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About prescription medicines
Prescription medicines, also known as prescription-only medicines, are pharmaceutical products that can only be accessed with a valid prescription from an authorised healthcare professional.
These include higher-risk treatments such as:
blood pressure medications
cancer therapies
strong pain relief medicines.
In Australia, all prescription medicines must be entered on the Australian Register of Therapeutic Goods (ARTG) as registered medicines.
We evaluate the safety, quality and efficacy of prescription medicines before they are approved for registration on the ARTG.
This ensures that each product meets rigorous standards for quality, safety, and efficacy.
We offer several regulatory pathways for registration, including:
the standard pathway
priority review
provisional determination
Comparable Overseas Regulators (COR) pathway.
Not all medicines we accept for evaluation are approved. Whether a medicine is approved depends on the outcome of our assessment.
If approved, sponsors must maintain ongoing compliance with regulatory requirements, and we continue to monitor the safety of these medicines to ensure they 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.
