In Short
- Selling pharmaceutical drugs online is heavily regulated, requiring specific licences and adherence to strict guidelines.
- Compliance with both federal and state laws is necessary, including rules regarding prescription medications.
- Ensure proper security measures are in place to protect customer information and prevent unauthorised access.
Tips for Businesses
Before selling pharmaceuticals online, secure the necessary licences and understand both federal and state regulations. Prioritise strict compliance, especially with prescription drugs, and safeguard customer data with robust security measures. Keep abreast of changes in legislation to maintain compliance and effectively manage the legal responsibilities of online pharmaceutical sales.
Running an online pharmacy, or app, or providing medicines as part of a wider service could potentially be a profitable business venture. However, this is an area which is heavily regulated, so you should proceed with caution. It might be harder than you think to sell even common over-the-counter medicines like paracetamol. This article will explore the relevant rules and some of the factors to consider if you want to sell pharmaceutical drugs online.
Which Rules are Relevant?
The Therapeutic Goods Act 1989 (Cth) and the Poisons Standard (created under section 52D of the Therapeutic Goods Act 1989 (Cth)) regulate the sale of drugs in Australia under the oversight of the Therapeutic Goods Administration (TGA). The TGA provides comprehensive guidance on compliance requirements for selling medicines legally.
You should check the Office of Drug Control’s list of drugs and ingredients as some drugs can only be imported into Australia with permission.
It is important to note that medicines purchased online from overseas companies are not regulated by the TGA. Their ingredients and contents may differ from Australian approved products, even if the branding appears the same.
Can I Supply Drugs?
Whether you can supply or sell drugs depends on what type of drug you want to sell. In general, you will need to have a valid listing or registration on the Australian Register of Therapeutic Goods (or ARTG) to import or supply drugs in Australia.
Only licenced entities, pharmacies or medical practitioners can sell specific drugs. Additionally, some drugs require a valid prescription from a doctor or health professional.
There are also restrictions on supplying medicines to others who intend to re-sell or distribute them further. For example, pharmacists can dispense to individual patients for personal use, or to doctors/practitioners for emergency treatment purposes only.
You are also not allowed to supply medicines to somebody who is going to sell or supply them to others. For example, a friend or family member. Pharmacists can only supply medicines to:
- patients for their personal use; or
- doctors or other authorised medical practitioners for emergency treatment.
Poisons Standard Schedules
The Poisons Standard places different drugs in different schedules. To sell the drugs listed in a specific schedule, you must be one of the specific entities or people authorised to do so. Drugs for therapeutic use are mostly included in Schedules 2, 3, 4 and 8.
For example, Schedule 2 contains pharmacy medicines that can be sold by pharmacists or other licensed personnel without a prescription.
Schedule 3 medicines are also pharmacist only medicines, meaning they can only be sold by a pharmacist. However, unlike Schedule 4 medicines, Schedule 3 medicines may be sold without a prescription.
Schedule 4 substances can only be sold with a valid prescription from an authorised person. Generally, an ‘authorised person’ will be a registered doctor or registered nurse. However, this is dependent on relevant State and Territory laws.
Schedule 8 lists controlled drugs with stringent restrictions due to their risk of abuse and addiction. Manufacture, supply and possession of Schedule 8 drugs is tightly regulated.
What About Supplements?
Some supplements, such as vitamins, minerals and protein powders, are considered therapeutic goods and must be listed or registered on the ARTG.
As of 30 November 2020, the TGA has declared that certain sports supplements will be considered therapeutic goods and regulated as medicines. This means that if you have previously sold sports supplements and they contain qualifying ingredients, such as a substance in the Poisons Standards or identified on the World Anti-Doping Code’s Prohibited List, you will need to consider altering product formulas to continue to supply them as foods. Alternatively, you will need to enter your supplement on the Australian Register of Therapeutic Goods.
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Similarly, if you advertise sports supplements that are now considered therapeutic goods, you must comply with the relevant advertising requirements. This includes any sponsored influencer posts promoting vitamin or protein powder.
Businesses should review their product ranges and consult the TGA guidance to determine what compliance actions are necessary for their supplement products moving forward.
And Vitamins?
The TGA will regulate and evaluate higher risk medications and will not evaluate lower risk medicines. However, the TGA does regulate the safety and quality of such medications by ensuring that certain ingredients or certain health claims from preapproved lists can be used.
This means that vitamins will not be checked before they are released to a market. Instead, the TGA might review a product as part of a general compliance check. These products must also be produced in certified facilities which meet the TGA’s manufacturing quality standards.
This means that clear evidence must be kept and provided to prove the efficacy of such products as well.
Can I Advertise Pharmaceutical Drugs Online?
For most medicines sold over the counter (which means that a customer can purchase them without a prescription), you can advertise to consumers but only from a pharmacy and in some cases a supermarket. In contrast, you cannot advertise prescription-only medicines directly to consumers in Australia.
The Therapeutic Goods Advertising Code sets out advertising regulations and restrictions for non-prescription and complementary medicines. Social media posts, such as posts on Facebook, LinkedIn or Instagram, which promote the use or supply of therapeutic goods, are also advertisements. Therefore, you must comply with the rules for advertising therapeutic goods when advertising on those platforms.
What Else Should You Consider?
Many people will be suspicious of buying drugs on the internet from an unknown website. To help reassure consumers that you are permitted to sell pharmaceutical drugs and that you have the proper authorisations in place, you may want to consider:
- displaying details of your pharmacy accreditation or registration;
- providing contact details for customers to talk to a pharmacist about what drugs are right for them, such as a phone number or email address; and
- showing that you have a physical address in Australia and an Australian Company Number.
Key Takeaways
The regulation of therapeutic goods (i.e. drugs and medicines) is complex. Whether you can sell them online will depend on:
- what type of drug you want to sell; and
- whether you are a pharmacist, doctor or licensed entity.
If you want to sell pharmaceutical drugs online, our experienced healthcare lawyers can assist as part of our LegalVision membership. For a low monthly fee, you will have unlimited access to lawyers to answer your questions and draft and review your documents. Call us today on 1300 544 755 or visit our membership page.
Frequently Asked Questions
This depends on what type of drug you want to sell. There are specific drugs that only licenced entities, pharmacies or medical practitioners can sell. Some drugs also require a valid prescription from a doctor or health professional.
Supplements and complementary medicines, like vitamins, minerals and protein powders, are usually treated as foods rather than pharmaceutical products. However, certain sports supplements are considered therapeutic goods and regulated in the same way as other medicines. It will ultimately depend on the ingredients and subsequent classification.
You can advertise to consumers for most over-the-counter medicines but only from a pharmacy or supermarket. However, you cannot advertise prescription-only medicines directly to consumers in Australia. This includes social media posts on Facebook, LinkedIn or Instagram.
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