Therapeutic Goods Administration

GA consulatation on definition of cosmetic Oct 2013

ASPS commented on a proposal to include definitions, such as cosmetic use and/or personal care use, in the Poisons Standard (SUSMP) to better define these terms and their intent and purpose. Dowload ASPS letter to the TGA.

The consultation is open until 1 November 2013.

 

Feasibility of a new to market risk communication scheme submissions

The TGA has concluded a round of consultation on the feasibility of a new to market risk communication scheme. Read more about the outcomes of the consultation.

Visit the TGA website to view other submissions.

 

Report adverse events to the TGA

The TGA’s new reporting system makes it easier to tell the TGA about problems with medical devices. The new reporting system consists of a number of forms with easy-to-follow instructions.

Visit the TGA website to download forms.

Once an Adverse Event Report (AER) is submitted, it is placed in the Incident Reporting and Investigation Scheme (IRIS) database. A risk assessment is then conducted and a decision made on what level of investigation is needed. The most serious adverse events are given the highest priority.

Contact IRIS on 1800 809 361 or by email iris@tga.gov.au.

 

Anaplastic Large Cell Lymphoma

Anaplastic Large Cell Lymphoma (ALCL) is a rare cancer of the immune system that can occur anywhere in the body. Since 2009, ASPS has been in discussion with TGA, FDA and the American Society of Plastic Surgeons to monitor the incidence of ALCL.

Visit the TGA website for further information.

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