You must submit this notification to the TGA to qualify as a transitional manufacturer under regulation 97 of the Therapeutic Goods Regulations 1990 and be exempt, between 1 January 2024 and 1 December 2024, from the requirement to hold a manufacturing licence under Part 3-3 of the Therapeutic Goods Act 1989 in relation to the manufacture of therapeutic vaping goods. You may only submit this notification if, as at 2 May 2023, you were carrying out a step in the manufacture of non-therapeutic vaping goods that is equivalent to the step of manufacture that you intend to undertake in relation to therapeutic vaping goods.
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