Therapeutic goods can only be lawfully imported into, supplied in or exported out of Australia if those goods are included on the Australian Register of Therapeutic Goods (ARTG). The ARTG is a publicly accessible repository of all therapeutic goods approved for supply in Australia. The Therapeutic Goods Administration (TGA) is the regulator that oversees the ARTG from an assessment and enforcement perspective to ensure that the benefits to consumers will outweigh any risks associated with products for therapeutic use. This article explains what the ARTG is and how to know if your product needs to be registered.
What is Included on the ARTG?
Generally, therapeutic goods are medicines or devices that are included on the ARTG where the TGA has assessed them to have met the requirements for quality and safety. That is, if the TGA has determined that the product does not meet acceptable standards, then it will not be registered on the ARTG. Therefore, it will not be legal for supply in Australia. In some circumstances, the TGA will assess certain medicines for quality and safety but will not evaluate each medicine individually to see if they are effective before listing it on the ARTG. These are referred to as listed medicines (compared to registered therapeutic goods). They are generally medicines that are considered to be low risk and therefore are capable of some self-assessment by sponsors.
If it is a listed medicine, it must also include a listing number on the label as proof of listing.
How Do I Know if I Need to Register My Product on the ARTG?
Even if your product is a therapeutic good, there are some exceptions to the general requirement for registration on the ARTG. To determine what products should be included in the ARTG, you should consider the following:
Is Your Product a Therapeutic Good?
Consider carefully if your product is, in fact, a therapeutic good. It is important at the outset to confirm the regulatory status of your product so that you can determine what legal requirements apply. That is, is your product a therapeutic good, or is it a food or cosmetic product that separate standards regulate?
Is Your Product an Excluded Good?
Excluded goods are those that the TGA has already determined to be low-risk products. They are not subject to TGA requirements and therefore it is not a requirement for them to be included in the ARTG.
Is Your Product a Medical Device?
A medical device is a type of therapeutic good that is intended for use on humans for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
- investigation, replacement or modification of the anatomy or of a physiological process; or
- control of conception.
Is Your Product an Exempt Medical Device?
Certain classes of medical devices may be exempt from ARTG registration. However, they may still be subject to other TGA compliance requirements.
Is Your Product Part of a Special Access Scheme or Clinical Trial?
In certain circumstances, you can supply unapproved products in Australia. Most commonly, this will be to a limited number of people where the product is subject to an approved clinical trial or special access scheme.
Is the Product Already Registered on the ARTG?
Are you acting as a retailer of a product that is already registered on the ARTG? In this case, you do not need to re-apply for ARTG registration. You should contact the sponsor of that product.
The process to include a product on the ARTG will depend on the type of therapeutic good you are supplying. Generally, however, the legal requirements that apply to all therapeutic goods will include:
- manufacturing requirements;
- product and labelling standards; and
- some evidence to support the therapeutic claims that you make about the goods,
before a product is included in the ARTG.
Continue reading this article below the formWhat Happens After Registration of My Product?
In short, registration on the ARTG is just the beginning. Whether you are a sponsor, manufacturer or agent, you have ongoing responsibilities to ensure that your product continues to meet the required regulatory standards, which TGA will continue to monitor. This will include:
- ongoing compliance with the advertising and labelling requirements for therapeutic goods that are consistent with your products ARTG registration; and
- reporting any adverse events related to your product to the TGA.
Adverse effects include side effects to medicines or a problem or incident involving medical devices. This includes any ‘near miss’ event that may have caused harm to patients, whether directly caused by the therapeutic good itself or as a result of the user or circumstantial factors.
Key Takeaways
Before you market or supply your product, it is important to consider if it requires registration on the ARTG and to determine what regulatory standards will apply. The process of TGA assessment and approval can be a costly and time-consuming exercise. If you have determined that your product is a therapeutic good (or medical device), it is worth understanding whether it will be subject to any TGA exemptions or exclusions. If no exceptions apply, then you will need to register or list your therapeutic good on the ARTG. Additionally, you will need to continue to comply with the ongoing compliance requirements that come with inclusion on the ARTG. For advice about registering therapeutic goods, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.
Frequently Asked Questions
The Australian Register of Therapeutic Goods (ARTG) is a publicly accessible repository of all therapeutic goods approved for supply in Australia.
The Therapeutic Goods Administration (TGA) is the regulator that oversees the ARTG from an assessment and enforcement perspective. It ensures that the benefits to consumers will outweigh any risks associated with products for therapeutic use.
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