You must comply with regulatory requirements when supplying or distributing OTC medicines.
You are responsible for maintaining quality during production, supply, transport, and distribution.
We regulate these activities to protect public health and ensure over-the-counter medicines remain safe, of good quality and effective.
If you import or export over-the-counter 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 OTC 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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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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GuidanceGuidance for supplying substitute medicines when registered medicines are unavailable or in short supply.
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