Therapeutic Goods Regulations 1990

This regulation applies if, before the commencement day:

a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and

the application had not been finally determined.

Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.

If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):

the designation:

comes into force when it is made; and

remains in force for 12 months; and

while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.