TGA Advises on Updating Medicine Ingredient Names

In order to bring the naming of medicine ingredients in line with international standards, the TGA instituted a programme in 2017 to harmonise Australia’s ingredient nomenclature with other jurisdictions. All medicines released for supply must carry the updated ingredient names by the time the transition period for updating medicine names ends on 30 April 2020. Sponsors need to be aware of which medicines will be affected by these changes and to ensure that all labelling and promotional materials are compliant by 1 May 2020. A complete list of affected ingredients can be read here Ingredient names affected .   Source: Updating ingredient names

Changes to Permissible Ingredients

As mentioned in last month’s edition of this newsletter the TGA has issued an updated version of Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019. As well as the changes to the 19 existing and 4 new ingredients referred to in that story, a number of changes to specific further ingredients should also be noted. Sponsors of products containing any of the following ingredients should take note: ingredients containing arbutin (arbutin will need to be disclosed as a component with associated specific requirements), poliglusam (maximum daily dosage of 1750 mg will apply), cysteine (its salts and cystine), caffeine (100 mg per dosage unit and 600mg total per day), methyl salicylate (not greater than 25% concentration), and menthol (oral, not more than 1g per day; topical, must not deliver more than 25% total menthol when administered according to the directions for use, label warnings required)   Source: Permissible ingredient update

TGA Updates Guidance on Medicines Labelling (TGO 91 & TGO 92)

Medicine label requirements are specified in two separate labelling Orders depending on whether they are for labels on prescription medicines (TGO 91) or for non-prescription medicines (TGO 92). These new Orders come with a transition period that ends on 31st August 2020. Listed medicines that are released for supply on or after 1 September 2020 must be fully compliant with TGO 92.    Source: TGO 92 label requirements

REMINDER: Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!

Due to the importance of this information we are repeating the story that we placed in previous month’s newsletters. Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently  $840 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG.   Source: Permitted indications

RFA Regulatory Affairs provide training on preparing and reviewing permissible indications for your products so you can make these changes. To book a course, enquire about pricing, or if you have any questions on the topics covered or your suitability for training, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it.

What Does 'TGA Assessed' Mean on my Medicine Label?

Regular readers of this newsletter will know that the “TGA assessed” claimer is now available for implementation. This new claimer indicates that a medicine has been assessed by the TGA for efficacy related to its indications. This claim is only applicable to ‘assessed listed’ and ‘registered’ complementary medicines, and not to those complementary medicines that have not undergone pre-market assessment. A sponsor seeking to use the TGA assessed claim on its label must seek pre-approval by providing a medicine label with the TGA assessed claim. For an existing registered complementary medicine, sponsors must have a new label assessed by the TGA before the claim can be used.    Source: 'TGA Assessed' fact sheet

TGA Rules on Advertising Health Products

The TGA reminds suppliers that the Therapeutic Goods Advertising Code (No.2) 2018 prevents advertisers from claiming that therapeutic goods (including medicines and medical devices) are safe, that their use cannot cause harm, or that they have no side-effects. Safety claims in advertising may be explicit or implicit - both are prohibited. The therapeutic goods legislation specifically prohibits the advertising of therapeutic goods as 'safe' or having 'no side effects', even for specific patient populations or particular dosages. This requirement applies even if suppliers think there is evidence to substantiate such a claim. Care must also be taken to ensure that using the term ‘natural’ does not imply that a product is safe, safer than other products or that excessive use cannot cause harm. Care is also needed to ensure that comparisons with other therapeutic goods do not imply that the other therapeutic goods are harmful or ineffective. For example, use of the word 'organic' may be acceptable if substantiated. However, it is not acceptable to compare the 'organic' product with non-organic products in a way that states or implies that the non-organic products could harm the consumer.    Source: Rules for advertising

TGA Issues Guidance on Use of Restricted Representations

The term ‘restricted representation’ refers to when a “serious form of disease, condition, ailment or defect” cannot be referred to in advertising on any medicine in any context, unless specifically approved, or permitted for use by the TGA prior to use. Generally, if an advertiser wishes to make reference to a restricted representation in advertising, including on labels, then a formal application to the Delegate of the Secretary is required. However, this guidance makes clear that applications to make restricted representations/reference to serious diseases or conditions are not required where the reference is contained or required in a mandatory label warning, contraindication or advisory statement.     Source: Restricted representations

