Most OTC medicines will require product registration, which requires pre-market evaluation of a product dossier by TGA.
Lower risk consumer medicines, such as complementary medicines (herbs, vitamins, nutritional/dietary supplements, homeopathic medicines) and sunscreens are regulated as listed medicines.
Listed medicines do not undergo the same level of pre-market evaluation by TGA, but can only contain certain low risk ingredients; must be manufactured under GMP conditions, and make claims for health maintenance/enhancement, or non serious , self limiting conditions. The sponsor must certify that the product meets all the legislative requirements.
We can conduct a product review, and advise on the appropriate TGA evaluation pathway, and the information requirements for your product. Once product classification is confirmed, we can assist in preparing and submitting applications to TGA.
Over the lifecycle of your product, there are likely to be variations required to the product. We can advise on the regulatory consequences of any proposed changes, prepare and lodge targeted submissions.
Specific advice projects for existing products are available, including:
- Labelling reviews
- Advertising & claim reviews