Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 97

Transitional vaping manufacturers--exemption from Part 3 - 3 of the Act

  (1)   For the purposes of this regulation, a person is a transitional vaping manufacturer if:

  (a)   the person carries out, on or after 1   January 2024, a step in the manufacture of therapeutic goods that are:

  (i)   a therapeutic vaping substance; or

  (ii)   a therapeutic vaping substance accessory; or

  (iii)   a therapeutic vaping kit; or

  (iv)   goods in a therapeutic vaping pack; and

  (b)   the person was, as at 2   May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph   (a) except that the other goods were not therapeutic goods; and

  (c)   before carrying out the step referred to in paragraph   (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph   (b).

  (2)   The Secretary may, in writing, approve a form for the purposes of paragraph   (1)(c).

Exemption

  (3)   For the purposes of subsection   34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part   3 - 3 of the Act in relation to the step in manufacture referred to in paragraph   (1)(a) of this regulation.

When exemption ceases

  (4)   Subregulation (3) ceases to have effect on 1   December 2024.



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