News
June 5, 2020

Fast Tracking Product To Market: Beware Of FOMO!

Living in our new pandemic environment we are confronted with companies wanting to fast track their “response products” to market. While the TGA has a fast […]
April 7, 2020

PPE Regulation & COVID 19

With the current pandemic the TGA (Therapuetic Goods Administration) has made concessions on the supply of certain goods. Specifically, medical devices designed to be worn by […]
April 2, 2020

Importing For Covid 19 – A Warning

David Dwyer Below is taken from an email from Fredrik Gronkvist of chinaimportal.com. I find their advice very conservative and intelligent and below is no exception. […]
February 4, 2020

Changes For Dangerous Goods and Hazardous Chemicals

Stellina Popplewell The next version (7.7) of the Australian Dangerous Good Code is being drafted to align with Revision 21 of the United Nations (UN) Model […]
January 8, 2020
Hand Holding Clock

How can we minimise time and costs with the APVMA?

Gavin Hall Two of the most common questions we get from our clients are ‘why does the APVMA take so long?’ and ‘why is it so expensive’? The […]
December 4, 2019

Changes To Cosmetic and Industrial Chemical Regulations

Stellina Popplewell From July 1, 2020 a new scheme will be adopted to improve the regulation of industrial and cosmetic chemicals in Australia. We are moving […]
November 4, 2019

How NZ and Aust Are Handling Changes To The GHS

Stellina Popplewell New Zealand At Consultation Stage Your views are sought on the EPA’s proposal to update the current classification framework for hazardous substances to the […]
October 10, 2019

Is your ‘Approved’ source of active constituent still Approved?

Dr Sharon Gossage Each source (manufacturing site) of an active constituent must be separately approved by the APVMA.  There are some active constituents exempted from the […]
September 23, 2019

Storage Stability Data In Veterinary Chemical Products

Veterinary chemical products can undergo physical, chemical and microbiological changes on storage. The rate at which these changes can occur depends on the nature of the active constituent(s), the formulation composition, the formulation type, the packaging and, most notably, the storage conditions (temperature, light and humidity).
August 19, 2019

Requirements for Listing Complimentary Medicines on the ARTG

Complementary Medicines (including vitamin, minerals, herbal medicines and homeopathic preparations) in Australia are regulated by the Therapeutic Good Administration (TGA) and must adhere to certain regulatory […]
July 25, 2019

Are Your Complementary Medicine Products Compliant?

By Zsuzsanna Sipos The TGA was established to safeguard and enhance the health of Australians through effective and timely regulation of therapeutic goods. It does this […]
July 3, 2019

Storage Stability Data In Agricultural Chemical Products

Dr Yasser Sokeirik Agricultural chemical products can undergo chemical and physical changes on storage. When registering products in Australia the APVMA (Australian Pesticides and Veterinary Medicines […]