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After an unapproved medicinal cannabis product has been supplied, you have specific responsibilities.
You must:
- maintain accurate records
- monitor product use
- report supply data every 6-months
- report adverse events.
We oversee these activities to ensure that unapproved medicinal cannabis products have been supplied appropriately.
Understanding and fulfilling your obligations is crucial for maintaining compliance.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.