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 [...]

2020-04-23T10:20:38+00:00June 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: [...]

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 [...]

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 [...]

Understanding the use of Population Qualifiers

Are population qualifiers mandatory? An indication must be qualified on medicine labels (or other advertising), either explicitly or by implication, if it is qualified in the ARTG entry. There is no need to add a qualifier on a medicine label [...]

FSANZ Role in Food Regulation

Are you clear on what FSANZ's role is in food regulation? If not take 2 minutes to view this simple explanation

2018-12-18T23:28:15+00:00December 18th, 2018|Foods, FSANZ|

Is your branding going to be affected by TGO 92?

TGO 92 impacts on product name presentation The new labelling legislation states that, as per TGO 92, ‘The name of the medicine on the main label must be presented in a continuous, uninterrupted manner and not be broken up by [...]

2020-04-23T10:20:39+00:00October 12th, 2018|Complementary Medicines, Listed Medicines, Regulation, TGA|

Herbal Component Names

The TGA will no longer be assessing Herbal Component Names (HCN's) as part of pre-market evaluations, effective immediately. Effective 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in [...]

2020-04-23T10:20:39+00:00September 7th, 2018|Complementary Medicines, TGA, Uncategorized|