Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.
(2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.
(3) In this regulation:
"inspection" means an inspection in relation to a metropolitan site.