Regulation of medicines

Why and how medicines are regulated 

Medicines are regulated to ensure their safety, effectiveness and quality.

The Commonwealths Therapeutic Goods Administration (TGA) regulates medicines and therapeutic goods in Australia. For more information see How therapeutic goods are regulated in Australia.

Additionally, each state or territory has its own laws that determine where consumers can buy a particular medicine. The 窪蹋勛圖厙 Ministry of Health Pharmaceutical Services is responsible for administering the laws that govern access to medicines and poisons. 

Why laws about medicines in 窪蹋勛圖厙 differ from those of states and the territories 

The differences in law that exist across Australia today are historical. Before Federation, each of the colonies (which would later become the states) had its own laws governing medicines, poisons and the practice of pharmacy. When the Constitution of Australia came into effect in 1901, the Commonwealth was given limited powers regarding medicine control, with most power remaining with the states.  

Currently, the Commonwealth controls the subsidisation of the cost of medicines, the registration of products and manufacturers, and the import and export of medicines. Meanwhile, the states and territories control other aspects of access to medicines and poisons. While differences still exist, significant effort has been made over the last 50 years to align the medicines and poisons laws across the states and territories. 

Scheduling of medicines 

In Australia, medicines and poisons are classified into Schedules that regulate how medicines and posions are made available and how they are distributed. The scheduling system categorises medicines and poisons based on their potential for harm, their therapeutic use, and the level of control needed to ensure public health and safety. More information can be found on the TGAs website at Scheduling basics of medicines and chemicals in Australia

Prescription medicines

Prescription medicines are categorised into either Schedule 4 or Schedule 8. 

Medicines classified under Schedule 8 are also known as controlled drugs or drugs of addiction and have strict legislative controls. Examples of these medicines include: 

  • opioid analgesics, such as morphine, fentanyl, oxycodone methadone and buprenorphine
  • cannabis medicines containing nabiximols and tetrahydrocannabinols
  • stimulant medicines used to treat ADHD, such as dexamfetamine, methylphenidate and lisdexamfetamine
  • the medicines flunitrazepam and alprazolam.

You can find other examples on the Schedule 8 medicines 漍漍w梗莉梯硃眶梗.

Schedule 8 medicines are prescription medicines that have a recognised therapeutic need but also a high risk of misuse, abuse, and dependence. In some circumstances, the doctor will need to get an approval or permission to prescribe or supply these medicines. For more information see Approval requirements for certain medicines.

Consumers should be aware of these legal issues when receiving treatment with these medicines.

窪蹋勛圖厙 requirements for repeat prescriptions  

It is a legal requirement for a pharmacist to keep repeat prescriptions for certain medicines at the pharmacy where the original prescription was dispensed.

The medicines that this applies to are those listed in Schedule 8 medicines and Schedule 4 Appendix B drugs - Special restricted substances.

In these cases, the pharmacist cannot give back the repeat prescription to take elsewhere when a future supply is needed.

If you are travelling, or cannot get back to this pharmacy for a resupply you can either:

  • arrange for someone to pick up the medicine for you
  • ask the pharmacy about arranging for it to be delivered to you
  • ask your doctor to issue you with a new prescription.

Who to contact for medicines advice

  • If you have immediate concerns about a person's health and safety, call triple zero (000) or visit a hospital emergency department.
  • For 24-hour health advice you can call the Health Direct hotline at 1800 022 222. You can also visit the website at Health Direct to check your symptoms, find a health service, or find health information.
  • For information on all types of medicines you can call the Medicines Line on 1300 MEDICINE (1300 633 424). Calls are answered by registered pharmacists, and the service is available Monday to Friday, 9 am to 5 pm AEST (excluding 窪蹋勛圖厙 public holidays).
  • The Poisons Information Centre provides the latest poisons information to the public. Advice is available 24 hours a day, 7 days a week, at 131126 from anywhere in Australia.
Current as at: Tuesday 11 February 2025
Contact page owner: Pharmaceutical Services