You must comply with regulatory requirements when supplying or distributing assessed listed medicines. This ensures their quality and safety.
Effective supply and distribution processes are essential to keep products available and safe for consumers.
If you import or export these medicines, you must comply with Australian legislative requirements.
Understanding these requirements helps you meet your legal obligations and manage risks throughout the supply chain for assessed listed medicines.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to assessed listed medicines. You may also have to meet obligations that apply to all medicines and all products.
Storage and handling
Access information about how the storage and handling of products is regulated.
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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.