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

2. 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

3. Implementing VICH Guidelines in Australia
Guidelines for applicants are published in our Manual of Requirements and Guidelines (MORAG)
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

4. 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