You must comply with regulatory requirements when supplying or distributing prescription medicines.
If you import or export prescription medicines, you must comply with Australian laws.
You are responsible for maintaining quality during supply, transport, and distribution.
We regulate these activities to protect public health and ensure prescription medicines remain safe and effective.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription medicines. You may also have to meet obligations that apply to all medicines and 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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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 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.
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
Import and export
Access requirements for import and export of therapeutic goods.
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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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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.