Before you can sell certain cosmetic or skincare products in Australia, it’s important to not only ensure that your products are safe for consumers to use, but also that your business is meeting all of its regulatory and compliance requirements.
Depending on what you are manufacturing, certification from the Therapeutic Goods Administration (TGA) may be needed before you can sell your products—but how can you find out if you need a TGA certificate?
Here we provide a quick overview of the rules around TGA-approved manufacturing to help you work out if it applies to your business and how you can ensure compliance.
First things first—what products are you making?
Before we get started, it’s important to draw attention to the fact that the TGA is only concerned with products which are classified as ‘therapeutic’. This includes products such as:
- prescription medications
- vaccines
- sunscreens
- vitamins and minerals
- medical devices
- blood and blood products.
Many products that you might assume to be therapeutic, are in fact classified as cosmetic products and do not require TGA approval. Generally, unless the product you want to manufacture is a listed or registered medicine, you won’t need to comply with any requirements set by the TGA.
If you’re at all unsure, your manufacturer should be able to provide you with guidance as to whether your product is classified as either therapeutic or cosmetic.
The rules around manufacturing and TGA-compliance
If you are producing a therapeutic product, it’s vital that your product is manufactured in compliance with all TGA requirements.
Do I need to register as a TGA sponsor?
Listed medicines in Australia require an Australian ‘sponsor’. As a retailer or distributor of a therapeutic good, you are considered the ‘sponsor’ of that product and will need to obtain TGA approval before you can sell your product. Being a sponsor entails taking responsibility for the product through its lifecycle. This includes ensuring that the product is manufactured according to TGA requirements, as well as maintaining quality and compliance after it is on the market.
How to register as a sponsor
- Submit an application to the TGA with relevant information about your business and the products you wish to sponsor.
- Ensure that your manufacturing processes comply with TGA standards.
- Pay any applicable fees associated with the registration process.
Ongoing responsibilities as a sponsor
Once your product is listed and on the market, as a sponsor, you are responsible for:
- Monitoring the product’s safety and performance
- Reporting any adverse events or issues to the TGA
- Ensuring ongoing compliance with all TGA regulations
Engaging a TGA-licensed manufacturer
As well as registering as a TGA sponsor, it’s integral that you use a manufacturer that holds a TGA manufacturing license if you are producing therapeutic goods.
You can check if a manufacturer holds a TGA manufacturing license by using the Australian manufacturer search tool on the TGA website.
For a therapeutic goods manufacturer to be able to obtain a license, they will have had to go through (and pass) a very regimented process set by the TGA, which includes an onsite inspection of their manufacturing facility to demonstrate that they comply with the TGA’s stringent requirements.
Do I still need a licensed manufacturer for non-therapeutic products?
While it’s a requirement that you use a licensed manufacturer to manufacture a therapeutic good, choosing a licensed manufacturer can still make good sense even if you are producing a non-therapeutic good. Not only does it provide an indication of the production and quality assurance processes the manufacturer adheres to, but it also provides added reassurance that your products will consistently be produced to the highest standards.
Looking for a TGA-approved manufacturer?
If you’re looking for a TGA-approved manufacturer to produce your cosmeceutical, sunscreen, skincare or cosmetic products, look no further than Wild Child Laboratories.
We are a highly experienced manufacturer specialising in the formulation, development and production of skin care and over-the-counter TGA-registered pharmaceuticals for the global market, and are a preferred supplier for a range of pharmaceutical and healthcare providers in both the hospital consumables and retail pharmacy arena.
Find out more about who we are and manufacturing your products with us.