Importing Medicines into Australia

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Introduction

Hepatitis Australia is aware some people have purchased, or are looking to import medicines from overseas for the treatment of hepatitis C.

Hepatitis Australia advises caution and recommends you consider the following information carefully:

  • Due to poor quality checks, buying medicines from overseas suppliers can be risky. It is hard to be sure that you will get the right medicine, in the right dose and without anything else in it which could be harmful. 
  • So that you do not unintentionally break the law, you also need to know the rules about bringing medicines into the country.
  • To check if you need treatment urgently, you can see your doctor for a liver health assessment and discuss what other options are available.
  • Using medicines from overseas may have a negative affect on your current care.
  • Be wary of offers that sound too good to be true and are from unfamiliar sources. 

The Therapeutic Good Administration (TGA) is responsible for approving the use of medicines and other therapeutic goods, such as herbal and dietary preparations.  The TGA ensures medicines are of high quality, authentic and safe to use.  The TGA provides comprehensive, helpful information relating to the importation of medicines.

Hepatitis C treatments.

 New, more effective and tolerable treatments are becoming available to treat and in most cases cure hepatitis C.  The Australian Government is currently working with pharmaceutical companies with a view to list these new medicines on the Pharmaceutical Benefits Scheme (PBS) and make these affordable for Australians. Hepatitis Australia recommends you always discuss hepatitis C treatment with your doctor before considering the purchase of any medicines from overseas or via websites. 

 It is important to discuss the following with your doctor:

  • Is your doctor up-to-date on the latest information about treating hepatitis C? (e.g. medicines available and the dosage)
  • Is it important for your health that you start treatment for your hepatitis C now?
  • What treatments are currently available to you in Australia?
  • If you need treatment now, are there any special access schemes you can access?
  • Would your doctor be able to provide you with the necessary prescriptions to purchase the medicine?
  • If you did use a medicine purchased overseas, would this impact on the doctor’s ability to prescribe other medicines and conduct, or order tests to monitor the effectiveness of the medicine?
  • What support would be available to you if you did start taking a medicine purchased overseas?

 The following information has been adapted from the TGA website. 

Buying medicines over the Internet

The Internet can offer you a convenient way to access products, but online purchases of medicines or medical devices should be approached with caution.

Products available on international websites are not regulated by the TGA. If care is not taken, you may inadvertently break the law, waste your money or risk your health. Ordering a medicine, including dietary supplements and herbal preparations over the Internet, is not recommended if you are unsure of the exact ingredients used in the product as you may accidently bring illegal substances into the country.

Without taking measures to ensure a website is legitimate, you may face risks, including using medicines and medical devices that:

  • Are counterfeit (fake)
  • Are too strong or too weak
  • Contain undisclosed, dangerous ingredients
  • Are past their use-by-date
  • Are contaminated or not manufactured to appropriate standards. 

If you are considering purchasing medicines over the Internet we recommend that you:

  • Consult a health professional first. In most cases you should obtain a prescription from a doctor and you should be advised about dosage, possible side-effects and any drug interactions.
  • Check to ensure the website provides adequate contact details. Write down the name of the site and any contact details. A legitimate site will provide a way for you to talk to someone if you have a problem.
  • Be suspicious of wild claims. Remember, if information sounds too good to be true, it probably is.
  •  

Warning signs to look out for include:

  • Emotive and sensational phrases with exclamation marks, such as 'miracle cure!' and 'scientifically proven breakthrough!'
  • Claims that the product is not available elsewhere
  • 'Testimonials' from cured customers or famous medical experts
  • Claims that the product can cure serious or incurable diseases
  • Greatly reduced prices and offers to supply medicines without a prescription
  • Unsolicited email (spam). If you receive an unwanted or unprompted email from an online pharmacy, delete it. Spam email offers are often designed to steal credit card details.

 If you want to report a problem with a product purchased over the Internet, please contact the TGA on 1800 020 653.

 Legal requirements for the personal importation of medicines.

 You need to comply with the legal requirements to import therapeutic goods for personal use under the Personal Importation Scheme. You can access more details at the TGA website

Under Australia’s Personal Importation Scheme, you may import a 3-month supply at the one time (at the maximum dose recommended by the manufacturer) of unapproved medicines into Australia without any approval required by the TGA provided that:

  • The goods are for your own treatment or the treatment of your immediate family
  • You do not supply (sell or give) the medicine to any other person
  • Where possible, you keep the medicines or medical devices in their original packaging with any dispensing labels intact
  • The goods are not restricted under Australian Customs’ controls or quarantine rules and the goods do not contain a controlled substance
  • The goods are not injections that contain material of human or animal origin (except insulin)
  • The total quantity of the goods imported within a 12-month period does not exceed 15-months’ supply of the goods (for medicines, at the maximum dose recommended by the manufacturer)
  • A prescription from an Australian-registered medical practitioner is required for some medicines before being brought into the country. 

If you wish to bring more than 3-months’ supply at the one time into Australia, an Australian-registered doctor will first need to apply to the TGA for Special Access Scheme approval. 

Customs - For more information about Customs and quarantine requirements for therapeutic goods, please refer to the TGA website.

What are counterfeit medicines?

Counterfeit medicines or medical devices are often packaged or marketed to mimic a genuine item. Products are considered counterfeit if the labelling, presentation, advertising, formulation or source of the goods is false. Counterfeiting can apply to both branded (originator) and generic products.

 The TGA, with cooperation from state and territory Governments, closely monitors the supply chain in Australia to prevent counterfeit medicines or medical devices from entering the market.

 Risks associated with counterfeit medicines.

Although counterfeit medicines may look like genuine medicines, they can potentially contain:

  • The wrong active ingredient
  • No active ingredient
  • Too much or too little active ingredient
  • Toxic or dangerous substances. 

People using counterfeit medicines risk unexpected or potentially serious negative reactions. You can also suffer harm from leaving a serious medical condition untreated or inappropriately treated. Furthermore, counterfeit medicines compete unfairly with legitimate products, and have the potential to weaken public confidence in the health system. You can find out more about counterfeit medicines at the TGA website.

Reporting suspected counterfeit medicine.

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Online: Visit the TGA Website  

In writing, via post to: 

Chief Investigator
Regulatory Compliance Unit
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

For more information visit the Therapeutic Good Administration (TGA) website at: https://www.tga.gov.au/importing-mail-or-courier

If you would like to talk about this issue you can call the Hepatitis Information Line on 1300 437 222

Disclaimer:  Hepatitis Australia does not endorse or provide comment on any specific products or websites.