application, address the application requirements and address relevant statutory criteria.
- Applications for permits and approvals and registrations can now only be madeonline through the APVMA portal (unless special circumstances exist). (Those who were using the electronic application registration system (EARS) will be automatically transferred to the new system, whereas those who have not used EARS before are required to register for the online portal.) There will also be greater online interaction with the APVMA.
- A preliminary assessment (previously called an administrative/technical screening) of applications will be undertaken. The purpose of this is to conduct an initial administrative check of, and identify any defects in, the application.
- New evaluation criteria will apply (for applications made post-1 July 2014). The APVMA must consider the safety, efficacy and trade criteria set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth).
- There will be restrictions on how the APVMA can use information provided to it during the application process, including restrictions on the use of certain information in one application to assess or make decisions in connection with another application. Similarly, there will be limitations on the information the APVMA can consider during evaluation of applications and reconsideration (previously called chemical review).
- New terminology will apply, including for agency arrangements and data protection.
- New legislative instruments have been introduced and will cover: pre-application assistance; efficacy criteria; application requirements (information to be included in applications); manufacturing principles; listed chemical products (eg joint health products for dogs and horses and swimming pool and spa products).
The APVMA also launched a new website on 1 July 2014.
New regulatory guidelines to help guide stakeholders' interactions with the APVMA
To help explain the legislative changes and provide technical and supporting information, the APVMA has introduced new regulatory guidelines which will replace the manual of requirements and guidelines (MORAG). Transitional arrangements will be in place from 1 July 2014 to 30 June 2015. During this time, the old legislation will continue to apply to applications received by the APVMA before 1 July 2014. If the application has not been determined by 30 June 2015, the new regulatory guidelines will apply. MORAG will also continue to be available during the transitional period.