The only question that matters!
It is important to understand no matter what your product is, it is very difficult for DTS to provide you with a fixed cost upfront. We can provide estimates once we have a good understanding of your product, its ingredients, its usage, your claims, similar products in the market and the regulation that is applicable.
To gain that understanding we normally perform a Pre Evaluation (PE), and this will cost somewhere between $1,500 and $5,000 (plus GST). This allows us to understand your product, evaluate the different registration pathways, highlight potential roadblocks and ultimately provide you with a time and cost estimate.
The PE also builds the foundation for the registration process.
We sign confidentiality agreements with all our clients that prohibits us from discussing or presenting any information related to the work we do with them
It is much easier and quicker to bring a cosmetic to market than to register as a Complimentary Medicine (Listed Medicines) in the Australian Register of Therapeutic Goods (ARTG).
Our cosmetic product review assesses each ingredient against the Poisons Schedule (SUSMP) and the Australian Inventory of Chemical Substance (AICS) to ensure the they are suitable for use in cosmetics, as well as reviewing the health claims and advising on which claims can/cannot be included. This review also provides you with a summary of findings outlining any issues identified and next steps.
To have products Listed as Complementary Medicines requires a more in-depth review assessing the viability of the ingredients in Listed Medicines. The product claims (ie reduce inflammation, sooth sore throat, reduce symptoms of fungal infection, reduce blood pressure) need to have evidence to support your claim.
For example, moisturisers that contain a sunscreening agent as a secondary component and have a stated therapeutic purpose (e.g. 'helps protect skin from the damaging effects of UV radiation') are Listed Medicines.
Some products need be registered as a Listed Medicine because of their ingredients. Other products will depend on what claims you want to make. For example, if you want to sell a foot cream that “helps nourish dry feet to keep your skin feeling supple and soft” then that can be a cosmetic. If you want to say “reduce symptoms of fungal infection and Tinea” then that most likely would need to be a Listed Medicine.
This simple question does not have a simple answer. Often it is what you want to claim about the product. The TGA uses garlic as an example. Selling crushed garlic in a bottle for cooking purposes is a food. Selling garlic in a capsule to help prevent the flu virus is a medicine.
In most cases it is clear cut however like all regulations there is some grey areas where a product could be one or the other, and this depends on the customers marketing intentions and how you can massage them to satisfy the regulatory agency.
There will always be “foods” sold that should be registered under the TGA because of their claims. And there will always be people pointing this out in news articles. In our experience it is much better to do the regulatory work upfront rather than face the wrath of the regulatory body after you have launched your product.
The TGA has a Food Medicine Interface Guidance Tool which may be useful.