New permitted ingredients for listed medicines

The Permissible Ingredients Determination (ingredients that may be use in listed complementary medicines) has been revised. 61 ingredients have been either added to the list, or had names, restrictions or label statements changed.    Source: TGA

 

Proposed changes to permitted ingredients list

Closing date for comments is Wednesday 15th September. Proposed changes address: Allergen statement for mollusc-derived ingredients - Peripheral neuropathy associated with lower dose vitamin B6 - Risk to infants from nasal use of benzalkonium chloride - Artemisinin and pregnancy risk. Click on link to view more details and respond to the consultation.    Source: TGA.

 

Compliance enforcement

Evolution Supplements Australia and its Director fined $12 million for advertising a range of unapproved sports products, including references to steroids, Selective Androgen Receptor Modulators (SARMs) and pre-workout products containing DMAA and other amphetamine derivatives. This is the largest penalty ever imposed by the Federal Court in relation to the Therapeutic Goods Act. The company Director failed to comply with TGA directions and attempted to conceal the unlawful advertising.    Source: TGA

Canberra dental practice issued with 20 infringement notices totalling $266,400 for importation and supply of unapproved dental implants and bone grafts.    Source: TGA

Gold Ant tablets seized and future shipments will be stopped at the border. The tablets contain the undeclared substance Sildenafil, a prescription-only medicine.    Source: TGA

He Absolute King sachets will be intercepted and destroyed by Australian Border Force as they contain undeclared Tadalafil.    Source: TGA

AB SLIM Slim-cellulose capsule tested and found to contain undisclosed sibutramine. Shipments will be destroyed at the border.    Source: TGA

 

Local GMP inspections

Where appropriate, these will take remotely during the COVD pandemic in place of on-site inspections.    Source: TGA.

 

Advertising nicotine vaping products

TGA has allowed pharmacies and pharmacy marketing to groups to promote that they are able to dispense nicotine vaping products (such as nicotine e-cigarettes, nicotine pods and liquid nicotine) on prescription.    Source: TGA

 

Post-market review of face masks

TGA is continuing its post-market reviews. List of cancelled products, non-compliance notices and other action are detailed.    Source: TGA

 

Guidance on regulation of personal protective equipment

Includes overview of regulations, manufacturing and standards, relevant to surgical masks and respirators, surgical gowns and gloves.    Source: TGA

 

Borderline disinfectant and related products with antiviral claims including COVID-19

This is a guide to those products that sit at the interface between consumer goods and therapeutic goods.    Source: TGA

 

TGA launches new information podcasts.

This is a 5 part series "Navigating Therapeutic Goods Regulations" to explain how the TGA works and includes "everything from how to supply therapeutic goods to the TGA Laboratories and remote GMP inspections".    Source: TGA

 

Independent review on MDMA and psilocybin

The Independent Expert Panel has been established to undertake a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions.    Source: TGA

 

Proposed refinements to the regulation of personalised medical devices

This is a comprehensive summary of 137 responses from a variety of stakeholders to the three proposals put forward. A number of alternative approaches were put forward. Submissions that gave permission to be published can be viewed here.    Source: TGA

RFA Breaking News

Cosmetic, Personal Care and TGA Listed Sunscreens:

New video explains the basics of AICIS registration This 2-minute video explains when you do – and don't – need to register your business with AICIS, and gives a quick…

Readmore..

Foods:

Applications, approvals and amendments to the Food Standards Code FSANZ has commended assessing applications for: The steviol glycoside, rebaudioside I, produced by enzymatic bioconversion of stevia leaf extract. The bioconversion…

Readmore..

Complementary Medicines and Medical Devices:

New permitted ingredients for listed medicines The Permissible Ingredients Determination (ingredients that may be use in listed complementary medicines) has been revised. 61 ingredients have been either added to the…

Readmore..

Cosmetics, Personal Care and TGA Listed Sunscreens:

New sunscreen standard in force New sunscreen standard in forceThe new sunscreen standard, AS/NZS 2604:2021, specifies requirements and test methods for broad spectrum and water resistant sunscreen products. Includes labelling…

Readmore..

Foods:

New biosecurity website A new website - biosecurity.gov.au - details measures in place to protect Australia from harmful pests, diseases and weeds. This gathers information previously found on different state…

Readmore..

Complementary Medicines and Medical Devices:

Hemp seed oil - change of status An interim decision has been made to exclude hemp seed oil from Schedule 9 of the poisons schedule whe used for oral consumption…

Readmore..

Go to top