Has COVID-19 impacted on your ability to comply with TGO92?

As of the  1st September 2020 all listed medicines released for supply on or after this date must be labelled according to the labelling order TGO92. Any medicines labelled as per TGO69 after 1st September 2020 will be non-compliant and [...]

2020-05-28T00:46:15+00:00May 28th, 2020|Complementary Medicines, Listed Medicines, TGA|

New Permissible Indications Determination (No. 2) 2019

The Permissible Indication Determination (No. 2) 2019 has been published on the Federal Register of Legislation and commenced on the 14th November 2020. It replaces the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2019. New listings must comply with the updated requirements from the [...]

2020-04-23T10:20:38+00:00December 11th, 2019|Complementary Medicines, Listed Medicines|

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 [...]

2020-03-03T02:08:39+00:00December 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 [...]

Updates to the Permissible Indications Determination

The TGA has advised us that updates to the Therapeutic Goods (Permissible Indications) Determination will be made in the next 2-3 weeks. The changes include; addition of 4 new indications changes to 32 existing indications to clarify/correct the wording of indications [...]

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, [...]

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 [...]

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 [...]