Permitted Indications - Reminder

The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice if you are uncertain of your obligations.

 

NSW Government Program to Support Domestic Manufacturing of Personal Protective Equipment (PPE)

The program includes a $5 million grants scheme to establish a reliable, domestic supply of PPE products that have been critical in the response to COVID-19 including masks, gowns, disinfectant, handwash and soap or their components. The key objective is to enable the supply of PPE for industry, private health care, NGOs, government and the community more broadly. This will allow industry to restart in a COVID-safe manner without relying on disrupted and volatile international source markets. Applications closed 12 October. This is a limited program available during this financial year only or until the funds are allocated, whichever comes first.    SourcePPE Manufacturing Grants

 

Medical Device Reforms 

The TGA is undertaking a program of reform to continue to improve the safety, performance and quality of medical devices in Australia. The TGA has published the following consultations:  Consultation 1: Proposed Enhancements to Adverse Event Reporting for Medical Devices - one for industry and one for consumers. Consultation 2: Exploring options for the introduction of an Australian Unique Device Identification [UDI] System [UDI Consultation paper 2].    Source: Consultation Hub

The TGA is implementing changes to the inclusion process for Class I non-sterile, non-measuring medical devices. These changes will include enhancements to the application for inclusion in the Australian Register of Therapeutic Goods (ARTG) form; and modification of the process by which the TGA reviews applications for inclusion in the ARTG. The changes are designed to make it easier for sponsors to provide the information the TGA needs to assess Class I applications. It will also make it easier for the TGA to assess applications and reduce the need to ask sponsors for more information to inform the decision to include a device in the ARTG.    Source: TGA

 

Medical Device Post Market Compliance Dashboard

Post-market reviews are conducted by the TGA on device applications to check product compliance with legislative requirements. If you have a product included in the Australian Register of Therapeutic Goods (ARTG), it may be selected by the TGA for post-market review at any time. Previously, you would respond to a post-market review by email.  A new Post Market Review Compliance Dashboard has been developed by the TGA to replace this existing process. You can find the dashboard and a user’s guide at the TGA website.    Source: New Compliance Dashboard

 

Therapeutic Goods Administration COVID-19 proceedings

The TGA continues to be busy with the prosecution of people and companies that unlawfully use the Coronavirus pandemic in their product advertising or to market products. TTB International was fined $13,320 for alleged unlawful importation of surgical face masks    Source: Unlawful import Sydney Tools Pty Ltd was issued with two infringement notices totalling $26,640 for the alleged unlawful importation of medical face masks in relation to COVID-19 . A pharmacist was fined $2,664 and Simply Elements was fined $13,320 for alleged unlawful importation of medical face masks and Livingstone International was fined $13,320 for alleged unlawful importation of infrared thermometers Source: Unlawful import.

 

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has been released.    Source: Federal Register of Legislation

From 30 November sports supplements with therapeutic claims containing higher-risk ingredients must be included in the Australian Register of Therapeutic Goods (ARTG). Sports supplements with therapeutic claims that are presented as tablets, capsules or pills as long as they do not contain higher risk ingredients, have 3 years (by 30 November 2023) to comply with the requirements.    Source: TGA

 

TGA Conviction for Unlawful Advertising of Sports Supplements

As part of the TGA's investigation targeting image and performance enhancing drugs a former owner of a Canberra-based sports supplements company has been convicted on four charges, for advertising therapeutic goods (sports supplements) not included in the Australian Register of Therapeutic Goods (ARTG), and those goods were neither exempt nor excluded from the operation of the Act.    Source:Unlawful advertising of sports supplements

 

Therapeutic Goods Advertising Compliance Annual Report 2019-20 Published

During the 2019-20 reporting period, the TGA received 2,227 complaints. This is a 52% increase on 2018-19, which is attributable in part to the increase of non-compliant adverting in relation to COVID-19. The advertising of illegal therapeutic goods and the use of references to serious forms of diseases, conditions, ailments or defects (prohibited and restricted representations) without TGA authorisation were the most common breaches of the Act. The TGA issued 155 infringement notices for alleged advertising contraventions, totalling nearly $1.6 million.    Source: TGA

 

Database of TGA Listed Medicine Compliance Reviews

The TGA has published the results of the outcomes of 36 listed medicine compliance reviews.    Source: TGA

 

TGA Provides Latest Guidance on Advertising Requirements

This guidance is to help sponsors and manufacturers of medicines meet the Australian advertising requirements. This page provides guidance on submitting an application for approval to use a restricted representation and a checklist for label compliance.    Source: TGA Advertising Code

 

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TGA Valerian Safety Alert

Valeriana officinalis is permitted for use in listed medicines in Australia with no restrictions on dose, concentration, or type of preparation. Since 1983, the TGA has received 15 reports of liver injury in consumers taking products containing Valeriana officinalis. In ten of these cases, the products contained other ingredients that were considered likely to be responsible for the liver injury. However, in three cases, Valeriana officinalis was the only ingredient, and in two cases the other ingredients were considered to be unlikely to cause liver injury. Most cases of liver damage resolved after the use of Valeriana officinalis was discontinued. However, three cases had markers for severe liver injury, and two required hospitalisation. In response to these reports, the TGA has initiated a safety investigation.    Source: TGA Safety Alert

 

TGA Artemisia Species Safety Alert

The TGA is warning consumers and health professionals that listed medicines containing herbal ingredients from the Artemisia species should not be taken by women who are pregnant, think they may be pregnant, or intend to become pregnant. The TGA is currently further investigating this issue.    Source: TGA Safety Alert

 

Herbs containing safrole

The TGA is reviewing listed medicines that may contain safrole. Listed medicines must contain no more than 0.1% of safrole when it is for internal use, and no more than 1% when it is for topical application. The TGA has identified 12 ingredients approved for use in listed medicines, which may contain safrole as a constituent.    Source: Listed medicines at risk of containing safrole.

 

Botanical Adulterants Programme

The American Botanical Council continues it work on identifying adulteration of herbal ingredients supplied to manufacturers, this time focussing on milk thistle (Silybum marianum) fruit, with many extracts found to have negligible amounts of the important compound silymarin.    Source: Botanical Adulterants Monitor

 

Manufacturers of medicinal cannabis

Clarifications of the type of licensing required for manufacturers has been released along with technical guidance on the interpretation of the PIC/S Guide to GMP in relation to cannabis.    Source: https://www.tga.gov.au/publication/medicinal-cannabis-manufacture

 

Proposal to change the way nicotine is regulated

This is to address concerns that simple and legal access to nicotine containing e-cigarettes for smoking cessation (an “OFF RAMP” for smokers) should be permitted but there is concern about the rapid growth of youth uptake (“an “ON RAMP” for non-smokers).    Source: TGA webinar

 

 

RFA Breaking News

Cosmetics, Personal Care and TGA Listed Sunscreens:

AICIS Release Guidance and Documents The AICIS (previously NICNAS) is the regulator responsible for industrial chemicals and cosmetic ingredients. Annual declaration and post-introduction declaration forms will be available at the end…

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Foods:

Failing Food Reports – September 2020 These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of September. Among the usual…

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Complementary Medicines and Medical Devices

Permitted Indications - Reminder The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after…

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Cosmetics, Personal Care and TGA Listed Sunscreens:

Ingredients added to the Inventory The AICIS (previously NICNAS) is the regulator responsible for industrial chemicals and cosmetic ingredients. Seven new industrial chemicals have been added to the Australian Inventory…

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Foods:

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has…

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Complementary Medicines and Medical Devices

Permitted Indications - Reminder The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after…

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