HIGHLIGHTS:
Application for the SoloFlow® Non Injection Needle accepted by TGA.
SoloFlow® can now be sold commercially in Australia.
The Board of Telezon® Limited (“the Company”) is pleased to advise the market that the Company’s flagship SoloFlow® Non Injection Needle has been accepted by Therapeutic Goods Australia (TGA). This achievement for SoloFlow® is in addition to the CE Mark for Europe (December 2012) and FDA registration for USA (October 2011).
SoloFlow® has been accepted onto the Australian Register of Therapeutic Goods and as such, is now approved to be sold in the Australian market.
“The TGA is part of the Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. Essentially, any product for which therapeutic claims are made must be listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market. The TGA legislation (1989) provides a framework for a risk management approach allowing the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.”
The Company’s solid record of accomplishments and the expanding markets available to the SoloFlow® Needle further demonstrates the global importance of our products.
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