Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

TGA to Change Online Listed Medicine Applications Process

The Therapeutic Goods Administration intends to remove the “free text” indication field which is currently available for online Listed Medicine applications. This field enables you to enter the wording you would like for product claims. The only indications that may be included in TGA product listing applications from 1st January 2018, will be from a database of permitted indications and the wording is specified. There will be a 3 year transition period to re-list products using only the permitted indications. From 1st January 2021, listed medicines will only be able to contain permitted indications. There will be no TGA fee for re-listing with permitted indications if sponsors re-list between 1st January 2018 and 30th June 2019. The AUST L number will remain the same.

What needs to be done now?  The TGA proposed permitted indications list is available on the TGA website for comment until 31st October 2017, and sponsors can apply to have new indications included in this list without any TGA fees. After this date, an application fee will apply. If you cannot find the indications for a product that is an existing Listed Medicines on the Australian Register of Therapeutic Goods on the list we suggest you submit your proposed indications to the TGA during the fee-free period, or RFA Regulatory Affairs can assist with applying for the indications to be included in the permitted indications list. Let us know!    Source: RFA Regulatory Affairs – Technical Report

TGA Provides Guidance on Pre-submission Meetings

This guidance is for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications to enter therapeutic goods on the Australian Register of Therapeutic Goods (ARTG); and for TGA Conformity Assessment Certification (for the manufacture of medical devices). It does not apply to applications for a manufacturing licence or Good Manufacturing Practice certification or clearance.    Source: TGA pre-meetings

TGA Provides Guidance on the Regulation of Tampons in Australia

Tampons are therapeutic products which are regulated as 'Other Therapeutic Goods'. Before they can be supplied in Australia, they must be listed on the Australian Register of Therapeutic Goods (ARTG). Tampons supplied in Australia must comply with Therapeutic Goods Order No.82 - Standard for Tampons - Menstrual. This aims to ensure that tampons are manufactured in a manner that will minimise recognised risks to health associated with the use of these products.    Source: Tampons

TGA Changes Ruling on Vitamin A – Beta Carotene Naming

Did you know that a Listed Medicine label can now refer to the retinol equivalents of betacarotene?  They can! The maximum daily dose of 3000 RE/microgram of vitamin A does not apply to this source of vitamin A and the TGA has advised that this is due to the unique action of betacarotene (where it is converted in the body to vitamin A selectively, depending on reserves of vitamin A). In the case of a combination product that contains betacarotene and another source of vitamin A, the dose of the other sources of vitamin A may not exceed 3000 RE/microgram, however the addition of betacarotene does not contribute to this quantity. Currently, in the Permissible ingredients determination 26BB, if vitamin A is declared as an equivalent of betacarotene, then the VITA3 and VIT warnings are required on the product label and the equivalent vitamin A should be expressed in the relevant R.E. units. The TGA have advised that the requirement for the VIT warning will be removed from betacarotene in the October 2017 update to the Permissible Ingredients Determination. As you are not required to declare the vitamin A content of betacarotene, it is also not a requirement to declare its quantity on the label even if it is included on the Australia Register of Therapeutic Goods entry for the product. If you would like your label reviewed or more advice on betacarotene or Vitamin A, get in contact with RFA. This is a significant policy change from the TGA, as previously betacarotene could not be stated in retinol equivalence Source: RFA Regulatory Affairs – Technical Report

TGA Announces Labelling Changes: Information for Health Professionals

The TGA has introduced improvements to help bring Australian medicine labels up to date and align them with international best practice. They will help Australians to make more informed choices about their medicines and to use them more safely.    Source: Label changes

TGA Addresses Issues Related to Supply of Medicinal Cannabis in Australia

The (recent ABC) Lateline story made claims that patients are turning to the black market for medicinal cannabis products because of excessive red tape, principally in seeking approvals under the Special Access Scheme Category B. This scheme has operated for many years and the TGA provides over 20,000 approvals per year for doctors to prescribe a range of unregistered medicines. The TGA claims that the approval system can and does work efficiently to meet the needs of patients so why are prescription levels for medicinal cannabis products relatively low? The Lateline story itself provided the answer. One of the interviewees, Justin Sinclair, stated, 'There is a great paucity of evidence in the literature, at least when it comes to human trials'.    Source: Medicinal cannabis      Editor’s note: See also related stories from TGA Presentations: Legislation and patient access schemes for medicinal cannabis ; &, Medicinal cannabis cultivation and manufacture update

