Prescription medicines
Find out about prescription medicines and how they are regulated.
A prescription medicine is a medicine that can only be made available to a patient on the written instruction of an authorised health professional. Examples of prescription medicines include blood pressure tablets, cancer medicine and strong painkillers.
All prescription medicines are registered in the Australian Register of Therapeutic Goods (ARTG) and can be identified by an AUST-R number on the label.
Key information
- See the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
- For more detailed information on prescription medicines go to Prescription medicines overview.
- For information on obtaining market authorisation go to Supply a prescription medicine.
- For information on manufacture go to Manufacture a medicine.
- For a list of standards and guidelines go to Standards and guidelines for prescription medicines
- Search the Prescription medicines collection
More information
- Prescription medicines overview
- Australian Public Assessment Reports for prescription medicines (AusPARs)
- Australian regulation of prescription medical products
- Prescription medicines regulation basics
- Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data
- List of countries and jurisdictions determined to be comparable overseas regulators (CORs)
New prescription medicines
Latest alerts
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Consumers and health professionals should be aware that two unrelated cases of counterfeit injectable botulinum toxin products have been stopped at the Australian border.
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All strengths of the Mounjaro vial presentation are discontinued but the Mounjaro KwikPen is available in the same strengths.
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Consumers and health professionals should be aware that examples of counterfeit products have been stopped at the Australian border. These tablets may pose a serious risk to your health and should not be used.
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GMP Clearance: backlog reduction strategy commences today
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Product Information safety updates - June 2025
Information for health professionals about medicines with safety related updates to their Product Information.
Latest publications
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Advisory Committee on Medicines meeting statement
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Advisory Committee on Medicines meeting statement
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