TGA Provides e-Learning Modules on Permitted Indications for Listed Medicines

'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit, for example: 'relieves coughs'. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance). Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor. This set of three e-learning modules provide information on the transition arrangements for permitted indications and instructions on how to create an application on the TGA Business Services portal to include permitted indications for listed medicines.    Source: e-Learning modules for permitted indications

TGA Issues Compositional Guidelines for Resveratrol and Calcified Lithothamnion species

A TGA compositional guideline is a summary of descriptions, tests and appropriate acceptance criteria that define the characteristics and specify the composition of an ingredient permitted for use in listed medicines. The TGA have recently published compositional guidelines for Resveratrol (an ingredient used widely in complementary medicines and manufactured by bacterial fermentation of genetically modified baker’s yeast - Cerevisiae), and also for Lithothamnion species (AAN) and Calcified Lithothamnion tophiforme (AAN). ‘Lithothamnion spp.’ is derived from skeletal deposits of Lithothamnion spp (L. corallioides, L. tophiforme) sourced from the Atlantic Ocean. ‘Calcified Lithothamnion tophiforme', is the skeletal deposits of Lithothamnion tophiforme sourced from Arnarfjordur fjord in Iceland.     Sources: Resveratrol & Lithothamnion-species

TGA Issues Compositional Guideline for Streptococcus salivarius M18

Streptococcus salivarius is a gram-positive bacterium found as part of the normal human oral microflora, predominately colonising the oral cavity (teeth, tongue). BLIS M18™ is a freeze-dried culture of Streptococcus salivarius M18 (NLT 1 x 1011 CFU/g) in a protective matrix of food-grade maltodextrin, trehalose dihydrate and lactitol. S. salivarius can be cultivated and used as an ingredient in listed medicines. The compositional guideline lists the appearance, particle size, morphology, biochemical profile and virulence of this organism.    Source: Compositional guideline for s. salivarius

TGA Issues Guidance on the Regulation of Exempt Disinfectants in Australia

The regulation of disinfectants depends on the claims made by the product on labels, packaging and product information leaflets. The following guidance relates to products that meet the definition of an exempt disinfectant. Exempt disinfectants are not required to be included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied, but must still meet all regulatory requirements including The ‘Poisons Standard’ (The SUSMP) and The Australian Dangerous Goods Code.    Source: Exempt disinfectants guidance . (Please see also related articles concerning ‘Listed Disinfectants’ which are disinfectants that make specific claims and must be included in the ARTG.     Sources: Listed disinfectants guidance and Specific and non-specific disinfectant claims )

TGA Changes Rules Concerning Nappy Rash Products

Changes will be made to the regulation of nappy rash products commencing 1st January 2020. These changes will apply to listed medicines and Class I medical devices which are indicated for the relief of nappy rash symptoms via a barrier effect only. The exemption will not apply to nappy rash preparations that are also indicated for other skin conditions, such as psoriasis, eczema or dermatitis. If relief of nappy rash symptoms are provided via another mechanism of action (e.g. the product has a physiological effect) it would not be exempt. The nappy rash products that are declared exempt will still be subject to any applicable standards for product quality, labelling and packaging, and with advertising requirements. They will also be subject to TGA recall provisions.    Source: Nappy-rash changes

TGA Safety Advisories- Source: https://www.tga.gov.au/current-year-alerts

GoLean Detox capsules: contain the undeclared substances sibutramine and phenolphthalein.

Slim Perfect Legs + High Fiber capsules: contain the undeclared substance sibutramine.

TGA Recall: Neutrogena Visibly Clear Light Therapy Acne Mask and Activator

Consumers and health professionals are advised that Johnson & Johnson Pacific, in consultation with the TGA, is recalling Neutrogena Visibly Clear Light Therapy Acne Mask and Activator. The device is also being withdrawn from the market. This product is a reusable non-sterile device, intended for home-use to treat mild to moderate acne on the face. The device comprises an ‘acne face mask’ and detachable corded ‘activator’. It delivers a combination of red and blue light via light-emitting diodes (LEDs). It has been identified that, for a small subset of potentially susceptible people, repeated exposure may cause varying degrees of retinal damage that could be irreversible and could accelerate peripheral vision impairment or loss. Other potential adverse events that may be associated with use of this device are eye pain, eye discomfort, eye irritation, tearing, blinding, blurring of vision, seeing spots/flashes and other changes in vision (for example vision colour).    Source: Light-mask fail

