In Australia, the Therapeutic Goods Administration (TGA) regulates complementary medicines (AUST-L). These include herbs, vitamins, nutritional supplements and natural health supplements.
DTS provide solutions to your regulatory headaches, helping you turn your ideas into a success.
> Are you looking for help to get approval for a complementary medicine with TGA so as to market them in Australia?
> Do you help with product labelling and advertising compliance?
> Are you interested in regulatory advice for complimentary medicine development?
> Do you need advice on importing complimentary medicines into Australia or exporting them from Australia?
> Are you in breach and need assistance negotiating with the TGA?
The experienced and efficient team at DTS can assist you in each of these areas by:
Providing professional regulatory and technical advice, with application submissions, labelling and product reviews of complementary medicines dietary supplements.
> Reviewing your existing product formulations data, and advise on eligibility of products and level of registration required in Australia.
> Assisting with listing of your product on the Australian Register of Therapeutic Goods (ARTG) or changing of recipient of your product after listing on the ARTG.
> Advising on compliance of product promotional material including labels, packaging, brochures, display stands and websites.
> For complementary and OTC medicines, we can coordinate the generation of evidence to support your product registration and advise on possible claims on product labels and promotional materials.
> We can also offer an efficient, flexible and customised solution to meet your specific needs.
‘Indications’ are statements that describe the specific therapeutic use for a complementary medicine. They describe a complementary medicine’s claimed purpose or health benefit, for example: ‘relieves coughs’. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance).