You must comply with regulatory requirements when supplying or distributing medicines.
You are responsible for maintaining quality during production, supply, transport and distribution.
We regulate these activities to protect public health and ensure medicines remain safe and effective.
If you import or export human cell and tissue products, you must comply with Australian laws.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. You may also have to meet obligations that apply to all products.
Supply
Understand your obligations to manage the ongoing supply of products.
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PageYou need to notify us if your reportable medicine is in shortage or is being discontinued.
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PageHow to supply a therapeutic good and get started. Find out how to confirm your product is a therapeutic good, how it's regulated and if it needs to be entered in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageWe welcome applications to register new generics of medicines included in the Australian Register of Therapeutic Goods (ARTG) that are in long-term shortage.
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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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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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PageInformation about special circumstances that may allow a medicine to be imported, exported or supplied in Australia.
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PageInformation on how to legally supply a prescription medicine in Australia. This includes how to register the product in the Australian Register of Therapeutic Goods (ARTG) and guidance to understand the ongoing responsibilities.
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GuidanceGuidance for supplying substitute medicines when registered medicines are unavailable or in short supply.
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LegislationThese Rules authorise specified classes of health practitioners to supply specified therapeutic goods in certain circumstances, under the TGA's Special Access Scheme category C pathway.
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Decision treeSponsors of medicines, use this decision tool to determine the patient impact level of a shortage (or an anticipated shortage) of products and if you need to report it.
Storage and handling
Access information about how the storage and handling of products is regulated.
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PageInformation about the shortage and the Serious Scarcity Substitution Instrument
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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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PageOverview of stability testing of listed complementary medicines for sponsors and manufacturers.
Import and export
Access requirements for import and export of therapeutic goods.
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FormsApplication form to import, supply or export a therapeutic good that does not comply with standards.
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PageNew database available
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PageRecords of special decisions made to help deal with COVID-19-related delays.
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PageTo export medicines from Australia, you must meet requirements set out in the Australian therapeutic goods legislation
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GuidanceThis guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).
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FormsForm to apply to add an export name to a product registered in the ARTG.
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PageInformation on the legal requirements for importing therapeutic goods into Australia, including 'unapproved' therapeutic goods and controlled substances.
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PageAustralia has rules on importing medicines and medical devices.
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GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.
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PageLegal requirements for importing therapeutic goods into Australia, including unapproved therapeutic goods and controlled substances.
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PageInternational agreements and arrangements for GMP clearance
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PageSponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.
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FormsApply to import and supply substitute medicines under section 19A
Product types