Therapeutic Goods Regulations 1990

For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.

Nothing in this regulation or in Schedule 5B is taken to prevent a disposal of unused emergency goods if:

the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):

registered goods or listed goods; or

exempt goods under section 18 of the Act; or

goods that are the subject of an approval or authority under section 19 of the Act; or

goods that are the subject of an approval under section 19A of the Act; and

the disposal is in accordance with other provisions of the Act and these Regulations relevant to the goods.

Nothing in this regulation or in Schedule 5B is taken to prevent a disposal of an unused emergency biological if:

the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):

included in the Register under Part 3‑2A of the Act; or

exempt under subsection 32CA(2) of the Act; or

the subject of an approval or authority under section 32CK or 32CM of the Act; or

the subject of an approval under section 32CO of the Act; and

the disposal is in accordance with other provisions of the Act and these Regulations relevant to the biological.