Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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312 result(s) found, displaying 251 to 275
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceGuidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.
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GuidanceGuidance for importation, supply and wholesale requirements for medicinal cannabis.
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Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG. -
GuidanceGuidance about how to promote your business and service, without advertising biologicals to the public.
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GuidanceFrom 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.
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GuidanceGuidance to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100.
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GuidanceGuidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceThis guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply.
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GuidanceGuidance on the transitional arrangements and obligations of sponsors and manufacturers.
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GuidanceGuidance on the transitional arrangements and obligations.
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GuidanceGuidance for sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) on transitional arrangements and obligations.
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GuidanceGuidance to assist sponsors of medical devices that administer medicines or biologicals by inhalation meet their obligations and comply with regulations
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GuidanceGuidance about how to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.
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GuidanceGuidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.
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GuidanceGuidance about how we define and regulate listed disinfectants, including how to submit a product application and the supporting data and other information required.
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceThis guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations.
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GuidanceGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
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GuidanceGuidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.
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GuidanceGuidance on what information to include in an application to vary the Therapeutic Goods (Permissible Ingredients) Determination.
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GuidanceThis guidance is for sponsors intending to use the priority review pathway for biologicals.