Technical Alerts

In the CMA response to the Government’s de-regulation agenda, we recommended the TGA streamline the evaluation of new substances for use as permitted ingredients for listed medicines.
We have been working to put forward a list of potential new substances that may be subject to an expedited evaluation or risk assessment, including potential substances approved by Health Canada or where substances have been subject to previous TGA review.

Click here to read the alert and to provide feedback.

CMA and its regulatory members have, over the last few years been progressing work in relation to the Permitted Indications Project. Recent work has included revising a list of current indications that the TGA considered as including wording that could arguably be termed a “restricted representation”. On the 10 October, CMA provided TGA with a detailed response to a range of proposed “re-worded” indications and “priority removal” of indications which were proposed to be archived.

A summary of recent changes in relation to permitted indications in listed medicines is provided in the attached alert, click here to read more.

The CMA highlights the following industry consultations that are now open for comment.

• TGA Regulatory Impact Statement for Medicine Labelling - Following public consultation undertaken in 2012, the TGA has prepared a Regulatory Impact Statement outlining options to address medicine labelling issues. Close 7 October 2014.
• FSANZ Health Claims - Formulated Supplementary Sports Foods & Electrolyte Drinks (P1030) Close 30 September 2014.

To read the Alert, click here.

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Click here to read the tech alert

Click here to read the technical alert

There appears to be widespread and ongoing confusion amongst industry as to which specific coded indications are considered by the Therapeutic Goods Administration (TGA) to be restricted representations requiring gazettal prior to being advertised to consumers.

The CHC was recently made aware of the TGA clarifying its position on the use of the term ‘arthritis’ in advertising. The CHC maintains that this issue be addressed as part of the permitted indications project and labelling reforms, however in the meantime advertising of these indications needs to be clarified.

Click here to read the Alert.

Call for Comment:The CHC invites comment on the proposed amendments to the current Poisons Standard contained in this notice, which are to be referred for scheduling advice to relevant expert advisory committees.

High compliance rates for imported foods:
Results of tests applied to food imported to Australia show a consistently high rate of compliance with
Australia's strict food standards. However, the latest report shows food labelling accounted for most
instances of non-compliance with Australia's imported food requirements.

To read the Alert, click here.

The TGA have made some important corrections to the listed medicines eBS validation rules. The changes are being made to align with the operation of the Therapeutic Goods legislation, in particular the operation of the Therapeutic Goods (Groups) Order No. 1 of 2001 and are expected to be made available in the ELF by the 6 January 2014.

Click Here to read the Alert.

The CHC is invited by the Committee on the Healthcare Complaints Commission to make a
submission to their Inquiry into the promotion of false and misleading health-related information or practices.

Click Here to read the Alert.