This Is A Custom Widget

This Sliding Bar can be switched on or off in theme options, and can take any widget you throw at it or even fill it with your custom HTML Code. Its perfect for grabbing the attention of your viewers. Choose between 1, 2, 3 or 4 columns, set the background color, widget divider color, activate transparency, a top border or fully disable it on desktop and mobile.

This Is A Custom Widget

This Sliding Bar can be switched on or off in theme options, and can take any widget you throw at it or even fill it with your custom HTML Code. Its perfect for grabbing the attention of your viewers. Choose between 1, 2, 3 or 4 columns, set the background color, widget divider color, activate transparency, a top border or fully disable it on desktop and mobile.
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New Permissible Ingredients Determination (No. 4) of 2019

The Permissible Ingredient Determination (No. 4 of 2019) has been published on the Federal Register of Legislation and commences 1st January 2020. It replaces the Therapeutic Goods (Permissible Ingredients) Determination ( No.3) 2019.

Key changes to note include;

Products containing Andrographis

Andrographis paniculata has […]

December 11th, 2019|Complementary Medicines, Listed Medicines, Regulation, TGA|

Changes for Caffeine and Caffeine Containing Ingredients

Following a safety review on the ingredient caffeine, an amendment has been made to the Permissible Ingredients Determination.

Safety concerns were raised in June 2019, when the TGA was contacted by the NSW Coroner’s Court regarding the death of an individual associated […]

Adulteration Risk in Therapeutic Goods

The Macquarie Dictionary defines adulterate as: ‘to debase by adding inferior materials or elements; make impure by admixture; use cheaper, inferior, or less desirable goods in the production or marketing of (any professedly genuine article).’

The following listed medicine ingredients, are […]

Using ‘natural’ in advertising

The TGA has released guidance on the use of the term ‘natural’ when advertising medicines.

The Advertising Code clearly states that marketing claims must not be misleading and must be truthful, valid and substantiated. Therefore, it is the advertiser’s responsibility to […]

TGA Fee Increase 1 July 2019

TGA fees will increase by 2.05% (subject to rounding) as of 1st July 2019.This increase is based on the previously used formula of 50% of the CPI and 50% of the WPI. The 2019-20 fees and charges have been published to […]

June 5th, 2019|Complementary Medicines, Listed Medicines, TGA|

TGA Annual Charge Exemption (ACE) – How to declare $0 turnover through TBS in 2019

The opportunity to declare $0 turnover for ARTG entries will be available through TBS, from 1 July 2019. Sponsors have until the 22nd of July to declare $0 turnover without incurring fees.

The following steps should assist in the process:

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Understanding the Permissible Indication Determination (2019)

The TGA has just released the new and updated instrument, Therapeutic Goods (Permissible Indications) Determination (No. 1) of 2019

The second determination repeals and replaces the first determination. The determination includes a number of changes compared to the first determination including in […]

Overall presentation of products

An issue that keeps presenting with permitted indications is that a products indications should not be viewed in isolation but  should be viewed through the lens of the overall and complete product presentation for compliance. When a combination of indications are […]

Updates to Label Statements

The Permissible Indications Determination requires certain label statements, depending on the potential risk associated with the use of a specific indication.  Label statements are being brought into line with the language being used in the new advertising code moving from […]

Indications for Pregnancy and Foetal development

Permitted indications for Pregnancy Supplements

Recent communication from the TGA has confirmed the guidelines around the use of permitted indications in Pregnancy and foetal development. These guidelines differ significantly to what has been acceptable in the past. Due to the vulnerability […]