Commenting on VICH Guidelines in Australia & New Zealand Debbie Morris, Director, ACVM, New Zealand Allen Bryce, Executive Director Veterinary Medicines, APVMA, Australia VICH Outreach Forum #4 – June 20143

Outline the consultation process within Australia and New Zealand on VICH guidelines providing ANZ comment on VICH guidelines incorporating VICH guidelines into the APVMA and ACVM requirements participating in VICH as an “observer” In each case, we need to consider whether the GL can be incorporated in its entirety, or whether some modification is required to suit Australian requirements. Minor modifications can be achieved through a covering note describing how the Australian requirements differ from the VICH ones. Major changes take more work as a revised Australian document would be needed.

AU/NZ Steering Committee representative VICH Secretariat EWG Chair AU/NZ Steering Committee representative AU/NZ EWG member(s) ratifying decisions consultation AU/NZ VICH Mgt Group Individual experts in industry or elsewhere ACVM APVMA AVMAC Public ILC AGCARM AMA ARRPA VMDA

The ANZ expert representative is supported by an working group made up of interested experts from industry and government to develop input into the EWG Any issue identified is bought to the attention of the ANZ SC for resolution or for raising at the VICH SC Once the draft GL is developed it is circulated by the regulators to a wide range of interested and affected parties for comment In each case, we need to consider whether the GL can be incorporated in its entirety, or whether some modification is required to suit Australian requirements. Minor modifications can be achieved through a covering note describing how the Australian requirements differ from the VICH ones. Major changes take more work as a revised Australian document would be needed.

VICH Guidelines are incorporated into the Guidelines by – In Australia, guidelines for applicants are published in the APVMA’s Regulatory Guidelines http://new.apvma.gov.au/node/1060 The Regulatory Guidelines replace the old Manual of Requirements and Guidelines (MORAG) from 1 July 2014. VICH Guidelines are incorporated into the Guidelines by – •    adding the entire VICH GL; or •    adding the VICH GL with an indication of how Australia departs from it; or •    modifying or creating our own guideline within MORAG to adopt all the elements of the VICH GL that are practical to adopt within Australia. In each case, we need to consider whether the GL can be incorporated in its entirety, or whether some modification is required to suit Australian requirements. Minor modifications can be achieved through a covering note describing how the Australian requirements differ from the VICH ones. Major changes take more work as a revised Australian document would be needed.

Participating in VICH as an “observer” Observers are expected to - Participate actively participation in VICH Steering Committee meetings Participate actively in working group and Guideline development provide subject experts to participate in EWGs Adopt VICH Guidelines to the fullest extent possible – the majority are adopted Must have an ongoing long term commitment to VICH processes