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Mary Gardam
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Hi James,

In my experience it is always best to call the TGA to try and get clarification, then get them to put it in writing so that you have evidence.

Now your situation:

Let’s say I want to start a health/nutrition supplement company called COMPANY A.

I contact a manufacturer (here in Australia) called COMPANY B – who provides a range of private label products.

While company B may have the manufacturing, packaging process covered for their own manufacturing, if you alter the labelling or packaging in any way then you will also need to have the appropriate TGA “process” in place as their product and your product are then 2 different products.

If you change the labelling and make it a different product then the business selling the product is responsible. Just think of a factory that manufactures a brand name vitamin supplement but also manufactures a generic product. Both products are treated separately by the TGA.

I’ve spoken to a couple of competitors in my market, and they all state that the TGA process is handled by their manufacturers. Which I don’t quite understand, as (1) I can’t find their product listed on the ARTG and (2) I though it was the “Sponsors” responsibility?

I don’t understand how this can be the case unless they are taking the product as it comes off the production line and reselling as is?? Maybe their products don’t contain an active ingredient that makes it a complementary medicine? I’ve put a link in to the ingredients that determine whether a product should be listed or registered or whether it is a complementary medicine at all which may help you. Unless I know the ingredients I can’t really comment any further on that one.

http://www.tga.gov.au/industry/cm-argcm-part-a-06.htm

http://www.tga.gov.au/industry/cm-basics-regulation-overview.htm#what

Good luck and if you’d like me to look further into it for you just send me a direct message.

Mary