TGA Safety Advisories

Bittermelon Slimming Capsules; Herbal Max Real Slim Capsules; Majestic African Mango capsules: the capsules contain the undeclared substance sibutramine &/or phenolphthalein.

Germany Black Gorilla tablets; Maxidus capsules; Rhino 9 capsules: the tablets contain the undeclared substance sildenafil.  

M Distribution - male herbal supplements: M Distribution, in consultation with the TGA, has initiated a recall of Oh Baby! capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000 mg capsules as they contain tadalafil, dimethylaminoethanol (DMAE or Deanol), &/or sildenafil and dapoxetine.

Source: TGA alerts



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NSW Food Authority Name and Shame Serves Up Nine Years of Food Safety

The NSW Food Authority’s 'Name and Shame' register reaches another important milestone this month, chalking up nine years of operation and more than 11 million views of its webpage. Minister Primary Industries, Niall Blair said more than 7,000 food retail businesses have appeared on the register since its establishment in July 2008. "It’s the list consumers can’t get enough of, but the one no business wants to be on," Mr Blair said. "I am pleased to say the vast majority of food businesses in NSW do the right thing – however those which don’t face the significant sanction of featuring on the well-read register. At its peak in 2009/10, 3.4 per cent of food businesses were placed on the register however that figure has fallen to just 1.6 per cent in the past financial year.    Sources: Name & Shame ; Penalty notices

Egg Producer Penalised $750,000 for Misleading 'Free Range' Claims

The Federal Court has ordered Snowdale Holdings Pty Ltd (Snowdale) to pay penalties totalling  $750,000 for making false or misleading representations that its eggs were ‘free range’, in proceedings brought by the Australian Competition and Consumer Commission. “This is the highest penalty that a Court has ordered in relation to misleading ‘free range’ egg claims. It reflects the seriousness of Snowdale’s conduct and the importance of egg producers being truthful about marketing claims they make,” ACCC Commissioner Mick Keogh said. “Consumers pay a higher price for free range eggs, so when a ‘free range’ claim is made, it’s important that consumers are purchasing eggs laid by chickens in free range conditions.”    SourceBad eggs        Further reading: This case forms part of the ACCC’s broader work in the area of free range claims made by egg producers, which include: $300k penalty for "free range eggs" 1 ; $300k penalty for "free range eggs" 2 ;  $250k penalty for "free range eggs"    (In April 2017, Commonwealth, State and Territory Consumer Affairs Ministers introduced a national information standard under the Australian Consumer Law. The standard requires eggs labelled as ‘free range’ to have been laid by hens with meaningful and regular access to the outdoors and with a maximum outdoor stocking density of 10,000 hens).

Sydney Chicken Processor Falls Foul of Food Safety Laws

A Sydney chicken producer was convicted and fined a total of $34,000 and ordered to pay more than $6,000 in professional costs after he pleaded guilty to twelve charges relating to failures in hygiene, maintenance and Food Safety Program monitoring in the Downing Centre Local Court.    Source: Poultry fine

'Nano Scare': Scientists Blast Friends of the Earth for 'Facile' Infant Formula Claims

Reports that some infant formula products on sale in Australia and New Zealand contain potentially 'dangerous' nanoscale particles have been dismissed by regulators and scientists — with one branding it blatant 'scaremongering'.    Source: Gary Scattergood+ NutraIngredients FoE fail ; FoE Claim

A National Approach to Better Combat Biosecurity Threats

The National Biosecurity Committee (NBC) has endorsed new national biosecurity Research, Development and Extension (RD&E) priorities, giving a more unified, strategic and nationally-consistent focus to biosecurity research. Head of biosecurity policy at the Department of Agriculture and Water Resources, Matthew Koval, said the new priorities would support improved national biosecurity outcomes.    Source: Bio-security

Editor’s note: For information about what can and can’t be sent to Australia go to Travelling or sending goods to Australia.

