Section 6A of the Agvet Code provides that the APVMA may make written guidelines for performing our functions and exercising our powers under the Agvet Code.
6A Guidelines are intended to assist our staff in making decisions in a consistent and transparent way. They are not guidelines for applicants, however, applicants may find it useful in preparing their applications to understand what our staff will consider in making their decisions. For this reason, the Agvet Code stipulates that all 6A Guidelines must be published.
6A Guidelines are not the same as other guidelines. If we make a 6A Guideline, APVMA decision-makers must have regard to it in performing the functions and exercising the powers under the Agvet Code.
6A Guidelines are not law. However, 6A Guidelines must not be inconsistent with an 'Agvet law' (which is defined in the Agvet Code to mean the Agvet Code, as well as certain other Acts). If there is a conflict between a 6A Guideline and an Agvet law, the Agvet law will prevail. Similarly, 6A Guidelines do not constitute legal advice and do not replace legal obligations under the Agvet law.
While we must 'have regard to' 6A Guidelines in performing our functions and exercising our powers under the Agvet Code, we are not bound to follow the guidelines and will depart from them in appropriate cases. This allows us to be appropriately flexible in circumstances particularly where the guidelines have not taken into account a specific circumstance or particular matter.
The APVMA is currently reviewing all 6A Guidelines. Some previous 6A Guidelines have been revoked as part of this review but remain available for reference purposes. We expect that the new 6A Guidelines will be issued throughout the first half of 2023.
Data guidelines provide technical advice and guidance to applicants. These are reference materials and do not relate to a function or power under the Agvet Code. Data guidelines are not 6A Guidelines, but rather provide important guidance on technical matters such as which modules would apply to different application types. Data guidelines are available on the APVMA website.