News - DTS Regulatory Consultants
Antimicrobial Coatings

Antimicrobial Coatings

Stellina Popplewell Antimicrobial coatings that are incorporated in manufacture or applied to surfaces (physical barrier) to protect itself are generally considered sanitation/environmental control/environmental detoxification equipment and fall under item 12 of...

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Over The Counter Cannabidiol

Over The Counter Cannabidiol

The TGA have announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine). The decision allows low-dose CBD containing products, up to a maximum of 150...

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Further Changes To Medical Device Regulation

Further Changes To Medical Device Regulation

From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) has changed.  Summary Of Changes Applicants need to provide a manufacturer's Declaration of...

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Changes To Class I Medical Devices

Changes To Class I Medical Devices

From early October 2020, the Therapeutic Goods Administration (TGA) will be implementing changes to the inclusion process for Class I non-sterile, non-measuring medical devices. These changes will include: ·    Enhancements to the application for...

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Classification and Labelling Of Chemicals

Classification and Labelling Of Chemicals

Safe Work Australia has been working towards adopting the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revision 7 for workplace hazardous chemicals under the model WHS laws since late 2019. A two-year transitional period was due to...

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NICNAS To AICIS

NICNAS To AICIS

David Dwyer On July 1, 2020 NICNAS has now become AICIS (Australia Industrial Chemical Introduction Scheme). In this article I look at some of the differnces and some important answers for those companies that already have a NICNAS registration. If you have a current...

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Fast Tracking Product To Market: Beware Of FOMO!

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 track for their assessment procedures for products that contribute to community health there has not been a...

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PPE Regulation & COVID 19

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 people to prevent the transmission of organisms (Personal Protective Equipment - PPE) are...

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Importing For Covid 19 – A Warning

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. Many importers rush to procure face masks and other medical devices right now. However, this is a...

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Changes For Dangerous Goods and Hazardous Chemicals

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 Regulations and incorporates changes adopted by the UN along with other Australian-specific changes. The key...

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How can we minimise time and costs with the APVMA?

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 APVMA is the national regulator for ‘agricultural chemicals and veterinary medicines’. The legislative definition of...

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Changes To Cosmetic and Industrial Chemical Regulations

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 from NICNAS (National Industrial Chemicals and Notification Assessment Scheme) to AICIS (Australian Industrial...

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How NZ and Aust Are Handling Changes To The GHS

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 Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Revision 7...

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Storage Stability Data In Veterinary Chemical Products

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).

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Requirements for Listing Complimentary Medicines on the ARTG

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 requirements. This is to ensure the safety and efficacy...

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Are Your Complementary Medicine Products Compliant?

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 through the application of the Therapeutic Goods Act 1989 (the Act). The Act outlines a...

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Storage Stability Data In Agricultural Chemical Products

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 Authority) requires evidence that the product will remain fit for...

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You Need To Act Now On Permitted Indications

You Need To Act Now On Permitted Indications

by Zsuzsanna Sipos The TGA implemented a new regulatory framework for complementary medicines in 2018, to take full effect in 2021.  The new framework applies to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This...

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