Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 Update.

This far reaching bill has implications for those involved in the supply of Listed Medicines, or Medical Devices, as it “…amends the Therapeutic Goods Act 1989 to: allow(s) the minister to specify, by legislative instrument, permitted indications for use with listed medicines; establish an additional pathway for intermediate risk medicines through a new application and assessment process for sponsors of listed complementary medicines seeking to use indications that fall outside the permitted indications list; strengthen monitoring powers in relation to biologicals; implement stronger compliance and enforcement powers and graduated penalties for non-compliant behaviours; remove the distinctions between advertisements for therapeutic goods for which an approval is, or is not, required; enable the secretary to utilise the work of comparable overseas regulators in the course of making assessments of medical devices; …”. The Bill has passed its 2nd reading in the House of Representatives and has been referred to the Federation Chamber for consideration.    Source: Bill update

TGA Safety Advisories –     Source 2017 alerts  

Melanotan – (Illegal therapeutic goods). Consumers are advised not to use Melanotan-I, Melanotan-II and similar injectable tanning products. These injectable tanning products are generally obtained through websites, which are often based overseas. They may cause serious side effects and should not be used.

Tamo 20 tablets. Tamo 20 tablets are not related to the approved medicine Tamoxifen Citrate. The tablets contain the substance tamoxifen at a strength lower than that described on the bottle. The supply of Tamo 20 tablets is illegal as they are considered to be counterfeit.

Hard Rod Plus capsules. They contain the undeclared (prescription only) substance aminotadalafil.

Super Soniic capsules. They contain the undeclared (prescription only) substance sildenafil and also contain (poison) strychnine (Yes, ‘strychnine’!)

Lishou Fuling Jiaonang capsules. They contain the undeclared substance sibutramine.

Maximum powerful (Baiwei USA) tablets.The tablets contain the undeclared substance sildenafil.

Red Ant tablets. They contain the undeclared substance sildenafil.

Beautiful Lose Weight Gold 30 Capsules. The capsules contain the undeclared substances sibutramine and phenolphthalein.

Lose Weight 30 capsules: They contain the undeclared substance sibutramine.

Semenax capsules: They contain the undeclared substance Yohimbine.


RFA Breaking News

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Cosmetics (& Household cleaning products):

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Pharmacovigilance Obligations Training - COURSE AVAILABLE

In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST…


RFA wishes all of our readers a Happy & Prosperous New Year

Sydney New Year fireworks


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