New Zealand Cosmetic Compliance Update

New Zealand Cosmetic Compliance Update

The Cosmetic Products Group Standard 2020 has been amended in January 2024 following a decision on updates released 30 January 2024. Main changes include: PFAS are banned; Group standard requirement now extends to non-hazardous cosmetics containing hazardous...

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TGA Advertising Compliance Checklist

TGA Advertising Compliance Checklist

The document, "Advertising Compliance Self-Assessment Checklist: Consumer Advertising," is a comprehensive guide designed by the Therapeutic Goods Administration (TGA) to aid advertisers in ensuring their consumer advertisements comply with the Therapeutic Goods Act...

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Developing An Evidence Package For A Listed Medicine

Developing An Evidence Package For A Listed Medicine

The purpose of an evidence package is to demonstrate to the TGA that the medicine will produce the therapeutic effects described by its indications, as stated by the sponsor's legal responsibilities. Evidence can come from sources showing traditional use or scientific...

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TGA Provides Clear Guidance On Beauty Devices

TGA Provides Clear Guidance On Beauty Devices

Beauty devices in Australia have lived in an area of regulatory uncertainty. Some businesses have taken advantage of this and some of those have felt the wrath of the TGA. The TGA has now provided clear guidance on what they require for regulatory compliance....

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Does Perfection Have A Place In Regulatory Compliance?

Does Perfection Have A Place In Regulatory Compliance?

(Based on an article published in the Financial Review dated 18 August 2023*.) At DTS, our call sign is "Right First Time," but this principle must always be balanced with the level of compliance necessary to satisfy regulators. No client wants to waste resources on...

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Major Change To DTS Working Hours

Major Change To DTS Working Hours

DTS will transition to a Four-Day Working Week from the 4th September 2023. Our operational days will now be from Monday to Thursday, with Fridays becoming an additional day off.  “At DTS, following our flexible work practices, our aim was to further evolve and offer...

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AICIS New Assessed Chemical Introduction

AICIS New Assessed Chemical Introduction

If you wish to use a chemical in Australia, then it must be listed with AICIS. If it is not, then it needs to be categorised. The AICIS categories are based on health/environmental risks and the importation volumes of the individual chemical and are listed below. The...

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TGA New Substance Evaluation

TGA New Substance Evaluation

The Therapeutic Goods Administration (TGA) is responsible for evaluating new substances for use in Listed therapeutic products in Australia. The evaluation process typically involves the following steps: Pre-submission phase -The first phase includes applying for new...

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APVMA Implements New Module Descriptors for Chemicals

APVMA Implements New Module Descriptors for Chemicals

Earlier this year the APVMA released new risk assessment Module Descriptors required for new applications for Agriculture and Veterinary chemicals for applications received after 1 February 2023. The new document can now be reviewed to understand better how the...

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Pharmacovigilance – Pay Attention To The Detail

Pharmacovigilance – Pay Attention To The Detail

Australian sponsors of listed or registered medicines must meet their pharmacovigilance reporting responsibilities for all the medicines you have registered or listed on the Australian Register of Therapeutic Goods (ARTG). As a sponsor of medicines approved for supply...

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Transition to GHS 7

Transition to GHS 7

Suppliers, Manufacturers, and Importers of workplace hazardous chemicals From 1 January 2023, all hazardous chemicals will need to adhere to GHS 7. Australia has decided to transition from GHS 3 to GHS 7 after key international trading partners have decided to make...

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Software As A Medical Device

Software As A Medical Device

Software is increasingly being used both as a medical device and in medical devices. Some of these devices inform clinical decisions. Others are wearable and provide day-to-day health or wellness-related monitoring and reporting functions. The demand for such devices...

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Bicon Permit Application Delays

Bicon Permit Application Delays

Recently importers have experienced longer than usual timeframes in the processing of import permit applications. This is due to an increasing volume of permit applications being received. Whilst the Biosecurity Act 2015 provides up to 123 days to assess permit...

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Therapeutic Goods Advertising Code

Therapeutic Goods Advertising Code

From 1 July 2022, advertisements must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. Online/social media advertising This requirement to comply with the 2021 Code applies retrospectively to advertisements including social...

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Draft Guidelines For Listed Medicines

Draft Guidelines For Listed Medicines

The Therapeutic Goods Administration (TGA) has provides an updated draft ‘Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines’ (the Guidelines), which is intended to replace the existing ‘Evidence guidelines – Guidelines on the...

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TGA New Advertising Code

TGA New Advertising Code

The TGA have published a new Advertising Code (2021) from commencement on 1 January 2022 with a 6 month transition period ending on 30 June 2022. Below is an overview provided by Complimentary Medicines Australia. Overall changes Definitions are made easier to access...

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Transition to GHS 7

Are you introducing chemicals under NICNAS exemptions?

There's less than a year to go before the transitional arrangements end. You can keep introducing chemicals under the following NICNAS exemptions until 31 August 2022: research and development – less than 100 kg cosmetic use (no unreasonable risk) – less than 100 kg...

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Borderline Disinfectants

Borderline Disinfectants

TGA has released a new guidance document on borderline disinfectants and related products. This has provided clearer guidance on Excluded goods that are exempt from regulation under the therapeutic goods framework. While these products may be required to meet relevant...

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