Consulting with NZ & AU industry on VICH matters 2 Consulting with NZ & AU industry on VICH matters 2. Implementing VICH Guidelines in Australia 3. Participating in VICH as an “Observer” Allen Bryce, Executive Director Veterinary Medicines, APVMA VICH Outreach Forum – February 2013

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 ILC AGCARM AHA ARRPA VMDA

Implementing VICH Guidelines in Australia Guidelines for applicants are published in our Manual of Requirements and Guidelines (MORAG) www.apvma.gov.au/morag_vet/ VICH Guidelines are incorporated into vetMORAG by – •    adding the entire VICH GL into MORAG; 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. 3

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