Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:56
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 56
Character Range: 449940–450594

56  Transitional—fee waivers in relation to certain designations
 (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.

Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017