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You’re responsible for keeping your medicine safe and complying with relevant regulations after it’s approved and supplied in Australia.
You must:
maintain your product’s inclusion in the Australian Register of Therapeutic Goods (if required)
apply for variations if required if there are any changes to your product
pay ongoing regulatory charges
monitor safety
report product issues.
We also monitor medicines to protect public health and work with you to address any safety concerns.
This stage helps ensure your medicine continues to meet safety, quality and compliance requirements while it's on the market.
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.