Note
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
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PageSection 7AA of the Therapeutic Goods Act 1989 allows the Minister to determine that specified goods are excluded goods for the purposes of the Act.
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PageSection 22 instruments refer to various regulatory instruments made under the Therapeutic Goods Act 1989. These include approvals for orphan drugs and therapeutic goods, as well as other regulations related to the regulation of pharmaceuticals and medical devices.
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PageSection 23 instruments for assessed listed medicines, registered complementary medicines and medicines listed applications.
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PageThe following instruments are made under section 47B of the Therapeutic Goods Regulations 1990.
Regulatory decision notices
- Therapeutic Goods (Medical Devices - Application Form for Priority Applicant Determinations) Approval 2020
- Therapeutic Goods (Medical Devices - Application Form for Inclusion) Approval (No. 2) 2021
- Therapeutic Goods (Medicine Shortages and Discontinuations - Notification Forms) Approval 2023
- Therapeutic Goods (Application Form for Conformity Assessment Body Determination) Approval 2021
- Therapeutic Goods (Custom-Made Medical Devices-Annual Reporting Form) Approval 2021
- Therapeutic Goods (Permissible Ingredients - Application for Variation) Approval 2023
- Therapeutic Goods (Mercury - Form for Application to Import or Export) Approval 2023
- Therapeutic Goods (Medicines and OTG - Authorised Supply Notification Form) Approval 2023
- Therapeutic Goods (Therapeutic Vaping Goods - Transitional Manufacturer Notification Form) Approval 2024
- Therapeutic Goods (Change of Sponsor Name - Notification Form) Approval 2024
- Therapeutic Goods (Change of Sponsorship - Notification Form) Approval 2024
- Therapeutic Goods (Clinical Trial Notification Form) Approval 2024
- Therapeutic Goods (Authorised Prescriber Scheme - Application Form) Approval (No. 2) 2024
- Therapeutic Goods (Special Access Scheme - Application and Notification Forms) Approval (No. 2) 2024
- Therapeutic Goods (Therapeutic Vaping Goods - Sponsor Notice and Restatement Form) Approval 2025
- Therapeutic Goods (Therapeutic Vaping Goods - Supply Information Form) Approval 2025
- Updates to legislative instruments exempting monographs as standards
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