AUSTRALIA - TGA/APVMA manufacturer, sponser or importer?

R

Regulation Maze

#1
Good morning all,

I have a question which relates to registration in Australia.

Our product falls under HS Code 3808 9490 - We currently have EPA approval on our product in the US, however we are branching into the Asia Pacific region. One of our first stops in Australia. Because we are not registered as a medical device (because we are absolutely not a medical device) in the US, I feel we would be more suitable placed under the APVMA in Australia.
My questions are:


  • With the TGA you can get a sponser to handle your application, as you do with the APVMA, however, with importing any chemcial that falls outside the scope of NICNAS you have to notify them that you are exempt and for what reason. Our distributor, who has an ABN, ACN etc is stating that as he is not the importer nor the manufacturer of the product (we are sourcing it in Australia) he does not think that he is the correct person to notify NICNAS. Because we are taking the product from the manufacturer and turning into a biocide (not altering the product - just the label etc) does that make us the manufacturer/our distributor the manufacturer?

I feel like I am going round in a never ending circle :bonk:


  • Finally, if we notify under APVMA, it states in the TGA that so long as no alteration is made to the product under which it was registered with the APVMA it is exempt from the TGA - has anyone else had any experience with this?

Thank you so much in advance for any help anyone can offer with this particular issue.
 
Elsmar Forum Sponsor
R

Regulation Maze

#2
I have actually found the answer for the first bit:)

However, I still have the query about the TGA and the APVMA

This is what I have at the moment
[FONT=&quot]Under the Theraputic Goods Order No. 54 – Standard for disinfectants and Sterilants Point 1(v) A disinfectant or sanitiser registered under the Agricultural and veterinary chemicals code act 1994 for which no claim or representation for disinfectant use is made other than a use which is registered for the disinfectant is exempt

Additionally, I have found this:
[/FONT][FONT=&quot]the determination of poison schedule classification for an agricultural or veterinary chemical product by OCS (Office of Chemical Safety) is authorised separately under the [FONT=&quot]Therapeutic Goods Act 1989[/FONT] administered by the Therapeutics Goods Administration (TGA) of the Commonwealth Department of Health and Ageing. In making its assessment of a chemical product, the APVMA is required to consider the poison schedule classification determined by a separate law of the relevant jurisdiction

Any thoughts greatly recieved! :popcorn::frust:
[/FONT]
 
M

MikeTi

#3
The decision as to whether a product is controlled by APVMA or TGA is made on the basis of uses.

APVMA controls agricultural and veterinary uses. Therefore, a product needs to be used for control of animal diseases or plant pathogens, or similar to be registered by APVMA.

TGA controls disinfectants in other situations. Do not be confused by the fact that disinfectants fall with the medical devices area at TGA.

Before deciding about sponsors, etc you need to determine if your product is controlled by TGA or APVMA, if the product is a disinfectant.

I know this is confusing so I am happy to discuss in some detail but an open forum may not be the best venue for this. If you want, you can send an email to me through a personal message or by blind email.
 
R

Regulation Maze

#4
Mike,

That is great thank you, I will certainly email you, as our product is registered under PT 2,3 and 4 in the BPD, and the APVMA have looked at our label and have said that we do need to register underneath them.

I'll drop you an email, many thanks again :)
 
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