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 14th […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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:
Login […]
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 […]
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 […]