Further Setback to New Zealand's Natural Health Products Bill as Parliamentary Time Dwindles

New Zealand's long-awaited Natural Health Products Bill is unlikely to be put before parliament before September's election, according to the Ministry of Health.    Source: Gary Scattergood+, NutraIngredients NZ NHP Bill

FSANZ Notices –

Application A1123 – Isomalto-oligosaccharide as a Novel Food: The purpose of the Application is to permit isomalto-oligosaccharide as a novel food for use as an alternative (lower calorie) sweetener and bulk filler in a range of general purpose and special purpose foods    SourceNovel food

A1131 – Aqualysin 1 (Protease) as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus for use as a processing aid in the manufacture of bakery products.    Source: Aqualysin 1

Reforms to the Regulatory Framework for Complementary Medicines

In February 2017 the TGA announced a public consultation, ‘Consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways’. A total of 60 submissions were received. All submissions that gave permission to be published on the TGA website are now available in PDF format.    Source: TGA reforms

Broad Support for New ‘Third Way’ Supplements (Complementary Medicine) Health Claims in Australia: TGA

Australian regulator the Therapeutic Goods Administration (TGA) says there is broad support for plans to introduce a ‘third level’ of health claims for supplements (complementary medicines).    Source: Gary Scattergood+, NutraIngredients TGA 3rd way

Updates to the Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in July 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017. A total of 67 changes have been made in the updated Determination. These changes include the addition of 4 new ingredients; Changes to 55 existing ingredient entries; and, the removal of 8 ingredients that have been determined not to be suitable for inclusion in listed medicines. A complete list of changes to ingredient availability is available here: Permissible ingredients

TGA Announces Electronic Signatures to Replace 'Wet Ink' Signatures

All Licences and Certificates of GMP Compliance issued by the TGA will be signed "electronically" and no longer contain a wet ink signature. This initiative will position industry for a future move to online self-service.    Source: e-Signatures

TGA Safety Advisories –

V8 tablets; & Sirrori Green Viagra Tablets: the tablets contain the undeclared substance sildenafil    Source: V8 tabs ; Sirrori tabs

Jing Pin Heijin Gang Tablets: the tablets contain the undeclared substances sildenafil and paracetamol    Source: Jing tabs

RUFF Natural Formula capsules: the tablets contain the undeclared substances tadalafil, sildenafil and dapoxetine    Source: Ruff tabs

Dishwasher Tablets: Campaign to Eradicate Products that aren't Squeaky Clean

In a move to protect Australia's waterways and wildlife from algal blooms, the environment pressure group DoSomething today launches a campaign to ban phosphates in automatic dishwasher detergents. All manufacturers have removed the chemical from tablets and powders sold in the US and Europe. However, many products have yet to clean up their act by introducing the phosphate-free formula in Australia.    Source: Tim Barlass, SMH Phosphate free

ACCC Statement on Aldi Flushable Wipes

The Australian Competition & Consumer Commission has raised concerns with ALDI regarding its promotion of ALDI Green Action Flushable Bathroom Cleaning Wipes (100pk) in its Special Buys catalogue. The ACCC’s concerns stem from the use of the term ‘flushable’, in particular the concern that such a claim may mislead consumers if the claim cannot be substantiated. The ACCC is already pursuing alleged misleading ‘flushable’ claims more generally, with two proceedings currently before the Federal Court against Pental and Kimberly-Clark Australia Pty Ltd. Part of the ACCC allegations around those two proceedings are the products do not, for example, disintegrate like toilet paper when flushed. The ACCC says Australian water authorities face significant problems when non-suitable products are flushed down the toilet as they contribute to blockages in household and municipal sewerage systems.    Sources: Un-flushable wipes ; Un-flushable wipes 2


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