Caffeine Supplement Death Triggers Health Warning

The Australian government has ordered an urgent review of the open sale of pure caffeine powder following the freak overdose death of a young man. Lachlan Foote collapsed on the bathroom floor of his family’s Blackheath home and never regained consciousness after making himself a protein drink that contained powdered caffeine. Just one teaspoon of the extremely potent but legal and widely available substance — popular among fitness enthusiasts — is enough to kill.    Source: Shannon Molloy, News.com.au Caffeine powder fatality

TGA Confirms that it has no Role in Regulating Fluoridated Drinking Water in Australia

The Therapeutic Goods Administration has clarified that state and territory governments will continue to be responsible for regulating fluoride in reticulated drinking water ('tap water'). Legislative amendments made on 11 July 2019 put an end to any uncertainties about regulatory responsibility by explicitly excluding fluoridated drinking water from the scope of Australia's therapeutic goods legislation.    Source: Fluoridated drinking water

NICM Confirms its Place as a World-Leader in Research

The National Institute of Complementary Medicine (NICM) Health Research Unit, run out of Western Sydney University, is Australia’s leader in integrative and complementary medicine research and policy. The Australian Research Council’s (ARC) latest ‘Excellence in Research for Australia’ (ERA) report confirms, for the third consecutive triennium of rating, NICM as a world-leading research institution, rated the highest possible - ERA 5. The NICM Director, Professor Alan Bensoussan, welcomed the report’s confirmation of NICM’s world-leading research and reputation for excellence. “NICM’s team of interdisciplinary world-class researchers, are included in the world’s best and brightest in the field of complementary medicine. We are thrilled to be recognised for our research in this field, and for our very significant contribution to an additional ERA 5 ranking in Pharmacology at Western Sydney University. We are the only research institute in complementary medicine that has achieved consistent ERA 5 rating since evaluation commenced in 2012 for our field of research”.    Source: NICM a world leader

Associations Forum Declares CMA Winner of the ‘2019 Association of the Year’

Established in 2004, Associations Forum is a commercial, member-based network of 500 associations, charities, clubs, societies and other not-for-profit organisations. The mission of Associations Forum is 'bringing associations together to boost performance', by assisting associations and charities in governance, operations, membership and finances. RFA Regulatory Affairs was very glad to hear that this year’s winner was awarded to the peak body, Complementary Medicines Australia (CMA), working in the complementary medicine space. Congratulations to Carl Gibson and all of the team at CMA for receiving this deserved recognition for all of the excellent work carried out on behalf of this sector. Well done!    Associations Forum website

ConsumerLab Tests Find 19% of B Vitamin Supplements Supplied in the USA Failed Quality Standard

USA based company ConsumerLab LLC. purchased and tested B complexes and individual B vitamins. The tests revealed that five of the 26 supplements selected for testing contained as little as 53% to as much as 223% of the listed amounts of certain B vitamins. This review also summarises the clinical evidence for B vitamin supplementation for uses such as helping to prevent birth defects, lowering cholesterol levels, and slowing age-related cognitive decline. The report goes on to explain important differences among forms of B vitamins, such as those of niacin (nicotinic acid, niacinamide, and inositol hexanicotinate), folate (natural folate, folic acid, and L-5-methyltetrahydrofolate), and B-12 (methylcobalamin and cyanocobalamin).    Source: Nutraceuticals World B-vitamin fails

Civil Penalties Ordered Against Peptide Clinics Pty Ltd for Advertising Breaches

Peptide Clinics Australia (Peptide Clinics Pty Ltd) has been ordered by the Federal Court to pay $10 million to the Commonwealth for breaches of the mandatory rules for advertising of medicines, including the ban on advertising prescription-only medicines to the public. The significant financial penalties serve as a reminder to businesses that prescription-only medicines cannot be advertised to the public without significant consequences. This includes being issued with infringement notices, being charged with criminal offences or having civil court proceedings commenced against them.    Source: Peptide clinics fail

USA Congressional Committee Discusses How to Legalize Cannabis

In a first-of-its-kind hearing, a key congressional committee met recently to discuss how to finally put an end to federal cannabis prohibition. Titled “Marijuana Laws in America: Racial Justice and the Need for Reform,” it was the latest indication of just how far Congress has come on cannabis reform after decades of intransigence.     Source: Cannabis law reform

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