Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.
(2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:
(a) paragraphs 45(12)(c) and (d);
(b) paragraph 46(2)(g);
(c) items 1 to 2B in Part 1 of Schedule 3;
(d) Part 3 of Schedule 3.