AWRS Advertising Compliance Services

Advertising Compliance Reviews (pre-vetting services) are a core offering of AWRS Advertising Compliance Reviews are a core service offered by AWRS. Over the past 20 years our Advertising Compliance Team have been working with sponsors to create impactful and compliant [...]

2020-05-28T05:04:30+00:00May 28th, 2020|Uncategorized|

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, [...]

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|

Changes to the Uniform Recall Procedure for Therapeutic Goods

The Uniform Recall Procedure for Therapeutic Goods (URPTG) is a guidance document, which provides a standardised systematic procedure, to assist sponsors to conduct both recall and non-recall actions of therapeutic goods which are supplied, imported into or exported from Australia. [...]

Consultation: Business Process Improvements Supporting Complementary Medicines Assessment Pathways

The TGA is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines, to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation. The consultation discusses: A risk-based approach [...]

Labelling Revised – Amendments to the Therapeutic Goods Order No. 92

The four-year transition period for the new labelling requirements (from TGO 69 to TGO 92), ends on 31 August 2020. During this time, you can choose to comply with the old labelling requirements under TGO 69 or the new labelling [...]